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ASEAN Common Technical Document (ACTD)
ASEAN Common Technical Document (ACTD)
Introduction
ASEAN Common Technical Dossier (ACTD) is a guideline upon common format for preparation of a well-organized Common Technical Dossier (CTD) applications that will be filed to the ASEAN regulatory agencies for the registration of drugs intended for human consumption.
This guideline outlines a CTD format that, in the future, will make it simpler to prepare electronic document submissions and will greatly cut down on the time and resources needed to put together in registration of applications.
The presentation of data should be transparent and straightforward throughout the ACTD in order to make it easier to evaluate the fundamental information and to aid in a reviewer’s quick orientation to the application’s contents.
Countries of ASEAN
1. Laos
2. Burma (Myanmar)
3. Thailand
4. Singapore
5. Vietnam
6. Cambodia
7. Malaysia
8. Brunei
9. Indonesia
10. Philippines
ACTD Parts
ACTD is organized into four parts:
Part I: Common Administrative data and Product Information.
Section A – Introduction.
Section B – ACTD Table of contents.
Section C – Administrative documents and Product Information
Part II: Quality – All categories of products
Section A- Table of contents
Section B- Quality overall summary
Section C- Body of data
Part III: Non-clinical data – Innovator drug, new chemical entity and biotechnological products
Part IV: Clinical data – Innovator drugs, new chemical entities and biotechnological products
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Each day is a brand-new opportunity for Taj Pharma Taj Pharmaceuticals has established itself as a top generic pharmaceutical company. With a product range that exceeds 4600 compositions across all therapeutic areas, it has successfully won the heart of consumers across the globe. The company is acclaimed as one of the top 10 pharmaceutical firms in India and the world’s leader in generics. Taj Pharma India is a market leader in therapeutic fields like Critaical care, transplantation, virology, and cancer. Taj Pharma’s generics and pharmaceuticals businesses work well together, and our knowledge of the bio-similar generic drugs enable us to create individualized therapeutic strategies and integrated healthcare solutions. The range of healthcare services and products offered by Taj Pharmaceutical includes genetic risk factor screening, disease diagnosis, disease prevention, treatment, and monitoring of the effectiveness of those treatments. Manufacturing of Lyophilized Products Taj Pharmaceuticals has spent the last ten years creating a brand-new category of healthcare organization. Building trust-based, long-lasting partnerships with Taj Pharma stakeholders is a goal shared by the whole Taj Pharma Group. This is clear in several ways. Through the discovery and development of cutting-edge, scientifically sound medications and services that enhance people’s health and general well-being worldwide, […]
Pharmaceutical firm Taj Pharma has announced that it has introduced Covid-19 treatment drug Molnupiravir under brand name “Molnutaj” in India. Molnupiravir is for treatment of adult patients hospitalised with COVID-19, under certain conditions, drug maker said.
Today, Taj Pharma has 4000+ products approved by the FDA to manufacture. We have a highly independent regulatory team ready to assist and ensure the registration of your products of prescription drugs, controlled substances, biological products, medical supplies and food supplements to be available in the global market. Taj Pharmaceuticals been in the business for 30 years from drug manufacturing company, wholesale to distribution and exports that has given us a holistic view of the industry and now have established a good network of partners across the 7,641 agents across the world. Taj Pharma has partnered with more than 1,000 distributors including the leading pharmaceutical company in 42 countries to co-market our products to the top doctors form the most prestigious tertiary hospitals and medical center that prescribes the products we market among many global hospitals. To further advance our network, we are always present in global conventions, WHO submits and our products are also listed in CIIMS – MIMS and the Global Pharmaceutical Directories. To ensure our quality and branding, all our exported products are rigorously tested with our partner local laboratory accredited by FDA / CDSCO / NABL. With global published USP/BP/EP/IHS standards an external COA is issued which […]
TAJ PHARMA (UK) LTD a UK based company and have developed our own Generic branded products for the infection prevention supplies for the medical care industry. Taj Pharma UK Division high-quality products and are working with reputable manufacturers in the industry to build an expanding portfolio of products for personal hygiene. Taj Pharma products can be used in hospitals and care home homes and for personal home use for those with restricted mobility. Taj Pharmaceutical products are retail ready for pharmacies and retail stores.We are now launching our products globally and in search for leading distributors and wholesalers. Taj Pharma UK is base for our OTC, Nutra and retail store non prescription products.During the current pandemic, infection control and protection is at the forefront of every mind. Today we specialise in both generic and branded medicines, improving the lives of patients, whether it is by fighting infections, controlling cholesterol, relieving the symptoms of asthma, or providing lifesaving injectable medicines and pain relief for cancer sufferers. Taj Pharma UK offers generic drugs and we are on e of the largest Generics medicine manufacturers in UK. What We Do Taj Pharma UK is a leading global supplier of generic medicines, branded medicines […]
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Taj Pharmaceuticals β-lactam division is certified for cGMP and are exporting to several countries overseas. Taj Pharma looks forward for business potential for Domestic and Exports market for product as below: Bactram( β-lactam Products) — Taj Pharmaceuticals Limited. Taj Pharma India manufacture products in our state-of-the-art dedicated manufacturing facility. Taj Pharma has gained advantages on cost competitiveness, making us your ideal sourcing partner.
{Taj Pharmaceuticals Limited} : Top Mumbai [generic] manufacturing company What Are Authorized Generics? Authorized generics might just be the answer for drug manufacturers whose patents for their branded drugs have expired. Instead of risking the loss of market share when other drug companies enter the generics marketplace, the brand name manufacturers could develop their own generics. An authorized generic is exactly the same product as an approved branded drug, but is marketed without the brand name on the label. Usually sold at a lower price, it can be marketed by a branded drug company or by another company with the brand company’s permission. “By making an authorized generic, a brand manufacturer gets a jump start on the competition as generics start to appear,” says Karen Berger, PharmD, a staff pharmacist at Plymouth Park Pharmacy in Fair Lawn, NJ. “Authorized generics, which are identical to the brand, should not be confused with a branded generic that has gone through the abbreviated new drug application (ANDA) process and is assigned a name other than its chemical name,” she says. Leaving nothing to chance: “While a separate NDA is not required for marketing an authorized generic, FDA requires that the NDA holder notify the […]
{Depression: Let’s talk} says WHO, as depression tops list of causes of ill health Depression is the leading cause of ill health and disability worldwide. According to the latest estimates from WHO, more than 300 million people are now living with depression, an increase of more than 18% between 2005 and 2015. Lack of support for people with mental disorders, coupled with a fear of stigma, prevent many from accessing the treatment they need to live healthy, productive lives. The new estimates have been released in the lead-up to World Health Day on 7 April, the high point in WHO’s year-long campaign “Depression: let’s talk”. The overall goal of the campaign is that more people with depression, everywhere in the world, both seek and get help. Said WHO Director-General, Dr Margaret Chan: “These new figures are a wake-up call for all countries to re-think their approaches to mental health and to treat it with the urgency that it deserves.” One of the first steps is to address issues around prejudice and discrimination. “The continuing stigma associated with mental illness was the reason why we decided to name our campaign Depression: let’s talk,” said Dr Shekhar Saxena, Director of the Department […]
New evidence supports inverse association between cancer and Alzheimer Among patients with a history of cancer, risk of Alzheimer disease (AD) might be lower: a study published in JAMA Network Open showed that elderly cancer patients had modestly higher memory function and slower memory decline both before and after their diagnosis compared with similarly aged individuals who remained cancer free. This result suggests that the risk of cancer may be lower among patients with AD, and that cancer survivors may have a lower risk of developing AD than people who did not develop any tumour. The inverse association between cancer and AD or other neurodegenerative diseases has been already described extensively in the literature, however evidence remains scarce on the long-term cognitive trajectories, as Monica Ospina-Romero, MD, from the department of epidemiology and biostatistics at University of California, San Francisco, and colleagues wrote. To compare long-term memory trajectories before and after cancer with those memory trajectories of individuals cancer free, researchers conducted a population-based cohort study which included over 14.500 U.S. adults from the Health and Retirement Study. Biennially, they assessed participants from 1998 to 2014 to determine composite memory score and compare the rates of memory change. Of 14,583 participants included […]
India is home to highest number of drug-resistant TB patients Administering anti-malarial drug Chloroquine (CQ) with anti-TB drugs can reduce the tolerance of the TB bacteria, mycobacterium tuberculosis (Mtb), towards it. That, in turn, can help fight drug-resistant TB, according to a new research whose findings were published in Science Translational Medicine, a journal of American Association for the Advancement of Science. The first-of-its-kind research was conducted on mice by scientists from the Indian Institute of Science in collaboration with the National Centre for Biological Science and Foundation for Neglected Disease Research. If it translates into positive results for clinical trials on humans, it will be an important milestone for India. The country has the most number of TB and drug-resistant TB cases, according to the Global TB report 2019. India contributed to as many as 27 per cent of the world’s drug-resistant TB cases, followed by China (14 per cent). That means India harbours 130,000 drug-resistant TB cases. A challenge in TB treatment is that it takes six months or more as the bacteria persists in the body for long and strongly fights the drug. The drug thus takes long to kill the bacteria. The duration gives the bacteria enough time […]
Reports suggest such is the medicine residue in water bodies that fish is changing character; oral contraceptive residue makes them ‘feminised’ Imagine this pollutant: It treats illness, but when it escapes into the environment it remains there; unregulated, it keeps affecting millions, making them further ill. Many of them end up with damaged organs. It not only impacts unsuspecting humans, but also other living beings. To sum up, the new pollutant is an agent of mass health disruption — it is the residue of our medicines, or pharmaceuticals, left unregulated and untreated. A new study by the Organisation for Economic cooperation and Development (OECD) has found that a “vast majority” of the 2,000-odd active ingredients in use in human and veterinary medicines are not regulated. They have not been yet evaluated for their risks once they escape to the environment. Every year more and more such active ingredients are approved for use. Thus, it adds to the pile of such unregulated residues in the environment. Residue of medicines enters into our environment — water bodies, streams, air and food — at all the stages of medicine preparation starting from manufacturing, uses and disposal. But the biggest source of it is the natural process of medicine absorption by […]
Down To Earth talks to doctors to get a sense of the ailments that residents of NCR are exposed to It has been more than a week of breathing heavily polluted air for Delhiites. It is safe to say that for more than 150 hours they breathed a toxic cocktail, with the air quality ‘severe’ or ‘severe +’ since October 30. Particulate matters (PM) 2.5 and 10 remained at least five times more their safe standards. These ultrafine particles can enter the respiratory system and reach the bloodstream. On an average, a person breathes 25,000 times a day. For those living in Delhi and the National Capital Territory (NCT) regions, this means breathing toxic air 25,000 times a day. Toxins once deposited in lungs cannot be cleansed. What does such continued exposure to ultrafine PM does to our bodies? According to doctors, such continued inhalation of toxic gases affects all organs and not just lungs. It even has the potential to cause hormonal imbalances. Being in such an environment full of pollutants constantly also affects the central nervous system of the brain. “Impairment in concentration abilities has been seen. There can be other short-term disturbances to what you normally do,” Prashant Saxena, who heads the department of Pulmonology […]
Warming catalyses antimicrobial resistance Warmer climatic conditions are giving rise to infectious diseases like malaria, dengue, gastroenteritis, wound infections, septicaemia and cholera, caused by Vibrio bacteria, warned the Lancet Countdown Report 2019 on Health and Climate Change. The annual update was on 42 indicators across five topics: Climate change impacts, exposures, and vulnerabilityAdaptation, planning, and resilience for healthMitigation actions and health co-benefitsEconomics and financePublic and political engagement The report identified the prevalence of infectious diseases due to climate change among the climate change indicators. As an example of how warmer conditions affect health, it cited how the number of days for the Vibrio bacteria to reproduce and spread has doubled since 1980. Also, increased sea-surface temperature increased the risk of Vibrio cholerae infections, Rachael Davies, communications consultant with Lancet told Down To Earth. The climactic conditions also favoured the quick spreading of other pathogens, Davies added. The report released November 13, 2019, warned that 2018 was second on record for suitable conditions for the transmission of diarrhoeal disease and wound infections from Vibrio (since 2000). Children were more susceptible to diseases such as diarrhoea and dengue. Warmer climate also acted as a catalyst in spreading antimicrobial-resistance (AMR). It has already emerged in […]
More than a sixth of suicides in India in 2016 due to health reasons More than a sixth of suicides in India were due to ‘illness’, according to data recently released by the National Crime Records Bureau. Mental health issues could have played a large role in this, the data indicated. The need to prevent suicides has drawn little attention in the country though they outstrip the combined toll of AIDS and maternal death. Reducing the count by a third by 2030 is among the United Nations-mandated Sustainable Development Goal. In 2016, ‘insanity’ or mental illness, cancer, paralysis and sexually transmitted diseases such as AIDS were among the major health issues that pushed people to take their lives. Alarmingly, 932 in the category were not yet adults. Cause Below 18 years 18 – Below 30 years 30 yrs. – Below 45 years 45 yrs. – Below 60 years 60 years & above Illness (total) 932 5297 6737 5611 3834 AIDS/STD 4 42 97 35 20 Cancer 5 110 246 320 194 Paralysis 14 117 209 245 157 Insanity/ mental illness 411 2329 2733 1987 1167 An estimated 150 million Indians live with mental health disorders; only one in 10 get necessary treatment. […]
Preschool children who had taken 2 or more antibiotic courses for acute respiratory tract infections in the preceding year had around a 30% greater chance of not responding to subsequent treatment GPs in the UK carry out over 300 million patient consultations every year and at least a quarter of these deal with children. Almost two-thirds of such appointments are for coughs, sore throats, or earaches — illnesses that young children commonly get. Doctors and nurses group these types of illnesses as “acute respiratory tract infections”. They are considered to be “self-limiting”, meaning that antibiotics have little or no benefit and that the illness will go away in time. Yet, in at least 30 per cent of these consultations, antibiotics are prescribed. That’s an estimated 13 million unnecessary antibiotic prescriptions. This is not only wasteful but may also have unintended consequences for the child’s health. Indeed, in our new study of over 250,000 children in the UK, we found that preschool children who had taken two or more antibiotic courses for acute respiratory tract infections in the preceding year had around a 30 per cent greater chance of not responding to subsequent treatment (including the need for hospital referral and admission) compared […]
Big Pharma Bets on Body’s Garbage-Disposal System to Beat Cancer New drugs called “degraders” could take disease-causing proteins out with the trash. Craig Crews pioneered protein degrader drug technology. At their most basic level, many of the deadliest diseases are caused by nests of misguided proteins. Most medicines work by attaching themselves to these proteins and temporarily shutting them down. In the 1990s, Yale University scientist Craig Crews and a colleague had a radical idea: What if a drug could destroy a bad protein by making it a target of the body’s own molecular trash disposal machines? For years, the idea remained a lab curiosity. Biotech investors wouldn’t initially back a company based on the concept, which Crews and a few other academics labored to prove could be a practical way to make drugs. The field got a big boost earlier this decade when scientists started discovering that some of the most successful medicines turned out to work by piggybacking onto these human trash collectors. Now it’s become one of the hottest new technologies for making pills. Crews and a biotech he founded, Arvinas Inc., are racing some of the world’s biggest pharmaceutical and biotech companies—Novartis, Amgen, and Gilead Sciences—to […]
An angiogram is an X-ray of the blood vessels. They can provide images of the blood vessels in many different organs. As a result, they often help doctors diagnose conditions affecting the heart, brain, arms, or legs. Angiograms can help doctors detect blood vessel abnormalities, including weakened blood vessels, plaque deposits, and blood clots. This articles discusses why doctors use angiograms, how they perform them, and the risks and side effects associated with the procedure. It also provides tips for people recovering from an angiogram. What is an angiogram? The term “angiogram” refers to a number of diagnostic tests that doctors can use to identify blocked or narrow blood vessels. Angiograms also help doctors diagnose a range of cardiovascular diseases, including coronary atherosclerosis, vascular stenosis, and aneurysms. To perform a traditional angiogram, a doctor inserts a long, narrow tube called a catheter into an artery located in the arm, upper thigh, or groin. They will inject contrast dye into the catheter and take X-rays of the blood vessels. The contrast dye makes blood vessels more visible on X-ray images. Not all angiograms involve X-ray machines, however. Doctors can also perform angiograms using CT scans and MRI scans. A doctor may […]
A study compared the prices of drug compounds across the world and found that only Thailand, Kenya, Malaysia and Indonesia are cheaper than India. Indians have to pay 70 per cent less than the rest of the world to buy medicines, a study has revealed. According to Medbelle, the London- and Berlin-based digital healthcare provider, India is among the five cheapest countries in the world for medicines, with prices that are 73.82 per cent less than the global median. Thailand tops the list, with 93 per cent lower prices than the global median for both branded and generic drugs, closely followed by Kenya, Malaysia and Indonesia. Methodology The study is based on a comparative index across 50 countries, which reveals the cost differences for some of the world’s most widely-used medicines, such as erectile dysfunction drug Viagra, high cholesterol drug Lipitor, common antibiotic Zithromax and insulin Lantus. Medbelle selected 13 popularly used pharmaceutical compounds and made “a comparison on a pound-for-pound basis of how much medicines cost in different countries, regardless of whether covered by a healthcare system, or paid directly from the individual’s pocket”. “The medications chosen for comparison span a variety of common conditions; from heart disease and asthma, […]
Compliance and Competitiveness in Indian Pharmaceuticals Industry: by Ms. Priyanka Singh Director Taj Pharma Group The word “compliance” in India took on a whole new meaning in 2012 when key Indian Pharma Products exports pushed to USA and European Markets without much apprehensions. In the sophisticated Indian pharmaceutical market, some local firms are increasingly looking to export not only to the Africa, Russia but other highly European regulated markets like the One such firm is Taj Pharma Group, a Mumbai based Generics Medicines exporter and Manufacturer. Compliance and Competitiveness in Indian Pharmaceuticals Industry: by Ms. Priyanka Singh Director Taj Pharma Group The word “compliance” in India took on a whole new meaning in 2012 when key Indian Pharma Products exports pushed to USA and European Markets without much apprehensions. That new status, known as the “Generalised System” of Preferences plus is linked to the implementation of 27 international conventions including labor rights, sustainable development, and good governance. In the sophisticated Indian pharmaceutical market, some local firms are increasingly looking to export not only to the Africa, Russia but other highly European regulated markets like the One such firm is Taj Pharma Group, a Mumbai based Generics Medicines exporter and Manufacturer. […]
You should check the registration number of the online pharmacy and cross-check it at the website of the regulatory body. The names of fake online drug stores will be blacklisted by the regulatory body. You should check whether an online pharmacy asks for a prescription before dispatching your medicines.
Though bound by law, neither doctors nor pharmacies want to dispense generic medicines to patients as the profit margin is low Laws in India specify that all medical prescriptions should give generic medicines and all pharmacies must make them available to patients. “Most cancer medicines still remain unaffordable to most Indians because there is no curb on profiteering by pharma manufacturers”. But aggressive marketing by private pharma companies, cut-throat competition and ignorance of the customers coupled with weak enforcement of rules allow private manufactures of branded medicines to make a killing through your “friendly pharmacy”. About 85% of total health expenditure in India is financed by household out-of-pocket expenditure (according to government figures) and medicines constitute 20% to 60% of total healthcare expenditure. Understanding the strain medical expenditure has on the common man, the central government has been working on “aggressive” marketing of generic drugs by opening pharmacies that sell these medicines, and asking pharmacies to display availability of these medicines. Missing display Sadly almost no pharmacy in the Capital seems to be in the mood to cooperate with the government in advertising the availability of generic drugs. “We provide what doctor has prescribed” is the common refrain. But just […]
It might be difficult to implement compulsory prescription of generics The enforcement by the drug regulator will not be easy given the shortage of drug inspectors – {Taj Pharmaceuticals Generic Drug Division} Prime Minister Narendra Modi wants to defeat the doctor-pharmaceutical company nexus and make medicines affordable by making it compulsory to prescribe drugs in the generic name. But, the good intentions may not give the desired results. The enforcement will not be easy given the shortage of drug inspectors. At an industry event at Surat last month, Modi announced plans for a new law to make generic prescriptions mandatory. Parallelly the government is already initiating steps to push for generic prescriptions. In a recent communication to all the states, the Centre has asked states to make sure all physicians write generic names of drugs in a legible manner. Business Standard has reviewed the letter. The government has issued a draft amendment which will make it mandatory for companies to print generic names of the drug in a bolder font than the brand name on the packaging. But, the government will face a difficult task in enforcing its decisions. Food and Drug Administration offices across the country are short staffed. […]
Read more on what is lung cancer here. Etoposide is the chemotherapy drug and is classified as a plant alkaloid (Epipodophyllotoxin) and a topoisomerase II inhibitor. Plant alkaloids are substances that are made from plants. Etoposide is available under the trade name VP-16 or Toposar. The drug acts by inhibiting topoisomerase II, thereby inhibiting DNA synthesis. Availability, Dosage and Administration of Etoposide Etoposide is available in tablet form and can be taken orally. It is also available in injectable form and can be administered as an infusion into the patient’s vein, it can be a short infusion or can be an infusion that lasts for over 24 hours. Availability In the oral form it is available as capsule with the dose strength of 50mg and in the injectable form it is available as 20mg/ml. Uses Small cell lung cancerNon-small cell lung cancerGerm cell tumorsNon-Hodgkin’s LymphomaStomach cancerAs a high dose therapy in the setting of transplantation. Dosage The recommended dose depends on the indication or use. It is generally given at 100 to 120 mg/m2, for 1 to 3 days, every 3 weeks. Side effects Most people do not experience side effects while being treated with etoposide. Even if side effects […]
Are you up to date on recent developments in cystic fibrosis (CF) care? Thanks to advancements in medical science, the outlook for people with CF has improved a lot in recent decades. Scientists continue to develop new drugs and strategies to improve the lives of people with CF. Let’s take a look at some of the latest developments. Updated guidelines to improve personalized care In 2017, experts from the Cystic Fibrosis Foundation released updated guidelines for diagnosing and classifying CF. These guidelines might help doctors recommend more personalized approaches to treating CF. Over the past decade, scientists have developed a better understanding of the genetic mutations that can cause CF. Researchers have also developed new drugs to treat people with certain types of genetic mutations. The new guidelines for diagnosing CF might help doctors determine who is most likely to benefit from certain treatments, based on their specific genes. New drugs to treat the underlying cause of symptoms CFTR modulators can benefit some people with CF, depending on their age and the specific types of genetic mutations they have. These drugs are designed to correct certain defects in CFTR proteins that cause symptoms of CF. While other types of medication […]
The higher price of new cancer drugs is rarely justified Most cancer drugs introduced since 2004 provide low added value compared to previously approved medications, but have much higher prices, according to a French study presented at the congress of the European Society for Medical Oncology (ESMO 2019) currently underway in Barcelona. Taj Oncology «Most of the new cancer drugs had low added value, so doctors and patients shouldn’t assume that just because a drug is new, it’s going to be better» said Marc Rodwin, Suffolk University, Boston (USA), co-author of the study. Researchers calculated the correlation between prices and value of medications for solid tumors registered by the European Medicines Agency (EMA) from 2004 to 2017. They found that 48% of drugs had low added value on the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) and 70% scored equally low on the and Added Therapeutic Benefit Ranking (ASMR). Overall, new drugs were in average 2,500 euro more expensive than their older counterpart, but this price increase price did not correlate with added value. A second study analysed 63 new drugs for adult solid (46) and hematologic (17) cancers approved by the US Food and Drug Administration from 2009-2017 and approved […]
The first biosimilar in India was approved in 2000, and, with the help of legislation and regulation from the Indian Government, the market has continued to grow since, reaching a value of $2.2bn in 2017. However, biosimilars remain challenging to manufacture for Indian pharmaceutical companies, at the emerging end of the market. India has firmly established itself in the global pharmaceutical market; it has been predicted that India will be the sixth largest market for pharmaceuticals by 2020, and the country exported pharmaceutical products worth more than $17bn in 2017-8. Indian pharmaceutical companies are especially known for producing generics, identical copies of branded drugs marketed under different names once the patent for the original drug has run out. Many of these companies are starting to move into the global biosimilars market. According to Associated Chambers of Commerce of India’s 2017 report, biosimilars are worth $2.2bn out of the $32bn total Indian pharmaceutical market and are expected to reach $40bn by 2030, which represents a 30% compound annual growth rate. This growth will be aided by a range of biologic patents expiring in the next few years. Biosimiliars are medicines that are highly similar and clinically equivalent to complex, biologic medicines […]
Biosimilars have the same clinical effect as a generic but are only as similar to the original branded drug as validation technologies can confirm. When a drug company introduces a costly new drug, they can do so because they have an exclusive patent on it. Once drug patents expire, pharmaceutical companies can copy that branded drug, and sell it for significantly less as a generic. The Hatch-Waxman Act of 1984 — designed to reduce the cost of patient therapies— allowed drug companies to produce generics of off-patent drugs. There are analytical methods to prove that generics are chemically identical to the original branded drug. The cost to the manufacturer and the consumer is much lower because the approval pathway is much shorter than branded drugs. With the make-up of the drug already approved, generics do not require the added time and cost of research and development. When pharma processors move to proteins like monoclonal antibodies however, certain sugar molecules exist on the outside surface of the protein. There is a lot of variety in how these molecules are positioned and the analytical methodologies that exist today are limited in the degree to which they can confirm absolute identity of all […]
Diabetes drug price to halve as patent expires; cheaper versions expected soon Diabetes drug price: Companies are talking of a significant price cut. Intas Pharmaceuticals, according to a senior official in the company, will hit the market today with two versions Diabetes drug price: There are currently four brands in the Indian market today There is good news for diabetic patients in India. The patent for Vildagliptin, a leading drug to treat diabetes has expired, opening doors for several companies to launch generic versions. Going by the fatigue doctors experience sending away medical representatives who pitch for their version of the drug at prices less than half of what is currently in the market, it is apparent that there are many rushing in. “As Indian pharma companies get ready to launch the branded generic version of Vildagliptin, we might see over 50 new brands launched over the next few days in the Rs 800 core Vildagliptin market in India (in terms of annual sales),” says Hari Natarajan, who has tracked Indian pharma retail sales for years and is the founder and managing director of Pronto Consult, an independent consulting company specialising in doctor perception studies and market Insights in India […]
Biosimilar drugs are often confused with generic drugs. Both are marketed as cheaper versions of costly name-brand drugs and are designed to have the same clinical effect as their pricier counterparts. But biosimilar drugs and generic drugs are very different. Biosimilar drugs are often confused with generic drugs. Both are marketed as cheaper versions of costly name-brand drugs. Both are available when drug companies’ exclusive patents on expensive new drugs expire. And both are designed to have the same clinical effect as their pricier counterparts. But biosimilar drugs and generic drugs are very different, mainly because while generic drugs are identical to the original in chemical composition, biosimilar drugs are “highly similar,” but close enough in duplication to accomplish the same therapeutic and clinical result. Another key difference is that generics are copies of synthetic drugs, while biosimilars are modeled after drugs that use living organisms as important ingredients. But many experts hope the two will share a critical commonality and that, like generics, biosimilars will dramatically lower the cost of biologic drugs. “ Branded drugs are either synthetic, meaning they’re made from a chemical process, or biological, meaning they’re made from living sources. Synthetic branded drugs can be exactly […]
Carcinogens Have Infiltrated the Generic Drug Supply – {Taj Pharmaceuticals} Valsartan Tablets are free of all Impurities. An FDA quality-control nightmare reveals how impurities end up in blood pressure pills. Valsartan The chemical N-Nitrosodimethylamine, or NDMA, is a yellow liquid that dissolves in water. It doesn’t have an odor or much of a taste. It’s known to cause cancer in animals and is classified as a probable carcinogen in humans—it’s most toxic to the liver. A single dose of less than a milligram can mutate mice cells and stimulate tumors, and 2 grams can kill a person in days. An Oklahoma man poisoned the family of an ex-girlfriend in 1978 by pouring a small vial of NDMA into a pitcher of lemonade. In 2018 a graduate student in Canada sickened a colleague by injecting the chemical into his apple pie. NDMA no longer has industrial uses—it was once added to rocket fuel—but it can form during industrial processes at tanneries and foundries as well as at pesticide, dye, and tire makers. It can be found in drinking water disinfected with chloramine. It’s in tobacco smoke, which is one reason secondhand smoke is dangerous, and it’s what makes eating a lot […]
Cancer treatment cost pushes 6 crore Indians below poverty line every year Cancer treatment While 16 lakh new cancer cases are diagnosed every year, the annual mortality is eight lakh. The current health infrastructure is grossly inadequate to handle the growing problem of cancer, a parliamentary report says Six crore Indian citizens are pushed below the poverty line every year because of treatment costs associated with cancer in their families, a parliamentary panel report suggests. While 16 lakh new cancer cases are diagnosed every year, the annual mortality is eight lakh. The current health infrastructure is grossly inadequate to handle the growing problem of cancer, the report says. The 325th report of the Parliamentary Standing Committee on Science and Technology, Environment, Forests and Climate Change, which looked into the expanded role of the department of atomic energy in cancer treatment in India through an enlarged network of the Tata Memorial Centre (TMC), pointed out that in the absence of availability of adequate facilities in their own region/states, a majority of cancer patients travel to far-off locations, sometimes thousands of kilometres, for their treatment. “The Committee would like to lay emphasis on the fact that mortality to incidence ratio of 0.68 […]
New research in mice shows “for the first time” that scientists can use protons to administer radiation therapy in a matter of milliseconds, killing cancer cells while protecting healthy tissue. Over half of the people with a cancer diagnosis receive radiation therapy. Radiation damages the DNA of cancer cells, either slowing their progression or killing them. However, this is a slow process; radiation does not destroy cancer cells right away — sometimes it takes weeks of treatment to damage the DNA of the cells enough to kill them. A further reason why radiation treatment can take several weeks is that the therapy is most likely to succeed when cancer cells are growing and dividing into new cells. So, spreading the treatment over a long period increases the chances that the radiation will target cancer cells when they are in a growing phase. Finally, administering radiation in small, daily doses helps protect healthy cells by giving them more time to repair. But new research suggests that there may be a way to administer radiation at record speed while also protecting healthy tissue. The innovative technique is called FLASH, or ultra-high dose rate radiotherapy, and according to previous research, it uses electrons […]
Eating chilies cuts risk of death from heart attack and stroke, Research Says {Taj Pharmaceuticals} That delicious penne all’arrabiata may have benefits that go further than putting a smile on your face, according to a new study. For many years, chili has been hailed for its therapeutic properties, and now researchers have found that eating chili peppers regularly can cut the risk of death from heart disease and stroke. Carried out in Italy, where chili is a common ingredient, the study compared the risk of death among 23,000 people, some of whom ate chili and some of whom didn’t. Participants’ health status and eating habits were monitored over eight years, and researchers found that the risk of dying from a heart attack was 40% lower among those eating chili peppers at least four times per week. Death from stroke was more than halved, according to results published Monday in the Journal of the American College of Cardiology. “An interesting fact is that protection from mortality risk was independent of the type of diet people followed,” said study lead author Marialaura Bonaccio, an epidemiologist at the Mediterranean Neurological Institute (Neuromed). “In other words, someone can follow the healthy Mediterranean diet, someone […]
Ranitidine is a commonly prescribed medicine for countering acidity and is on the WHO’s Model List of Essential Medicines. Our drug Ranitidine Tablets are safe: Taj Pharmaceuticals Amid a raging controversy over commonly used heartburn drug Ranitidine, Mumbai-based Taj Pharmaceuticals Limited today said that its formulation drug is safe. The company said that the test results found that Taj Pharmaceuticals’ Ranitidine tablets was within the “acceptable limits” for the presence of a probable cancer causing substance. On 29th September 2019 US FDA had raised a global alarm over the presence of a probable cancer causing substance—NDMA or N-Niteosodimethylamine—in some Ranitidine medicines. The company is likely to continue Ranitidine drug sale, following the report. “The Company intends to provide additional updates in the next coming days, including potential recommencement,” it said in a statement. Taj Pharma Ranitidine Free of ALL NDMA / NDEA Impurities NDMA Risk Assessment Report is done in much more advanced for all potential APIs (Valsartan) on our ROS of Ranitidine Hydrochloride and analyzed few batches for NDMA content in Ranitidine HCL API by validated LC-MS/MS and GC-MS methods. As per our initial investigation and assessment report, it is found that the formation of NDMA in ROS of our […]
What is Prostate cancer screening test? A large new trial is testing whether MRI scans could be an effective way to screen men for prostate cancer, in a similar way to mammograms offered to women to check for breast cancer. In this article for the BBC, leading expert Prof Mark Emberton explains why finding a suitable screening method for this common male cancer is vital but has proved difficult so far. “Prostate cancer is the most common form of cancer in men, with around 130 new cases diagnosed in the UK every day and more than 10,000 men a year dying from the disease. “Unfortunately, the way we currently spot the disease is not very precise. “Traditionally, we have used a blood test looking for raised levels of prostate-specific antigen (PSA) and then carried out a biopsy which means taking some tissue from the prostate gland to examine under the microscope. “But PSA levels are not a reliable indicator of prostate cancer – about 75% of men who get a positive result are not found to have cancer, while it misses the cancer in about 15% of men with prostate cancer. “So we currently diagnose cancers that are harmless, leading […]
FDA Approves First Generic of Popular Blood Thinner The first generic versions of the powerful blood thinner Eliquis (apixaban) were approved by the U.S. Food and Drug Administration on Monday. Heparin Sodium Injection – Taj Pharmaceuticals “Today’s approvals of the first generics of apixaban are an example of how the FDA’s generic drug program improves access to lower-cost, safe and high-quality medicines,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in an agency news release. “These approvals mark the first generic approvals of a direct oral anticoagulant,” Woodcock noted. “Direct oral anticoagulants [blood thinners] do not require repeated blood testing.” The two types of generic tablets were approved to reduce the risk of stroke and systemic clotting in the lungs of patients with non-valvular atrial fibrillation and for the prevention of deep vein thrombosis (DVT), which may lead to pulmonary embolism (lung clots), in patients who have had hip or knee replacement surgery. Atrial fibrillation is a heart rhythm disorder that raises the risk of blood clots. It is estimated that between almost 3 and 6 million Americans have atrial fibrillation, according to the U.S. Centers for Disease Control and Prevention. Many of these […]
{Taj Pharmaceuticals} Stomach cancer symptoms, diagnosis and treatment: STOMACH cancer is one of the most common types of cancer and one of the top causes of cancer deaths worldwide. Survival rates for the deadly disease stand at just 14 percent. With these worrying statistics its imperative for one to spot the early signs of stomach cancer, and feeling a certain burning sensation could mean you’re at risk. Stomach cancer is characterised by a growth of cancerous cells within the lining of the stomach. Also known as gastric cancer, it’s a type of cancer that is difficult to diagnose. The National Cancer Institute (NCI) estimates there’ll be approximately 28,000 new cases of stomach cancer in 2017. Since stomach cancer usually doesn’t cause any early symptoms, it often goes undiagnosed until after it spreads to other parts of the body. Feeling an acid reflux that persists and a burning sensation could signal the deadly disease. Stomach cancer is directly linked to tumours in the stomach. Risk factors for the disease include a group of blood cancers, a common stomach infection that can sometimes lead to ulcers, tumours in other parts of the digestive system or abnormal growths of tissue that form on […]
{Taj Pharmaceuticals} Finding a cure for hepatitis B: The NIH announced a plan to “intensify” ongoing hepatitis B virus research that is focused on finding a cure and improving screening and treatment for the infection. For nearly 40 years, there has been an effective vaccine to prevent HBV, but the virus still causes an increasing number of illnesses and deaths worldwide each year. Focusing on three critical research areas, the Strategic Plan for Trans-NIH Research to Cure Hepatitis B aims to address the global public health challenge that HBV presents. Healio spoke with National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD, about the plan, the “crucial” role that clinicians play, and how close the world is to a cure for HBV. – by Marley Ghizzone Q: What was the impetus for the plan? A: Hepatitis B is a prevalent and serious disease. The global disease burden is approximately 257 million chronic infections worldwide — 850,000 to 2.2 million in the United States — and approximately 900,000 deaths per year, with those numbers increasing. There are new scientific opportunities to pursue due to the identification of a cell receptor for HBV, more advanced cell culture systems and […]
Schedule daily ‘me’ time and start practicing mindfulness, says Hong Kong-based life coach Steffi Lopez Gonzalez As 2020 looms on the horizon, many people see it as an opportunity to better themselves and start working on new projects and goals through New Year’s resolutions. Often, our resolutions revolve around things like getting fit, getting better grades or spending less money. Mental health often takes a back seat, despite the fact that it affects our emotional, physical and social well-being. With the help of certified NLP Life Coach and speaker Steffi Lopez Gonzalez, who runs the Hong Kong-based Your Life Your Playground, which focuses on yoga, meditation and life coaching, we’ve assembled a list of New Year’s resolutions you can make to improve your mental health in the new year. The quest for perfection can lead to depression – don’t let it take over Take one day a week off social media “Social media has addictive qualities,” says Lopez Gonzalez. “It’s easy to become obsessed with the rewards of ‘likes’ or ‘retweets’ and get caught up in chasing the approval of others instead of being involved and interested in your own life and the lives of those around you.” Not only can […]
Indian pharmaceutical market update Generic affordable alternatives are much more easily available India With around 1.3 billion residents, India is home to just a fraction fewer people than China, the world’s most populous nation. India is also developing fast, consistently posting annual gross domestic product (GDP) growth rates in the mid-to-high single digits since the turn of the millenium, and outpacing all other nations in 2018 with growth of 7.3%. The country’s GDP is now roughly equivalent to that of the UK in nominal terms. Adjusting for purchasing power differences it is the third largest, behind the USA and China. Despite these impressive figures, hundreds of millions of people live in poverty. India remains a developing nation, with a healthcare system to match. At around $30 billion, the country’s pharmaceutical market generates revenues roughly equivalent to those of the newly-enlarged Japanese drugmaker Takeda Pharmaceutical (TYO: 4502). The market for pharmaceutical products does not, therefore, move the needle for global drugmakers, but as it continues to grow in line with wider economic development, new opportunities will continue to emerge. “By 2020, the value of pharma products sold in the country is is expected to reach $55 billion.” By 2020, the value […]
FDA approves new generic valsartan to make up for drug shortage Generic valsartan Taj Pharmaceuticals (CNN)- The US Food and Drug Administration approved a new generic of valsartan on Tuesday to help relieve the recent shortage of the medicine, which is used to treat high blood pressure. Since last summer, the FDA has issued multiple recalls of generic valsartan medications from several manufacturers after discovering that certain lots contained nitrosamine impurities that pose a cancer risk to patients. The FDA discovered impurities in only the generic, not brand-name, valsartan, which is a form of angiotensin II receptor blockers, or ARBs. Common heart drug recalled in 22 countries for possible cancer Following the initial recall, the FDA found that other types of generic ARBs, those containing either losartan or irbesartan as the active ingredient, had also been tainted with impurities. “We know that the ongoing recalls to prevent certain lots of valsartan that contain unacceptable limits of impurities from reaching patients has resulted in a shortage of these important medicines,” FDA Commissioner Dr. Scott Gottlieb said in a statement Tuesday. The FDA prioritized review of the newly approved generic version of this medicine to address this shortage, he said.Sometimes one company’s […]
FDA Allows for a New Generic Valsartan Approval comes in response to ARB shortage The FDA approved a new generic for valsartan tablets after a priority review, according to an agency announcement. This valsartan product is made by Indian company. Approval comes in the middle of a valsartan shortage stemming from multiple rounds of recalls of the angiotensin receptor blocker (ARB). Products were taken off the shelves starting last year in response to findings of potentially carcinogenic impurities, including N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), in numerous lots of generics. “So to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “For this approval, the FDA evaluated the company’s manufacturing processes and also made sure they used appropriate testing methods to demonstrate that the valsartan product approved today does not contain NDMA or NDEA,” the statement continued. “The FDA’s assessment of the manufacturing processes for the product determined that there is no known risk for the formation of other nitrosamine impurities.” “We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to […]
Solving the ‘parking’ problem in the drug monopoly game Drug prices are too high. One reason is that brand-name drug firms delay generic entry. Another is that generic companies themselves delay entering the market. And they delay not only their entry but those of other generics as well. Congress is considering addressing this “parking” of generic exclusivity. One proposal, the BLOCKING Act of 2019, would not solve the problem. Another, the recently-introduced Expanding Access to Low-Cost Generics Act, would. The BLOCKING Act has received significant attention. Supported by the White House and included in legislation approved overwhelmingly by the Senate HELP Committee and House Energy & Commerce Committee, the Act provides that a generic that does not quickly enough receive FDA approval will lose exclusivity. It promises to address the “parking” of exclusivity. But it would not. Why? Because there’s no guarantee, a later generic will enter the market just because the first filer has lost exclusivity. These later generics might not be ready to launch or might be unwilling to challenge the first filer’s patents or launch “at-risk” (before a court decision). In addition to the BLOCKING Act not introducing competition, the first filer could lose exclusivity through no […]
{Taj Pharmaceuticals} Manufacturing Drug that prevents half of [Breast cancers growth]: A drug that halves a woman’s risk of breast cancer continues to work long after they stop taking it, say researchers. Anastrozole blocks the production of the hormone oestrogen, which fuels the growth of many breast cancers. It is already available on the NHS, but researchers at Queen Mary University of London said only a tenth of eligible women were receiving it. Cancer Research UK said the findings were reassuring. Who can take it? Anastrozole can be given only after the menopause because it cannot suppress oestrogen in younger women. It is already used as a treatment once breast cancer has been discovered, but now trials are focusing on preventing cancers emerging in the first place. Previous research, has shown anastrozole halves the risk of breast cancer during the five years women took the drug. But now, trials on 3,864 women show those taking it had 49% fewer breast cancers, even seven years after stopping treatment. In other words – the benefit lasts. The findings have been published in the Lancet and presented at the San Antonio Breast Cancer Symposium in Texas. “Breast cancer is the commonest cancer in […]
Cancer cure: (Taj Pharma) makes breakthrough in curing the disease with a fast, affordable type of therapy Cancer is a disease that has been around since ancient Egyptian times, and throughout the years, many doctors and scientists alike have been looking and developing a cure. But there is a possibility that the definite cure for cancer has already been made, as India [Taj Pharmaceuticals] makes a breakthrough with their kind of cancer therapy. Cancer cure Bloomberg reports that the new kind of therapy in question was referred to as Chimeric Antigen Receptor-T cells or CAR-T. This process involves drawing blood from the cancer patient to extract the white blood cells or the cells known to fight diseases also known as T-cells. The white blood cells are then engineered in a laboratory, introducing chimeric antigen receptors into the mix. These receptors would then be able to identify and destroy cancer cells, which would then be reintroduced into the body. This incredible breakthrough in cancer treatment was developed by Indian company Taj Pharmaceuticals Ltd, its scientists being a group of renowned Indian cell-therapy researchers. What makes this such a breakthrough is that compared to the usual weeks’ long procedures of many cancer therapies […]
We need a common regulator for pharma sector: FICCI chairman The pharmaceuticals and medical devices sector, which is currently governed by multiple regulators and ministries, needs a common regulator to simplify processes, said Federation of Indian Chambers of Commerce and Industry (FICCI) chairman here. Speaking at the sidelines of a seminar at the Vibrant Gujarat Global Summit here, Pankaj Patel, chairman and managing director of Cadila Healthcare and said that there was a need to simplify the regulatory processes governing the pharmaceutical sector. “A common regulator for the entire sector covering drugs, medical devices and others would simplify the processes and improve ease of doing business,” Patel who is also the chairman of FICCI said. He added that now there were multiple regulators including the National Pharmaceutical Pricing Authority (NPPA), the Central Drugs Standard Control Organisation (CDSCO) and others which come under the purview of various ministries. Department of Pharmaceuticals The NPPA which comes under the Department of Pharmaceuticals, Ministry of chemicals and fertilisers looks after drug pricing in the country and comes out with directives on the same. The CDSCO, in turn, has regulatory control over the import of drugs, approval of new drugs, clinical trials, among several others. […]
Govt’s generic push will dent Rs 90,000-cr branded pharma market Pharma companies may soon start wooing chemists as the Narendra Modi government plans to make it mandatory for doctors to prescribe pure-generic drugs, instead of branded generics as they do now. Medicines Though the plan was first announced in this year’s Budget, the prime minister spoke about it for the first time at a public event on Monday. The health ministry has now started working on amending the Drugs and Cosmetics Act to this effect. “Indian patients may face quality issues without price benefit as intense competition among marketers will lead to incentivising a chemist,” says D G Shah, secretary-general of the Indian Pharmaceutical Alliance. India, like most of other emerging markets, is predominantly a branded generics play with a 90 per cent share in the Rs 1-lakh-crore market. Which means that drug makers sell these off-patent drugs through their relationships with doctors. In developed countries such as the US, only patented drugs are sold under a brand, which is marketed through their ties to doctors. Off-patent drugs are sold only as pure generic, without using any brand name. It helps in making pure generics cheaper. It is this nexus […]
While over 50 different biosimilars already exist in the Indian market, the big money lies launching these drugs in Europe and the United States It has been more than a decade since Indian pharmaceutical companies began looking at the biosimilar opportunity. It is not an easy space to be in and quite unlike their traditional stronghold of generics. However, it is a space that is linked to the nature of future drugs – today, as is often quoted by pharma experts, one out of every three new drugs approved in the global matkets is a biotech drug, specially in fields like cancer care. While over 50 (and counting) different biosimilars already exist in the Indian market, the big money lies launching these drugs in Europe and the United States. So far, hardly a couple of Indian companies have been able to do this and much of this happened in the decade that has just concluded. In February 2015, Intas Pharmaceuticals became the first Indian company to get a biosimilar registered – the biotech drug Filgratsim under the brand Accofil – in the European Union. It is now getting ready to foray into US with more products. “We launched pegylated granulocyte-colony […]
Global Call To Action on Familial Hypercholesterolemia: Aims to Improve Diagnosis and Treatment Worldwide The FH Foundation and the World Heart Federation announced today a Global Call to Action on familial hypercholesterolemia (FH), a vastly under-recognized and poorly managed public health concern. Published in JAMA Cardiology and authored by a global panel of scientific experts, advocacy leaders, public health officials, and individuals with FH from 40 countries, the report notes glaring gaps in screening and guideline-based care for FH, the most common cause of early and aggressive heart disease. FH is an inherited metabolic disorder found in all races and ethnicities and impacts 34 million people worldwide. FH causes high LDL-cholesterol from birth and should be diagnosed and treated within the first two decades of life. Left untreated, individuals with FH have a 20-times higher risk of illness and death from cardiovascular disease (CVD). However, if diagnosed and treated, heart attacks, strokes and the need for surgery can be prevented. The international coalition was convened by the FH Foundation and World Heart Federation to reexamine and update key recommendations issued by the World Health Organization (WHO) in their report on Familial Hypercholesterolemia in 1998. In the 20 years since that report, […]
Half of pediatric cancers undiagnosed and untreated worldwide Nearly one in two children with cancer are never diagnosed and may die untreated, according to a a new model proposed in a study published in The Lancet Oncology by Zachary Ward and colleagues from Harvard University T.H. Chan School of Public Health. In fact, the model estimates that there were 397.000 childhood cancer cases globally in 2015, while only 224,000 had been previously recorded as diagnosed that year, leading ultimately the researchers to say that over 43% of childhood cancer cases were undiagnosed. But there was substantial regional variation: it ranges from 3% in both Western Europe (120 undiagnosed cases out of 4,300 total new cases) and North America (300 of 10,900 cases), to 57% (43,000 of 76,000 new cases) in Western Africa. With such path, at current levels of health system performances, If no improvements are made, the study authors estimated that nearly three million out of 6.7 million total cases will be missed between 2015 and 2030. Accounting for underestimation is vital: accurate estimates of incidence are important for policy makers, however, many countries do not have cancer registries that quantify that incidence (and often even if they do […]
The crisis in access to essential medicines in India: key issues which call for action Author: Anurag Bhargava, SP Kalantri | DOI: https://doi.org/10.20529/IJME.2013.028 Abstract The government is planning to introduce free generic and essential medicines in public health facilities. Most people in India buy healthcare from the private sector, a compulsion that accounts for a high proportion of healthcare-related expenditure. To reduce the burden of healthcare costs, the government must improve availability and affordability of generic and essential medicines in the market. It can do so because India’s large pharmaceutical industry is a major source of generic medicines worldwide. In this article, we discuss three factors that have impeded access to generic and essential medicines: mistaken notions among policymakers, prescribers and patients about branded drugs and generic drugs in India; high prices of medicines due to the progressive dismantling of the system of regulation of medicine prices, and a drug approval and regulatory system that allows medicines (including fixed dose combinations) of doubtful efficacy, rationale, safety and public health relevance to dominate the market at the cost of access to affordable generic and essential medicines. The consequences of ill-health and wasted expenditure on drugs raise issues of public health ethics. […]
Despite more than a decade of efforts to address the problem, cancer patients across Europe and the US still cannot rely on essential drugs being available when they need them. Rachel Brazil looks at the size of the problem, its impact on patients and professionals, and the efforts to put in place policies and alternative business models that could offer a solution. For the last decade, headline stories about problems accessing cancer drugs have focused almost exclusively on novel ‘targeted’ treatments. Less publicised is the story of growing problems accessing traditional cytotoxics and other oncology medicines that are no longer on patent, but remain the real workhorses of oncology care across most cancer types. Health services have traditionally relied on the generics market to provide affordable copies of brand-name drugs once the patent that gives market exclusivity has expired. But a persistent problem of re-occurring shortages across a wide range of generics is damaging patient outcomes, adding to the workloads of hospital pharmacists and others in the care team, and raising questions about how to balance the need for competition against the requirement of a guaranteed supply line. Whilst the problem is not unique to oncology, shortages of generic drugs […]
Kids born with assisted reproduction are not at higher risk of getting cancer Recently, Allison and Honjo have been awarded with the Nobel prize for their findings leading to the new cancer treatment approaches known as immune checkpoint inhibitors (ICIs). Thanks to these discoveries in fact, the management of the disease has profoundly changed, producing remarkable results on several tumors, even if checkpoint inhibitors have significant side effects, that according to an analysis published in Jama are still poorly known by many health professionals. It is “urgent”, according to authors, “to identify who is at highest risk of severe outcomes, and then develop evidence-based therapies to manage toxicity”. Understanding these adverse effects is essential not for oncologist only, but for every physician in any discipline, as said by Douglas B. Johnson, MD, of Vanderbilt University, Nashville, Tennessee, and colleagues. Indeed, they underlined what are the most common effects which occur in practice in an article published online in JAMA. Many organs can be involved, commonly the skin, the gastrointestinal tract, the lungs, endocrine organs, musculoskeletal, renal, nervous, hematologic, cardiovascular, and ocular systems, thus counting such side effects as a problem to be faced jointly among the various physicians. Autoimmune events are […]
Researchers have zoomed in on the fine molecular and epigenetic mechanisms that explain the aggressive spread of melanoma. Scientists examine the epigenetic silencing of circRNA and how this drives the spread of melanoma. Along with DNA and proteins, RNA is one of the three essential macromolecules necessary for all forms of life. The typical process at the basis of all known forms of life comprises three steps: The genetic information from our DNA — which works as the “blueprint” of the cell — is converted into an RNA “photocopy,” which, in turn, helps create proteins required by the cell. Most RNA is in linear form. However, some RNA molecules are circular. These are called circular RNAs (circRNA). Linear RNA encodes proteins, but very few circRNAs have clearly understood functions. In fact, the medical community is only now beginning to elucidate the contribution of circRNA to normal physiology and disease, write the authors of a new paper. So, what is the role of circRNAs in the spread of melanoma? Senior study author Eva Hernando, Ph.D. — an associate professor in the Department of Pathology at New York University (NYU) Langone Health — and colleagues set out to investigate. The question is […]
Radiation therapy | Immunotherapy | Hormone therapy | Targeted therapy | Making a decision | Outlook | Takeaway Doctors use chemotherapy either as a first-line therapy or in combination with other treatments, such as surgery. If chemotherapy does not work, a person may need to consider other treatment options.
The symptoms of frontotemporal, or early onset, dementia can appear as early as age 40. Have researchers found a new way to treat this condition using antibiotics?
What is melanoma? | Melanoma Stages | Melanoma Types | Melanoma Risk factors | Melanoma Symptoms | Melanoma Treatment | Prevention melanoma | Melanoma Diagnosis | Melanoma Outlook Melanoma is a type of skin cancer. It is not the most common, but it is the most serious, as it often spreads. When this happens, it can be difficult to treat, and the outlook may be poor. Risk factors for melanoma include overexposure to the sun, having fair skin, and a family history of melanoma, among others. melanoma Receiving an early diagnosis and getting prompt treatment can improve the outlook for people with melanoma. For this reason, people should keep track of any changing or growing moles. Using adequate protection against sun exposure can help a person prevent melanoma altogether. This article covers the symptoms of melanoma, how a doctor would diagnose it, and ways to treat it. We also explain how best to prevent melanoma. What is melanoma? A person may be more at risk of melanoma if they have a family history of the condition. Melanoma is a type of skin cancer that occurs when pigment producing cells called melanocytes mutate and begin to divide uncontrollably. Most pigment cells […]
China coronavirus: All you need to know – A new virus has killed 81 people in China and infected almost 3,000 people, with cases confirmed in several countries. Coronavirus: Everything you need to know Health authorities around the world are grappling with an outbreak of a new coronavirus, which originated in the Chinese city of Wuhan. At least 81 people have died in China and almost 3,000 have been infected worldwide. What is a coronavirus? Coronaviruses are a large family of viruses that cause illnesses ranging from the common cold to more severe diseases such as Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), according to the World Health Organization (WHO). They circulate in animals and some can be transmitted between animals and humans. Several known coronaviruses are circulating in animals that have not yet infected humans. The new coronavirus has been named novel coronavirus (2019-nCoV). It is the seventh coronavirus known to affect humans. What are the symptoms? Common signs of infection include fever, coughing and breathing difficulties. In more severe cases, infection can cause pneumonia, SARS, kidney failure and death. The incubation period of the new coronavirus is thought to be between one and 14 […]
WHO officially names new coronavirus disease Covid-19 The World Health Organization (WHO) has officially named the disease caused by the new coronavirus, initially identified in Wuhan, China, as Covid-19.
Here’s the timeline of how the Coronavirus outbreak evolved from Wuhan city in China and spreading its tentacles across the world. Update: DBS evacuates 300 after one is infected – Singapore’s DBS bank has evacuated 300 employees after one employee was confirmed to have contracted the coronavirus. Japan cruise cases increase to 174 – The total confirmed cases on the Diamond Princess cruise ship, quarantined in Japan, have surged to 174. Death toll reaches 1,115; recoveries rise – Deaths from the new coronavirus have reached 1,115, while the total number of cases exceeded 45,100, including 44,653 reported in mainland China by authorities as of the end of 11 February. – According to NHC official Mi Feng, the proportion of recovered patients in China increased to 8.2% as of 10 February, from 1.3% on 27 January. WHO gives name to new coronavirus disease – The WHO has officially named the disease caused by the new coronavirus as ‘Covid-19’. – Ukraine is screening five of its citizens for the novel coronavirus, Health Minister Zoriana Skaletska said at a press briefing on 11 February. – According to Skaletska, three of the five suspected patients returned from China while the remaining two were in […]
This is how HIV decides to become active Researchers have found the molecular mechanism underpinning HIV’s decision to remain in an active or dormant state. This may lead to new therapies that work by keeping the virus in a permanently dormant state. The study, led by a team from the Gladstone Institutes in San Francisco, CA, features in a paper now published in the journal Cell. The findings may also explain cell fate decisions that occur elsewhere in biology — such as how stem cells decide whether to remain as stem cells or differentiate into specialized cells, including brain or heart cells, when they divide. Senior study author Prof. Leor S. Weinberger, the director of the Center for Cell Circuitry at the Gladstone Institutes, likens the process to how we “hedge our bets” when we make decisions about financial investments. To “protect against volatility in the market,” we may choose to place some funds in high-risk stocks with potentially high yields and the rest in low-risk, low-yield options. “Similarly,” he explains, “HIV covers its bases in a volatile environment by generating both active and dormant infections.” HIV latent reservoir: Once it enters the human body, HIV inserts its genetic material […]
India reported the first confirmed case of the coronavirus infection on 30 January 2020 in the state of Kerala. The affected had a travel history from Wuhan, China.
We Taj Pharmaceuticals are in the midst of challenging times, brought upon us due to the unimaginable spread of COVID-19. As we grapple with this difficult and ever evolving situation, we wanted to reach out to make sure that you are doing okay and in case you needed any help. It is hard to think of a business that is not impacted by this pandemic, the effects of which we will all continue to feel for a long time. Considering the current situation across the globe wherein everyone is trying their best to tackle the Coronavirus pandemic, we understand that we aren’t insulated from any uncertainties too. We, as an organisation, are doing our bit to ensure the safety and security of our employees, partners, etc. while ensuring that the work isn’t hampered. coronavirus As a firm, we have always placed the highest emphasis on delivering quality generics to all our clients, consistently. I want to take this opportunity to assure you that our professional commitments continue to occupy an important place for all of us at Taj Pharmaceuticals even as we steer our way through the crisis. Our Values of Care and Working Together come to fore in difficult […]
Taj Pharmaceuticals Biotechnological Division has announced the research in order to create an mRNA vaccine against SARS-COV-2 (coronavirus). Development will be based on previous pipelines for mRNA-oncovaccines creation: an area where the company has a great expertise. The first animal studies are scheduled for the end of April.
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