The U.S. Food and Drug Administration's accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients' lives? In a new study, researchers found that most cancer drugs granted accelerated approval do not demonstrate such benefits within five years. Five years after the initial accelerated approval, you should have a definitive answer, said Dr. Ezekiel Emanuel, a cancer specialist and bioethicist at the University of Pennsylvania who was not involved in the research. Thousands of people are getting those drugs. That seems a mistake if we don't know whether they work or not." The program was created in 1992 to speed access to HIV drugs. Today, 85% of accelerated approvals go to cancer drugs. It allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases. In exchange, drug companies are expected to do rigorous testing and produce
A study reveals that bandages contain cancer-causing toxic 'forever chemicals'. The study was performed on 40 different bandages and 18 brands
Speaking at the launch event, Murmu said indigenous development of the therapy was an example of the Make in India initiative
Experts say tech still nascent, diversified dataset for correct risk profiling currently unavailable
This new pill will reduce the side effects of cancer treatment like chemotherapy by about 50 per cent and the chances of getting cancer for a second time by 30 per cent
Vladimir Putin did not specify the details of the vaccine but said it could be available to patients soon. According to the WHO, nearly 10 million people die from the disease annually
Biocon Ltd on Tuesday said it has received approval from the US health regulator for a generic anti-cancer medication. The company has received approval from the US Food and Drug Administration (USFDA) for Dasatinib tablets to market in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, Biocon said in a regulatory filing. The approval will further strengthen the company's portfolio of vertically integrated, complex drug products, it added. Shares of Biocon settled 4.97 per cent higher at Rs 298.75 apiece on the BSE.
In 2022, India had more than 14.1 lakh new cancer cases and over 9.1 lakh deaths due to the disease, and breast cancer was the most common, according to the latest estimates of the disease's global burden by the World Health Organization (WHO). Cancers of lip, oral cavity and lung were the most common ones in men, accounting for 15.6 and 8.5 per cent of the new cases, respectively, whereas, cancers of breast and cervix uteri were the most frequent ones in women, making up close to 27 and 18 per cent of the new cases, the International Agency for Research on Cancer (IARC), WHO's cancer agency has estimated. It also calculated that the number of people alive within 5 years following a cancer diagnosis was nearly 32.6 lakhs in India. Globally, the agency estimated 2 crore new cancer cases and 97 lakh deaths, and about 5.3 crore people were alive within 5 years following a cancer diagnosis. About 1 in 5 people develop cancer in their lifetime, and roughly 1 in 9 men and 1 in 12 women di
Envafolimab is a first-in-class PD-L1 inhibitor, a type of immunotherapy drug that harnesses the body's immune system to fight cancer
A sex-specific group of ten plasma proteins were found to detect 18 different early-stage cancers, representing all major organs of the body, according to a study published in the British Medical Journal Oncology. Researchers said that while cancers of kidney in men and colon in women were easier to detect using their test, bladder cancer in women and thyroid cancer in men were "more challenging but achieved with relatively high accuracy after optimisation". The proteins could also detect liver and ovarian cancers, among others. The research team at Novelna Inc, the US company that designed the test, found that while each of these proteins, by itself, was only moderately accurate at picking up the disease at an early stage, it was highly accurate when combined with other proteins in the group. They said that these proteins were particularly effective at picking up early-stage disease, even as they showed an ability to pick up stage I-III disease and all types of cancer. The team sa
Enhertu, an antibody-drug conjugate, is being used in the treatment of HER2-positive metastatic breast cancer in a number of countries globally
20 companies will be mentored for solutions that 'positively impact various industries and transform lives', says tech giant
The British drug major is developing next-generation vaccines that have the potential to generate potent and long-lasting immune responses
Pharma major Venus Remedies on Monday said it has received marketing approval from the Philippines for six key chemotherapy drugs. The approved drugs include bortezomib, cisplatin, doxorubicin, docetaxel, fluorouracil, and paclitaxel, which are crucial for cancer treatment, according to a company statement. With this, Venus Remedies has secured 525 marketing approvals for its oncology products across 76 countries, it said. This achievement marks a significant step towards achieving the company's goal of emerging as the top oncology medicine supplier from India in Southeast Asia, said Saransh Chaudhary, chief executive officer, Venus Medicine Research Centre. "While oncology drugs account for 157 of our 205 marketing authorisations in the ASEAN region, we are banking on these product registrations from the Philippines to pave the way for faster approval of these drugs in other Southeast Asian countries as well," Chaudhary added. The company will further extend its operations to oth
The study said that the value of unpaid cancer caregiving in India was 2.53 per cent of its national health expenditure
Natco Pharma on Friday said the company and other drug makers have been named defendants in an antitrust lawsuit regarding a generic cancer treatment drug in the US. The Hyderabad-based drug firm along with Celgene Corporation, Bristol Myers Squibb, Breckenridge Pharmaceutical Inc and others have been named defendants by Louisiana Health Service & Indemnity Company, D/B/A Blue Cross and Blue Shield of Losisiana and HMO Louisiana Inc, regarding anti-cancer treatment medication Pomalidomide. The company believes this matter is without merit, Natco Pharma said in a statement. Breckenridge is the abbreviated new drug application (ANDA) holder and distribution partner for the generic product in the US, it added. Natco Pharma shares were trading 3.13 per cent down at Rs 885.00 apiece on the BSE.
This new method allows cancer patients to receive the immunotherapy drug 'Atezolizumab' through an injection, as opposed to intravenous administration which can take up to an hour
Pharma major Venus Remedies on Monday said it has received market authorisations for its key cancer drugs from Philippines, Paraguay, Georgia and Moldova. With this, the company has secured 506 marketing approvals for its oncology products across 76 countries. While Venus Remedies has secured marketing approval for topotecan from Philippines, it has also reinforced its position as a leading exporter of oncology drugs with product registration for irinotecan in Paraguay, docetaxel in Georgia and topotecan and irinotecan in Moldova, said the company in a statement. "This accomplishment is a decisive move towards achieving our goal of emerging as the top oncology medicine supplier from India in the Association of Southeast Asian Nations (ASEAN) region and further expanding the reach of our cancer drugs in South America and Eastern Europe. With these marketing authorisations, the company will be able to further extend its operations to new markets offering "advanced cancer treatment ..
Shares of J&J, which recently spun off its consumer health unit to focus on drugs and medical devices, rose about 2% in premarket trading
The GST Council at its next meeting on Tuesday is likely to exempt cancer medicine Dinutuximab imported by individuals from tax, decide on applicability of GST on food or beverages served in multiplexes and come out with a clear definition of utility vehicles for levying a 22 per cent cess, sources said. The Council, chaired by Union finance minister and comprising state ministers, will also decide on GST exemption for satellite launch services provided by private players. Besides, import of medicines and Food for Special Medical Purposes (FSMP) used in the treatment of rare diseases for personal use and also by centres of excellence are likely to be exempted from Integrated GST. Currently, such imports attract an IGST of 5 per cent or 12 per cent. The fitment committee, comprising central and state tax officers, has recommended to the Council to clarify on these major issues at the 50th meeting of the Council on July 11. In addition to the recommendations of the fitment committee,