Zydus Cadila, the pharmaceutical arm of the Zydus group, said it has launched a next-generation breast cancer drug in India at a fraction of its existing cost. The drug, Trastuzumab Emtansine, is considered the first targeted chemotherapy drug for breast cancer as it directs the cytotoxic activity at cancer cells by using a known biomarker. […]
Less than a month after it approved for clinical trial approval, Hyderabad-based Natco Pharma said it has begun dosing patients in its phase III clinical trial for molnupiravir, a promising candidate for treating COVID-19 that is being studied across the world. Phase III trial data can be submitted to regulatory agencies for seeking approval of […]
Aarti Drugs, one of the biggest manufacturers of ingredients for the pharmaceuticals industry in India, reported a strong performance for the fourth quarter and full year 2020-21. All three of the Mumbai-based company’s business divisions — APIs or pharmaceutical ingredients, formulations or medicines, and specialty chemicals — contributed to a strong peformance, resulting in an […]
A week after Natco Pharma sought a compulsory license from government of India to manufacture COVID treatment drug Baricitinib, the US firm holding the rights to the drug — Eli Lilly — seems to have agreed to let several companies to manufacture and sell the drug. Baricitinib is used for treating joint inflammation in rheumatoid […]
Pharmaceuticals manufacturer Dr. Reddy’s Laboratories Ltd said it received permission from India’s drug regulator to import and supply the Sputnik V COVID-19 vaccine in India. Like the other two vaccines approved in India, the nod for Sputnik V is also an ’emergency use authorization’, meaning that it cannot be sold to anyone and everyone, but […]
Gufic Lifesciences Ltd, one of the oldest pharma companies in India, today said it has won the last pending regulatory approval for the amalgamation of its injectables unit with itself. It said it won approval from National Company Law Tribunal Mumbai for the merger last week. Since the transaction has a date of Jan 1, […]
Glenmark Pharmaceuticals Ltd said it has launched a new diabetes drug in India at a price that is around 65% cheaper than those of competing offerings. The new drug is a combination of a Sodium Glucose Co-Transporter Inhibitor (SGLT2i) and a Dipeptidyl Peptidase 4 inhibitor. “Glenmark’s Remo V and Remozen V are priced at Rs. […]
Bicon Ltd and Lupin Ltd, two India-based pharmaceutical manufacturers, launched two drugs in the US, separately. Bangalore-based Biocon launched an immunosuppressant, while Lupin launched a pain relief drug. Biocon’s drug is called Tacrolimus, and it is a calcineurin inhibitor. The company said the drug is used in organ transplant patients to reduce the body’s ability […]
Pharmaceuticals manufacturer Indoco Remedies has won a major contract to supply Allopurinol, used to bring down uric acid in the blood, from Germany. The two-year contract will generate around Rs 70 cr per year for the company. “This is Indoco’s first own label product in Europe,” said Managing Director Aditi Kare Panandikar. “Germany is totally […]
Pharmaceutical manufacturer Zydus Cadila said it received permission to initiate clinical trials for ZYIL1, an oral small molecule NLRP3 inhibitor, as an anti-inflammatory agent. The molecule is being explored for treating a variety of inflammation-related conditions, including Acute Respiratory Distress Syndrome (ARDS), auto-immune diseases, inflammatory diseases, cardiovascular diseases, metabolic disorders, gastro-intestinal diseases (inflammatory bowel disease), […]
Indian drugmaker Laurus Labs said it signed a definitive agreement to acquire a majority stake in a Bangalore-based, fast-growing biotech company, Richcore Lifesciences, for Rs 246.67 cr. Richcore has advanced R&D and manufacturing facilities to develop and manufacture biotech products critical for manufacturing biological drugs. Richcore also helps its global customers to develop and scale-up […]
Mumbai-based pharmaceuticals manufacturer Vaishali Pharma said it has entered the US market by launching its orthopaedic belts and similar products. The company is among the smaller sized pharmaceutical manufacturers in India, with annual sales in the range of around Rs 40 cr. Established in 1989, it manufactures and supplies bulk drugs, pharmaceutical ingredients, formulations, surgical […]
Pharma major Lupin Limited (Lupin) said it has received tentative approval from US FDA for Empagliflozin and Linagliptin tablets used to control blood sugar levels. The approval is for selling combinations of 10 mg+5 mg and 25 mg+5 mg of the drugs. In these dosages, the tablets have annual sales of around 242 million in […]
Glenmark Pharmaceuticals Ltd said its trial of Favirpiravir showed a 28.6% faster recovery among those treated with the antiviral drug than on those who were on standard therapy. The 150-person trial showed “numerical improvements for the primary efficacy endpoint with 28.6% faster viral clearance in the overall population as measured by the median time until […]
Dr. Reddy’s Laboratories, one of India’s biggest pharmaceuticals manufacturers, said it has signed a licensing agreement with Japan-based FUJIFILM to manufacture anti-viral drug favipiravir. Favipiravir is traditionally used to treat infuenza, and is also being tested in COVID-19 patients. Dr Reddy’s said the tie-up is part of the Japanese company’s efforts to ramp up the […]
Indian Council of Medical Research, India’s top body for the formulation, coordination and promotion of biomedical research, said it will start a new trial next week to study the efficacy of anti-TB vaccine BCG in preventing mortality in COVID-19. The statement comes even as the World Health Organization has said that there is no evidence […]
Aurobindo Pharma Ltd has said that the US FDA has lined up one of its oral solids formulation plants in Telangana for regulatory action, following adverse findings in an October inspection. The company’s shares had fallen by 19% in intra-day trading on October 8, soon after the company disclosed that FDA inspectors had made seven […]
The US Food and Drug Administration has issued a Form 483 with five observations for Biocon’s API Manufacturing facility. Form 483 observations are issued when US FDA inspectors notice shortcomings in a company’s manufacturing processes, data storage and so on during an inspection. The company has to address the issues raised in the Form 483 […]
Alembic Pharmaceuticals, one of India’s biggest drug makers, received two observations from US FDA officials who inspected its plant at Karkhadi in Gujarat. Observations, given in Form 483, indicate that the inspectors were not fully satisfied with what they found during the visit. In a Form 483, the FDA typically outlines conditions or practices at […]
India-based Natco Pharma has filed an application with the US Food and Drug Administration seeking permission to market a generic copy of Lonsurf, a drug approved just four years ago to treat colorectal/gastric cancers. The application has been filed with a ‘Paragraph IV’ declaration. Such a declaration essentially states that the filer, Natco, believes that […]
