Zydus Cadila launches affordable breast cancer drug in India

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. […]

Natco Pharma starts Ph III trial of new COVID drug molnupiravir

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 caps strong year with Q4 growth

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 […]

COVID-19: Eli Lilly lets Torrent Pharma manufacture Bartinicib

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 […]

Dr Reddy’s gets nod to start supplying Sputnik V

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 gets nod for injectables unit merger

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, […]

Biocon, Lupin launch new drugs in USA

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 […]

Indoco Remedies wins big order from Germany for uric acid tablets

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 […]

Zydus’ cytokine inhibitor moves into clinical trial

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), […]

Laurus Labs buys Bangalore-based biotech firm Richcore for Rs 247 cr

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 […]

Vaishali Pharma enters US market

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 […]

Glenmark says Favipiravir trial shows 29% faster recovery in COVID-19

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 […]

COVID-19: Dr Reddy’s signs deal to make and sell favipiravir globally

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 […]

ICMR to start BCG Vaccine study for Coronavirus next week

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 […]

Biocon gets Form 483 observations for API plant

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 gets two observations for Karkhadi plant

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 […]

Natco Pharma seeks nod for generic copy of Taiho’s cancer drug Lonsurf

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 […]