Zydus Cadila gets US-FDA nod for antidepressant drug

Zydus Cadila said it received approval from the US Food & Drug Administration to sell new generation anti-depressant Vortioxetine in the US market. The drug was first approved around seven years ago, and was developed by Denmark-based pharmaceuticals maker Lundbeck in the late 2000s. Around 2007, Japanese pharmaceuticals maker Takeda agreed to pay an upfront […]

Lupin gets license to manufacture new TB drug

Indian pharmaceuticals manufacturer Lupin Ltd said it received a non-exclusive license to manufacture the anti-TB drug pretomanid from non-profit drug developer, TB Alliance. The company said it plans to sell the drug in 140 countries and territories, including many of the highest TB burden countries around the world. Pretomanid will be administered as part of […]

Zydus Cadila gets 6-month exclusivity in US for arthritis drug

Zydus Cadila said it received six-month exclusivity for the sale of generic tofacitinib, a drug that has annual sales of over $2 billion in the US. The exclusivity was provided by the US FDA, since Cadila Healthcare was the first to file an abbreviated new drug application or ANDA for the drug. An ANDA is […]

Zydus Cadila gets nod for ZyCoV-D DNA COVID vaccine

Zydus Cadila has finally said it got Emergency Use Authorization (EUA) from Indian authorities to administer ZyCoV-D — the world’s first DNA-based COVID-19 vaccine — for both adults and teenagers. This is the first time any COVID-19 vaccine has been approved for those below 18 years of age in India. The approval has been given […]

Cadila Healthcare hopes to get Zydus COVID vaccine approval in 1-2 weeks

Cadila Healthcare MD Sharvil Patel said the company has started stockpiling the ZyCoV-D COVID vaccine, and is in the process of providing additional data to drug regulators and hopes to get the shot approved in one or two weeks. If approved, ZyCoV-D will become the first vaccine anywhere in the world to use DNA to […]

Alkem’s Taloja test facility passes US FDA inspection

Pharmaceuticals manufacturer Alkem Laboratories said its bioequivalence center at Taloja in Maharashtra has successfully undergone a US FDA inspection without attracting any adverse remarks. “US FDA had conducted a remote and virtual Bio-Analytical inspection of the Company’s Bioequivalence Center located at Taloja, Maharashtra from 26th July, 2021 to 28th July, 2021. At the end of […]

Sanofi sells India nutraceuticals unit to Kedaara-backed firm

The Indian unit of French pharmaceuticals maker Sanofi said it decided to sell its nutraceuticals business Universal Nutriscience Private Ltd for Rs 587.0 cr ($80 mln) plus debt-like obligations such as retirals and provisions for sales returns. Universal Nutriscience is a joint venture between Kedaara Capital Fund II LLP and Universal Medicare Private Limited. The […]

COVID-19: Zydus Cadila’s DNA vaccine shows 100% efficacy in teens

Indian Pharmaceutical major Zydus Cadila has become the world’s first to seek approval for a DNA-based vaccine against COVID-19, with trials indicating 100% efficacy in adolescents against moderate disease after three doses. The vaccine, which is likely to be approved by Indian authorities, also promises relief for those afraid of needles, as it can be […]

Dr Reddy’s launches 2DG Covid drug for Rs 990

Dr Reddy’s Laboratories, one of India’s largest pharmaceutical manufacturers, commercially launched 2DG COVID-19 treatment today, starting with the bigger cities. The drug, formulated by DRDO’s Institute of Nuclear Medicine & Allied Sciences in collaboration with Dr Reddy’s, is supposed to reduce the viral load in patients suffering from COVID-19. The drug, 2-deoxy-D-glucose, is supposed to […]

Glenmark, Cipla get US nod for inhaler drug

Indian pharmaceutical manufacturers Cipla and Glenmark Pharma said they received approval from the US Food and Drug Administration to launch a generic version of Sunovion Pharma’s inhaler therapy Brovana. The drug has substantial sales in the US of around $438 million in the 15 mcg dose and is approved for long-term, twice daily usage for […]

Lupin gets US FDA warning letter for Somerset plant

Lupin Ltd, one of the world’s largest generic drug makers, today said it received a warning letter from the US Food and Drug Administration relating to its US-based manufacturing plant located in Somerset, New Jersey. “We wish to inform you that the Company has received a warning letter from the US FDA for the company’s […]

Wockhardt says in talks with COVID-19 vaccine makers

Mumbai-based pharmaceuticals manufacturer Wockhardt officially confirmed that it is indeed in negotiations with multiple companies to explore the option of manufacturing their COVID-19 vaccines. The confirmation comes in the wake of recent media reports quoting government sources that the company had suggested to the government that it can divert some of its manufacturing capacities for […]

AstraZeneca annuls diabetes drug deal with Abbott Healthcare

AstraZeneca India, which entered into a licensing deal with Sun Pharma for a key diabetes drug, said that it had terminated a distribution agreement for the same drug with Abbott Healthcare. The drug, dapagliflozin, was being supplied to Abbott Healthcare by the Indian unit of the British-Swedish company under a distribution agreement, which has now […]

AstraZeneca rejigs diabetes drug deal with Sun Pharma

AstraZeneca Pharma India, the local unit of the global pharmaceuticals giant, said it has decided to end its marketing agreement with Indian pharmaceutical giant Sun Pharma for two diabetes medications after the Indian company acquired a license to manufacture the same locally. In a separate statement, Sun Pharma said it has acquired the patent license […]

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 […]