Indoco Remedies gets USFDA warning letter for significant violations at Goa facility Medical Dialogues Bureau26 July 2019 9:30 AM ISTStating the specific violations, the US Food and Drug Administration (USFDA) said Indoco Remedies failed to prepare batch production and control...
Allergan announces worldwide recall of textured breast implant tied to rare cancer Medical Dialogues Bureau26 July 2019 9:15 AM ISTThe U.S. Food and Drug Administration said it called for the removal after new information showed Allergan Inc's Biocell breast implants account for a...
Pharma lobby group opposes senators' proposal to lower drug prices: Report Farhat Nasim26 July 2019 9:00 AM ISTThe proposal aims to lower drug prices by forcing pharmaceutical companies to pay rebates to Medicare if they raise prices above the rate of...
Zydus Cadila launches Ramelteon tablets in US to treat insomnia Medical Dialogues Bureau25 July 2019 11:23 AM ISTIn a BSE filing, Zydus Cadila announced the "launch of Ramelteon tablets, 8 mg upon receiving the final approval from the USFDA. Ramelteon is a...
Manipal Group Stempeutics, Kemwell strike deal worth Rs 95 crore for global commercialisation of Stempeucel Medical Dialogues Bureau25 July 2019 9:45 AM ISTThe funds will be utilized for achieving key regulatory milestones in the US, Europe and Japan, and for establishing a cGMP cell therapy manufacturing...
Syngene International Q1 net profit rises 9 percent to Rs 72 crore Medical Dialogues Bureau25 July 2019 9:30 AM ISTThe company had posted a net profit of Rs 66.2 crore for the same period previous fiscal, Syngene International said in a BSE filing.New Delhi:...
Merck biosimilar to AbbVie blockbuster Humira wins USFDA approval Medical Dialogues Bureau25 July 2019 9:00 AM ISTHumira is the world's best-selling prescription medicine and in the six years since AbbVie spun out from device maker Abbott Labs, the drug has...
Pfizer gets USFDA nod for biosimilar to Rituximab Medical Dialogues Bureau25 July 2019 8:59 AM ISTRuxience is a mAb biosimilar to Rituxan which works by targeting a protein called CD20, which is present on the surface of B cells. Ruxience is...
Alembic Pharma gets tentative USFDA nod for Dapagliflozin Tablets to improve glycemic control Medical Dialogues Bureau24 July 2019 10:00 AM ISTThe approved Dapagliflozin Tablets is therapeutically equivalent to the reference listed drug product Farxiga Tablets of AstraZeneca AB.New Delhi:...
Dr Reddys unveils generic version of Rozerem Tablets in US for treating insomnia Farhat Nasim24 July 2019 9:35 AM ISTThe product is a therapeutically equivalent generic version of Rozerem (ramelteon, 8 mg) Tablets, approved by the U.S. Food and Drug Administration...
Torrent Pharma Q1 net profit up 33 percent to Rs 216 crore Medical Dialogues Bureau24 July 2019 9:30 AM ISTThe firm's India business was up nine per cent year-on-year to Rs 907 crore for the quarter. The US revenues at Rs 376 crore were up by 13 per cent...
Sanofi strikes deal for US rights to Roche Tamiflu Medical Dialogues Bureau24 July 2019 9:15 AM ISTUnder the terms of the agreement, Sanofi will be responsible for leading FDA negotiations for the OTC switch and subsequent exclusive marketing,...
