Knew about Zolgensma data problems before US approval: Novartis Medical Dialogues Bureau9 Aug 2019 9:15 AM IST"We made the decision to progress our quality investigation prior to informing FDA and other regulatory authorities so that we could provide the best...
Bayer buys BlueRock in USD 600 million bet on stem cell therapies Medical Dialogues Bureau9 Aug 2019 9:00 AM ISTFRANKFURT: German drugmaker Bayer is paying up to $600 million for full control of cell therapy developer BlueRock Therapeutics, stepping up...
Bayer Rivaroxaban tablets win CDSCO Committee nod for waiver of local clinical trial; directed to carry Phase IV trial Medical Dialogues Bureau8 Aug 2019 5:28 PM ISTNew Delhi: The apex drug regulatory body, Central Drugs Standard Control Organisation's (CDSCO) Technical Committee has recommended for grant of...
Cadila Healthcare gets OAI letter from USFDA for Moraiya facility Medical Dialogues Bureau8 Aug 2019 10:00 AM ISTThe company has received a letter from the USFDA classifying the inspection conducted at its Moraiya facility from April 22 to May 3 as OAI, Cadila...
Aurobindo Pharma Q1 net profit up by 39.52 percent to Rs 636 crore Farhat Nasim8 Aug 2019 9:45 AM IST"We have started the year with a healthy performance. Enhancing our quality management practices and adhering to the regulatory requirements continues...
GSK ends Ebola vaccine RnD; transfers license to US institute Medical Dialogues Bureau8 Aug 2019 9:30 AM ISTGSK had put its Ebola vaccine work on hold after it was unable to progress the product through the final stage, or Phase III, clinical trials toward...
Novartis concealed data problem before seeking approval for USD 2.1 million gene therapy Zolgensma: USFDA Medical Dialogues Bureau8 Aug 2019 9:15 AM ISTThe FDA said in a statement that AveXis Inc., the Novartis AG subsidiary that manufactures Zolgensma, told the agency five weeks after the approval of...
Paras Healthcare appoints Max Healthcare ex-GM Puneet Srivastava as Vice President Farhat Nasim8 Aug 2019 9:00 AM ISTPuneet Srivastava will lead the Sales and Marketing function at a group level. Prior to joining Paras Healthcare, Srivastava was associated with the...
Price Cap: NLEM Committe to now target intraocular lens, dialysis fluid, hearing aids; Farhat Nasim7 Aug 2019 5:30 PM ISTNew Delhi: After fixing the prices of various stents including cardiac stents and orthopaedic implants and even cancer drugs, the government is soon...
Granules India arm wins USFDA approval for stimulant drug Amphetamine Sulfate tablets Medical Dialogues Bureau7 Aug 2019 9:30 AM ISTAmphetamine Sulfate tablets is a generic version of Arbor Pharmaceuticals LLC's Evekeo tablets in similar strength, it added.New Delhi: Drug firm...
Daiichi Sankyo CEO capped USD 37 billion recovery with AstraZeneca deal: Bloomberg Medical Dialogues Bureau7 Aug 2019 9:10 AM ISTDaiichi Sankyo CEO, Nakayama decided the company needed a change, so he sold the Sun Pharmaceutical stake and shifted his focus to cancer drugs,...
Novo Nordisk buys drug factory in North Carolina for assistance in manufacturing, packaging new diabetes drug Medical Dialogues Bureau7 Aug 2019 9:05 AM ISTThe tablet version of Novo Nordisk diabetes drug, known as semaglutide, is an important growth prospect for the Danish drugmaker, which faces pressure...
