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...
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...
Natco Pharma gets EIR from USFDA for Kothur facility Medical Dialogues Bureau6 Aug 2019 4:35 PM ISTNew Delhi: Drug firm Natco Pharma on Monday said it has received establishment inspection report (EIR) from the US health regulator for its Kothur...
Zydus Cadila completes phase III trial of Diabetes drug Lipaglyn in India Medical Dialogues Bureau5 Aug 2019 10:00 AM ISTSaroglitazar Magnesium was launched in India during September 2013, under the brand name 'Lipaglyn', for the treatment of hypertriglyceridemia and...
Lupin gets EIR from USFDA for Oral Dosage facility in Aurangabad Medical Dialogues Bureau5 Aug 2019 9:45 AM ISTLupin Ltd's Aurangabad facility is involved in the manufacture of Oral Solid Dosage, Oral Liquid and Powder for Oral Suspension products for the US...
Families say OxyContin maker Purdue Pharma must be held accountable for its role in opioid epidemic Medical Dialogues Bureau5 Aug 2019 9:00 AM ISTThe parents and their supporters rallied outside a Boston courthouse Friday as a judge heard arguments in Massachusetts' lawsuit against Purdue...
Protest planned outside court during Purdue Pharma hearing Medical Dialogues Bureau4 Aug 2019 9:00 AM ISTPurdue Pharma will argue in Suffolk Superior Court that Democratic state Attorney General Maura Healey's lawsuit distorts facts, makes oversimplified...
Sun Pharma sudden closure of Vadodara RnD units leaves around 85 employees in lurch Farhat Nasim3 Aug 2019 3:26 PM ISTMumbai: In a move that will axe job of around 85 employees (as pegged my market sources), Dilip Shanghvi led Sun Pharmaceuticals Ltd. (Sun Pharma) has...
Zydus Cadila wins USFDA nod for Minocycline Hydrochloride ER tablets to treat acne Medical Dialogues Bureau3 Aug 2019 9:45 AM ISTMinocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-modular moderate to severe acne vulgaris in...
Pfizer, GSK completes transaction to form new consumer healthcare JV Medical Dialogues Bureau3 Aug 2019 9:40 AM ISTThe Joint Venture brings together two highly complementary portfolios of trusted consumer health brands, including GSK's Sensodyne, Voltaren and...
Unichem Labs gets 4 USFDA observations for Goa formulation facility Farhat Nasim3 Aug 2019 9:39 AM ISTAt the end of an inspection, the facility received four observations, with no repeat observations and are mostly procedural in nature, Unichem Labs...
