Roche wins US antitrust nod for USD 4.3 billion deal to buy Spark Therapeutics Medical Dialogues Bureau17 Dec 2019 9:12 AM ISTThe FTC approved the deal, which was originally announced in February, without requiring any asset sales to ensure that the planned merger complies...
Axsome Therapeutics depression drug AXS-05 meets goal in late-stage trial Medical Dialogues Bureau17 Dec 2019 9:10 AM ISTThe trial results of Axsome Therpeutics' oral tablet, AXS-05 takes the company a step closer to acquiring a share of the multi-billion dollar market...
Glenmark Baddi unit gets GMP certificate from State Institute for Drug Control Medical Dialogues Bureau16 Dec 2019 3:22 PM IST"The European regulator has just issued a certificate of compliance for the facility stating that it complies with the principles and guidelines of...
Issue of Corruption in CDSCO raised in Parliament; Details Farhat Nasim16 Dec 2019 12:56 PM ISTNew Delhi: The sensitive issue of corruption plaguing every sector including the nodal drug regulatory body, Central Drugs Control Organisation...
Amarin fish-oil drug Vascepa gets USFDA nod for cutting cardiac risks Medical Dialogues Bureau16 Dec 2019 11:48 AM ISTFish-oil based Vascepa sales brought Amarin just $287 million over 2019's first nine months, but analysts forecast the much-broader approval could...
Horizon Therapeutics thyroid eye disease drug Teprotumumab gets USFDA panel votes Medical Dialogues Bureau16 Dec 2019 10:00 AM ISTIf approved, Horizon Therapeutics Plc's teprotumumab, a type of immunotherapy, is expected to become a standard of care for the vision-threatening...
Abbott CEO Miles D White to step down in 2020, Robert B Ford to take over Medical Dialogues Bureau16 Dec 2019 9:30 AM ISTRobert B Ford will become the 13th CEO of Abbott in its 131-year history, all having been appointed from within the Company, a testament to Abbott's...
Sackler-owned opioid maker pushes overdose treatment abroad Medical Dialogues Bureau16 Dec 2019 9:00 AM ISTNew Delhi: The gleaming booth towered over the medical conference in Italy in October, advertising a new brand of antidote for opioid overdoses. "Be...
CDSCO to set up Public Relations Offices at all Zonal, Sub-Zonal Offices for regulator guidance Farhat Nasim15 Dec 2019 1:42 PM ISTNew Delhi: In order to make regulatory guidance more accessible across the country, the nodal drug regulator, Central Drugs Standard Control...
Pfizer gets USFDA nod for Xeljanz XR Extended-Release Tablets to treat Ulcerative Colitis Farhat Nasim15 Dec 2019 10:00 AM ISTNew Delhi: Pfizer Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved XELJANZ XR (tofacitinib) extended-release 11...
GSK seeks marketing licence for baby-friendly HIV pill Dolutegravir Medical Dialogues Bureau15 Dec 2019 9:40 AM ISTGSK's ViiV is planning licensing agreements with two generic drugmakers, Mylan Laboratories and Macleods Pharmaceuticals, who aim to make cheaper...
Alkermes gets USFDA warning letter for misleading Vivitrol ads Medical Dialogues Bureau15 Dec 2019 9:15 AM ISTUsers of Vivitrol as a treatment for opioid dependence should be made aware of the vulnerability to a potentially fatal overdose at the end of a...
