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...
Regular review of CDSCO functioning, deaths due to spurious drugs: Minister Medical Dialogues Bureau15 Dec 2019 9:15 AM ISTNew Delhi: Through a recent reply, the Union Health Minister, Dr Harsh Vardhan informed the Parliament about the regular review of the function of the...
Sanofi lauded as newest member of Systems-based Pharmaceutics Alliance Medical Dialogues Bureau15 Dec 2019 8:59 AM ISTThe Alliance further comprises leading pharma companies Eli Lilly, GlaxoSmithKline, Pfizer and F. Hoffmann-La Roche and supplier of mechanistic...
Biogen halts development of Gosuranemab, therapy for rare brain disease Medical Dialogues Bureau15 Dec 2019 8:58 AM ISTThe therapy, Gosuranemab, failed to hit statistical significance in its main goal and did not demonstrate effectiveness on key secondary goals when...
Sanofi to reduce investment in Onduo, USD 500 million joint venture with Verily Farhat Nasim14 Dec 2019 1:55 PM ISTHowever, after several years of partnership, the two parties do not seem to align well as Sanofi recently withdrew from the Joint Venture, Onduo...
Sun Pharma Halol facility gets 8 USFDA observations post GMP inspection Farhat Nasim14 Dec 2019 12:50 PM ISTThe U.S Food and Drug Administration (USFDA) conducted a Good Manufacturing Practices (GMP) inspection of the company's Halol facility (Gujarat,...
NPPA raises MRP of 21 essential, life saving drugs by 50pc; Details Farhat Nasim14 Dec 2019 11:56 AM ISTNew Delhi: In a first, the apex drug price regulator, the National Pharmaceutical Pricing Authority (NPPA), through a recent notification has...
Patent Infringement: Bristol-Myers wins case against Gilead; awarded USD 752 million in damages Medical Dialogues Bureau14 Dec 2019 9:35 AM ISTA jury in Los Angeles awarded the damages after finding that Yescarta, a treatment sold by Gilead's Kite Pharma unit, infringed on a patent...
