Sanofi pulls popular heartburn drug Zantac in US, Canada Medical Dialogues Bureau21 Oct 2019 9:30 AM ISTIn September, the Food and Drug Administration said a potentially cancer-causing chemical had been detected at low levels in prescription and...
Landmark trial expected after opioid settlement talks fail Medical Dialogues Bureau21 Oct 2019 9:00 AM ISTNew Delhi: A landmark trial over the U.S. opioid epidemic is on track to begin on Monday after drug companies and local governments failed to agree on...
AstraZeneca, Daiichi Trastuzumab deruxtecan gets USFDA priority review for treating breast cancer Medical Dialogues Bureau20 Oct 2019 9:50 AM ISTNew Delhi: AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) recently announced that the US Food and Drug Administration (FDA) has...
Novartis Jakavi meets primary endpoint in study of acute graft-versus-host disease Medical Dialogues Bureau20 Oct 2019 9:35 AM ISTNew Delhi: Novartis recently announced positive topline results from the Phase III REACH2 study evaluating Jakavi (ruxolitinib) in patients with...
Boehringer Ingelheim enrolls patients in Phase 2 trial of cystic fibrosis treatment Medical Dialogues Bureau20 Oct 2019 9:30 AM ISTNew Delhi: Boehringer Ingelheim recently announced the first patient enrolled in its Phase II clinical trial BALANCE-CF to evaluate a new potential...
Five drug firms, distributors offer to settle US opioid suits with USD 50 billion package: Report Medical Dialogues Bureau20 Oct 2019 9:00 AM ISTDistributors McKesson Corp, Amerisource Bergen Corp and Cardinal Health have offered to pay $18 billion in cash over 18 years, while drugmaker Johnson...
USFDA alerts iconic Johnsons Baby Powder contaminated with Asbestos Medical Dialogues Bureau19 Oct 2019 12:34 PM ISTThe move marks the first time the company has recalled its iconic baby powder for possible asbestos contamination, and the first time U.S. regulators...
Lupin largest, most advanced oral solid dosage facility gets EIR from USFDA Medical Dialogues Bureau19 Oct 2019 11:16 AM ISTThe inspection for the oral solid facility at Nagpur closed without any Form 483 observation. The Nagpur facility is Lupin Ltd’s largest and most...
Indoco Remedies successfully clears USFDA inspection of CRO facility AnaCipher Medical Dialogues Bureau19 Oct 2019 11:05 AM ISTCommenting on this development, Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited said, “This achievement is for the fifth time in a...
Merck gets European nod for Ebola vaccine Ervebo Medical Dialogues Bureau19 Oct 2019 9:15 AM ISTThe European Medicines Agency (EMA) said its human medicines committee (CHMP) has recommended granting conditional marketing authorization in the...
Eli Lilly pancreatic cancer drug Pegilodecakin fails to meet endpoint Medical Dialogues Bureau19 Oct 2019 9:00 AM ISTNew Delhi: Eli Lilly and Company recently announced top-line results from its Phase 3 SEQUOIA trial evaluating pegilodecakin plus FOLFOX (folinic...
USFDA rebukes Torrent Pharma management of inadequacy, violations at multiple sites Farhat Nasim16 Oct 2019 6:20 PM ISTRepeated failures at multiple sites of Torrent Pharma demonstrate that executive management oversight and control over the manufacture of drugs is...