US to wrap criminal trial of Insys Therapeutics' executives tied to opioid crisis Medical Dialogues Bureau6 April 2019 8:59 AM ISTBOSTON: Prosecutors on Thursday will present their closing arguments in the trial of the wealthy founder of pharmaceutical company Insys Therapeutics...
Setback: USFDA rejects Sanofi, Lexicon Sotagliflozin for type 1 diabetes Farhat Nasim24 March 2019 9:45 AM ISTThe decision comes about two months after an FDA advisory panel failed to reach a consensus over whether the once-daily oral drug, sotagliflozin,...
USFDA puts partial hold on Abbvie Venclexta clinical trials after deaths Farhat Nasim21 March 2019 9:45 AM ISTThe clinical hold does not impact any of the approved indications for Venclexta, such as chronic lymphocytic leukaemia (CLL) or acute myeloid...
Allergan depression drug fails trial, loses over Rs 100 crore expected sales Farhat Nasim8 March 2019 9:00 AM ISTStanicky said the data was the most anticipated release of the year and likely means that Allergan will lose what had been expected to be a $1 billion...
Sanofi officials to be charged over dengue vaccine deaths Farhat Nasim3 March 2019 9:45 AM ISTMANILA: The Philippine Department of Justice on Friday said it had found probable cause to indict officials from French drugmaker Sanofi and former...
Novartis signs deal with Gan & Lee as US government seeks to slash insulin cost Medical Dialogues Bureau30 Dec 2018 9:20 AM ISTZURICH: Swiss drugmaker Novartis aims to become a big player in supplying insulin to swelling numbers of diabetics, signing a deal with China's Gan...
FDA approves Pfizer's Lorbrena treatment for certain lung cancer patients Medical Dialogues Bureau7 Nov 2018 9:40 AM ISTLorbrena, known chemically as lorlatinib, received an accelerated approval, Pfizer said. Its continued approval may depend on verification of clinical...
FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery Medical Dialogues Bureau4 Nov 2018 9:36 AM ISTNew Delhi: The U.S. Food and Drug Administration permitted marketing of two devices that provide real-time location of parathyroid tissue during...
SGLT2 inhibitors can lead to serious genital infection: USFDA warning Ruby Khatun Khatun31 Aug 2018 4:50 PM ISTThe SGLT2 inhibitors approved by the FDA include Johnson and Johnson's Invokana, Eli Lilly & Co's Jardiance, as well as those from Bristol-Myers...
Mylan launches generic Angiomax injection Ruby Khatun Khatun22 Jun 2018 10:15 AM ISTHERTFORDSHIRE, England, and PITTSBURGH: Global pharmaceutical company Mylan N.V. announced the U.S. launch of Bivalirudin for Injection, 250 mg...
USFDA approves Mylan, Biocon's Fulphila, the first biosimilar to Neulasta Ruby Khatun Khatun6 Jun 2018 10:30 AM ISTHERTFORDSHIRE/PITTSBURGH and BENGALURU: Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's...
Loxo-Bayer cancer drug gets priority review from FDA Ruby Khatun Khatun1 Jun 2018 9:30 AM ISTLoxo Oncology and Bayer AG said the U.S. Food and Drug Administration granted priority review to their cancer drug and would decide on the marketing...