USFDA issues warning letter to Indoco Remedies for Goa plant Medical Dialogues Bureau16 July 2019 11:39 AM ISTThe facility had received six observations in Form 483s and was classified as Official Action Indicated in March. Indoco Remedies responded to these...
Natco Pharma gets zero USFDA observations for Chennai facility Medical Dialogues Bureau16 July 2019 9:30 AM ISTNatco Pharma announced "successful completion of regulatory inspection from the US Food and Drug Administration (USFDA) for its active pharmaceutical...
GSK drug Zejula helps ovarian cancer patients live longer in late-stage study Medical Dialogues Bureau16 July 2019 9:26 AM ISTGSK bought the drug when it acquired U.S. cancer specialist Tesaro for $5.1 billion in December and Zejula is already approved for certain ovarian...
AstraZeneca Farxiga fails to win USFDA approval for Type-1 diabetes Medical Dialogues Bureau16 July 2019 9:25 AM ISTAstraZeneca said USFDA issued a complete response letter, declining its application for using the drug in patients with Type-1 diabetes where insulin...
Boehringer buys up AMAL Therapeutics, eyes oncology combo strategy Medical Dialogues Bureau16 July 2019 9:15 AM ISTThe total transaction could amount up to EUR 325 million and is comprised of upfront payment as well as contingent clinical, development and...
Sun Pharma unveils Ezallor Sprinkle capsules for treating lipid disorder in US Farhat Nasim15 July 2019 2:40 PM ISTEzallor Sprinkle (rosuvastatin) capsules are indicated for three types of lipid disorders in conjunction with diet in adults, Sun Pharma said in a...
GSK to appoint Novartis, Astrazeneca ex-executive Jonathan Symonds as new Chairman: Bloomberg Medical Dialogues Bureau15 July 2019 2:29 PM ISTThe appointment of Jonathan Symonds, currently the deputy chairman at HSBC Holdings Plc, still needs to be finalized and is subject to approval from...
Lupin to focus on launch of biosimilar, inhalation product in US this fiscal Medical Dialogues Bureau15 July 2019 9:45 AM ISTCoupling this with the building of Solosec brand in the US, NaMuscla in Europe and Bipresso in Japan will help Lupin drive sustainable growth, they...
Gilead to raise stake in Belgian Biotech Galapagos in USD 5.1 billion deal: Report Medical Dialogues Bureau15 July 2019 9:30 AM ISTThe deal is the largest Gilead has executed since new Chief Executive Officer Dan O'Day took the reins in March as he attempts to bolster the San...
First-in-human Trial: Cyxone begins Phase 1 trial with T20K for treatment of multiple sclerosis Medical Dialogues Bureau15 July 2019 9:00 AM ISTCyxone's application to start a first-in-human, phase I, trial with their prophylactic drug candidate T20K targeting multiple sclerosis (MS) has been...
Aurobindo Pharma in focus on launch of generic version of Sensipar tablets in US Farhat Nasim14 July 2019 10:15 AM ISTAurobindo Pharma's Cinacalcet Hydrochloride tablets 30mg, 60mg, and 90mg is a generic version of Amgen Inc's Sensipar tablets, Cinacalcet...
Laurus Labs gets no USFDA observations for Vizag unit Medical Dialogues Bureau14 July 2019 10:00 AM ISTThe maiden United States Food and Drug Administration (USFDA) audit for the unit was successfully completed without any observations and no Form 483...
