Non-compliance of norms: USFDA recommends action against Strides Pharma Puducherry facility Farhat Nasim6 May 2019 10:05 AM ISTStrides Pharma has received a communication from the US Food and Drug Administration (USFDA) on May 4, 2019, classifying the facility as OAI based on...
Lupin, Zydus Cadila recall products in US; includes BP drug Carvedilol Farhat Nasim6 May 2019 10:00 AM ISTLupin Somerset is recalling 46,700 bottles of Morphine Sulfate extended-release tablets in various strengths due to "failed impurities/degradation...
Patent Infringement: Vectura wins case against GSK; awarded $89.7 million in damages Farhat Nasim6 May 2019 9:30 AM ISTVectura started legal proceedings against GSK in July 2016 after a patent license agreement between the two companies expired and GSK declined to...
China war on healthcare costs lure Indian drugmaker Sun Pharma: Report Medical Dialogues Bureau6 May 2019 9:15 AM ISTChina has rolled out an ambitious multi-city bulk procurement program that's driving down prices and providing an opening for Indian manufacturers...
CDSCO Committee rejects proposal for additional Indications of Dapaglofizin Meghna A Singhania5 May 2019 12:52 PM ISTNew Delhi: British-Swedish multinational drugmaker, AstraZeneca's stride to win approval from the Indian drug regulators for the additional...
Eli Lilly to present new data on Emgality, Lasmiditan at AAN annual meeting Farhat Nasim5 May 2019 10:00 AM ISTEmgality is also currently under Priority Review by the FDA as an investigational drug for the preventive treatment of episodic cluster headache in...
Amgen, Syapse enters precision medicine collaboration in Oncology Garima5 May 2019 9:30 AM ISTUnder the terms of the agreement, Amgen and Syapse will develop observational research analytics to assess treatment outcomes for areas of unmet need...
Novo Nordisk Q1 profit tops forecast as new diabetes drug Ozempic shines Medical Dialogues Bureau5 May 2019 9:15 AM ISTSales of the treatment, branded Ozempic, rose to 1.4 billion Danish crowns ($209 million) in the quarter, trumping analyst forecasts for 1.3 billion...
McKesson to pay $37 million to settle West Virginia opioid lawsuit Medical Dialogues Bureau5 May 2019 9:00 AM ISTUnder the agreement, McKesson will pay $14.5 million this year and another $4.5 million annually for the next five years. It said the money will go...
NPPA fixes retail price of 20 drugs including FDCs for Blood pressure control, dual antiplatelet Meghna A Singhania4 May 2019 12:31 PM ISTNew Delhi: Through a recent notification, the government regulatory agency, the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail...
Cadila Healthcare gets 14 USFDA observations for Moraiya plant Farhat Nasim4 May 2019 10:00 AM ISTThe US Food and Drug Administration (USFDA) inspected the plant from April 22, 2019 to May 3, 2019, Cadila Healthcare said in a regulatory filing.New...
Generic of Sensipar: US court denies Amgen request for preliminary injunction against Cipla Farhat Nasim4 May 2019 9:45 AM ISTCipla's cinacalcet hydrochloride tablets in the strengths of 30mg, 60mg and 90mg are generic versions of Sensipar, a branded drug marketed by Amgen...
