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Novartis is hoping its multiple sclerosis candidate siponimod's performance in secondary progressive patients can help secure it a blockbuster approval. And now it has more data to put toward that case. [...]
Fri, Apr 20, 2018
Source FiercePharma
WHO advisers changed their recommendations for Sanofi's Dengvaxia, saying it should be used after a diagnostic confirms a prior infection. But as of now, fast and reliable tests don't exist. [...]
Fri, Apr 20, 2018
Source FiercePharma
Allergan was in and out of pursuit for Shire as Takeda's third offer was rejected, Hanmi ditched its would-be Tagrisso rival olmutinib, Grail is reportedly considering a $1 billion financing before its expected Hong Kong IPO, and more. [...]
Fri, Apr 20, 2018
Source FiercePharma
The PharmaTimes Communications Team of the Year competition is the only pharma industry award that tests the competencies and potential of communications agency teams, benchmarking talent agency side – and as such, entry is a must. [...]
Fri, Apr 20, 2018
Source PharmaTimes
With just 9 days to go until the prestigious PharmaTimes Clinical Researcher of the Year Awards Ceremony, the 2018 finalists are gearing up for their biggest challenge yet. [...]
Fri, Apr 20, 2018
Source PharmaTimes
Shire has now confirmed that it has thus far rejected three merger proposals from Takeda, the last one being valued at around $44 billion. [...]
Fri, Apr 20, 2018
Source PharmaTimes
As expected, an FDA advisory panel has backed approval of GW Pharmaceuticals/Greenwich Bioscience's Epidiolex for treating seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. [...]
Fri, Apr 20, 2018
Source PharmaTimes
Novartis' prospects for launching a copy of GlaxoSmithKline's Advair this year just went from highly unlikely to not happening. Rejected by the FDA earlier this year, the copycat needs a small bridging study before the agency can take another look, CEO Vas Narasimhan said. [...]
Thu, Apr 19, 2018
Source FiercePharma
Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Hemlibra (emicizumab-kxwh) for people with haemophilia A without factor VIII inhibitors. Breakthrough Therapy Designation is designed to accelerate the development and review of medicines intended to treat a [...]
Tue, Apr 17, 2018
Source WorldPharmaNews
Novartis
Novartis announces a five-year commitment to the fight against malaria in conjunction with the 7th Multilateral Initiative on Malaria Conference and the Malaria Summit of the Commonwealth Heads of Government meeting. Further, the company releases new African research on progress and remaining challenges toward the 2030 malaria elimination targets, together [...]
Tue, Apr 17, 2018
Source WorldPharmaNews
Boehringer Ingelheim
Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) have announced an academic collaboration with the University of Oxford. EMPA-KIDNEY will investigate the effects of empagliflozin on the progression of kidney disease and the occurrence of cardiovascular death, in people with established chronic kidney disease with and without diabetes. [...]
Mon, Apr 16, 2018
Source WorldPharmaNews
Bristol-Myers Squibb
Bristol-Myers Squibb Company (NYSE: BMY) today announced a worldwide collaboration with Janssen Pharmaceuticals, Inc. (Janssen) on a Factor XIa (FXIa) inhibitor program that includes the development and commercialization of Bristol-Myers Squibb's Factor XIa (FXIa) inhibitor, BMS-986177, an investigational anticoagulant compound being studied for prevention and treatment of major thrombotic conditions. [...]
Mon, Apr 16, 2018
Source WorldPharmaNews
Sponsors submitting pediatric study plans should consider whether a product affects adults and children similarly when choosing an approach, the FDA says. [...]
Fri, Jan 16, 2015
Source FDANews