DUBLIN – Sanofi SA CEO Olivier Brandicourt turned up the heat on Medivation Inc. Thursday, by publicly releasing another letter to the company's board in support of its $9.3 billion cash bid, just hours ahead of Medivation's first quarter earnings call. Read More
Two FDA advisory committees weren't bowled over by the abuse-deterrent properties of Kempharm Inc.'s Apadaz, but they said the immediate-release (IR) opioid has a place on the market. That wasn't enough to curb the reaction on Wall Street. Read More
Analysts and investors found plenty to like in first quarter earnings from Regeneron Pharmaceuticals Inc., which beat consensus revenue forecasts with approximately $1.2 billion in global sales, including a 44 percent increase in U.S. and global net sales of Eylea (aflibercept). Read More
With the FDA having specifically called out alopecia areata in its list of patient-focused drug development concerns, Concert Pharmaceuticals Inc. could be "in the right place at the right time" with new pipeline candidate CTP-543, CEO Roger Tung told BioWorld Today. Read More
LONDON – A government-mandated study of how to accelerate access to new drugs will recommend that a select group of highly innovative products be singled out for special treatment, with plans agreed during development to take them all the way through regulatory approval, health technology assessment and commissioning at scale in the U.K.'s single payer National Health System (NHS). Read More
Viewpoint Therapeutics Inc., of San Francisco, said it closed a $4 million series A financing, which was co-led by Mission Bay Capital and Lagunita Biosciences LLC. Read More
Promis Neurosciences Inc., of Toronto, said it identified a fourth in a series of potential therapeutic targets on strains of misfolded amyloid beta, implicated in the development and progression of Alzheimer's disease. Read More
The U.S. Court of Appeals for the Federal Circuit in Washington heard arguments Thursday during an en banc hearing regarding disputed patents relating to The Medicines Co.'s anticoagulant drug, Angiomax (bivalirudin). Read More
Ionis Pharmaceuticals Inc., of Carlsbad, Calif., provided an update on its CARDIO-TTR study, which is on clinical hold by the FDA while London-based Glaxosmithkline plc answers protocol questions. On a call related to earnings, management confirmed that the concerns focus on platelet reductions seen in TTR patients in the NEURO-TTR study, which is fully enrolled and expected to read out in the first half of next year, noted analyst Michael Schmidt with Leerink. The compound is an antisense drug designed to reduce the production of transthyretin, or TTR, to treat all forms of TTR amyloidosis. Read More