Bayer garnered support from FDA staff for its submission for approval of riociguat for two forms of pulmonary hypertension, though reviewers recommended clearing the experimental drug at a lower dose than the company sought.
Bayer is warning that its 2013 profits goals look a bit too ambitious now, but thanks to unexpectedly strong new-drug sales, it expects pharma revenue to jump by a high single-digit percentage. In fact, it hiked its forecast for sales from its newest products by 40%.
The company not only finally managed to make the IPO leap, it joined a select few which have priced their shares above the range, boosting their take and proving once again that the IPO door has swung wide open and the welcome mat is out--for now. The company sold 4.8 million shares at $17, above the $14 to $16 shares range laid out earlier. The offering raised $82 million.
Onyx Pharmaceuticals doesn't want to sell itself to Amgen for $120 a share. But it would sell out to a bidder with the right offer. The cancer-drug developer says it's entertaining shoppers, expecting a price tag markedly higher than Amgen's $10 billion.
A little more than a day after the Financial Post broke the story that Amgen had bid $120 a share for Onyx Pharmaceuticals, the biotech company has confirmed the offer and put the company up on the auction block.
The European Medicines Agency's experts have backed approval for two drugs that have already gained green lights for the U.S. market.
The FDA keeps offering up tough news to Johnson & Johnson for its warfarin replacement, Xarelto. It has twice turned it down for treatment of acute coronary syndrome (ACS), and today the company said it had a complete response letter for use of the bloodthinner to prevent stent thrombosis in patients with ACS.
The U.K.'s cost-effectiveness watchdog gave final clearance to Bayer's anticoagulant drug Xarelto for use in preventing potentially fatal blood clots in the lungs and legs. Meanwhile, Boehringer Ingelheim was filing for European approval for its new-generation anticoagulant, Pradaxa, for similar uses.
Seattle Genetics, which has a who's who in oncology drug development signed on as ADC collaborators, gets $20 million of that upfront with the rest in milestones.
Bayer has wrapped up its $1.1 billion acquisition of Conceptus, adding the company's permanent birth control device to its flagging contraceptive business.