Anthera Pharmaceuticals Inc., of Hayward, Calif., completed patient recruitment for its phase III RESULT trial testing Sollpura in patients with exocrine pancreatic insufficiency caused by cystic fibrosis. Results of an interim futility analysis are expected in December and top-line data should be available in the first quarter of 2018. Read More
Otsuka Pharmaceutical Co. Ltd., of Tokyo, said the FDA accepted the resubmission of its NDA for tolvaptan in the treatment of adults with autosomal dominant polycystic kidney disease. The resubmission, which was assigned a PDUFA action date of April 24, 2018, is a response to a complete response letter issued in August 2013. Read More
Apellis Pharmaceuticals Inc., of Crestwood, Ky., said it priced its IPO of 10.7 million shares of common stock at $14 per share for total gross proceeds of approximately $150 million. In addition, the company has granted the underwriters a 30-day option to purchase up to 1.6 million additional shares of common stock at the public offering price. Read More
Sage Therapeutics Inc. scored a big win Thursday, disclosing positive top-line data from its pivotal program testing brexanolone in postpartum depression (PPD), results that should support regulatory filings next year and position the intravenously administered drug (previously known as SAGE-547) as potentially the first treatment specifically for PPD. Read More
SHANGHAI – At China Trials 10, the optimism around the recent regulatory reforms – specifically those opening China to early stage and multiregional clinical trials – come with a hint of anxiety, as evidenced in the conference title: "Entering the New Era of China Clinical Development – Are We Ready?" Read More
Otonomy Inc. CEO David Weber told BioWorld that researchers at his firm "have what we need to continue moving forward" in Ménière's disease with Otividex, the sustained-exposure formulation of dexamethasone that cheered investors by ringing the phase III bell after a similar late-stage experiment failed. Read More
With an eye to sustaining its multiple sclerosis (MS) franchise, Sanofi SA plucked a Bruton's tyrosine kinase (BTK) inhibitor from Principia Biopharma Inc. The Paris-based pharma agreed to pay $40 million up front, with milestone payments that could reach $765 million, for the oral candidate, PRN-2246, which recently became the subject of a phase I study in healthy volunteers. Read More
The FDA finalized a 2015 draft guidance on evaluating drug effects on the ability to drive a vehicle. In response to comments on the draft, the FDA said it made multiple clarifications throughout the final guidance. Read More
