Mabvax Therapeutics Holdings Inc., of San Diego, priced a public offering o $8.625 million of common stock and series F preferred stock at $4.81 per share of common stock or series F preferred stock. Laidlaw & Co. (UK) Ltd. acted as the sole book-running manager. Underwriters have a 45-day option to purchase up to an aggregate of 169,179 additional shares (with additional class A warrants and class B warrants) solely to cover overallotments. Read More
The FDA sent a warning letter to Zhejiang Medicine Co. Ltd. referencing data and quality testing issues at its API facility in Xinchang, China. During an inspection at the plant more than a year ago, FDA investigators observed staff conducting multiple unofficial gas chromatography (GC) analyses of samples for residual solvents and recording the data in separate folders before conducting the officially reported sample analyses. The unofficial data, some of which showed large peaks, were not used to evaluate the quality of the API or to make batch release decisions. . Read More
The Female Health Co. (FHC), of Chicago, and Aspen Park Pharmaceuticals Inc. (APP), of New York, said the FDA agreed to an expedited regulatory pathway for APP's tamsulosis DRS (delayed-release sachet) for benign prostatic hyperplasia under the 505(b)(2) pathway. A three-week bioequivalence study will be initiated in the fourth quarter, with plans to submit an NDA in 2017. FHC and APP inked a merger agreement earlier this year. Read More
In January, after Eleven Biotherapeutics Inc. disclosed mixed phase III data in severe allergic conjunctivitis with the interleukin-1 (IL-1) signaling inhibitor EBI-005 (isunakinra) – which also proved a dud in the late-stage experiment for dry eye disease in May 2015 – the stock took a 77 percent hit and Wall Street retreated. Read More
Avelas Biosciences Inc. raised $20 million in a series C financing that the company will use to carry its cancer imaging agent, AVB-620, into late-stage trials while also developing new targeted cancer therapies that leverage its Activatable Cell Penetrating Peptide platform. Read More
DUBLIN – Shares in Indivior plc rose more than 21 percent to an all-time high during early trading Wednesday on news that RBP-6000, a once-per-month depot injection of buprenorphine, hit the primary endpoint of a phase III trial in patients with opioid use disorder. Read More
As the Exome Aggregation Consortium (Exac) published findings from their deep dive into the genetic well Wednesday, another set of scientists published a cautionary tale illustrating the sort of clinical problem that Exac's Exome Sequencing Project (ESP) can address. (See story in this issue.) Read More
LONDON – The power of big data in human biology is exemplified in a paper published Wednesday in Nature analyzing genetic variation in the protein-coding exomes of 60,706 healthy volunteers. Read More
