Loxo Oncology Inc. wasn't actively seeking a partner for its two most advanced contenders for the treatment of a rare type of genetically defined cancer but, given the opportunity to nail down a potential $1.55 billion deal with Bayer AG, "we saw the financial and strategic rationale," Jacob Van Naarden, Loxo's chief business officer, told BioWorld. Read More

Proteus Digital Health Inc. and Otsuka Pharmaceutical Co. Ltd. have received FDA approval to market what they call 'digital pill' technology to treat mental health disorders. Abilify Mycite is a drug-device combination product that consists of Tokyo-based Otsuka's oral aripiprazole tablets, embedded with Redwood City, Calif.-based Proteus' ingestible event marker sensor. Read More

Torque Therapeutics Inc. emerged from the deep, disclosing a series A by Flagship Pioneering that was opened in conjunction with its founding in 2015 and, with a second tranche pulled down in August, amounts to $25 million. Read More

Envisioning the potential of CRISPR to cure cancers, sickle cell anemia, eye diseases and possibly even Alzheimer's, members of the Senate Health, Education, Labor and Pensions (HELP) Committee searched for ways Congress could help advance the technology while ensuring ethical standards and safeguarding against unintended consequences and its use by the dark side. Read More

WASHINGTON – "There is nothing more beautiful than 20/20 hindsight," Huda Zoghbi told the audience at the 2017 Annual Meeting of the Society for Neuroscience. Read More

TOKYO – At least one multinational pharmaceutical giant may be considering introducing into the Japanese market a new drug pricing mechanism that would link the effectiveness with drug cost. Novartis Pharma K.K. is reported to be working with the Japanese government and the Ministry of Health, Labour and Welfare (MHLW) toward introducing a drug payment mechanism based on patient outcomes for a new and innovative therapy. Read More

SHANGHAI – Shanghai-based Ark Biosciences Inc., a virtual biotech, and the California Institute of Biomedical Research (Calibr), of La Jolla, an affiliate of The Scripps Research Institute (TSRI), one of the world's largest private biomedical research institutes, have partnered to develop preclinical assets for chronic obstructive pulmonary disease (COPD). Read More

Exithera Pharmaceuticals Inc. CEO Neil Hayward told BioWorld he's hoping to build a "continuum of care" around factor XIa inhibitor EP-7041, after phase I data showed the intravenous (I.V.) version of the antithrombotic safe and well-tolerated in healthy volunteers after single or multiple ascending intravenous doses – and even turned up some clues to efficacy. Read More

Apellis Pharmaceuticals Inc., of Crestwood, Ky., closed its IPO of about 10.7 million shares at $14 each for gross proceeds of about $150 million. Read More

Oncoquest Inc., of Edmonton, Alberta, presented preclinical data from its IgE-based immunotherapy platform at the Society for Immunotherapy of Cancer meeting in National Harbor, Md., demonstrating the generation of an antigen-specific immunity that protected against pancreatic cancer in a transgenic animal tumor model using combinatory immunotherapy with that class of antibodies. Read More

Oramed Pharmaceuticals Inc., of Jerusalem, said Israel's Ministry of Health granted the firm approval to start an exploratory study of its oral insulin capsule, ORMD-801, in patients with nonalcoholic steatohepatitis (NASH). Read More

The FDA hit Lupin Ltd., of Mumbai, with a warning letter citing problems with how the company dealt with out-of-specification results at several of its drug manufacturing plants and set hold times that were inadequate to assure drug quality. "These repeated failures at multiple sites demonstrate that your company's oversight and control over the manufacture of drugs is inadequate," the FDA said. The agency instructed Lupin to immediately and comprehensively assess its global manufacturing operations to ensure that the systems and processes, as well as the drugs, conform to FDA requirements. Read More

Cambridge Epigenetix Ltd., of Cambridge, U.K., appointed Hayden Jeffreys chief operating officer, and Joanne Mason vice president of biomarker discovery. Read More