Clarus Ventures has a two-pronged, "roughly equal-weighted" strategy with its latest fund, Clarus III, which closed at $500 million, well above the targeted $375 million, managing director Scott Requadt told BioWorld Today: therapeutics-focused companies at all stages, with breakthrough science and/or best-in-class assets, and R&D risk-sharing partnerships with the pharmaceutical and biotech industries. Read More
LONDON – The EMA is opening the way for the approval of bacteriophages as approved medicinal products for treating bacterial infections, convening academics, clinicians, industry and regulatory experts to discuss the issues involved at a workshop in London. Read More
FDA reviewers spotlighting the first two drugs in a new class of cholesterol-lowering therapies to be considered by its advisors this week suggested that each injectable medicine provides benefits, but also expressed concerns about which patients might benefit most and what side effects patients taking the new drugs may encounter. Read More
BOSTON – Overall, physicians and patients can take heart from the results of two cardiovascular outcomes trials presented at the 75th annual meeting of the American Diabetes Association. Read More
SHANGHAI – The Beijing-based oncology company Beigene Co. Ltd. continuing its string of upbeat news, announcing the first human dosing of its programmed death-1 (PD-1) antibody, BGB-A317, in Australia. Read More
TAIPEI, Taiwan – Pharmaengine Inc. said it submitted a new drug application (NDA) to the TFDA, Taiwan's drug regulatory body, for the liposome version of irinotecan, PEP02, as a second-line treatment for pancreatic cancer patients who have failed gemcitabine therapy. Read More
Celtaxsys Inc. corralled a stable of investors, led by Domain Partners, to complete a $40 million series D round that was supplemented by an additional $5 million grant from Cystic Fibrosis (CF) Foundation Therapeutics, the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation (CFF). Read More
The FDA is being hauled into court again over its refusal to grant a five-year new chemical entity (NCE) exclusivity. Ferring Pharmaceuticals Inc., of Parsippany, N.J., filed suit last week in the U.S. Read More
Spero Therapeutics LLC, of Cambridge, Mass., secured $30 million in a series A financing that was led by new investor Lundbeckfond Ventures with participation from additional new investors Merck Research Ventures and the Kraft Group. Read More
Insys Therapeutics Inc., of Phoenix, completed a 2-for-1 stock split, effected through a stock dividend. On June 5, shareholders received one additional share of Insys common stock for each share they held at the close of business on May 26. Read More
Paion Inc., a Mahwah, N.J.-based subsidiary of Aachen, Germany-based Paion AG, has started the second pivotal U.S. phase III trial of remimazolam, an ultra-short-acting sedative/anesthetic, for procedural sedation in patients undergoing bronchoscopy. Read More
Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, reported phase III results showing that the use of initial combination therapy of canagliflozin and metformin extended release (XR) in people with type 2 diabetes with higher A1C levels and who treat their type 2 diabetes with diet and exercise only – where monotherapy is unlikely to be adequate to reach glycemic goals – was effective and generally well tolerated. Read More
