The U.S. federal budget blues are not going anywhere anytime soon, but Sen. Roy Blunt, chairman of a Senate Appropriations subcommittee, said in a March 8 hearing that Senate appropriators are committed to a $2 billion annual increase in the NIH budget, which would combine with other recent increases to boost NIH funding by more than $44 billion over the coming decade. Read More
Spero Therapeutics LLC completed a $51.7 million series C preferred financing led by new investor GV (formerly Google Ventures) with the participation of additional new investors RA Capital Management and Rock Springs Capital as well as existing investors, including Atlas Venture, S.R. One Ltd., MRL Ventures Fund, Lundbeckfonden Ventures, the Kraft Group and Osage University Partners. Read More
Ocera Therapeutics Inc. CEO Linda Grais told BioWorld Today that a closer look at data from the failed-but-validating phase IIb STOP-HE study with intravenous (I.V.) OCR-002 (ornithine phenylacetate) gives the company "the basis for an argument that [ammonia levels] should at least be part of a potentially composite endpoint, but we do expect we would still need a clinical component as well" in the next experiments with the compound, in the works for hospitalized patients with hepatic encephalopathy (HE). Read More
DUBLIN – Breath Therapeutics Holding BV raised €43.5 million (US$46 million) in a series A round – Europe's largest so far this year – to undertake phase III trials of a drug-device combo, comprising a nebulizer-delivered, liposome-based formulation of cyclosporine A, in lung transplant patients with bronchiolitis obliterans syndrome (BOS), a chronic progressive airway inflammation that has a major impact on survival rates. Read More
TAIPEI, Taiwan – The government here, despite its good intentions, needs to make changes in its approach to the biopharma industry quickly, said speakers on the first day of the Biologics World Taiwan 2017 conference. Read More
PERTH, Australia – More patients with Pompe disease in New Zealand will now have access to Sanofi Genzyme's enzyme replacement therapy Myozyme (alglucosidase alfa), but not because the country's single payer will pay for the drug. Rather, Sanofi Genzyme, of Cambridge, Mass., part of Sanofi SA, has stepped in to provide the therapy for free to patients in New Zealand. Read More
Beyondspring Pharmaceuticals Inc., of New York, which is developing an immuno-oncology agent plinabulin, in a phase III trial for the reduction of docetaxel-induced neutropenia, has amended its IPO filing to now raise up to $3 million by offering 143,000 shares in the price range of $20 to $22. Read More
Allergan plc, of Dublin, said the FDA accepted for filing its supplemental NDA for Vraylar (cariprazine), seeking the addition of new clinical data evaluating the drug for the maintenance of efficacy in adults with schizophrenia to the current product label. Read More
Menlo Therapeutics Inc., of Menlo Park, Calif., said a phase II trial (TCP-102) evaluating serlopitant to treat pruritus (itch) associated with prurigo nodularis met its primary efficacy endpoint and key secondary endpoints, demonstrating a statistically significant reduction in pruritus (p Read More
Morton Grove Pharmaceuticals Inc., a subsidiary of Mumbai, India-based Wockhardt Ltd., received an FDA warning letter stemming from an inspection conducted more than a year ago at the Illinois facility. Read More
