The widely expected approval of Sage Therapeutics Inc.'s 60-hour intravenous (I.V.) Zulresso (brexanolone) in postpartum depression (PPD) opens the marketing door to the first therapy approved in the indication and raised investor hopes for Marinus Therapeutics Inc., developing a similar PPD therapy in I.V.-to-oral form as well as an all-oral version. Read More
DUBLIN – Alexion Pharmaceuticals Inc. is loading up on 'Scandi' technologies to broaden its clinical and research pipeline, striking deals with Solna, Sweden-based Affibody AB on clinical-stage "affibody" drug ABY-039, which targets the neonatal Fc receptor (FcRn), and with Copenhagen, Denmark-based Zealand Pharma A/S on an alliance to develop up to four peptide-based therapies for complement-mediated diseases. Read More
Pfizer Inc. joins several big pharma companies, including Roche Holding AG and Novartis AG, who have recently cut gene therapy deals, with its acquisition of a 15 percent equity interest in privately held Vivet Therapeutics SAS. Read More
DUBLIN – PDC*line Pharma SAS could earn up to €108 million (US$122.7 million) in up-front and milestone payments from a license and option agreement with LG Chem Ltd. for its cell-based cancer vaccine, PDC*lung, which is in development for non-small-cell lung cancer. Read More
It's been nearly a decade since Congress mapped out a route for biosimilars in the U.S. and four years since the FDA approved its first biosimilar. Over the past four years, the agency has approved 17 more biosimilars, but the handful that have come to market have met with mixed success. Read More
SINGAPORE – The days of blockbuster drugs may be coming to an end, but Harish Dave, chief medical officer at Singapore-based Aum Biosciences Pte. Ltd., offered companies a new term. During the second day of the Phar-East Pharma and Biotech Festival biopharma conference, Dave said companies should focus on "niche-busters" and finding new sectors to dominate instead. Read More
An inhibitory protein that has been used for proof of principle of Myc inhibition through transgenic delivery was also able to inhibit Myc after intravenous delivery in animal models. Read More
SAN FRANCISCO – Investors and entrepreneurs at the 12th Annual Cooley Healthtech Conference, undaunted by the trenchant challenges of integrating new technologies into a slow-changing U.S. health care system, said they're finding increasing purchase for businesses built on rich and growing datasets, ever-present connectivity and, in some cases, the irreplaceable magic of the human touch. With the pressures of macroeconomic uncertainties weighing less heavily on the sector than at last year's end, optimism abounded during two presentations assessing med tech's progress at the Wednesday event. Read More
Dermira Inc., of Menlo Park, Calif., said it priced its underwritten public offering of 9.81 million shares at $13.25 each for gross proceeds of approximately $130 million. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 1.47 million shares on the same terms and conditions. Read More
Hemoshear Therapeutics LLC, of Charlottesville, Va., said it extended its 2017 partnership with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, for the discovery and development of therapeutics to treat liver diseases, including nonalcoholic steatohepatitis, which so far has generated several drug discovery therapeutic targets. Additional financial terms were not disclosed. Read More
As part of its Brexit planning, the Medicines and Healthcare Products Regulatory Agency (MHRA) issued guidance Wednesday on the registration of clinical trials, publishing of trial results and future requirements if the U.K. leaves the EU without a deal. Read More
