Like it or not, "we are going to bring negotiation to [Medicare] Part B drugs, and we are going to give Part D plans more bargaining power," U.S. Health and Human Services (HHS) Secretary Alex Azar vowed Wednesday, taking aim at industry pushback on the Trump administration's plan to bring down prescription drug prices. Read More
Prolific researcher, serial entrepreneur and investor Gregory Verdine nailed another nameplate to his wall with the formal introduction of 2016 startup Fog Pharmaceuticals Inc. (Fogpharma) in conjunction with the close of a $66 million series B. The round was led by 6 Dimensions Capital with participation from additional new investors GV (formerly Google Ventures), Blue Pool Capital, Horizons Ventures, Nan Fung Group and Leerink Partners. Existing investors Deerfield Management, Boyu Capital, Wuxi Apptec Corporate Ventures and undisclosed international noninstitutional investors joined the round. Read More
Hifibio Therapeutics, a platform player until now, has secured an oversubscribed $37.5 million series B financing aimed at helping it build its own pipeline of antibody therapies for cancer and autoimmune disorders. Meanwhile, the company will continue to form new strategic partnerships, it said, such as earlier-established tie-ups with Pfizer Inc. and Janssen Biotech Inc. Read More
With the countdown continuing to the Aug. 13 PDUFA date for Amicus Therapeutics Inc.'s migalastat in Fabry disease, Idorsia Ltd. has enrolled its first patient in a phase III registration study investigating the oral monotherapy lucerastat in that indication as well. Read More
The FDA has floated a rewrite of the so-called Part 3 appeals process for combination product designation to address widespread confusion about the process, but regulatory attorney Brad Thompson, of Epstein Becker Green, said the proposed changes would effectively reduce the rule to a guidance, which benefits the FDA in that "guidance can't be cited as a binding requirement against FDA" in legal proceedings. Read More
TEL AVIV, Israel – Corporate venture capital investors have taken an outsized role in biotech deals, adding to a flood of capital that is driving up valuations in the pharma and biotech spaces. Read More
HONG KONG – Denmark's Novo Nordisk A/S has teamed up with Singapore's Duke-NUS Medical School to provide funding for the next three to five years for stem cell-based research aimed at growing heart muscle and retinal cells to treat heart failure and vision loss. Read More
Cytrx Corp., of Los Angeles, closed its registered direct offering of 5.6 million shares priced at $1.25 apiece for gross proceeds of $7 million. The oncology-focused company will use net proceeds of about $6.5 million for working capital and general corporate purposes, including possible new drug discovery activities and acquisitions or mergers. H.C. Wainwright & Co. acted as the exclusive placement agent. Read More
Pharmacyte Biotech Inc., of Laguna Hills, Calif., said the cells it will encapsulate and then use in its planned clinical trial in patients with locally advanced, nonmetastatic, inoperable pancreatic cancer passed all 29 tests required by the FDA. Read More
