Spark Therapeutics Inc. told BioWorld there was "not much more we can say beyond the press release" and the company wasn't offering executive interviews, but the buyout by Roche Holding AG generated vigorous buzz on Wall Street as pundits tried to guess which gene therapy firm might be next for a takeover in the space. Read More
DUBLIN – Ipsen SA is putting down $25 per share, or $1.04 billion in cash, to acquire Clementia Pharmaceuticals Inc. and is on the hook for a contingent value right (CVR) worth another $6 per share, or $263 million, which is tied to FDA acceptance of Clementia's NDA for its lead drug, palovarotene, in multiple osteochondromas (MO). Read More
Amid a growing global incidence of cardiovascular disease (CVD), Novartis AG has exercised the first of two options it holds on antisense drugs developed by Ionis Pharmaceuticals Inc. affiliate Akcea Therapeutics Inc., triggering a $150 million payment to Akcea from Novartis and boosting its shares (NASADQ:AKCA) by 16.7 percent to $31.91 on Monday. Read More
U.S. prescription drug prices will be on the menu again Tuesday, as Congress continues to serve up a steady diet of outrage over what some biopharma companies are charging. Read More
General Electric Co.'s (GE) spinout of its Healthcare business in an IPO has been a highly anticipated med-tech industry event for 2019. But now all that is back into play. The Boston-based conglomerate has opted to sell its Biopharma business for $21.4 billion to Danaher Corp. That Biopharma unit accounted for about 15 percent, or about $3 billion, of the almost $20 billion in 2018 Healthcare revenues. Read More
HONG KONG – Taiwan-U.S. biopharma company Foresee Pharmaceutical Co. Ltd. said its core program, FP-001 LMIS (leuprolide mesylate injectable suspension) 25 mg, has shown positive phase III data, similar to those of its FP-001 LMIS 50 mg and marketed drugs of the same class. Read More
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is asking industry stakeholders for feedback on a draft guidance to reform the generic drugs market authorization process. Read More
Karyopharm Therapeutics Inc. (NASDAQ:KPTI) was still reeling Monday, a day ahead of its meeting with the FDA's Oncologic Drugs Advisory Committee. Hitting an all-time record for the Newton, Mass.-based company, nearly 16.6 million shares were traded Friday when the FDA released its briefing materials for the meeting, raising concerns that Karyopharm's lead agent, selinexor, wouldn't get support for accelerated approval to treat refractory multiple myeloma. Read More
Biomarin Pharmaceutical Inc., of San Rafael, Calif., said its net loss for 2018 decreased $39.8 million, or 34 percent, to $77.2 million, compared to $117 million in 2017. The net loss for the quarter ended Dec. 31 decreased to $3.6 million, compared to a net loss of $51.4 million for same period in 2017. Read More
Melinta Therapeutics Inc., of Morristown, N.J., which is focused on the development and commercialization of antibiotics, said it received the initial $75 million disbursement under a convertible loan facility from Vatera Healthcare Partners LLC. In addition, an amendment to the facility agreement with funds managed by Deerfield Management Co. LP also became effective. Read More
TC Biopharm Ltd. (TCB), of Glasgow, Scotland, disclosed a collaboration with Trinity College Dublin to accelerate in-house production of medicines based on donor cell banks for the treatment of solid tumors. TCB will manufacture GMP-compliant candidates that will be combined with its off-the-shelf tumor-targeted T-cell platform to generate candidates to treat a range of cancer types. Initial studies are planned for late 2019. Read More