Forward Pharma A/S, a Danish biotech developing a dimethyl fumarate (DMF) therapy for immune disorders, filed to raise up to $200 million in an initial public offering (IPO) that revealed at least one of the company's patents could conflict with a central claim protecting Biogen Idec Inc.'s Tecfidera, a fast-rising DMF-based multiple sclerosis (MS) therapy.
Daiichi Sankyo Co. Ltd. is investing up to $650 million in a Charleston Laboratories Inc. subsidiary to back development and U.S. commercialization of its hydrocodone combination drug portfolio, including CL-108, a late-stage therapy providing the pain relief of hydrocodone without the common nausea and vomiting associated with the widely prescribed opioid.
The FDA approved The Medicines Co.'s antibiotic Orbactiv (oritavancin) after the market close Wednesday, making the acute care specialist the latest player to market a product to treat acute bacterial skin and skin structure infections (ABSSSIs) outside hospitals, where multi-day stays can lead to big bills for both patients and payers.
Enumeral Biomedical Holdings Inc., an early stage immunomodulator discovery and development venture, has transitioned to the OTCQB through a reverse merger with a shell company simultaneous with the close of a $21.5 million equity financing.
Roche AG is deepening its investment in the attractive but challenging field of RNA-targeting antisense therapies by acquiring Santaris Pharma A/S, one of its two partners in the space, for $250 million up front plus an additional $200 million should Santaris meet pre-determined milestones.
Ophthamology specialist Ocular Therapeutix Inc. downsized its initial public offering (IPO), raising $65 million through the sale of 5 million shares sold at $13 each instead of the company's desired $14 to $16.
Merck & Co. Inc. enrolled the first patient in a global phase III study of letermovir (MK-8228, AIC246), an experimental cytomegalovirus (CMV) antiviral it licensed from Aicuris GmbH.
Gilead Sciences Inc. reported that Sovaldi (sofosbuvir) sales hit nearly $3.5 billion for the second quarter, blowing past analyst forecasts of about $2.6 billion for the quarter and accounting for more than half its total antiviral sales.
Profits at Biogen Idec Inc. surged in the second quarter on strong sales of Tecfidera (dimethyl fumarate) and its other multiple sclerosis (MS) therapies, beating analyst expectations and pumping up sales forecasts as the company notched a new drug approval in Europe.
Policy changes expanding access to patient health data and better fostering collaboration through transparency will be crucial to expediting patient access to new therapies, witnesses told members of the House Subcommittee on Health Tuesday, where lawmakers and experts alike testified to their frustrations over the yawning gap between the power data-sharing has enabled in the private sector and the barriers created by regulation and interoperability issues in American health care.
