Cardiologist Robert Califf of the Duke Clinical Research Institute was the target of some opposition from inside and outside of Capitol Hill in his nomination for the position of FDA commissioner, but the Senate hearing Tuesday went so smoothly the physician didn't have to say a word on his own behalf. The nomination passed out of a unanimous voice vote that next goes to the Senate floor in what seems a certain confirmation of the Obama administration's nominee. Read More
Even with a lineup of FDA-cleared therapies available for the condition, age-related macular degeneration (AMD) continues to draw interest, as drug developers work to invent still more efficacious and longer-lasting treatments for the blindness-causing scourge of the elderly. Read More
The Psychopharmacologic Drugs Advisory Committee (PDAC) voted 12-5 to recommend approval of Braeburn Pharmaceuticals Inc.'s Probuphine, a subdermal buprenorphine implant intended to fight opioid dependence. Read More
SAN FRANCISCO – Investors gathered to glean new details of the pending $160 billion combination of Pfizer Inc. and Allergan plc at the J.P. Morgan Healthcare Conference came away with little more than a better picture of each company's enthusiasm for the other and disappointment in outside appraisals of their pipelines. Read More
SAN FRANCISCO – Rough start for the year to the public markets? No worry for privately held Moderna Therapeutics Inc., which has no plans to go public this year, according to CEO Stéphane Bancel. Read More
SAN FRANCISCO – FDA support for Mesoblast Ltd.'s plan to nearly halve the size of an ongoing phase III study in chronic heart failure and alter its endpoint will make the study significantly cheaper and faster to read out, while also making it more clinically and economically meaningful, CEO Silviu Itescu told BioWorld Today. Read More
SAN FRANCISCO – Ironwood Pharmaceuticals Inc., of Cambridge, Mass., has set out to show investors that it has a strategy in place to build a sustainable commercial enterprise generating high-margin growth. Read More
The enzyme kynurenine mono-oxygenase (KMO), which metabolizes tryptophan, plays an important role in the progression from acute pancreatic inflammation to multiple organ failure in animal models, researchers from the British University of Edinburgh reported in the Jan. 11, 2016, advance online issue of Nature Medicine. Read More
DUBLIN – The latest contender to emerge from Spain's fledgling biotech sector is Aelix Therapeutics SL, which has raised €11.5 (US$12.6 million) in a series A round to fund clinical development of a therapeutic vaccine for HIV infection. Read More
A week ahead of the Medicare Payment Advisory Commission's (MedPAC) vote on its draft payment recommendations for fiscal 2017, the American Hospital Association (AHA) is sounding an alarm on a recommendation that would reduce Medicare payments to hospitals participating in the 340B drug pricing program by 10 percent of the average sales price. Read More
Cardiome Pharma Corp., of Vancouver, British Columbia, executed a purchase agreement with Lincoln Park Capital Fund LLC (LPC), a Chicago-based institutional investor, to purchase up to $20 million worth of common shares in the capital of the company. Under the terms, Cardiome can sell the amount to LPC from time to time over the 24-month term of the purchase agreement. Read More
Merck & Co. Inc., of Kenilworth, N.J., acquired Iomet Pharma Ltd., a privately held U.K.-based drug discovery company focused on development of cancer medicines, with an emphasis on fields of cancer immunotherapy and cancer metabolism. Read More
Brainstorm Cell Therapeutics Inc., of New York, said an amyotrophic lateral sclerosis (ALS) treatment using a stem cell infusion protocol developed by the firm and performed at Hadassah Medical Organization has significantly slowed the progression of ALS. Read More
