A Series C financing round of $10 million will support clinical studies and commercial launch of Regentis Biomaterials Ltd.'s knee cartilage regeneration product, GelrinC, in Europe, including a sales force and a postmarket study.
The FDA Antiviral Drugs Advisory Committee (AVAC) voted 13 to 1 in favor of approval for Gilead Inc.'s single-tablet Quad regimen (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) for treatment-naive adult patients with HIV-1 Friday after a day-long deliberation that exhaustively examined the issue of renal impairment.
GlaxoSmithKline plc's $2.6 billion acquisition offer for Rockville, Md.-based Human Genome Sciences Inc. (HGS) turned hostile when GSK announced that it would not participate in a strategic alternatives review process with HGS, and that it would instead commence its tender offer for all outstanding shares for $13 per share in cash, which it first put forward April 11.
Briefing documents released in advance of Thursday's meeting of the FDA's Endocrinological and Metabolic Drugs Advisory Committee (EMDAC) suggested Arena Pharmaceuticals Inc. may have allayed many of the agency's concerns about the safety of its weight loss drug Lorqess (lorcaserin).
Cystic fibrosis patients received welcome good news Monday, as Vertex Pharmaceuticals Inc. reported that its ongoing Phase II trial of VX-809 and Kalydeco (ivacaftor) showed significant lung function improvements in an interim analysis of patients homozygous for the F508del mutation.
Alexza Pharmaceuticals Inc. (NASDAQ:ALXA) stock closed at 49 cents Friday, a loss of 12 cents, or about 20 percent, on news that the FDA had issued a complete response letter for its new drug application for Adasuve (loxapine) inhalation powder for agitation in schizophrenia and bipolar disorder.
Gilead Sciences Inc. began a Phase III trial of its PI3K inhibitor, GS-1101, in chronic lymphocytic leukemia (CLL). If successful, the company could add a cancer candidate to its powerhouse lineup of products currently led by its HIV and hepatitis C virus franchises.
After dropping its price drastically from a target range of $12 to $14, Supernus Pharmaceuticals Inc., of Rockville, Md., priced an initial public offering of 10 million shares of common stock at $5 per share. But the stock (NASDAQ:SUPN) opened strong and by the end of the day had gained 37 cents, or 7.4 percent, to close at $5.37.
The privately held UK specialty oncology firm EUSA Pharma Ltd. is to be acquired by Jazz Pharmaceuticals Inc. in a $700 million cash deal that is motivated by the early commercial success of EUSA's Erwinaze treatment for pediatric acute lymphoblastic leukemia (ALL), approved by the FDA in November 2011.
