Merrimack Pharmaceuticals Inc., of Cambridge, Mass., said data showing that MM-141 is able to inhibit oncogenic signaling through the PI3K/AKT/mTOR pathway was published in Molecular Cancer Therapeutics. Read More
Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., said it completed enrollment and dosing of 500 patients in the pivotal study of Ampion for the treatment of acute osteoarthritis (OA) of the knee. Read More
Actavis plc, of Dublin, said it plans to acquire Forest Laboratories Inc., of New York, for a combination of cash and equity valued at approximately $25 billion or $89.48 per Forest share ($26.04 in cash and 0.3306 Actavis shares for each share of Forest common stock). Read More
Bayer Healthcare, of Whippany, N.J., reported positive results from the PROTECT VIII trial evaluating the company’s investigational long-acting site-specific pegylated recombinant human factor VIII compound BAY 94-9027. Read More
The majority of biologic license application (BLA) sponsors are fulfilling their postmarket requirements and commitments (PMRs/PMCs) in a timely manner, but there is room for improvement, according to the FDA. Read More
With phase IIb experiments under way in nondialysis chronic kidney disease patients with anemia, Akebia Therapeutics Inc. filed for an initial public offering (IPO) that would raise as much as $75 million, as plans also firm up for a phase II study in dialysis patients, slated to begin in the first half of this year. Read More
The long, hazard-fraught road for Chelsea Therapeutics International Ltd. with Northera (droxidopa) – including unfavorable briefing documents, followed by a positive advisory committee (adcom) vote – came to a happy end with approval of the drug by the FDA for neurogenic orthostatic hypotension (NOH), or a sudden drop in blood pressure when the patient stands up. Read More
Advanced Accelerator Applications SA (AAA) added €41 million (US$56 million) to its coffers in a private equity round led by HBM Healthcare Investments Ltd., which put up €20 million of the total. Read More
CHICAGO – “Never be lonesome; you are host to millions of microscopic guests.” While that thought may be a comfort to some, those guests in the gut flora are not necessarily well-behaved, friendly commensals, as recent findings on the relationship between the microbiome and diseases such as obesity, diabetes and cardiometabolic disease highlight. Read More
Synaffix BV closed a series A round to take forward its antibody-drug conjugation (ADC) technology, which offers a fresh take on the problem of ADC heterogeneity. Read More
CHICAGO – It has taken long years of effort to devise an effective T-cell cancer immunotherapy that can comprehensively break immune tolerance, but now clinical evidence is mounting that those constructs are “serial killers” with profound and long-lasting effects. Read More