TopoTarget A/S' positive results from the BELIEF pivotal trial with belinostat could mean upside for U.S. partner Spectrum Pharmaceuticals Inc., if the histone deacetylase (HDAC) inhibitor is approved for peripheral T-cell lymphoma, but the latest outcome with belinostat is "not really a game changer for this drug," said Decision Resources analyst Lisa Murch. Read More
In a last-minute vote before leaving for a five-week vacation legislators funded the federal government, avoiding a shutdown. But the resolution may lack amendments that would have prevented new user fees from being enacted. Congress passed a partial fix on Sept. 19. Read More
WASHINGTON – Rather than serve up across-the-board cuts mandated by sequestration that would slice deeply into the National Institutes of Health (NIH) budget, Congress needs to be more selective when carving out savings, Rep. Brian Bilbray (R-Calif.) said at a United for Medical Research (UMR) policy briefing in Washington last week.Mixing in a morality argument, Bilbray added, "For this city to accept across-the-board cuts regardless of what's going on would be as outrageous as any father or mother" employing the same strategy with the household budget. Read More
BOSTON – A common refrain heard last week at BioPharm America 2012 in Boston was the need for biotechs to consider partnering opportunities at every step along the path to commercialization, from preclinical to post-approval. The optimum success strategy? In a word: Differentiate. Read More
BILBAO, Spain – The coming months will be a crucial period in the development of Zeltia Group, Spain's flagship biotechnology company, which is due to report data from several clinical trials, including a Phase IIb trial of Nypta (tideglusib) in Alzheimer's disease and a Phase III trial of Aplidin (ptilidepsin) in multiple myeloma. Read More
LONDON – Wellington Partners announced the first closing of its fourth life science fund at €70 million (US$90.8 million), putting the firm well on to the way to its final target of €120 million and of achieving a significant increase over its third life science fund, which raised €78 million. Read More
• Ironwood Pharmaceuticals Inc., of Cambridge, Mass., and Almirall SA, of Barcelona, Spain, said the European Committee for Medicinal Products for Human Use issued a positive opinion recommending the marketing approval for Constella (linaclotide) for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation in adults. Read More
• MorphoSys AG, of Martinsried, Germany, said results from a Phase Ib/IIa study demonstrated signs of efficacy with HuCAL antibody MORE103 in rheumatoid arthritis patients. The best response was achieved in the 1 mg/kg dose cohort, with an ACR20 sore of 68 percent at week four, which was significantly higher than in the control arm (p < 0.0001). Data also showed fast onset of action: Within two weeks, up to 40 percent of patients achieved an ACR20 score. Read More
• Actinium Pharmaceuticals Inc., of New York, said it intends to raise up to $20 million in new funds to be used for further clinical development of immunotherapeutic candidates Actimab-A and lomab-B in hematologic malignancies and for continued preclinical development of additional drug candidates in solid cancer indications, as well as for general corporate purposes. Read More
• Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, said they received a positive opinion from the European Committee for Medicinal Products for Human Use for DPP-4 inhibitor Trajenta (linagliptin) in combination with insulin in adults with Type II diabetes. Read More
Xenotropic murine leukemia virus-related virus (XMRV) made a splash a few years back when researchers suggested it was the viral cause of chronic fatigue syndrome (CFS). Read More
