By Catherine Shaffer Staff Writer AstraZeneca plc will be Ironwood Pharmaceuticals Inc.'s development and commercialization partner for linaclotide in the vast China territory. Ironwood filed a clinical trial application with China's State Food and Drug Administration for a Phase III study of linaclotide in irritable bowel with constipation (IBS-C). The companies will share the responsibilities and profits of advancing the drug in China, with London-based AstraZeneca taking a 55 percent share of
By Nuala Moran Staff Writer LONDON – International Biotechnology Trust (IBT) reported strong returns for shareholders, driven by new drug approvals, high levels of merger and acquisition activity and the resilience of leading biotech companies in the current growth-stunting environment. The London-based investment trust saw net asset value (NAV) rise by 41.9 percent to £2.32 (US$3.70) per share in the year ended August 2012. And while – inevitably – the unquoted investments in IBT's portfolio
By Peter Winter BioWorld Insight Editor The disappointing returns on biopharmaceutical research and development, despite the availability of advanced molecular technologies and the investment of billions of dollars, is forcing companies to a re-evaluate their business plans. One idea that appears to be coming back into vogue again is the strategy of giving older drugs a makeover. Reformulating and repurposing older drugs for new uses or improved versions is more attractive than developing a drug
By Catherine Shaffer Staff Writer It was compassion that moved Yutaka Niihara to start Emmaus Medical Inc. more than 10 years ago. The hematologist and University of California Los Angeles (UCLA), professor would have been content to continue with his medical practice and teaching, had it not been his passion for research and his desire to find a treatment for the intense pain crises his sickle cell patients suffered. In the course of their academic research at UCLA, Niihara and Charles Zerez
By Randy Osborne Staff Writer Merck & Co. Inc.'s tie of the licensing knot with AiCuris GmbH & Co. brought €110 million (US$142.2 million) up front and could mean another €332.5 million in milestone payments for AiCuris, with a cytomegalovirus (CMV) candidate impressive in Phase II trials. Wuppertal, Germany-based AiCuris, a spinout from Bayer AG, earlier this year disclosed Phase II data showing that the oral quinazoline letermovir worked and proved tolerable in a trial with 133 bone marrow
By Anette Breindl Science Editor Understanding the structure of a biological molecule, whether it's a protein, DNA or RNA, is often critical for understanding its function. But for a biological molecule, unlike a bridge or a building, its structure is not an unchanging thing. Biological molecules are, in fact, somewhat akin to fidgety children – they are constantly changing their shapes, wiggling around just a bit. For a long time, such wiggling took place out of sight of the prying eyes of
By Peter Winter BioWorld Insight Editor What a difference a year makes. When biotechnology execs and investors converged on the Palace Hotel in San Francisco last year for the two-day annual BIO Investor Forum, the biotech sector had just come through a tough third quarter in terms of fundraising, with public and private financings for the industry down 48 percent compared to 2010. (See BioWorld Today, Oct. 12 and Oct. 25, 2011.) This time around, the environment surrounding the 2012 event
By Anette Breindl Science Editor Freshly minted Nobelist Shinya Yamanaka has a pretty humble explanation for his success: He wasn't any good as a surgeon. "I started my career as a surgeon," he said. "But it turns out I am not talented as a surgeon. So I decided to change my career from the clinic to the laboratory. But I still feel I am a doctor. . . . I really want to help patients. So my goal all my life has been to bring . . . stem cell technologies into the clinic." On Monday, his
By Cormac Sheridan Staff Writer BRUSSELS, Belgium – Continuing the habit of starting the day's proceedings with unexpected musical choices, the audio-visual technician in charge of the Silver Hall meeting room chose Louis Armstrong's and Ella Fitzgerald's inimitable rendition of "Let's call the whole thing off" to kick off Tuesday's sessions at the BioPartnering Future Europe meeting at the Square Brussels Meeting Centre Tuesday. The song was hardly an appropriate scene-setter for a meeting
By Randy Osborne BioWorld Today Contributing Writer CEO Sapan Shah calls ARMGO Pharma Inc. "one of biotech's better-kept secrets," but news about the company has begun to leak – not unlike the faulty calcium channels in diseased tissue that ARMGO's Phase II drug candidates are designed to fix. Tarrytown, N.Y.-based ARMGO's partly acronym-based name derives from that of Andrew R. Marks, founder and chairman of the scientific board. The Columbia University scientist was the first to clone and
By Catherine Shaffer Staff Writer Shares of ArQule Inc., of Woburn, Mass., plummeted 56.3 percent Tuesday following news that an independent data safety monitoring committee had terminated its Phase III MARQUEE trial of ARQ 197 in nonsquamous non-small-cell lung cancer (NSCLC). There was a statistically significant improvement in progression-free survival, but it didn't extend to overall survival. "Unfortunately the trend in overall survival that we observed in Phase II did not materialize in
By Anette Breindl Science Editor The transcription factor c-Myc is an oncoprotein; that much has long been clear. The c-myc gene is a known or suspected driver mutation in many cancer types. In fact, one of the major goals is making induced pluripotent stem (iPS) cells, where it is one of the four "magic factors" that can transform fibroblasts back into a stem-cell-like state. But as for how Myc does what it does has been the subject of contradictory findings and heated debate. For example, Myc
By Nuala Moran Staff Writer 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. While the main base of investors is in Germany and elsewhere in Europe, the fourth fund also has attracted investors from the Middle East and the U.S. Alongside institutional
By Catherine Shaffer Staff Writer 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. The FDA User Fee Corrections Act of 2012 (HR 6433) allows the FDA to collect nearly $300 million in generic drug user fees. However, there is no corresponding fix for prescription drug, medical
By Anette Breindl Science Editor At the 2011 meeting of the American Society of Clinical Oncology (ASCO), outgoing president George Sledge told the audience that while drug developers were becoming smarter than "stupid cancers" – cancers defined and driven largely by a single mutation that could be attacked with targeted therapies – they needed to become smarter than "smart cancers" that are characterized by an overall high mutational load and will quickly mutate their way around any targeted
By Peter Winter BioWorld Insight Editor Most American consumers are optimistic about the potential benefits from advances in genetic testing, according to a national survey of U.S. adults conducted by UnitedHealth Group and Harris Interactive, the results of which are included in a report published by UnitedHealth Group's Center for Health Reform & Modernization. About three-quarters of survey respondents agree that genetic tests help doctors diagnose preventable conditions and offer more
By Catherine Shaffer Staff Writer The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) released briefing documents in advance of its Wednesday meeting to discuss the use of cell lines derived from human tumors for vaccine manufacture. The Center for Biological Evaluation and Research (CBER) has consulted with VRBPAC a number of times since 1998 in order to shape policy for new types of cell substrates being used for viral vaccine production. The current meeting will
By Peter Winter BioWorld Insight Editor The growth of antibiotic-resistant "superbugs" is leading to the fear that it is only a matter of time before the world is faced with an infectious disease of pandemic proportions. Despite this situation, research and development for new antibiotics has languished. Indeed, it has been an uncomfortable subject to raise in industry circles but the plain fact is that the emergence of antibiotic resistant strains of bacteria are outpacing our ability to bring
By Cormac Sheridan Staff Writer CureVac GmbH closed what will in all likelihood go down as the largest private equity round in European biotechnology this year, an €80 million (US$104.9 million) investment from dievini Hopp BioTech Holding GmbH & Co. KG, which will enable it to take forward two mRNA-based therapeutic cancer vaccines, in clinical development for prostate cancer and non-small-cell lung cancer (NSCLC). The deal is both a major endorsement of CureVac's RNActive platform technology
By Mari Serebrov Washington Editor With one piece of the budget puzzle about to be put in place, at least temporarily, the FDA, National Institutes of Health (NIH) and other federal agencies can start planning for fiscal 2013, which begins in two weeks. By a vote of 329-91 Thursday, the House passed a continuing resolution, in lieu of a 2013 budget, that would fund federal agencies at current levels for the first half of the fiscal year that begins Oct. 1. The Senate is expected to pass the
By Catherine Shaffer Staff Writer AstraZeneca plc will be Ironwood Pharmaceuticals Inc.'s development and commercialization partner for linaclotide in the vast China territory. Ironwood filed a clinical trial application with China's State Food and Drug Administration for a Phase III study of linaclotide in irritable bowel with constipation (IBS-C). The companies will share the responsibilities and profits of advancing the drug in China, with London-based AstraZeneca taking a 55 percent share of