By Mari Serebrov Washington Editor With sequestration set to trigger in less than three weeks, the FDA, National Institutes of Health (NIH) and other federal agencies are preparing for the worst while still hoping to be spared. The agencies sent out notices last week to their employees, informing them that furloughs, or unpaid leave, may be necessary over the next seven months to help achieve the $85 billion in across-the-board cuts mandated by the revised 2011 Budget Control Act. The "agencies

By Anette Breindl Science Editor The current thinking about mutations in cancer cells holds that there are two types – driver mutations that are behind cancer growth because they give tumor cells a growth advantage, and passenger mutations that are along for the ride. "Historically, passenger mutations have been largely ignored," Leonid Mirny told BioWorld Today, because cancer development is seen largely as "a series of unfortunate events" in the form of accumulating driver mutations. But in

By Randy Osborne Staff Writer Say "emerging markets," and anyone within earshot is likely to think of Brazil, Russia, India and China, the so-called BRIC countries. Africa, not so much. Common ideas about the world's second largest land mass date back a decade or so, when The Economist famously dubbed Africa "the hopeless continent." Pharmaceutical firms, though, have recognized Africa's potential for a few years now, said Sarah Rickwood, director of European Thought Leadership with IMS Health

By Cormac Sheridan Staff Writer Shares in Zealand Pharmaceuticals A/S hit an all-time high Monday on news that it will shortly start logging double-digit percentage royalty payments from its partner Sanofi SA, following formal European Union approval of the once-daily glucagon-like peptide 1 (GLP-1) agonist Lyxumia (lixisenatide, AVE0010) in Type II diabetes. "It marks the beginning of a new era. How many European biotechnology companies have commercial products?" Zealand CEO David Solomon told

By Catherine Shaffer Staff Writer The FDA convened a public hearing to receive input on its proposal to expedite development of new drugs for serious or life-threatening conditions with unmet need. The pathway, which is being considered primarily for development of agents to combat antibiotic-resistant infections, would involve smaller, faster clinical trials with narrow, tightly enforced labeling for use in patients without other options. The agency received feedback Monday morning from pharma

By Anette Breindl Science Editor "For much of the 1900s, we studied neurons" to understand brain function, Philip Haydon told BioWorld Today. "And the reasons were purely technical. . . . We could listen to neurons, and we could talk to them." Neurons communicate electrically, and electrical recording and stimulation techniques made them amenable to studying. But in terms of what goes on in the brain, looking only at neurons is bound to deliver a minority report. "Ninety percent of the volume of

By Mari Serebrov Washington Editor With exclusivity assuming a bigger role in the life cycle of a drug, Gilead Sciences Inc. wants more for its Stribild HIV drug than the three-year exclusivity the FDA typically grants to new fixed-dose combination (FDC) drugs. In a citizen petition filed this month, Gilead made a case for five years of exclusivity, noting that two of the four drugs in the product, elvitegravir and cobicistat, contain new active moieties, which should qualify the FDC for the

By Cormac Sheridan Staff Writer Shares in Active Biotech AB fell almost 13 percent Monday on news that its immunotherapy Anyara missed the primary endpoint of a Phase II/III trial in advanced renal cell cancer. The trial was by no means a complete failure, however, as a subgroup analysis attained statistical significance in around a quarter of the patients recruited, and the Lund, Sweden-based company has a firm understanding of what happened from a biological perspective. "We're encouraged that

By Anette Breindl Science Editor Researchers have created a mouse with a reporter gene that appears to light up at the earliest stages of tumor development, regardless of the tissue type in which the tumor is developing. "It really does seem to work in every malignancy we've tested," Norman Sharpless told BioWorld Today, which makes the mouse in question a broadly useful tool to study the earliest stages of tumor development. The reporter is a luciferase gene that reports expression of the tumor

By Nuala Moran Staff Writer LONDON – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has had another Glybera moment, turning down the rare disease drug Raxone (idebenone) by a narrow majority, despite the rapporteurs on an expert committee recommending approval of the drug, which treats a hereditary cause of blindness. "We're not disclosing the size of the majority against, but we do know, and I can confirm it's very narrow," Thomas Meier, CEO of Raxone's

By Peter Winter BioWorld Insight Editor The "new normal" is not only causing big pharma firms to adapt their business strategies to current realities (see the cover story in this issue), but it also has cascaded down to impact companies which are just starting out on their journey of drug development. The "new normal" might not seem that much different from previous periods of fiscal constraints the biotech sector has experienced during its history. However, back then there was an expectation

By Anette Breindl Science Editor Autoimmune diseases are one area where it's a man's world. "Many autoimmune diseases are much more frequent in females," Jayne Danska told BioWorld Today. "That's been known for decades. But we don't have any insight into how to take that insight and do something useful for women with it." In the Jan 18, 2012, issue of Science, Danska, who is at the Hospital for Sick Children Research Institute in Toronto, and her colleagues presented evidence that one way to do

By Cormac Sheridan Staff Writer Although Galapagos NV is best known for its whopper of an alliance with AbbVie Inc. for its JAK inhibitor, GLPG0634, the company's rapidly growing drug discovery services business is set to expand further in 2013, following the acquisition of Cangenix Ltd., a UK-based specialist in structure-based discovery, and the establishment of its Fidelta unit in Croatia as an externally focused services arm. Mechelen, Belgium-based Galapagos is paying £1 million (US$1.6

By Staff Reports SAN FRANCISCO – The J.P. Morgan Healthcare Conference is always bigger than life and full of memorable moments. This year was no different. Here, members of BioWorld Today's team share vignettes captured during the jostling, cajoling, schmoozing and snarking that enlivened the Westin St. Francis and every nearby nook and cranny for four overindulging, sleep-deprived days and nights. The Mood CEOs seemed more casual and upbeat. There was a sense of hunkering down, sticking to the

By Marie Powers Staff Writer SAN FRANCISCO – Improving economic indicators portending a positive year for biotech was the early theme of the 31st annual J.P. Morgan Healthcare Conference. Doug Braunstein, JPMorgan Chase & Co.'s vice chairman, noted in opening remarks that the size of the conference has grown from 21 presenting companies to 398 companies this year, with a combined market capitalization of more than $3 trillion. The 2013 conference also boasts 8,600 registered attendees and 7,700

By Marie Powers Staff Writer SAN FRANCISCO – Ironwood Pharmaceuticals Inc. played to a packed house Monday afternoon following the luncheon keynote by journalist Bob Woodward at the J.P. Morgan Healthcare Conference. Though the celebrated Woodward drew a capacity crowd in the Grand Ballroom at the Westin St. Francis, Ironwood CEO Peter Hecht, along with Thomas McCourt, chief commercial officer and senior vice president of marketing and sales, attracted their own respectable following as

By Peter Winter Editor, BioWorld Insight SAN FRANCISCO – For more than a decade now the technologies associated with the regenerative medicine and cell therapy sectors have been hailed as the "future of medicine." While that lofty projection still holds true, investors have started to become impatient with companies developing therapies and their slow rate of progress, a fact acknowledged by Geoff MacKay, president and CEO of Organogenesis Inc., and the incoming chairman of the Washington-based

By Randy Osborne Staff Writer SAN FRANCISCO – At the lectern and away, talks at the 31st Annual J.P. Morgan Healthcare Conference are sure to concern the steadily worsening revenue shortfall, and how major pharma firms might satisfy profit-hungry shareholders as more casualties topple down the patent cliff. The bellwether meeting, which opens today, long has been a venue where the beginnings of such solutions – in the form of deals with biotech companies offering innovative solutions – might be

By Cormac Sheridan Staff Writer Phenex Pharmaceuticals AG and Johnson & Johnson subsidiary Janssen Biotech Inc., have thrown in their lot together in a combined effort to develop antagonists of retinoic acid-related orphan receptor gamma (RORγt) for inflammatory disease. J&J, of New Brunswick, N.J., could pay Phenex up to $135 million in an undisclosed up-front payment and development milestones for molecules emerging from the collaboration. The total potential value of the deal is actually