By Cormac Sheridan Staff Writer Without revealing much in the way of new data, TopoTarget A/S enjoyed a 45 percent bounce in its share price during early trading Tuesday, as an analysis of the final top-line results from a registration trial of belinostat in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) confirmed the drug exceeded the efficacy level defined by the study's primary endpoint, a minimum objective response rate (ORR) of 20 percent. The threshold had been

By Anette Breindl Science Editor By targeting one specific type of inhibitory brain receptor, researchers have been able to improve neural function and memory in a mouse model of Down syndrome. The findings give additional support to the idea that some neurodevelopmental disorders can be reversed, at least partially, after they are established. The team published their findings in the Feb. 27, 2013, issue of the Journal of Neuroscience. "By targeting this type of receptor, we can normalize not

By Sharon Kingman Staff Writer LONDON – Identification of a protein that orchestrates many of the changes that permit a normal cell to turn into a cancer cell will open up an entirely new field of cancer therapeutics, the researchers who made the discovery predicted. The team, from ICREA in Barcelona, Spain, also established a screening system to identify compounds that will inhibit the protein. Raùl Méndez, group leader at the Institute for Research in Biomedicine in Barcelona, told BioWorld

By Cormac Sheridan Staff Writer DUBLIN, Ireland – Shares in Elan Corp. plc (NYSE:ELN) rose 5 percent to $11.14 Monday in response to an indicative $11 per-share takeover offer from Royalty Pharma. Although Dublin, Ireland-based Elan issued a critical response to the offer, which represents a 4 percent premium to its closing share price Friday, it was not an outright refusal. The investor response suggested there is an appetite in the market for an exit. The company is now in play. With the ink

Sharon Kingman Staff Writer LONDON – While the development of biosimilars – biological medicines designed to be very similar to ones that have already been approved for clinical use – is really still in its infancy, people already are looking to the future and considering what sorts of molecules will come next. Anyone who thought that the son-of-biosimilar might be something that is bigger, better and more important than a biosimilar itself – a kind of molecule that has been dubbed a "biobetter

By Mari Serebrov Washington Editor Provided budget constraints don't derail the FDA's plans, the agency is on track to begin conducting biennial inspections of all drug facilities, both domestic and foreign, in five years, according to FDA Commissioner Margaret Hamburg. That goal is within reach thanks to new and increased user fees included in the FDA Safety and Innovation Act passed last year. Since its implementation in October 2012, the new generic drug user fee has resulted in 2,000 generic

By Anette Breindl Science Editor Memory T cells, because of the sheer speed with which they can respond to an infection, are "the best thing you can have" to protect against a disease, Mark Davis told BioWorld Today. But memory appears to be a misnomer: Davis and his team have shown that every one of more than 20 individuals had memory T cells to viruses they had never been exposed to. Davis said that the findings came as a surprise to his team, which identified the cells in the course of

By Catherine Shaffer Staff Writer A partnership between Roche AG and Chiasma Inc., of New York, promises to take the pain out of therapy for acromegaly, the overproduction of growth hormone. Chiasma's Octreolin is an oral form of octreotide, an analogue of somatostatin that is currently given by injection. Under the agreement, Roche will have a worldwide exclusive license to the drug and will take responsibility for commercialization, with its Genentech Inc. subsidiary in charge of marketing

By Nuala Moran and Cormac Sheridan Staff Writers LONDON – One of the UK's oldest biotech companies looks to be on its way out after reporting the failure of the lead program in Parkinson's disease. Shares in Phytopharm plc fell 80 percent after the announcement Monday that the long-running trial of Cogane showed no difference between the active compound and placebo in the 400-patient Phase II trial. The Godmanchester, UK-based company has begun a strategic review, but Robin Davison, analyst at

By Nuala Moran Staff Writer LONDON – The Innovative Medicines Initiative (IMI) officially launched the European Lead Factory, a €196 million (US$266 million) project in which seven pharma companies will make at least 300,000 compounds available for screening via an open platform. That will allow academic and small company partners access to industry-quality high-throughput screening and speed the translation of new target biology through to drug leads. The cash for the five-year project comes

By Catherine Shaffer Staff Writer Lycera Corp. doubled its sweet 2011 deal with Merck and Co. Inc., of Whitehouse Station, N.J., in a new agreement designed to expand on the companies' prior relationship, which has centered on retinoic acid-related orphan receptor (ROR[gamma]t). Lycera will receive an undisclosed up-front payment and research funding, and could receive more than $300 million in milestone payments based on research, development, regulatory and commercial accomplishments, plus

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