By Cormac Sheridan Staff Writer Sweden is making its largest ever investment in life sciences research, in the form of a $320 million funding package that is intended to secure its future as a global location for high-quality research. The country's prime minister, Fredrik Reinfeldt, led a delegation of four government ministers who announced the spending plans to the Swedish parliament Tuesday. It forms part of a four-year $1.7 billion research spending package it is introducing in this fall's

By Mari Serebrov Washington Editor As the cost of conducting clinical trials helps drive drug prices beyond the wallet of many U.S. patients, the Department of Health and Human Services (HHS) is looking for ways to streamline those trials. The goal is to bring the cost down while ensuring the safety of drugs and speeding access to innovative therapies. As part of that effort, consulting firm Eastern Research Group Inc. will analyze trial cost data to identify factors that delay or derail

By Peter Winter BioWorld Insight Editor There is plenty of evidence to suggest that small and emerging biotechnology companies could significantly benefit from modifications to the existing SEC rules and regulations affecting their access to the capital markets. Front and center has been the burden placed on smaller companies to comply with the Sarbanes-Oxley (SOX) Act, enacted 10 years ago to increase investor protection. Last year, the SEC found that the cost of complying with Section 404 of

By Peter Winter Editor Despite the availability of advanced molecular technologies and the investment of billions of dollars in research and development every year, biopharmaceutical companies have not yet managed to improve their efficiency rate for bringing novel therapies to the marketplace. Not much has changed since this state of affairs was first identified. It has been more than eight years since the FDA released a report titled "Innovation or Stagnation? Challenge and Opportunity on the

By Anette Breindl Science Editor Scientists have developed a mathematical model that they hope will ultimately be able to help determine how to best prevent resistance to currently available HIV drugs – and how to find effective combinations of new drugs early on in clinical development. Collection of drug metabolism data that the model uses as one of its measurements is a standard part of preclinical development, co-corresponding author Alison Hill, of Harvard University, told BioWorld Today

By Jennifer Boggs Managing Editor The diabetes arsenal is chock full of marketed therapies – glucagon-like peptide-1 agonists, dipeptidyl peptidase-4 inhibitors and the so-called "glitazones" to name a few (though the latter has suffered from safety concerns over the past few years) – but the space has seen a shortage of promising new targets. Enter Apofore Corp., a Cambridge, Mass.-based start-up founded last year to advance discoveries that naturally occurring protein, Apolipoprotein A-IV

By Nuala Moran Staff Writer LONDON – Genmab A/S signed up a "dream partner" last week for its anti-CD38 monoclonal antibody daratumumab, agreeing a worldwide commercialization deal with Janssen Biotech Inc., with a total potential value of more than $1.1 billion, of which $135 million is to be paid up front. In addition, Janssen will pay all costs for developing the product, which currently is in two Phase I/II trials in multiple myeloma, and has agreed to a development plan involving 10 or more

By Marie Powers Staff Writer Relmada Therapeutics Inc., which last month closed the first $3 million in a planned $5 million Series A financing, is seeking to muscle in on the chronic pain space by moving three of its candidates into Phase III studies by the middle of 2013. The company's lead product is LevoCap, a once-daily extended-release form of the opioid levorphanol in a tamper-resistant delivery system. Unlike most other opioids, levorphanol modulates pain through both opioid and

By Brian Orelli BioWorld Insight Contributing Writer Earlier this month, the U.S. Court of Appeals for the Federal Circuit upheld the validity of Myriad Genetics Inc.'s patent claims based on the composition of isolated DNA. (See BioWorld Today, Aug 17, 2012.) This was the court's second take on Association for Molecular Pathology v. Myriad Genetics, which is seen as setting precedence for the whole class of patent protection claims on DNA sequences. A year ago, the appeals court issued

By Cormac Sheridan Staff Writer Shares of TopoTarget A/S gained 10 percent Tuesday following an additional analysis of data from a Phase II trial of belinostat in 89 patients with cancer of unknown primary (CUP) origin, which raises hopes that the drug, a histone deacetylase inhibitor, could have potential in solid tumors. Top-line data, released at the end of June, indicated that belinostat, which was administered in combination with carboplatin and paclitaxel (BelCaP), failed to attain the

By Mari Serebrov Washington Editor An appeals court Friday upheld federal funding of human embryonic stem cell (hESC) research and, in a case involving cigarette labeling, gave a boost to corporate free speech rights that could encourage biopharma to challenge restrictions on off-label promotion. While the three-judge panel from the U.S. Court of Appeals for the District of Columbia Circuit unanimously upheld the National Institutes of Health's (NIH) 2009 guidelines that permit funding of hESC

By Jennifer Boggs Managing Editor Gilead Sciences Inc.'s four-drug, single-tablet HIV drug Quad got its much-anticipated approval Monday, and the drug is expected to shore up the firm's top-selling HIV franchise, which brought in $7.05 billion in revenue in 2011 but faces patent expiries starting in 2018. The FDA nod for Quad, branded Stribild, which combines the ingredients of Truvada (emtricitabine/tenofovir disoproxil fumarate) plus elvitegravir and boosting agent cobicistat, came after

By Mari Serebrov Washington Editor Researchers who have acclimated to a publish-or-perish environment are in for a climate change when the first-to-file provision of the America Invents Act (AIA) settles over the land next March. At the front of that change is the Patent and Trademark Office's (PTO) proposed rule to expand the reach of prior art. If the rule is finalized, researchers who publish too soon before a patent application is filed could see the claims perish. "There's a real danger to

Molecular Partners AG is banking $62.5 million up front and could receive up to $1.4 billion more in development, regulatory and commercial milestones in its second ophthalmology deal with Allergan Inc. The present pact has two components. The first involves MP0260 (AGN-150998), a bispecific Darpin (designed ankyrin repeat protein) molecule, which binds vascular endothelial growth factor A (VEGF-A) and platelet-derived growth factor B (PDGF-B), and which is in development for exudative or wet

By Mari Serebrov Washington Editor Drugmakers that have been splashing in the social media waters may get official pool rules – in another two years. That's how long Congress, under the FDA Safety and Innovation Act (FDASIA), has given the FDA to issue guidance on its policy regarding drug promotion via social media. "It's time," said David Rosen, a partner and co-chair of the life sciences team at Foley & Lardner LLP. "Swimming at your own risk" is no way to run a business, he added. Biopharma

By Peter Winter BioWorld Insight Editor It certainly has been a wild ride for RNA interference (RNAi), a unique class of therapeutics believed to be the next wave of novel medicines. From the initial euphoria about the technology with its huge potential for the development of targeted therapeutics for cancer and other diseases, we have witnessed a reality check in recent years as serious challenges began to surface related to the problems of finding effective delivery of these constructs to

By Anette Breindl Science Editor By using a forward genetics approach, two separate teams of researchers have identified related genes as potential oncogenes and mediators of receptor tyrosine kinase inhibitors. Their findings were published back-to-back in the Aug. 13, 2012, online issue of the Journal of Clinical Investigation. Forward genetics, Mark Jackson told BioWorld Today, is the opposite of a candidate gene approach to identify genes that are related to a trait of interest. The method

By Anette Breindl Science Editor The typical headache for drug developers is a drug that won't cross the blood-brain barrier. But researchers from the National Institutes of Health and Jenrin Discovery Inc. hope to find success by preventing that crossing. In the Aug. 8, 2012, print issue of Cell Metabolism, they described a drug that can reduce appetite, body weight, insulin resistance and fatty liver in mice with diet-induced obesity – all without crossing the blood-brain barrier. The compound

By Mari Serebrov Washington Editor In passing PDUFA V, Congress piled on the homework for the FDA, and much of it has nothing to do with user fees. Some of the assignments, for instance, deal with implementing incentives for new antibiotics. The Generating Antibiotic Incentives Now (GAIN) program, included in the FDA Safety and Innovation Act (FDASIA), gives the FDA, through the Department of Health and Human Services (HHS), until July 2014 to come up with a list of pathogens that qualifying