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

By Anette Breindl Science Editor Myotonic dystrophy leads to muscle weakness – but also to cardiac arrhythmias, diabetes and cognitive disorders. In fact, Charles Thornton told BioWorld Today, "dystrophy is a bit of misnomer" for the disorder, which he considers closest to a neurodegenerative disease. The disease exists in several different forms, ranging from mild to severe. Currently, it is possible to treat the symptoms and manage the complications of myotonic dystrophy, but there is no cure

By Cormac Sheridan Staff Writer DUBLIN, Ireland – The headline on a note from Jefferies & Co. research analyst Corey Davis said it all: "At least it's not ambiguous: Bapi's Dead." Following a second Phase III miss within a couple of weeks, Pfizer Inc. and Johnson & Johnson decided to terminate development of bapineuzumab, the anti-amyloid beta antibody originally discovered and developed by Elan Corp. plc, which retained an approximate 25 percent stake in the asset. The writing was on the wall

By Peter Winter BioWorld Insight Editor According to the American Cancer Society an estimated 1.6 million new cancer cases and 577,190 deaths from cancer are projected to occur in the U.S. in 2012. It is not surprising then that recent studies have found that there are more ongoing clinical trials focusing on cancer indications than any other disease. However, costs are rising in cancer treatment, putting tremendous strains on the health care system. In a paper by Thomas Smith and Bruce Hillner

By Mari Serebrov Washington Editor WASHINGTON – In vacating a preliminary injunction that protected Momenta Pharmaceuticals Inc.'s $1 billion a year monopoly on generic Lovenox, the Federal Circuit gave the makers of generic drugs a much wider safe harbor under Hatch-Waxman. Drugmakers typically use the safe harbor to freely infringe brand patents to develop generics that can then be approved and marketed as soon as patent protection ends for the brand product. But in Friday's split decision

By Peter Winter BioWorld Insight Editor As expected, the FDA gave the green light last Thursday to Amarin Corp. plc's Vascepa (icosapent ethyl) capsules (formerly known as AMR101) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (TG greater than or equal to 500 mg/dL) hypertriglyceridemia. The decision came after the markets had closed, and trading of Amarin's shares had been suspended just over an hour before the close. At that time the shares (NASDAQ:AMRN

By Mari Serebrov Washington Editor Executives of biopharma companies got a little good news and a lot of bad news when an appeals court, in a split decision, upheld the federal exclusion of three former Purdue Frederick Co. officials, clearing the way for more corporate officers to be forced out of the industry over off-label drug promotion. The good news is that the U.S. Court of Appeals for the District of Columbia (DC) found that the length of exclusion, 12 years, set by the Department of

By Nuala Moran Staff Writer LONDON – The first gene therapy to be approved in a Western regulated market finally made it over the finishing line on Thursday when the European Medicines Agency (EMA) gave the nod to Glybera after considering the treatment for lipoprotein lipase deficiency (LPL) for the fourth time. The developer, uniQure BV, is now looking at filing for FDA approval on the basis of the same clinical data that eventually convinced the EMA. "I'm pretty certain [the FDA] will accept

By Mari Serebrov Washington Editor WASHINGTON – Biopharma has a lot at stake as the political theater continues around the Affordable Care Act (ACA). But rather than waiting on the edge of their seats to see what happens in Congress, drugmakers need to start planning now for the consequences of the law. The ACA's direct impact on brand drugmakers will average about 2 percent to 3 percent of net revenue, but its indirect impact could reach about 14 percent, due mainly to increased pricing

By Mari Serebrov Washington Editor It will be a while before all the provisions of the Jumpstart Our Business Startups (JOBS) Act kick in, but a number of emerging growth biotechs are already queuing for an initial public offering (IPO). With only a few pieces of the law in effect yet, Mark Heesen, president of the National Venture Capital Association, said the line is starting to form with several biotechs registering to go public. The result is an IPO pipeline that started to flow late last