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

By Anette Breindl Science Editor The notion that one gene can make only one protein, once a central tenet of molecular biology, has long since been revised. One gene can make several proteins through alternative splicing. Now, scientists have discovered another way that several proteins can result from the same gene. In the July 20, 2012, issue of Cell, they reported that the transcription factor RfaH can morph into a translation initiation factor by refolding a large part of itself into a

By Mari Serebrov Washington Editor WASHINGTON – In a decision that's likely to head to the Supreme Court, a federal appellate court struck down pay-for-delay settlements between makers of brand and generic drugs, claiming they violate antitrust laws. In the opinion handed down Monday, the Court of Appeals for the Third Circuit said such settlements are "prima facie evidence of an unreasonable restraint of trade." The only way such agreements wouldn't violate antitrust law is if they are for a

By Mari Serebrov Washington Editor WASHINGTON – While the Federal Circuit is still digesting the Supreme Court's ruling on patents involving laws of nature and natural correlations, the Patent and Trademark Office (PTO) has translated its Mayo Collaborative Services v. Prometheus Laboratories Inc. decision into temporary guidance for patent examiners. The guidance instructs examiners on determining the patent eligibility of method claims involving natural principles. Echoing the Supreme Court

By Nuala Moran Staff Writer DUBLIN, Ireland – It has not been long since the first research programs got under way, but there is evidence already that projects undertaken by the €2 billion (US$2.4 billion) Innovative Medicines Initiative (IMI) are having an impact on the environment for drug development in Europe. The signs of improvement include the scrapping of some poorly predictive preclinical models, improvements in patient enrollment and trial design and getting regulators to engage with

By Cormac Sheridan Staff Writer CureBeta, the diabetes research alliance between Evotec AG and Doug Melton's lab in Harvard University's Department of Stem Cell and Regenerative Biology, has found an early taker for its preclinical portfolio of small molecules and biologics that can trigger growth of insulin-secreting pancreatic beta cells. Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, is paying $8 million up front and could pay between $200 million and $300 million more in

By Anette Breindl Science Editor In the biotech world, zinc finger nucleases got their start as gene correction tool. But their ability to precisely target and cut specific DNA sequences could be used for other purposes as well, and two recent papers reported methodological advances that could ultimately expand the uses of the technology. In one of those papers, which appeared in the July 1, 2012, advance online edition of Nature Methods, a team from the University of California at Los Angeles

By Mari Serebrov Washington Editor WASHINGTON – Although the SEC told Congress it was doing what it could to amp up the rulemaking process to implement the Jumpstart Our Business Startups (JOBS) Act, it didn't hit its first deadline. The act, signed into law April 5, gave the SEC 90 days, or until July 4, to release proposed rules to remove the ban against general solicitation and advertising in offerings conducted under Rule 506 of Regulation D and Rule 144A of the Securities Act. (See BioWorld

By Cormac Sheridan Staff Writer Shares in Diamyd Medical AB dropped 30 percent Tuesday on news that its gene therapy treatment for cancer pain missed the primary endpoint in a Phase II placebo-controlled trial. The study, which was conducted in 18 clinical centers across the U.S., found no difference in average pain scores among patients who received a single dose of the treatment, NP2 Enkephalin, (n = 17) and those who received placebo (n = 16). NP2 Enkephalin comprises a replication-defective

By Anette Breindl Science Editor Wnt is a signaling pathway that plays critical roles in development, and its proteins can go awry in many cancers. Now, researchers from the University of Michigan have gained new insights into the relationship between Wnt signaling, metabolism and mitochondria. The research identifies "a new role for an old signaling pathway, the Wnt pathway," senior author Ormond MacDougald told BioWorld Today. MacDougald is a professor of molecular and integrative physiology

By Anette Breindl Science Editor The American Association for the Advancement of Science published full details of a paper by Dutch researchers that demonstrates H5N1 avian influenza, a highly lethal but to date not very contagious strain of the flu, can acquire mutations that allow it to be spread via aerosol transmission. The paper, which appeared in the June 22, 2012, issue of Science, and a related paper by U.S. scientists, had first entered public consciousness late last summer, when

Peter Winter BioWorld Insight Editor BOSTON – Patients are becoming more involved in their own health care decisions, and companies that realize this and integrate those changing dynamics into their own business models will be the ones that ultimately profit and be successful in the future. That was the theme discussed in a panel at BIO 2012, titled "New rules of patient engagement." Innovation in health care is no longer just about the product; it now encompasses how companies mobilize their