By Mari Serebrov Washington Editor The backlog of new applications is growing again at the Patent and Trademark Office (PTO), thanks in part to sequestration. Using new fees included in the 2011 patent reform to hire and train more examiners, the office had been plowing through the backlog, reducing the pile of nearly 722,000 applications in December 2010 to about 593,000 in February. But since the sequester hit in March, the backlog has grown to more than 600,000. And patent experts expect it
By Anette Breindl Science Editor Major depression affects more than 15 percent of the population at some point in their lives, and about 7 percent in any given year. Currently approved antidepressants are effective only about half the time – and even then, with a lag time of several weeks after a patient starts taking them. The time lag of antidepressant's effectiveness is something of a mystery. The effects of the newest generation of antidepressants, selective serotonin reuptake inhibitors
The backlog of new applications is growing again at the Patent and Trademark Office (PTO), thanks in part to sequestration. Using new fees included in the 2011 patent reform to hire and train more examiners, the office had been plowing through the backlog, reducing the pile of nearly 722,000 applications in December 2010 to about 593,000 in February. But since the sequester hit in March, the backlog has grown to more than 600,000. And patent experts expect it to continue growing because of the
By Mari Serebrov | BioWorld Today | Tuesday, May 21, 2013
Generic drugmaker Actavis Inc.'s plan to take over Dublin, Ireland-based Warner Chilcott plc in a stock-for-stock transaction worth about $8.5 billion, thus forming the world's third-largest specialty pharmaceutical firm, would put the combined firm – with about $11 billion in annual revenues – on even more solid footing in the busily consolidating biosimilars realm. "Due to the Irish takeover rules, there's very little we can say at the moment," Paul Bisaro, president and CEO of Actavis, told
By Randy Osborne | BioWorld Today | Tuesday, May 21, 2013
Elcelyx Therapeutics Inc., of San Diego, said it is enrolling patients with Type II diabetes in a Phase IIb trial of NewMet, a delayed-release formulation of generic metformin. Results of the trial's primary endpoint of change in fasting plasma glucose are expected in late summer, and the read-out for long-term glucose lowering and weight benefits is due in the fourth quarter. Intercept Pharmaceuticals Inc., of New York, reported initial results from OBADIAH, an ongoing Phase IIa trial of
For more than half a decade, researchers have understood translation to be a key step in gene expression, but it's only recently that drugmakers have begun looking at restoring translational control as a means of treating disease. "People thought of [translation] as the boring half of gene expression," said Steve Worlund, who co-founded and now serves as the president and CEO of Effector Therapeutics Inc., a recent start-up working to develop selective translation regulators. Translation is
By Jennifer Boggs | BioWorld Today | Tuesday, May 21, 2013
Major depression affects more than 15 percent of the population at some point in their lives, and about 7 percent in any given year. Currently approved antidepressants are effective only about half the time – and even then, with a lag time of several weeks after a patient starts taking them. The time lag of antidepressant's effectiveness is something of a mystery. The effects of the newest generation of antidepressants, selective serotonin reuptake inhibitors (SSRIs) seem to be dependent on the
By Anette Breindl | BioWorld Today | Tuesday, May 21, 2013
DUBLIN, Ireland – Elan Corp. plc continues to execute its M&A strategy at a dizzying pace, while its would-be acquirer, Royalty Pharma has tabled a revised offer for the company, worth $12.50 per share or $6.37 billion. On Monday, Elan unveiled an acquisition agreement with AOP Pharmaceuticals AG worth €263.5 million (US$339.3 million) in cash (€175.7 million) and shares (€87.8 million) initially – plus another potential €270 million in milestones – and a deal to acquire a 48 percent stake in
By Cormac Sheridan | BioWorld Today | Tuesday, May 21, 2013
Shares of Xenoport Inc. (NASDAQ:XNPT) dropped almost to the bottom of their 52-week range early Monday, opening at $5.04 after the company terminated its late stage arbaclofen placarbil (AP, previously XP19986) program in spasticity due to multiple sclerosis (MS) after a pivotal Phase III trial failed to demonstrate statistically significant improvement compared to placebo. The stock lost $1.03 on the day, or 15.3 percent, closing at $5.72. The Santa Clara, Calif.-based company said it would
By Marie Powers | BioWorld Today | Tuesday, May 21, 2013
Abbvie Inc., of Chicago, initiated a Phase III study called SONAR (Study Of Diabetic Nephropathy with Atrasentan) to assess the effects of the investigational compound atrasentan, when added to standard of care, on progression of kidney disease in patients with stage 2 to 4 chronic kidney disease (CKD) and Type II diabetes. SONAR is a multinational, double-blind, placebo-controlled clinical study that is expected to enroll more than 4,000 patients with diabetic nephropathy. The study will
Asmacure Ltee, of Quebec City, reported findings from four studies of ASM-024, its lead compound for asthma and chronic obstructive pulmonary disease (COPD), at the 2013 American Thoracic Society International Conference in Philadelphia. In a Phase II allergen challenge trial, ASM-024 was shown to reduce methacholine airway responsiveness and improve baseline lung function when delivered as a solution for nebulization formulation in people with mild allergic asthma. A second study evaluating
LONDON – Merck Serono is enlarging its venture fund from €40 million to €100 million (US$51 million to $128 million) – increasing its capacity to invest in early stage companies, technologies and products that can be shaped up for the company's internal pipeline. "We started four years ago with €40 million and that was always on the understanding it was not enough for a sustainable long-term fund," said Roel Bulthuis, head of the MS Ventures fund. "What the organization has seen is that the
By Nuala Moran | BioWorld Today | Tuesday, May 21, 2013
Why PARP Inhibitors Kill BRCA Mutants Inhibitors of the enzyme poly(ADP-ribose) polymerase (PARP) selectively kill cells with BRCA mutations, and researchers at the University of Michigan have discovered one reason that they do so. In their studies, the authors showed that poly(ADP-ribose) (PAR) recruits BRCA1, in complex with the protein BARD1, to sites of DNA damage. When PAR polymerization is inhibited, such binding cannot occur, and BRCA1 cannot be recruited to repair DNA damage. Many BRCA1
PTC Therapeutics Inc. made last week a biotech trifecta for initial public offerings (IPO), filing an S-1 with the SEC seeking to raise up to $85 million. Earlier, gene therapy firm bluebird bio Inc. and Esperion Therapeutics Inc., a company working on a drug to lower LDL-cholesterol, joined the IPO queue. PTC, which filed as an emerging growth company under the Jumpstart Our Business Startups Act of 2012, plans to list its common stock on the NASDAQ Global Market under the symbol "PTCT." The
By Marie Powers | BioWorld Today | Monday, May 20, 2013
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said preclinical data showed that RNAi therapeutics targeting ALAS-1 (aminolevulinate synthase-1) can completely block the abnormal production of toxic intermediates of the heme biosynthesis pathway that cause the symptoms and disease pathology of acute intermittent porphyria (AIP). Data were presented at the International Congress of Porphyrins and Porphyrias in Lucerne, Switzerland. Alnylam is developing ALN-AS1 as part of its "Alnylam 5x15
Through the indirect targeting of toll-like receptors via their co-receptor, researchers have boosted the immune response to infection, and helped animals with experimentally induced sepsis fight off the bacteria that set off the septic response. Given that one effect of sepsis is massive hyperinflammation, the notion of helping sepsis patients by boosting their innate immune response might seem counterintuitive at best, or like the punch line of a bad mother-in-law joke, at worst. But the
By Anette Breindl | BioWorld Today | Monday, May 20, 2013
As sales of Incyte Corp.'s approved JAK inhibitor Jakafi (ruxolitinib) begin to pick up steam, a competing myelofibrosis candidate from Sanofi SA moved a step closer to market. The Paris-based big pharma, which gained rights to JAK drug SAR302503 in its 2010 buyout of TargeGen Inc., reported solid top-line data from the Phase III study dubbed JAKARTA, showing that both dose groups of the drug hit the primary endpoint of reducing spleen volume. The study was conducted under a special protocol
By Jennifer Boggs | BioWorld Today | Monday, May 20, 2013
Taking an inventive route to drug development, Oncos Therapeutics Ltd. has its roots in a type of compassionate use program that was started in 2007 at the international comprehensive cancer center, Docrates, in Helsinki, Finland. The Advanced Therapy Access Program for experimental treatments with the company's oncolytic viruses was made possible through European Union (EU) regulation EC/1394/2007, designed to improve safe access by patients across the EU to gene therapy, somatic cell therapy
By Marie Powers | BioWorld Today | Monday, May 20, 2013
By Mari Serebrov Washington Editor The backlog of new applications is growing again at the Patent and Trademark Office (PTO), thanks in part to sequestration. Using new fees included in the 2011 patent reform to hire and train more examiners, the office had been plowing through the backlog, reducing the pile of nearly 722,000 applications in December 2010 to about 593,000 in February. But since the sequester hit in March, the backlog has grown to more than 600,000. And patent experts expect it