Biogen Idec Inc. reported total revenues of $1.4 billion in the first quarter of 2013, a 10 percent increase compared to the first quarter of 2012. Avonex led revenues with a 13 percent year-over-year gain, for $746 million, with multiple sclerosis drug Tysabri (natalizumab) up by 9 percent and cancer drug Rituxan (rituximab) losing 7 percent. Non-GAAP EPS of $1.97 beat the Street consensus of $1.63 by a wide margin. That was an increase of 41 percent over the first quarter of 2012. "The

As advocates for Alzheimer's research swarmed Capitol Hill this week, they told lawmakers, in polite terms, to put federal funding where their mouths are. Meeting individually with lawmakers and testifying before the Senate Special Committee on Aging, advocates and researchers pushed for support of the president's 2014 budget request for an additional $100 million in funding for Alzheimer's, with about $80 million of that to be used for research. Under the proposed 2014 budget, the National

BioMarin Pharmaceutical Inc., of San Rafael, Calif., said it submitted a marketing authorization application to the European Medicines Agency for Vimizim (BMN-110, elosulfase alfa), an enzyme replacement therapy for patients with rare lysosomal storage disorder mucopolysaccharidosis Type IVA, also called Morquio A syndrome. A biologics license application for the drug was submitted last month. OvaScience, of Cambridge, Mass, said its common stock was approved for listing on Nasdaq under the

Radius Health Inc.'s new equity cash of $43 million will go toward further work with its anabolic bone builder BA058, in Phase III trials as an injectable therapy and Phase II as a "short-wear" patch. Cash on hand with the latest financing "should take us neatly through the patch data [due in September], and then we'll make a decision on what the next steps are," said Michael Wyzga, president and CEO of Cambridge, Mass.-based Radius. Phase III data with the subcutaneous version will be

Pfizer Inc., of New York, said that top-line data for a Phase IV trial of Celebrex (celecoxib) capsules or naproxen in juvenile idiopathic arthritis patients demonstrated no difference in changes to systolic blood pressure, the primary endpoint, and diastolic blood pressure, the secondary endpoint. The safety profile was similar in both groups. Celebrex has been approved by the FDA for juvenile rheumatoid arthritis since 2006, but little is known of the impact of nonsteroidal anti-inflammatory

CHICAGO – The BIO International Convention is always full of memorable moments. This year was no different. Here, members of BioWorld Today's team share vignettes, quotes and afterthoughts captured through the week in the Windy City. BIO Women Move into the Spotlight Perhaps it was appropriate in a year when Rachel King, founder and CEO of GlycoMimetics Inc., was elected BIO's incoming chairwoman that Monday evening's Women in Bio (WIB) reception was quite the popular ticket at BIO 2013. The

Actavis Inc., of Parsippany, N.J., reached a settlement agreement with Shire plc, of Dublin, Ireland, resolving patent litigation related to Actavis' generic version of INTUNIV (guanfacine hydrochloride) to treat attention deficit hyperactivity disorder. In October 2012, the FDA granted approval of Actavis' abbreviated new drug application. Under the agreement, it can launch its generic version on Dec. 1, 2014, or earlier under certain circumstances, and Shire will receive a 25 percent royalty

Anterios Inc., of New York, a privately held aesthetic medicine and medical dermatology biopharmaceutical company, closed an $8.5 million corporate financing. Anterios' investors include Ascent Biomedical Ventures, DRW Trading Group, Praesideo Private Equity Partners, Quantum Technology Partners, Scientific Health Development and the Spring Bay Companies. The company is conducting Phase IIb trials studying ANT-1207, a topical botulinum toxin type A treatment for treatment of lateral canthal

GE Healthcare, of Chalfont St. Giles, UK, and Eisai Inc., of Woodcliff Lake, N.J., inked a research collaboration agreement for use of the GE Healthcare investigational PET amyloid imaging agent [18]flutemetamol to help select patients for a Phase I trial testing Eisai's E2609, a BACE inhibitor for the potential treatment of Alzheimer's disease. Financial terms were not disclosed. Merck & Co. Inc., of Whitehouse Station, N.J., reported the FDA has designated lambrolizumab (MK-3475) as a

Achaogen Inc., of South San Francisco, was awarded a $60 million contract option from the Biomedical Advanced Research and Development Authority (BARDA) supporting a global Phase III superiority study that will evaluate the efficacy and safety of plazomicin in treating patients with serious Gram-negative bacterial infections due to Carbapenem-resistant Enterobacteriaceae. The pathogen-specific clinical study represents a new development approach to address unmet medical needs for multidrug

CHICAGO – Innovation was the topic of a heavily attended supersession at BIO 2013 that featured presenters from big pharma, academia, federal agencies and the venture capital (VC) community but, interestingly, no biotechs. The omission was all the more surprising considering the topic was how to accelerate the timetable and reduce the cost between concept and cure, with a focus on improving the research and development process. Panelists roundly agreed that partnerships represent an

CHICAGO – Navigating the patent landscape in developing countries is hard enough, and made even trickier by such moves as the one made earlier this month by El Salvador, which passed a law that cut prices by at least 30 percent for more than 6,000 medicines, and as much as 60 percent for the most common therapies. So said members of a panel on managing intellectual property in such territories during the BIO International Convention. "If the drug actually gets to market and has value, you'll

DUBLIN, Ireland – Two days after the board of Elan Corp. plc unanimously rejected Royalty Pharma's $7.3 billion takeover offer, CEO Kelly Martin set out, as best he could, the contours of the company's M&A strategy during a first-quarter results call with analysts Wednesday. The Dublin, Ireland-based firm, which has sequentially shed and adopted several identities during its 44-year existence, has almost completed its latest transition, from being a neurology-focused biotechnology firm to

To spur innovation in biopharma and other industries, Congress must make it a national priority, according to the Congressional Budget Office (CBO). In a review of the nation's commitment to innovation over the past three decades, CBO Director Douglas Elmendorf noted the decrease in federal spending on R&D, relative to GDP, and the decline of innovation as a priority in regulatory policy. At one time, encouraging innovation was an important consideration in drug approvals, but in today's

With more than 15,000 patients in the U.S. waiting for a liver, and nearly 100,000 for a kidney, the most dramatic need for artificial organs is for transplant. But artificial organs are needed not just by transplant surgeons. Forty percent of drug development costs go toward molecules that ultimately fail, often due to unforeseen toxicities. Drugs fail for many reasons, of course. But part of the problem lies in the systems used to identify candidates at the earliest stages. "There is a

Amgen Inc.'s first quarter earnings fell short of Wall Street estimates, with the Thousand Oaks, Calif.-based company posting $4.24 billion in revenues, shy of the $4.38 billion expected by consensus. Adjusted earnings per share of $1.96 exceeded consensus estimates of $1.80, while total product sales were $4.15 billion, up 6 percent from the first quarter of 2012, but down 4 percent from the previous quarter. When taken individually, the only product to outperform expectations was Sensipar

Within hours of Wednesday's announcement that OPKO Health Inc. and Israeli firm Prolor Biotech Inc. are seeking to merge in an all-stock transaction valued at about $480 million, several law firms said they were launching investigations into the deal on behalf of shareholders. The transaction, designed to combine the firms' complementary drug development technologies and add to OPKO's pipeline Prolor's late-stage long-acting human growth hormone product, hGH-CTP, calls for holders of Prolor