Regeneron revised its earnings guidance for Eylea (aflibercept) for 2012, from $140 million to $160 million to a range of $250 million to $300 million, after the newly launched therapy for wet age-related macular degeneration had a strong performance in its first quarter of sales. The Tarrytown, N.Y.-based firm reported that 30,000 injections of Eylea had been given to date. Read More
NEW YORK – An age-old problem with the business-as-usual model in the biotech market is that the objectives of the principal stakeholders are integrally at odds with one another. The executives, investors and researchers who make things happen in the drug development world all want to see their drugs approved or they want to experience an exit strategy come to fruition, but they have different ideologies on achieving that goal. Read More
WASHINGTON – If the FDA gets its way, it will see a 17 percent increase in its 2013 budget, but nearly all of that will be footed by the biopharma and food industry through new and increased user fees. Read More
Chelsea Therapeutics International Inc. delivered unhappy news Monday morning, acknowledging the FDA had raised questions about safety and efficacy in a briefing document released in advance of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting on the new drug application (NDA) for lead candidate Northera (droxidopa), scheduled for Feb. 23. Read More
• Amarin Corp. plc, of Dublin, Ireland, said it was notified by the FDA that no advisory meeting will be scheduled in connection with the new drug application for AMR101 (icosapent ethyl), a prescription-grade omega-3 fatty acid, for use in patients with very high triglycerides (less than or equal to 500 mg/dL). The agency has set a PDUFA date of July 26. Read More
• Diffusion Pharmaceuticals LLC, of Charlottesville, Va., said it started enrollment in a Phase I/II trial to test its lead drug, trans sodium crocetinate (TSC), as a first-line treatment in newly diagnosed patients with glioblastoma. The study is expected to enroll up to 68 patients. Clinical endpoints are overall survival at two years and progression-free survival at six months. Read More
• Ironwood Pharmaceuticals Inc., of Cambridge, Mass., said the underwriters of its previously announced public stock offering fully exercised their option to purchase an additional 787,500 shares at a public offering price of $15.09 per share. Including the overallotment, Ironwood sold 6.0375 million shares at $15.09 each for gross proceeds of $91.1 million and estimated net proceeds of $85.3 million. Proceeds will support launch preparations for linaclotide, which is under FDA review for irritable bowel syndrome and chronic constipation. Read More
• Merck & Co. Inc., of Whitehouse Station, N.J., said the FDA approved Zioptan (tafluprost ophthalmic solution) 0.0015 percent, a preservative-free prostaglandin analogue ophthalmic solution for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Read More
