Biogen Idec and Isis Pharmaceuticals Inc. signed their fourth partnership deal in two years with the goal of applying antisense technology to the discovery and development of therapies for neurological diseases. The financial terms call for $100 million up front to Isis, $220 in potential milestones for each antisense candidate and additional funding for clinical trials conducted by Isis under the collaboration. Read More
The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee convened Monday morning for a two-day meeting to hammer out the difficult ethical issues related to development of pediatric medical countermeasures (MCM). Read More
Only a few months after its impressive Nasdaq debut, antiviral firm Chimerix Inc. started dosing in its Phase III SUPPRESS trial testing oral nucleotide analogue lipid-conjugate brincidofovir (CMX001) for the prevention of cytomegalovirus (CMV) infection in hematopoietic cell transplant recipients. Read More
Biodel Inc. officials, during a conference call with investors, sounded rightly happy about the top-line Phase II win with BIOD-123, an ultra-rapid-acting mealtime insulin for Type I diabetes, which proved non-inferior to Eli Lilly and Co.’s Humalog – but injection-site pain data between the two compound failed to match, and Wall Street moved the shares’ needle down instead of up. Read More
LONDON – Almac Discovery sealed a £13 million (US$20.4 million) collaboration with Queen’s University Belfast, which will see 17 Almac scientists seconded for three years to work at the Centre for Cancer Research and Cell Biology at the university. Read More
With the start of a Phase III trial of its lead compound tinnitus drug AM-101 imminent, Auris Medical AG has completed a second Phase II trial, which further rounds out its understanding of how to administer the therapy. Read More
The 2013 Lasker Awards were announced Monday morning, with basic and clinical awards both going for advances in the field of neuroscience, albeit of a very different kind. Read More
• Sagent Pharmaceuticals Inc., of Schaumburg, Ill., said it plans to offer 3.4 million shares of its common stock. The company did not disclose pricing. Read More
• Astellas Pharma Inc., of Tokyo, said in liver transplant patients, initiating Advagraf prolonged-release capsules (tacrolimus) therapy immediately post-transplant, at a dose 25 percent lower than the upper recommended limit, in combination with basiliximab, resulted in significantly better renal function and a lower incidence of acute organ rejection when compared with standard dose Advagraf therapy. Read More
• Boehringer Ingelheim GmbH, of Ingelheim, Germany, reported Phase III data at the European Respiratory Society meeting in Barcelona, Spain, showing that once-daily olodaterol Respimat maintained lung function improvements in addition to usual care over 24 hours and demonstrated rapid onset of action within five minutes after the first dose in patients with chronic obstructive pulmonary disease. Read More
• Update Pharma Inc., of Reno, Nev., said it entered a binding term sheet for a merger with Resolute Oncology Inc., of Bridgewater, N.J., under which Update will merge with Resolute and will own 70 percent of the surviving entity. Read More
• The FDA published a draft guidance for industry regarding the Generic Drug User Fee Amendments of 2012 intended to offer updated answers to common questions from the generic drug industry. GDUFA establishes fees for abbreviated new drug applications, prior approval supplements to ANDAs, and drug master files, annual facility fees and a one-time fee for original ANDAs pending as of Oct. 1, 2012. Read More
The year 2013 is emerging as a banner one for East-West partnerships among biotech companies. More Western biopharmas with innovative capability and patented molecules in need of development are partnering with local companies in China to tap the potential of the market. Read More
