- Elan signs $1B royalty drug agreement with Theravance
Elan agreed to pay Theravance $1 billion in exchange for a 21% stake in future sales royalties on four respiratory drugs co-developed by Theravance and GlaxoSmithKline. The agreement covers the recently approved chronic obstructive pulmonary disease drug Breo and three drug candidates also for COPD. The deal is expected to be finalized next month. BioWorld (free content) (5/14)        | Complimentary Whitepaper: Automated Audit Management Best Practices
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| Health Care & Policy |  |  | | - Report lists 100 best-selling pharmaceuticals in 1Q 2013
A report by Drugs.com ranked AstraZeneca's acid blocker Nexium, or esomeprazole, and Otsuka Pharmaceutical's antipsychotic drug Abilify, or aripiprazole, as the best-selling prescription medications in the first quarter of 2013. Eli Lilly & Co.'s Cymbalta, or duloxetine, AstraZeneca's Crestor, or rosuvastatin, and GlaxoSmithKline's Advair Diskus, or salmeterol-fluticasone propionate, rounded out the top five. Medscape (free registration) (5/10) - FDA expedites review of Janssen-Medivir's hep C drug simeprevir
The FDA granted priority-review status to Janssen Research & Development and Medivir's experimental drug simeprevir as a treatment for genotype 1 chronic hepatitis C. Janssen said the FDA is likely to make a final decision this year. Simeprevir, intended to be taken with pegylated interferon and ribavirin, inhibits the protease enzyme that allows the virus to reproduce itself inside cells. The Star-Ledger (Newark, N.J.) (5/13)  | Free Orphan Drug Report 2013
Get the latest updates on the market, plus projections on where costs, ROI and sales are headed with the Orphan Drug Report 2013. Compiled by the experts of EvaluatePharma, this comprehensive 19-page report will help you develop your business plans, understand market trends and evaluate opportunities. Download your report now. |
 | Global Developments | | | | - Abbott wins approval for HbA1C test in Europe
Abbott Laboratories has obtained CE mark approval to market its ARCHITECT clinical chemistry Hemoglobin A1c test in Europe. The blood assay, which measures an individual's average blood glucose level over the most recent three months, is intended to help doctors diagnose and monitor patients with diabetes, as well as identify those who may be at risk for developing the illness. RTT News (5/9) - Australia OKs Curis' cancer treatment Erivedge
Australia's Therapeutic Goods Administration approved Curis' Erivedge, or vismodegib, to treat metastatic basal cell carcinoma or locally advanced basal cell carcinoma in adults when radiation and surgery are not options. Curis is expecting regulatory approvals in other areas this year, including the European Union, CEO Dan Passeri said. Pharmaceutical Business Review Online (5/13) | Food & Agriculture | | | | - Monsanto wins Supreme Court case over biotech seed patents
The U.S. Supreme Court ruled unanimously in favor of Monsanto in its biotech soybean patent case against Indiana farmer Vernon Bowman. The court ruled that Bowman infringed on Monsanto's patent when he reproduced and used the latter's soybean seeds without seeking Monsanto's permission. For every branch of the the biotechnology sector, the decision reaffirms the idea that patent protection applies to copies of a patented technology, said lawyer Patricia Millett, who filed a brief in the case on behalf of BIO. Reuters (5/13) | Industrial & Environmental | | | | - Volcano-dwelling algae could boost advanced-biofuel development
A scientist at Oklahoma State University and his colleagues have finished mapping the genes of volcano-dwelling red algae that they say could help better unlock biofuels from algae and other biomass. "The idea is that if we understand how this red algae can deal with hostile environmental conditions, it may enable us by genetic modification to toughen biofuels-producing algae, to introduce this ability into biofuels algae," said researcher Gerald Schoenknecht. The Oklahoman (Oklahoma City) (5/10) | News from BIO | | | | - April 2013 BIO therapeutic newsletters
The BIO Emerging Companies Section Policy Team has compiled the latest news to keep you informed on the action in Washington with respect to the disease category on which your company is focused. Topics covered comprise: Allergy/Infectious Disease/Antiviral; Cardiology/Pulmonology/Blood; Nephrology/Endocrinology/Metabolism/Gastroenterology; Neurology/CNS; Oncology; and Rheumatology/Anesthesia/Inflammation/Pain. BIO has attempted to include updates from biotech stakeholders around Washington, including Congress, FDA, NIH and patient organizations. Access our April 2013 Therapeutic Newsletters. Should you have any comments or questions, please contact Charles Crain.
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