The US District Court for the Southern District of New York upheld the validity of Endo Pharmaceuticals' patent for its non-crush-resistant Opana by maintaining its previous ruling that would prevent generic-drug developers from manufacturing and commercializing copies of Opana, which is indicated for the treatment of moderate to severe pain.
The FDA has launched a $35 million campaign to discourage young lesbian, gay, bisexual and transgender individuals from using tobacco. The campaign particularly focuses on "social smokers" -- those who occasionally use cigarettes or other products. "LGBT young adults in this country are nearly twice as likely to use tobacco as other young adults," said Mitch Zeller, director of the FDA's Center for Tobacco Products.
A new-drug application has been filed with the FDA by Cempra for its antibiotic drug solithromycin as a treatment for patients with community-acquired bacterial pneumonia. The firm anticipates launching the drug in January following approval from the FDA, which is expected later this year.
A feasibility study will be conducted by Takeda Pharmaceutical and Prosetta Biosciences to explore the potential development of treatments for central nervous system disorders using Prosetta's compounds. Under the agreement, Prosetta is eligible for an undisclosed upfront payment and milestone fees plus sales royalties on commercialized products, while Takeda gains the right to negotiate a separate partnership and licensing deal with Prosetta for additional target-related research and development.
Baxalta received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for the expanded use of HyQvia, a recombinant human hyaluronidase immunoglobulin given subcutaneously, to treat primary and certain secondary immunodeficiencies in pediatric patients. The European Commission could make a decision in about two months.
Eisai has won approval from the FDA for Fycompa, an oral suspension formulation of perampanel, as an adjunctive treatment for patients at least 12 years old with primary generalized tonic-clonic seizures and those with partial-onset seizures with or without secondarily generalized seizures. The approval was backed by data from a bioequivalence study. Eisai plans to launch the treatment next month.
Perrigo's generic version of Valeant Pharmaceuticals' acne vulgaris treatment BenzaClin Pump topical gel, a combination of clindamycin phosphate and benzoyl peroxide, has received approval from the FDA. Shipments of the treatment have begun.
Sen. Chuck Grassley, R-Iowa, said Congress will not be able to come up with legislation that would prevent the implementation of state-by-state biotech food labeling laws before Vermont's labeling policy goes into effect on July 1. But Senate Majority Leader Mitch McConnell, R-Ky., said he is hopeful that a national standard for biotech food labeling can still be established.
The US has depended heavily on fossil fuels, and forests cannot sequester carbon emissions without using bioenergy instead of natural gas and other fossil fuels, writes BIO Executive Vice President Brent Erickson in a letter to the editor in The Washington Post. Biorefineries create a market that allows farmers to harvest biomass sustainably and helps market forces balance carbon emissions and sequestration, Erickson writes.
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