Sanofi's dengue vaccine Dengvaxia is being fast-tracked by Singapore's Health Sciences Authority, which hopes to make an approval decision in six months instead of the standard nine-month time frame. Sanofi filed the registration application in March.
Swiss Pharma International has challenged three patents related to the formulation and preparation of Biogen's multiple sclerosis drug Tysabri natalizumab by filing inter partes review petitions with the US Patent and Trademark Office. The petitions claim that, on the grounds of obviousness based on prior art, the patents should not have been granted.
London-based DalCor Pharmaceuticals is recruiting 5,000 patients for a clinical trial of a cholesterol drug that Roche abandoned after it failed to meet endpoints in a Phase III trial. The drug showed promise in a subset of patients with a certain genetic variation, and only patients with that variant will be recruited.
Generic-drug makers in India including Sun Pharmaceutical Industries, Dr. Reddy's Laboratories and Lupin are investing in research and development capacity, and are applying for FDA approval of drug combinations and delivery methods as well as modified versions of existing drugs.
A second-generation microdevice developed by Massachusetts Institute of Technology researchers can identify the best of 100 therapeutic options for a patient with cancer, according to preclinical data from a trial presented at the American Association for Cancer Research's annual meeting. The device is designed to release drugs at a tumor site where it is implanted, then be retrieved after 24 hours along with surrounding tissue for analysis.
Two recent studies found that recurrent, difficult-to-treat head-and-neck cancer and Merkel cell carcinoma respond to immunotherapies. The studies indicate that "virus-driven cancers can be amenable to treatment by immunotherapy," said Paul Nghiem, who led the carcinoma study.
Allowing the federal government to negotiate Medicare prices with drugmakers would limit choice for seniors, says Pharmaceutical Care Management Association President and CEO Mark Merritt. "Many don't know that price controls require a one-size-fits-all, national drug list that's built and run by the government. That would completely disrupt Medicare Part D and restrict choices for seniors," Merritt said.
Roche filed suit against India-based Intas Pharmaceuticals, charging infringement of patent rights of Mircera, an injectable used to treat anemia in chronic kidney disease. Roche has requested an injunction order from the Delhi High Court.
Two patent applications were filed by Faron Pharmaceuticals in Finland for Clevegen, a cancer drug that can stimulate the body's immune responses to fight the disease. The patents could be applied worldwide through the Patent Co-operation Treaty.