A marketing authorization application for BAY 81-8973, a recombinant factor VIII compound, has been filed in Japan by Bayer HealthCare as a treatment for hemophilia A patients. Regulatory applications were also submitted in the U.S. and the European Union for the same indication.
A recall involving 1,641 units of Maquet Cardiovascular's Flow-i anesthesia technology has been categorized by the FDA as Class I. The recall was made over concerns about loose gas flow cassettes caused by a faulty locking mechanism, which could lead to anesthesia gas leaks and inhibit breathing support from the ventilator.
Baxter BioScience, a division of Baxter International, has become an independent company named Baxalta, Baxter announced. Baxalta will concentrate on the development of rare disease treatments and intends to boost its portfolio of hematology and immune globulin drugs. It also will expand its cancer drug pipeline to accommodate patients who have limited treatment options.
Sandoz's Tri-Lo-Estarylla estrogen and progestin combination contraceptive has been approved by the FDA. The pill, which will be distributed in 0.18 mg/0.215 mg/0.25 mg and 0.025 mg/0.025 mg/0.025 mg strengths, is therapeutically equivalent to Janssen's Ortho Tri-Cyclen Lo.
Shrimp Fried Rice and Shrimp Sorrentino products under the Tastee Choice brand were pulled in Canada by Choice Canning over undeclared use of gluten and milk. The affected products were distributed in 680-gram packages in Saskatchewan, Quebec, Ontario, Manitoba, British Columbia, Alberta and possibly across the country.
The Russian Federation's Ministry of Healthcare has granted marketing authorization to Theravance Biopharma's Vibativ, or telavancin, as a treatment for Gram-positive bacteria-caused skin and soft tissue infections and nosocomial pneumonia. Theravance is eligible to receive undisclosed milestone fees, contingent payments and sales royalties from R-Pharm, which will be responsible for the marketing of the drug in Russia starting in September.
In a Federal Register notice published Wednesday, the FDA ordered drugmakers to stop making and distributing prescription ear drops that have not been approved by the agency as a treatment for ear inflammation, infection and pain. The FDA has not assessed the quality, efficacy and safety of the products, which may include hydrocortisone, benzocaine, pramoxine, chloroxylenol, zinc acetate and antipyrine in various combinations as active ingredients. The order does not cover over-the-counter drugs marketed legally or prescriptions with FDA approval.
Experts in India agreed with Prime Minister Narendra Modi's sentiment that the use of biotech crops can help the country achieve a "second green revolution" and greater agricultural production. "With the advent of modern tools of biotechnology, it has become possible to address those challenges of agriculture like climate change, control of pests or malnutrition, which have been difficult to be overcome by conventional plant breeding methods," said Dr. K. C. Bansal, director of the Indian Council of Agricultural Research.
Seattle-based Adaptive Biotechnologies plans to establish an office in New York City to house its business development and corporate development operations and at least 10 employees. The firm specializes in the development of immunosequencing technology.
An additional $1.4 million has been raised by 908 Devices, bringing the total for its Series C funding round to $13 million. The firm plans to use the proceeds to further commercialize its M908, a miniature mass spectrometry technology, and create new uses for the device in life sciences and other markets.