OR WAIT null SECS
September 02, 2020
The agency sent a warning letter to Acella Pharmaceuticals detailing CGMP violations and failures to oversee contract manufacturers.
The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.
September 01, 2020
Negotiations for a final advance purchase agreement where the Government of Canada purchases the vaccine candidate on a not-for-profit basis for emergency pandemic use are underway.
The vaccine will be supplied by Moderna and distributed in Japan by Takeda Pharmaceutical starting in the first half of 2021 if the vaccine candidate receives regulatory approval.
The facility offers office, production, sampling, and warehouse space and delivers products to all major global markets.
Novavax and the Government of Canada will finalize an advanced purchase agreement under which Novavax will supply doses of NVX-CoV2373 to Canada beginning in the second quarter of 2021.
The Ventofor Combi Fix will be brought into the Turkish market via Bilim’s development program, while the PowdAir Plus DPI is manufactured and commercialized by H&T Presspart under a patent license from Hovione.
Oxford Biomedica will reserve capacity for AstraZeneca in three of its manufacturing suites in its new commercial manufacturing center, Oxbox, for 18 months.
August 31, 2020
The new facility, located in Lenexa, KS, will rapidly expand production of viral transport media.
The acquisition will expand Nestlé’s portfolio with access to Aimmune’s Palforzia, the first and only FDA-approved treatment to help reduce the frequency and severity of allergic reactions to peanuts in children.