News

BIO leaders urge biopharmaceutical companies to apply scientific principles in seeking drug and vaccine approvals.

Avomeen will offer contract product development laboratory services to support the advancement of Daré’s innovative pipeline of investigational products dedicated to women’s health.

The new line will add capacity to Catalent’s pipeline of clinical programs and commercial launches at the site.

The companies have signed a partnership agreement to provide extractables and leachables testing at the SG US Technology Excellence Center in Boston, MA.

The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.

The agency sent a warning letter to Acella Pharmaceuticals detailing CGMP violations and failures to oversee contract manufacturers.

Oxford Biomedica will reserve capacity for AstraZeneca in three of its manufacturing suites in its new commercial manufacturing center, Oxbox, for 18 months.

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.

The facility offers office, production, sampling, and warehouse space and delivers products to all major global markets.

Under expanded FDA authorization, Gilead Sciences’ antiviral treatment for COVID-19 can be administered to all hospitalized patients.

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.

The transaction will give Ionis access to Akcea's pipeline and commercial products, as well as its cash on hand of approximately $390 million.

Hahn promises transparency in the review and approval of COVID-19 vaccines.

AstraZeneca has dosed the first participants in its Phase I clinical trial assessing the safety, tolerability, and pharmacokinetics of a combination of two monoclonal antibodies (mAbs) for the prevention and treatment of COVID-19.

Müller + Müller will become part of DWK upon closing in September 2020 and will continue to function under the same name and management.

Merck’s anti-PD-1 therapy, Keytruda, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency.

Mapp has selected Avid to provide process transfer, scale-up, and clinical manufacturing services for one of its development programs for a novel antiviral drug candidate.

Medical management services provider, Europital, has announced the opening of a new site in Oxford, United Kingdom, in response to demand from small and medium innovators within the biotech industry.

The European Commission (EC) and Moderna have concluded exploratory talks on the potential purchase of Moderna’s COVID-19 vaccine candidate for Europeans.

The contract is valued at $106.3 million and is supported by Operation Warp Speed.

FDA announced it had issued an emergency use authorization for convalescent plasma that would make it easier to provide this treatment to COVID-19 patients.

EC finalizes agreement to purchase millions of doses of AstraZeneca's COVID-19 vaccine.

The UK's MHRA will resume on-site risk based GxP inspections from September 2020.

Avacta Group has expanded its drug development partnership with LG Chem Life Sciences to include new programs incorporating Avacta’s Affimer XT technology.

Novavax has signed an agreement with the UK government for 60 million doses of a COVID-19 vaccine and a Phase III clinical trial.

The collaboration will increase the supply of the potential treatment to at least three and a half times the current capacity.

A new FDA guidance provides answers to such questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely.

Bristol Myers Squibb will handle the development and commercialization of DF6002 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding, and manufacturing.