The companies will collaborate on the production of a novel anti-SARS-CoV-2 immunoadhesin in iBio’s FastPharming manufacturing system.

The guidance recommends steps to detect and prevent nitrosamine impurities in pharmaceutical products.

The agency is reviewing an application for Dexamethasone Taw for treating adult patients with COVID-19.

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.

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.

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

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.

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

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

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

How real estate can accelerate productivity as life sciences companies prioritize COVID-19 therapeutics, vaccines, and new diagnostics R&D amidst new guidelines.

The collaboration includes an integrated program that encompasses formulation development, drug substances, and drug product manufacturing.

The company has appointed Liam Tayler as CEO to guide the growth of the company’s iPSC technologies, products, and services.

The register supports cross-functional teams of chemists and biologists in developing non-natural, chemically-modified therapeutics for drug discovery.

AbCellera’s recent acquisition of the OrthoMab bispecific platform is expected to accelerate antibody product development.

In the study, GigaGen presents a novel technology for producing a new class of drug, recombinant hyperimmunes, that may potentially generate new COVID-19 therapies.

Thermo Fisher Scientific is increasing access to cry-electron microscopy with the help of contract research organizations.

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

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.

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.

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

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.

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