News

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 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.

The deal is expected to close during the second half of 2020.

The acquisition will give Sanofi access to Principia’s Bruton tyrosine kinase (BTK) inhibitors to add to its portfolio of next-generation transformative treatments for autoimmune diseases.

The cell banks were created using current good manufacturing practices and can be used each time CombiGene produces new plasmids for the production of its gene therapy, CG01.

The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.

In combination with BARDA’s previous award, the commitment for early access to Moderna’s vaccine candidate has now reached to up to $2.48 billion.

ANA will use Quotient’s formulation and manufacturing knowledge to develop and supply the drug product for clinical trials by the third quarter of 2020.

SK bioscience will manufacture the vaccine antigen component for use in the final drug product at its vaccine facility in Andong L-house, South Korea.

The companies will work to establish an operational footprint across North America and Europe that will offer customers supply chain assurance for a combined portfolio of leading solutions.

The company will use the acquisition to further its drug development pipeline in women’s healthcare.

The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.