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FDA issued emergency use authorization for bamlanivimab for patients at risk for severe COVID-19.

The agreement provides Novo Nordisk with full access to Emisphere’s Eligen SNAC technology, which will boost Novo Nordisk’s portfolio of oral therapeutics.

Interim efficacy data suggests the Pfizer/BioNTech has an efficacy rate above 90%.

Through the acquisition, Merck will gain access to VelosBio’s lead investigational candidate, VLS-101, an antibody-drug conjugate that targets receptor tyrosine kinase-like orphan receptor 1.

Bayer will own the rights to AskBio’s AAV-based gene therapy platform, its intellectual property portfolio, and an established CDMO.

Gilead’s antiviral drug Veklury is the first approved treatment in the US for COVID-19.

200 employees will be hired by the end of 2020, with 300 more planning to be hired by 2023.

Regeneron will distribute Inmazeb treatment doses over the course of six years to BARDA.

Roche will use Dyno’s CapsidMap platform to develop next-generation adeno-associated virus vectors for gene therapies for central nervous system diseases and liver-directed therapies.

The companies are entering into an agreement for the late-stage development and large-scale manufacturing of AZD7442, AstraZeneca’s investigational product for treatment and prevention of COVID-19.

Through the acquisition, Bristol Myers Squibb will gain access to MyoKardia’s mavacamten, a cardiovascular drug for the treatment of obstructive hypertrophic cardiomyopathy, a chronic heart disease.

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

Samsung will offer large-scale commercial manufacturing for drug substance and drug products to support AstraZeneca’s biologics therapeutics capabilities in the Asia-Pacific region.

Roche will gain full rights to Inflazome’s portfolio which includes clinical and preclinical orally available small molecule NLRP3 inhibitors.

Valneva will supply the UK government with an initial 60 million doses of the vaccine in the second half of 2021, if successful, and will provide more doses thereafter.

The acquisition will give Gilead access to an anti-cancer antibody drug conjugate in clinical development for treating breast and bladder cancers.

The White House issued an executive order Sunday, Sept. 13, 2020 implementing a policy to link payments for medicines provided through Medicare to prices charged in other industrial countries.

In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.

Takeda is divesting its portfolio of select, non-core prescription pharmaceutical products sold in Europe and Canada to Cheplapharm, a German pharmaceutical company.

As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.

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

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.

FDA issued an emergency use authorization for COVID-19 convalescent plasma treatments following a report on NIH concerns about insufficient studies and data.

BioMarin received the complete response letter for valoctocogene roxaparvovec, its gene therapy intended for treating severe hemophilia A.

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.

A new FDA guidance provides answers to 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.

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.

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.