As America’s researchers race to develop the scientific solutions needed to eradicate COVID-19, leaders within the Biotechnology Innovation Organization (BIO) released an open letter to their biopharmaceutical colleagues that articulates key principles to ensure the “integrity, transparency, and objective assessment” of COVID-19 clinical data and secure public trust in new medical products developed in response to the […]

The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi have signed a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines. All nine CEOs signed the following pledge: We, […]

The FDA has issued Emergency Use Authorization (EUA) for Abbott’s BinaxNOW rapid antigen test for detection of COVID-19 infection. The $5 test is highly portable, affordable and provides results in 15 minutes. It uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing by healthcare providers. Abbott will ship […]

Takeda has entered into an agreement to divest Takeda Consumer Healthcare Company (TCHC), a wholly-owned subsidiary of Takeda focused on the consumer health care market primarily in Japan, to a company controlled by funds managed by The Blackstone Group for a total value of 2.3 billion USD. The transaction is expected to close by March […]

The FDA has approved Foundation Medicine’s comprehensive pan-tumor liquid biopsy test, Called FoundationOne Liquid CDx. Using a blood sample, the test analyzes over 300 cancer-related genes for alterations. Results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies and delivers information about the genomic signatures microsatellite instability and blood tumor mutational […]

Momenta Pharmaceuticals has agreed to be acquired by Johnson & Johnson for $52.50 per share in an all-cash transaction, implying a fully-diluted equity value of $6.5 billion. The agreement was unanimously approved by the Boards of Directors of both Momenta and Johnson & Johnson. “The agreement with J&J recognizes the value created by years of […]

Sanofi and San Francisco-based Principia Biopharma have entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Principia for $100 per share in cash, which represents an aggregate equity value of approximately $3.68 billion (on a fully diluted basis). Principia Biopharma is a late-stage biopharma focused on developing treatments […]

Gilead Sciences and Cambridge-based Tango Therapeutics have announced an expanded strategic collaboration focused on the discovery, development and commercialization of innovative targeted immune evasion therapies for patients with cancer. Under the expanded multi-year collaboration, which builds on an agreement signed in 2018, Tango will continue to leverage its proprietary, CRISPR-enabled functional genomics target discovery platform […]

The U.S. government has secured 100 million doses of Moderna’s vaccine candidate mRNA-1273 as part of the goal of securing early access to safe and effective COVID-19 vaccines for the American people. The award of up to $1.525 billion is for the manufacturing and delivery of 100 million doses of mRNA-1273 including incentive payments for timely delivery of the product. […]

Biogen and Eisai today announced that the FDA has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally. The application has been […]