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 […]

Biogen and Denali Therapeutics have signed a binding agreement to co-develop and co-commercialize Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for Parkinson’s disease. Biogen will also receive rights to opt into two programs and a right of first negotiation for two additional programs, in each case for neurodegenerative diseases leveraging Denali’s Transport […]

Cambridge-based Seres Therapeutics has reported positive topline results from its Phase 3 study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). “Based on our prior discussions with the FDA, we believe this trial should provide the efficacy basis for submitting an application for product approval. We look forward to meeting with the […]

Sanofi and GSK have entered into a collaborative effort with the U.S. government to accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine. The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant […]

Gene editing company CRISPR Therapeutics is building a new cell therapy manufacturing facility in Framingham, Massachusetts for clinical and commercial production of the company’s investigational cell therapy product candidates. “We look forward to building a state-of-the-art manufacturing facility, which will accelerate our programs and allow us to scale for commercial supply. We are thankful for […]

AstraZeneca and Daiichi Sankyo have entered into a global development and commercialization agreement for Daiichi Sankyo’s DS-1062, a TROP2 directed DXd antibody drug conjugate (ADC). DS-1062 is currently in phase 1 clinical development for non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC). Daiichi Sankyo and AstraZeneca will jointly develop and commercialize DS-1062 […]

The Massachusetts Biotechnology Council has released its 2020 Industry Snapshot report, which shows that the Massachusetts biopharma industry raised $2.1 billion in venture capital (VC) investment in the first half of 2020. The IPO market also remained strong, with seven IPOs from Massachusetts biotech companies in the first half of 2020, making up 33% of all […]

Watertown-based, clinical-stage biotech Pandion Therapeutics has announced the initial public offering of 7,500,000 shares of its common stock at a public offering price of $18.00 per share, for gross proceeds of $135 million. The common stock is expected to begin trading on the Nasdaq Global Market on July 17, 2020 under the symbol “PAND.” The offering is expected to close on July […]

Cambridge-based Glympse Bio has closed an oversubscribed $46.7 million Series B financing. The proceeds from the financing will support continued development of Glympse’s novel biosensor platform in fibrotic diseases such as Non-Alcoholic Steatohepatitis (NASH), oncology, and infectious diseases. NASH is a disease that impacts 16 million people in the U.S. and 100 million worldwide. The […]

Waltham-based Adagio Therapeutics has launched with the closing of a $50 million Series A financing to advance its portfolio of coronavirus antibodies as both therapeutics and prophylactics against SARS-CoV-2 as well as future coronavirus outbreaks. Adagio’s antibody candidates have been uniquely engineered and optimized to provide broad protection against SARS-CoV-2, SARSCoV-1, and additional circulating bat […]