The Biogen Foundation has committed $10 million to support global response efforts and communities around the world impacted by the COVID-19 pandemic. The Biogen Foundation supports access to science education and to essential human services for children and their families in the communities in which Biogen facilities are located. The funds will be used to […]

Novartis has announced that Sandoz, its generics and biosimilars division, has started to ship a consignment of 30 million doses of hydroxychloroquine (HCQ) tablets to HHS for immediate use in controlled clinical studies. The study will evaluate the medicine’s effectiveness in people who have tested positive for COVID-19. The shipment is part of the previously […]

A consortium of life sciences companies will collaborate with the Bill & Melinda Gates Foundation to accelerate the development, manufacture and delivery of vaccines, diagnostics, and treatments for COVID-19 in response to the pandemic. Companies participating in the collaboration include: BD, bioMérieux, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck, […]

Sanofi and Regeneron have begun a second Phase 2/3 trial for Kevzara (sarilumab) in COVID-19 patients in Italy, Spain, Germany, France, Canada and Russia following initiation of the first trial in the US. Sanofi is leading the trials outside the US, with Regeneron leading the US trials. Jointly developed by Sanofi and Regeneron under a […]

Looking for resources during the global COVID-19 public health emergency? ISPE has you covered. Click HERE for related articles, webinars, and other information or see below.   Global/Local Resources ISPE Affiliates and Chapters are a true local extension of the Society, so please reach out to the affiliate/chapter in your area for ground support and resources. […]

Genentech is working with the FDA to initiate a randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the safety and efficacy of Actemra (tocilizumab) for hospitalized patients with severe COVID-19 pneumonia. This is the first global study of Actemra in this setting and is expected to begin enrolling in early April with a target […]

Leading Massachusetts life sciences and healthcare organization executives Robert Coughlin (MassBio), Steve Walsh (Massachusetts Health and Hospital Association), Brian Johnson (Massachusetts Medical Device Industry Council) and Patricia McMullin (Conference of Boston Teaching Hospitals) have joined together to make the following appeal to the area’s life sciences and healthcare organizations: As the leading life sciences and […]

The FDA has issued the fourth COVID-19 diagnostic Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit. The FDA issued an EUA to Thermo Fisher for its diagnostic test within 24 hours of receiving the request. This is the second commercially distributed test to receive an EUA during the COVID-19 outbreak. […]

Kymera Therapeutics has announced the closing of a $102 million Series C financing round. was led by Biotechnology Value Fund (BVF) and Redmile Group. Kymera also received a strategic investment from The Leukemia & Lymphoma Society‘s Therapy Acceleration Program directed toward advancing the company’s work to treat blood-based cancers. “We are very excited to be […]

Rajeev Venkayya, President of Takeda’s Global Vaccine Business Unit, has announced that Takeda is “initiating the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) to treat high-risk individuals with COVID-19, which we’re calling TAK-888. SARS-CoV-2 is the virus that causes COVID-19.” He went on to explain that “Hyperimmune globulin is a plasma derived-therapy that has previously been […]