News

Vibalogics is contracted to manufacture Janssen's COVID-19 candidate vaccine at its GMP-accredited facility in Cuxhaven, Germany.

Leadership was announced for the US government’s Operation Warp Speed program, which aims to deliver COVID-19 vaccines, therapeutics, and diagnostics.

Michelle McMurry-Heath will assume the role of BIO president and CEO on June 1, 2020 after Jim Greenwood, who has led the organization since 2005, retires from the positions.

A temporary restraining order was entered against Xephyr LLC, doing business as N-Ergetics requiring the company to immediately stop distributing colloidal silver products.

The CHMP has issued a recommendation that the compassionate use of remdesivir be expanded in the treatment of more patients with severe COVID-19 symptoms.

The Center for iPS Cell Research and Application Foundation and the Cell and Gene Therapy Catapult have announced the launch of a new collaborative research project that will focus on induced pluripotent stem cell characterization.

Santen Pharmaceutical has concluded a licensing agreement with jCyte for the development, registration, and commercialization rights to jCell, an investigational retinitis pigmentosa therapy, in Japan, Asia, and Europe.

The company will invest $180 million to construct a new 290,000-ft2 facility in Plainville, MA.

Hitachi Chemical Advanced Therapeutics Solutions and apceth Biopharma entered into long-term development and manufacturing services agreements for the clinical and commercial supply of multiple bluebird bio therapies.

Some observers fear that political interference in the process may erode confidence in the scientific basis for FDA regulatory decisions.

The Coalition for Epidemic Preparedness Innovations will invest up to $384 million of additional funding, in addition to the $4 million it invested in March, to advance the clinical development of NVX-CoV2373, Novavax’s COVID-19 vaccine candidate.

The agency is responding to companies promoting and selling medical products that claim, but are unproven, to prevent or treat COVID-19.

A high-level meeting on COVID-19 policies, organized by EMA under the auspice of the International Coalition of Medicines Regulatory Authorities (ICMRA), has brought together global regulators to ensure a coordinated pandemic response.

A rolling review of data on the use of remdesivir, an investigational antiviral medicine, for the treatment of COVID-19 has been started by EMA’s Committee for Medicinal Products for Human Use.

Boehringer Ingelheim will use the partnership to reveal novel insights into the complexities of various inflammatory diseases, which opens the potential for a clearer understanding of potential candidate biomarkers.

AbbVie and Allergan have satisfied all required antitrust clearances for the acquisition.

The center will be located at NJIT’s Life Sciences and Engineering center and will feature two good manufacturing practices suites that are expected to be completed and operational during the summer of 2020.

The collaboration will add diversity to Alexion’s commercial portfolio and will give the company access to Portola’s commercialized medicine, Andexxa (coagulation factor Xa [recombinant], inactivated-zhzo).

Remote, machine health monitoring services reduce the need for on-site visits.

Catalent will manufacture a mRNA-based COVID-19 vaccine for clinical trials and potential commercialization.

Trial begins in the US for the Pfizer-BioNTech mRNA COVID-19 vaccine; manufacturing plans announced.

The extension of the company’s product offerings to include the anti-certolizumab pegol antibodies offers critical reagents for the development of assays for TNF alpha inhibitor biologics and their biosimilars.

The companies have entered into a manufacturing agreement to supply leronlimab, an investigational new drug currently being used in clinical trial protocols for COVID-19.

Kindeva Drug Delivery plans capital investment and jobs growth.

Fujifilm allocates production volumes for COVID-19 treatments in 2021 at its Denmark facility.

Congressional leaders are developing the next version of the 21st Century Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster.

FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.

The ASTM standard describes how to evaluate single-use systems for foreign particle analysis.