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.

Under the terms of the agreement, Catalent will develop a powder-in-capsule formulation of Ennaid’s ENU200 program at its site in San Diego, CA.

Through the agreement, Mylan will manufacture and distribute remdesivir in 127 low- and middle-income countries, including India.

In light of the current social distances measures, in place as a result of COVID-19, IMA Digital, part of IMA Group, has been providing virtual experiences for those interested in packaging and processing.

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 companies have entered into a partnership to produce hydroxychloroquine, a treatment currently under investigation for COVID-19.

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.

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.

Tabrecta is approved to specifically target metastatic non-small cell lung cancer with a mutation that leads to MET exon 14 skipping (METex14).

Human cells form the source material for cell therapies and they require a variety of assays to detect bacterial, fungal, and viral contaminants.

Conventional cleaning methods can risk product loss of biologics, prompting biopharmaceutical manufacturers to seek alternative criteria to validate cleaning processes.

Quartic.ai and Bright Path Laboratories have agreed to develop an artificial intelligence (AI)-powered continuous manufacturing platform for APIs and other small-molecule drugs using Bright Path Labs’ continuous bioreactor and the Quartic.ai smart manufacturing technology.

CMO Evonik begins capacity expansion of APIs and intermediates at its sites in Dossenheim and Hanau Germany to increase EU supply security for drug products.

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).

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.

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

EMA's Committee for Medicinal Products for Human Use has recommended that all ranitidine medicines be suspended within the European Union as a result of the presence of low levels of NDMA.

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

Through the acquisition, Orbis will work to heighten Adare’s Pharmaceutical Technologies business, which handles the development and manufacturing of products for pharmaceutical, animal health, and over-the-counter markets.

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.

FDA approved hydroxychloroquine sulfate for emergency use as a treatment for some hospitalized patients with COVID-19.