News

WHO’s solidarity plus trial will enroll hospitalized patients to test artesunate, imatinib, and infliximab in hospitalized COVID-19 patients.

BlackBerry’s QNX real-time operating system may create cybersecurity vulnerabilities, according to FDA.

Lilly’s insulin, lyumjev, receives FDA approval for an expanded label.

Cipla receives final approval from FDA for its abbreviated new drug application for difluprednate ophthalmic emulsion 0.05%.

TriRx hosts various leaders at a ribbon-cutting ceremony for their new facility.

BlueAllele has been granted a US patent for its advanced gene-editing technology, PALIDON, which is compatible with existing gene editing nucleases and delivery systems.

The Cleveland, Ohio facility will produce critical anti-infective drug products for US hospitals.

Artiva Biotherapeutics’s new R&D and GMP manufacturing center in San Diego, Calif., for NK cell therapies is expected to open in 2022.

Thermo Fisher’s manufacturing site in Greenville, NC was recognized for manufacturing excellence.

Syngene’s additions include a new microbial facility and an expanded mammalian facility.

Primates inoculated with CV2CoV show improved immune response and protection from various COVID variants.

FDA has granted its first approval for an idiopathic hypersomnia treatment.

Biotage’s new facility in Cardiff, UK, will produce lipids using large-scale flash purification.

FDA has opened a public docket soliciting feedback on the regulation process surrounding PANDAs.

Terumo Blood and Cell Technologies and PhotonPharma announced a collaboration to develop a novel tumor-specific immunotherapy for solid tumors.

PNI expands global headquarters with a new 75,000-square-foot facility, which will include multiple GMP suites for manufacturing RNA therapeutics and vaccines.

The companies announce the results of a research collaboration that applied machine learning to significantly advance the scalability of spirulina-based biologic drugs.

Eli Lilly and Company and Incyte have announced promising results that patients with COVID-19 on mechanical ventilation saw a reduction in deaths with the addition of baricitinib treatment.

Almac Sciences has signed a manufacturing agreement with Pila Pharma for the production of the API XEN-D0501.

Bayer has acquired Vividion Therapeutics, a US-based biopharmaceutical company.

Rentschler Biopharma has broken ground nearby its Milford, Mass., site where it will build its new multi-product manufacturing facility for commercial production of complex molecules.

Lykan Bioscience and Vineti will combine their capabilities to streamline process development and manufacturing to move cell therapies through clinical phases to commercialization.

The President calls for granting Medicare authority to negotiate drug prices and penalties for pharma companies that raise prices faster than inflation.

The agency has amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow certain immunocompromised people to receive an additional dose of the vaccine.

Recro acquires CDMO IRISYS, establishing a bi-coastal presence in the US.

A research team at the Keck Graduate Institute will work to adapt its decade-long low-cost vaccine R&D for developing countries into a COVID-19 vaccine.

FDA has awarded Fast Track designation to Vivet Therapeutics’ novel gene therapy, VTX-801.

A collaboration between Aldevron and Ginkgo Bioworks has resulted in a manufacturing enhancement that can improve production of an enzyme used for mRNA therapeutics.

Veraxa and Indivumed will work together to develop colorectal antibody drugs.

Lonza and Sheba Medical Center have successfully dosed four patients with a CD19 autologous CAR-T cell therapy using Lonza’s Cocoon automated manufacturing platform.