Biopharma News

FSD Pharma has entered a definitive agreement to acquire all of the issued and outstanding shares of Lucid Psycheceuticals for approximately US$9 million (CAD$11.3 million) in FSD Pharma stock.

FDA has cleared QSAM Biosciences’s IND application for Samarium-153 DOTMP (CycloSam).

Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.

Eli Lilly and Company and industry partners, including Ziath, are focused on speeding up the drug discovery process with a fully automated lab.

BioMed X has partnered with Janssen to start two new research programs for autoimmune diseases and drug delivery.

NGM Biopharmaceuticals has disclosed a fourth antibody drug candidate, NGM831, for development into an oncology therapeutic.

Pfizer’s proposed $2.26-billion acquisition of Trillium Therapeutics will add next-generation hematology-targeted immuno-therapeutics to its oncology pipeline.

FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.

HHS Public Health and a team of medical experts recommend that COVID-19 vaccine booster shots will soon be necessary.

FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.

Novartis' Cosentyx has been granted further approval from the China National Medical Products Administration for use in pediatric patients.

FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.

Bristol Myers Squibb has exercised the option to in-license an immune-modulating drug candidate developed by Exscientia.

Merck KGaA has partnered with Telix Pharmaceuticals to conduct combination clinical studies for cancer therapy.

The collaboration will focus on the interactions between WTX-124 indukine and KEYTRUDA (pembrolizumab).

A new method developed by the NIH bypasses genetic RNA extraction, simplifying the testing process.

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

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

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

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

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.

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

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

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

Moderna will build an mRNA vaccine manufacturing facility in Canada to provide access to domestically manufactured vaccines against respiratory viruses.

The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.

The MHRA has approved GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.

FDA has approved the intravenous medication Nexviazyme for treatment of Pompe Disease.