BioPharm International Editors

The agency discusses its response to COVID-19 and other milestones in its year-end review.

The agency’s COVID-19 task force says latest data shows use of COVID-19 mRNA vaccines during pregnancy is safe.

In their collaboration, Bristol Myers Squibb and Prellis Biologics aim to generate human antibody libraries for select targets to enable drug discovery.

After a previously announced merger, Protagen Protein Services, BioAnalytix, and GeneWerk have formed a new CRO under the name ProtaGene.

CDMO Forge Biologics will accelerate its manufacturing capacity expansion using an additional $80 million in funding it recently secured.

Pfizer will pay Beam $300 million upfront to conduct research on three undisclosed base editing targets in the liver, muscle, and central nervous system.

The UK’s National Institute of Health and Care Excellence has recommended the use of Janssen’s Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) to treat adults with multiple myeloma.

Fosun Pharma and Insilico Medicine will collaborate on AI-driven drug discovery and development of product candidates targeting multiple disease targets.

The collaboration between Bristol Myers Squibb and Century Therapeutics will combine Century’s iPSC-derived allogeneic cell therapy platform with Bristol Myers Squibb’s expertise in cell therapy and oncology drug development.

Fujifilm Diosynth Biotechnologies' 89,000 square-foot expansion of its BioProcess Innovation Center in Research Triangle Park, N.C., will double its capacity to support process characterization.

The collaboration will leverage Alynlam’s proprietary small interfering RNA (siRNA) technology to inhibit a target discovered by Novartis.

FDA granted Oncoloze’s OM-301 an orphan drug designation for the treatment of acute myeloid leukemia (AML).

Bio-Rad’s new assays are designed to measure neutralizing antibodies against wild-type and significant variants of COVID-19.

FDA amended it’s Emergency Use Authorization to shorten Moderna’s vaccine booster dose interval from six to five months.

FDA has cleared an IND from Poseida Therapeutics, allowing continued development of the company’s allogeneic CAR-T cell therapy candidate for treating multiple solid tumors.

The acquisition of Protein Metrics expands Insightful Science’s R&D solutions to include proteomics.

Neurimmune will receive up to $760 million for NI006, an investigational human monoclonal antibody in development for the treatment of transthyretin amyloid cardiomyopathy.

With this investment into Yapan Bio, Piramal Pharma adds new technologies and capabilities in large molecules, including vaccines and gene therapies, to its global offering.

Thermo Fisher Scientific’s Invitrogen TrueCut HiFi Cas9 Protein offers the advantage of significantly minimizing off-target events while aiming to retain maximum on-target editing efficiency.

The partnership between OpenEye Scientific and Specifica has generated AbXtract, an antibody discovery model that is included in the Orion Antibody Suite.

The agency is expanding the use of a single booster of the Pfizer-BioNTech vaccine to children ages 12–15 and is shortening the time between primary vaccination and booster to at least five months.

Moderna’s vaccine is weaker against the Omicron variant, but boosters can increase neutralizing antibody levels by as much as 83-fold.

Sanofi’s acquisition will grant access to Amunix's promising immuno-oncology pipeline.

Tezpire (tezepelumab-ckko) has been approved as an add-on maintenance treatment for severe asthma.

The agency recommended granting conditional marketing authorization for use of Nuvaxovid in people 18 years of age and older.

Amgen and Syngene International have extended their research collaboration to 2026.

Genezen has opened its new process development and analytical lab for viral vector production.

Bionique Testing Laboratories has been acquired by Asahi Kasei Medical and will join the company’s biosafety testing services unit.

FDA approved American Regent’s Injectafer (ferric carboxymaltose injection) for the treatment of pediatric patients with iron deficiency anemia.

Lonza plans to ensure consistent product quality by incorporating Agilent’s analytics technology into its Cocoon platform.