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FDA has granted Janssen breakthrough therapy designation for teclistamab, an investigational bispecific antibody under development for treating relapsed or refractory multiple myeloma.

Janssen Receives FDA Breakthrough Therapy Designation for Multiple Myeloma mAb

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

FDA Grants Accelerated Approval for Biogen’s Alzheimer’s Drug

Celltrion Healthcare has revealed positive one-year results from a Phase III trial comparing biosimilar adalimumab, Yuflyma, with the reference adalimumab in patients with rheumatoid arthritis.

Celltrion Reveals Positive Clinical Trial Data for Biosimilar Adalimumab

Moderna and Aldevron have expanded their existing collaboration to support Moderna’s COVID-19 vaccine program as well as additional clinical programs in Moderna’s pipeline.

Moderna and Aldevron Expand Partnership for mRNA Vaccine and Therapeutic Pipeline

Biogen and Ginkgo Bioworks have partnered to develop a next-generation AAV production platform to accelerate Biogen’s gene therapy drug development efforts.

Biogen and Ginkgo Bioworks in $120-Million Deal to Develop Novel Gene Therapy Manufacturing Platform

Codagenix and Univercells have partnered on a research collaboration to pursue an undisclosed, high-priority human vaccine target.

Codagenix and Univercells Collaborate on Vaccine Research for Undisclosed Target

In the study, which enrolled 3700 US participants ages 12 to less than 18 years, no cases of COVID-19 were found in participants who had received two doses of the Moderna COVID-19 vaccine.

Moderna’s COVID-19 Vaccine Study in Adolescents Has Met its Primary Endpoints

The Committee for Medicinal Products for Human Use of the European Medicines Agency presented a positive opinion of bluebird bio’s SKYSONA (elivaldogene autotemcel, Lenti-D), a one-time gene therapy for the treatment of early cerebral adrenoleukodystrophy, an X-linked metabolic disorder.

bluebird bio’s One-Time Gene Therapy for CALD Receives Positive Opinion from CHMP

VectorY, a Netherlands-based biotechnology company, has been selected as the European winner of MilliporeSigma’s 2021 Advance Biotech Grant Program. 

MilliporeSigma Announces European Winner of its 2021 Advance Biotech Grant Program

Sanofi and GlaxoSmithKline reported that their adjuvanted recombinant COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase II trial.

Bio/Pharma News