RegulationApprovals February 7, 2022 US FDA approves Sanofi’s Enjaymo for cold agglutinin disease treatment By PBR Staff Writer Enjaymo is intended to reduce the need for red blood cell transfusion caused due to hemolysis in CAD patients. The drug is a humanised monoclonal antibody that selectively
Drug DiscoveryResearch & Development February 4, 2022 Mersana, Janssen Biotech partner to discover new ADC product candidates By PBR Staff Writer As part of the collaboration, Janssen will provide its antibodies and Mersana will apply its Dolasynthen platform and expertise for the discovery of the new ADC product candidates.
Research & DevelopmentDrug Manufacturing February 3, 2022 Alvotech, BiosanaPharma partner to develop biosimilar for Xolair By PBR Staff Writer As part of the collaboration, both the companies will co-develop AVT23, an investigational compound, that is now in late development stage. The companies will develop the proposed biosimilar
RegulationApprovals February 2, 2022 ViiV Healthcare gets FDA nod for two-month dosing of Cabenuva to treat HIV By PBR Staff Writer Cabenuva has now been cleared for every-two-month dosing for the treatment of HIV-1 in people who are virologically suppressed on a stable regimen, with no prior treatment failure,
RegulationApprovals February 1, 2022 Novavax seeks EUA from FDA for Covid-19 vaccine By PBR Staff Writer The protein-based vaccine candidate is intended to immunise individuals aged 18 years and above against Covid-19. Developed using Novavax’ recombinant nanoparticle technology, NVX-CoV2373 is engineered from the genetic
RegulationApprovals January 31, 2022 EMA’s CHMP recommends approval for Bristol Myers’s Breyanzi to treat lymphoma By PBR Staff Writer The drug is intended to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) in
Research & DevelopmentDrug Manufacturing January 28, 2022 Ocugen to buy Liminal’s vaccine manufacturing facility in Canada By PBR Staff Writer The biopharmaceutical company stated that the dormant vaccine manufacturing site would add new capabilities to its medicine portfolio of Canadian and US companies. It is expected to allow
RegulationApprovals January 27, 2022 Roche gets FDA priority review for Evrysdi to treat SMA in new-borns By PBR Staff Writer The US regulator has accepted the company’s supplemental new drug application (sNDA) for Evrysdi to treat SMA in pre-symptomatic babies, aged below two months. Evrysdi is a survival
Drug DiscoveryResearch & Development January 26, 2022 Twist Bioscience, Artisan Development Labs partner to discover cell therapies By PBR Staff Writer As part of the collaboration, the US-based company will use its Library of Libraries for the discovery of new antibodies against Artisan Bio’s immunotherapy targets. Meanwhile, Artisan will
Drug Manufacturing January 25, 2022 Amyris to buy women’s wellness firm MenoLabs By PBR Staff Writer The acquisition will help accelerate the company’s growth and establish a footprint in the menopause market. Previously, Amyris announced plans to establish a new consumer brand to offer