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Home » Newsletters » BioWorld

BioWorld

Aug. 31, 2022

View Archived Issues
Person receiving vaccine

Bivalent COVID-19 boosters coming to the US next week

Right on cue, the U.S. FDA authorized bivalent COVID-19 vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE to be given as boosters at least two months following a primary vaccine series or a previous booster. “These updated boosters present us with an opportunity to get ahead of the next wave of COVID-19,” FDA Commissioner Robert Califf said, following the Aug. 31 announcement. Read More

FDA clears Sanofi’s Xenpozyme for rare disease ASMD

Five months after winning its first approval in Japan, Sanofi SA’s enzyme replacement therapy, Xenpozyme (olipudase alfa), earned a U.S. FDA nod for use in pediatric and adult patients with acid sphingomyelinase deficiency (ASMD), becoming the first medication designed to treat symptoms not related to the central nervous system. Read More
IV drips

Zynteglo’s US approval sparks call for reimbursement reform in Europe after Bluebird’s walkout

Access to advanced therapies proved to be a major talking point at a conference in London, following the U.S. approval of Bluebird Bio Inc.’s Zynteglo (betibeglogene autotemcel) cell-based gene therapy for beta thalassemia and its $2.8 million price tag. Regulators in Europe backed Zynteglo in 2019 but Bluebird opted to withdraw the therapy in 2021 after deciding that the complex thicket of pricing bodies in Europe was too difficult to negotiate. Read More

SPAC sets sail with Ocean Biomedical deal

Ocean Biomedical Inc., a company with preclinical programs in oncology, fibrosis, infectious disease treatments and vaccines, is poised to go public via a merger with Aesther Healthcare Acquisition Corp., a special purpose acquisition company (SPAC). Read More
Cancer cells

Via splice variant, universal protein yields tumor-specific antigen

Collagen is the most abundant protein in the human body, which would seem to make it an unlikely source for an immunotherapy target. But it is where researchers from Immatics SA and the University of Pennsylvania have found a target that was expressed on stromal cells in a number of different solid tumors, but very rare in normal tissues. Read More
Eye wireframe illustration

Brim Biotech announces $18M raise to advance dry eye drug to phase III

Taiwan’s Brim Biotechnology Inc. announced a capital raise of $18 million to advance its lead candidate, regenerative peptide therapy BRM-421, to phase III trials for dry eye syndrome. It’s designed to offer relief from dry eye symptoms by stimulating proliferation and differentiation of stem cells to repair damage to the cornea. “Our goal is restoration and repair of the damage caused by DES,” said Brim founder and CEO Haishan Jang. Read More

Appointments and advancements for Aug. 31, 2022

New hires and promotions in the biopharma industry, including: Leo, Prokidney, Vaxart. Read More

Financings for Aug. 31, 2022

Biopharmas raising money in public or private financings, including: Bright Minds, Iqure, Satellos, Shuttle. Read More

In the clinic for Aug. 31, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, Aristea, Clover, Connect, Cybin, Forge, Hemostemix, Janssen, Jounce, Journey, Poxel, Sangamo, Vascular. Read More

Other news to note for Aug. 31, 2022

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Codiak, Marinus, Myovant, Pfizer. Read More

Regulatory actions for Aug. 31, 2022

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bavarian Nordic, Biocytogen, Biogen, Curis, Daiichi, Jaguar, Moderna, Novavax, Okyo, Outlook, Sanofi, Sobi, Stemcyte, Takeda, Y-mabs. Read More

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