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Home » Newsletters » BioWorld

BioWorld

Dec. 30, 2022

View Archived Issues
Nexobrid

Mediwound fends off a CRL and COVID for FDA’s burn treatment approval

After working through a complete response letter (CRL) brought about by COVID-19 from the U.S. FDA in June 2021, Mediwound Ltd. has received the agency’s approval for Nexobrid (anacaulase-bcdb) to treat severe burns in adults. Read More

US report citing 'atypical' Aduhelm approval calls on FDA, drugmakers to do better

Citing an "atypical FDA review process and corporate greed" ahead of the controversial approval of Biogen Inc.'s Aduhelm (aducanumab), Energy and Commerce Committee Chairman Frank Pallone (D-N.J.) called for "corrective actions" at the agency to "re-earn the trust of the American people." Pallone's comments prefaced a report drawn from 18 months of investigation around the regulatory review and approval process for the Alzheimer's disease drug, as well as Biogen’s pricing strategy. Read More
HKEX on phone, digital stock chart

Boan Biotech nets almost $19.6M in Hong Kong IPO

Boan Biotechnology Co. Ltd. raised HK$152.8 million (US$19.6 million) from a Hong Kong IPO, capital the company will use to speed up product development, expand marketing and ramp up manufacturing. Read More
Health professional pointing stethoscope at Clinical Trial words, icons

Clinical data down 17% in 2022; COVID reports cut in half

The proportion of clinical data focused on COVID-19 therapeutics and vaccines has dropped from 21.3% in 2020 at the height of the pandemic to only 7.7% for 2022. Read More
Diagram of of the main human adipose tissue depots in the body.

As weight loss medicine advances, its relevance recedes

Metabolic health is at an odd juncture. With the advent of glucagon-like peptide (GLP-1) agonists, pharmacologically induced weight loss has matured into a viable therapeutic option at long last. And research into the drug class is continuing apace. Read More

Holiday notice

BioWorld's offices will be closed Monday, Jan. 2. No issue will be published. Read More

Financings for Dec. 30, 2022

Biopharmas raising money in public or private financings, including: Cyclo, GT, Hoth, Palisade, Unicycive. Read More

In the clinic for Dec. 30, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Novavax, Oncoc4. Read More

Other news to note for Dec. 30, 2022

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bluebird, Carisma, Cellectis, Cipla, Connect, Ethris, Gemini, Primera, Sesen. Read More

Regulatory actions for Dec. 30, 2022

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB, Beigene, Calliditas, Everest, Mediwound, Merck & Co. Read More

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