Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy

Final decision from the European Commission is anticipated within the coming months

Briefs: Venus Remedies and GPT Healthcare

Venus Remedies secures marketing authorization in Philippines

European Commission approves Pfizer’s HYMPAVZI for treatment of severe Hemophilia A or B without inhibitors

HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors

CDSCO, NRAI meets WHO international standards for vaccine regulations

India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI

Sun Pharma and Philogen enter into a exclusive commercialization and supply agreement for Fibromun

Sun Pharma will have the exclusive worldwide rights to commercialise Fibromun

Venus Remedies secures marketing authorisations for key oncology drugs from Morocco

The authorization of bortezomib will enhance the company’s ability to deliver advanced cancer solutions in Southeast Asia

Lupin signs distribution agreement with Celnova for orphan drug NaMuscla

Agreement enables access of EU-approved treatment for myotonia symptoms in non-dystrophic myotonic disorders to patients from Argentina and Colombia

Biocon partners with Tabuk to commercialize its Glucagon-like peptide-1 products in the Middle East

Bavarian Nordic receives EMA approval of mpox vaccine for adolescents

MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA

Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19

Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization