Pfizer boosts its obesity plans with $2bn GLP-1 YaoPharma deal
The move builds on its recent billion-dollar acquisition of the obesity-focused biopharma company Metsera.
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Impurities findings could enhance peptide drug safety
EpiVax and Cubrc research supports FDA guidance on impurity risk assessment in generic peptides.
Gamida Cell wins cell therapy first in severe aplastic anaemia from FDA
The US approval for the Ayrmid company’s novel transplant option Omisirge adds to its existing licence in haematological malignancy.
CSL opens $1bn Australian vaccine and antivenom manufacturing facility
The Melbourne site adds Australia to a select group of nations with advanced cell-based influenza vaccine capabilities.
European Pharmacopoeia updates monoclonal antibody standards
The Ph. Eur. Commission also adopted seven new monographs and two new general chapters at its recent 183rd session.
Takeda expands its ADC and immuno-oncology pipeline as Innovent deal closes
The $11bn collaboration with the Chinese biopharma company gives Takeda the rights to several next-generation candidates.
Bristol Myers Squibb wins fifth US approval for CAR T cell therapy Breyanzi
The FDA’s latest authorisation makes it the most widely approved of any CD19-directed CAR T therapy in cancer.
FDA appoints another new CDER director, selecting Dr Tracy Beth Høeg
She will become the fifth leader at the Center, following the surprise retirement decision by her soon-to-be predecessor Richard Pazdur.
J&J biologic Imaavy achieves EU first in generalised myasthenia gravis
The monoclonal antibody becomes the first neonatal Fc receptor (FcRn) blocker to be approved in Europe for the condition.
CDER director Richard Pazdur to retire from FDA
In the interim, Dr Tracy Beth Høeg will serve as acting director for FDA's Center for Drug Evaluation and Research.
Regeneron and Tessera partner to develop gene therapy for AATD
The in vivo, one-time gene editing therapy has potential to transform outcomes for alpha-1 antitrypsin deficiency (AATD).
UK first country to secure zero-tariff US pharmaceuticals deal
New trade deal to “ignite economic growth” and help boost the UK’s position as a superpower in life sciences.
AbbVie’s atogepant illustrates migraine therapy label expansion potential
If approved in Europe, atogepant would provide patients with a new acute treatment option for migraine attacks.
BSI launches a world-first environmental standard for the pharma industry
New BSI standard PAS 2090 could reshape how the pharmaceutical industry reports and minimises its environmental footprint.
Novel NMR-based method could facilitate safer API manufacturing
The innovative approach for detecting nitrosamine impurities in APIs addresses limitations of traditional mass-based techniques, research says.
