FDA to pilot faster review of generic drugs manufactured in the US
Sets bioequivalence and active pharmaceutical ingredient (API) requirements for its new ANDA prioritisation programme.
List view / Grid view
News
Europe unveils science strategy as it looks to become an ‘AI continent’
Establishes Resource for AI Science in Europe and eyes frontier AI models and autonomous agentic AI for pharma.
![Eli Lilly logo sign [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Eli-Lilly-300x278.jpg)
![Eli Lilly logo sign [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Eli-Lilly-e1629971959212.jpg)
Lilly outlines $1bn India manufacturing expansion
The investment will cover CMO collaborations and a new manufacturing and quality hub in Hyderabad.
Boehringer’s Jascayd becomes first new IPF treatment in US for a decade
FDA approval for the idiopathic pulmonary fibrosis drug supported by the pharma company’s FIBRONEER phase III clinical trials.
CDMO Wheeler Bio appoints Jay Benson as chief operating officer
He joins the US company with over two decades of experience in pharma operations, supply chain and manufacturing.
![Close up view of the Merck logo on the top corner of a glass building [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Merck-aquisition-300x278.jpg)
![Close up view of the Merck logo on the top corner of a glass building [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Merck-aquisition-scaled-e1605009301887.jpg)
Merck & Co starts phase IIb study of tulisokibart in rheumatoid arthritis
The study is one of three to start, along with those in hidradenitis suppurativa and radiographic axial spondyloarthritis.
Novel topical formulation demonstrates potential in peripheral neuropathy
Offers potential symptomatic relief for cancer patients with chemotherapy-induced peripheral neuropathy (CIPN).
AstraZeneca and Daiichi’s Datroway gets phase III breast cancer boost
Companies’ first-line ambitions for the antibody drug conjugate buoyed by the TROPION-Breast02 clinical trial.
Manufacturing roundup: Symbiosis, BioGrad, Abzena, Eschbach and more
This update includes sterile manufacturing, bio-manufacturing, cell line development and radiopharmaceuticals.
Takeda withdraws from clinical cell therapy activities
The company will instead focus its attention on advancing candidates for modalities that include biologics and ADCs.
AI adoption in life science labs faces a growing skills barrier
Pistoia Alliance survey also found that the greatest benefit for lab digitalisation has shifted from efficiency to innovation.
Teva closes in on sale of API business TAPI
The pharma company’s plan to divest its active pharmaceutical ingredient interests was first announced in 2024.
Bassem Saleh joins Netherlands CRO Julius Clinical as its new CEO
He arrives at the Netherlands-based contract research organisation from TFS HealthScience.
Call for greater investment and innovation from pharma to address RSV
Despite progress from AstraZeneca, Sanofi, Merck & Co, GSK and Pfizer, analysts say effective respiratory syncytial virus treatments are still needed.
Polpharma Biologics splits into biosimilars and CDMO businesses
Contract development and manufacturing services will be provided as Rezon Bio from Poland, with the biosimilars company operating from Switzerland.
