Novo Nordisk manufacturing facility, and clients, hit by FDA action
Regulator classifies former Catalent site as ‘official action indicated’, impacting biotech clients such as Regeneron.
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Bristol Myers Squibb acquires cell therapy biotech Orbital for $1.5bn
Gains access to OTX-201, a preclinical CAR T therapy being developed to treat autoimmune diseases.
Rovi’s injectables CDMO rebrands as Rois and acquires BMS facility
Gains US-based operations with its new Phoenix, Arizona injectable drug product manufacturing and packaging site.
AstraZeneca increases scope of new US API manufacturing facility by $500m
The company will now put a total of $4.5 billion into the Virginia site, expanding its remit to include active pharmaceutical ingredients for cancer drugs.
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.
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.
