Nick Paul Taylor

Nick is a freelance writer who has been reporting on the global life sciences industry since 2008. With a BSc in biology, Nick writes about the science and business of biopharma and medtech for numerous healthcare publications. He can be reached at nick.paul.taylor@gmail.com or on LinkedIn.

The Belgian drugmaker plans to hire about 330 people at a facility that will use advanced manufacturing technologies including AI, robotics and automation to meet rising demand for key products. This will be UCB’s first biologics manufacturing facility in the U.S.
FDA
Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace, particularly emphasizing the agency’s recommendations around defining NAMs’ regulatory purpose.
Like its pharma peers, Novartis is pouring money into Chinese operations, including expansions and upgrades at an existing manufacturing facility.
Healthcare investor Kevin Tang and his allies now hold almost every leadership position at Aurinia Pharmaceuticals, the company at the heart of former CDER Director George Tidmarsh’s exit from the FDA.
The company is establishing commercial production capabilities to fuel plans to launch autologous CAR T cell therapies in China.
Constructing the cGMP facility will increase availability of actinium-225, a nuclear material central to radiopharmaceutical programs at AstraZeneca, Bristol Myers Squibb, Eli Lilly and Novartis.
Industry and FDA representatives have reached a general agreement on planned pre-submission facility meetings but have expressed different views about the specifics.
Analysts expect the market for manufacturing cell and gene therapies, worth less than $20 billion in 2024, to expand rapidly as approvals drive higher volumes of production.
Industry groups have identified upfront costs as a barrier to streamlining U.S. drugmaking. The nonprofit API Innovation Center has a proposed answer for how to tilt finances in favor of investments in continuous manufacturing.
The companies have been embroiled in a row about compounded GLP-1 drugs that escalated to a lawsuit last month. The legal action has now been dropped and the former adversaries have struck a deal that could increase access to Novo’s obesity medicines.
Having targeted Hims & Hers last year, the FDA has issued warnings to more telehealth companies over their promotion of GLP-1 drugs used to treat diabetes and obesity. In one case, compounded products were linked with multiple ER visits.
Infrastructure and location have helped make Holly Springs a future hub for obesity drug production, with Amgen and Roche planning to manufacture GLP-1 therapies there to compete in the growing market.
As Novo Nordisk continues to lose ground in the obesity market to rival Eli Lilly, the Danish company has started construction projects to establish the ex-Alkermes plant as a hub for supplying oral GLP-1 products to global markets.
The CDC’s changes threaten to cut vaccine sales for makers including Pfizer, Moderna, Merck and more, but a legal expert suspects affected manufacturers will stay on the sidelines rather than back a push to declare the revised schedule unlawful.
The Denton site is part of a network of manufacturing plants Novartis is building across the U.S. to make cancer drugs that must be shipped to patients quickly.