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 license, which Innovent’s Altruist business said is the first of its kind, positions the CDMO to support commercial clients as it works to expand the plant’s capacity to 172,000 liters.
FDA
Aiming to protect patients, the FDA sent lawmakers a wish list of legislative proposals intended to clarify and expand its oversight of updates to approved drug production processes.
BioNTech envisioned the site making hundreds of millions of vaccines a year, but has since shifted its pipeline to other modalities while mRNA technology continues to face headwinds in the U.S.
While some large companies could start paying the full tariff in 120 days, many products, including orphan drugs, cell and gene therapies, and antibody-drug conjugates, will enjoy exemptions that waive or greatly reduce the levies.
COVID-19 partners Pfizer and BioNTech have been unable to recruit healthy adults aged 50 to 64 fast enough to deliver relevant post-marketing data. Moderna is apparently also facing enrollment challenges.
As Novo Nordisk cuts 400 jobs at the troubled site, Scholar Rock has seen enough progress that it included the facility in a resubmission for FDA approval.
Following Insmed’s decision to hold off on launching a newly approved lung disease drug in Europe, experts anticipate more companies will do the same as they seek to avoid price erosion in the U.S. Will Chinese biotechs fill the void?
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Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace,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.