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.

Teams at facilities being developed by Eli Lilly, Regeneron and other companies will receive early technical guidance and additional perks from the FDA.
Unicycive Therapeutics and Sobi received complete response letters for kidney disease and gout filings, respectively, after the FDA found fault with their manufacturing partners.
M&A
The company is “especially excited” about an immune cell therapy manufacturing technology included in the deal, a Merck KGaA executive said.
Jubilant HollisterStier received a warning letter over problems that the FDA said necessitate an immediate and comprehensive assessment of the contract manufacturing organization’s global operations.
Having stuck with local production in the years when offshoring to lower-cost locations was in fashion, Aquestive’s CEO is well placed to explain what the recent reshoring drive means for manufacturers.
The takeovers depend on Moderna reaching an agreement with the German government, which risks losing investment from drugmakers over planned healthcare reforms.
Weeks after Boehringer Ingelheim and Eli Lilly retracted billions of dollar in German commitments, the nation’s government is reportedly changing a contentious element of its planned healthcare reforms.
Officials sanctioned Dabur India months after FDA inspectors found bird droppings and data integrity deficiencies during an inspection of the plant.
The money will enable the addition of aseptic filling and oral solid dose capabilities to support Hikma’s products and contract manufacturing clients.
FDA
The FDA has expanded the regulatory toolkit during President Donald Trump’s second term, adding new mechanisms for rare diseases while putting the Biden-era platform technology designation into action.
With Germany moving to curb healthcare spending, Eli Lilly and Boehringer Ingelheim have rethought plans to invest in facilities, including a manufacturing plant for GLP-1 drugs.
FDA inspectors found that Medline, which raised billions of dollars last year, failed to prevent repeat bacterial contamination of finished drug products.
The forecast makes pharma one of the fastest-growing manufacturing industries in the U.S.
Swiss service provider CordenPharma is acquiring AmbioPharm, gaining facilities such as a plant in South Carolina to provide a fully U.S.-based supply.
Interim overall survival data on a TROP2 ADC from Merck and Chinese partner Kelun-Biotech provide support for the pharma’s big bet on its potential to help navigate Keytruda’s impending loss of exclusivity.