Manufacturing

Amgen’s product sales grew 24% to $8.15bn in Q3 and its gains are being reinvested in R&D and manufacturing, including for MariTide, which will report Phase II obesity data in late 2024.

In first of two articles from recent interview, president and CEO Steve Mister discusses examples the trade group provides for self-regulation, “where people or companies who might not do it on their own because it would put them at a disadvantage if they were the only ones.”

High patient needs, a large healthcare market and innovation potential in the biotech sector in China still appear to be maintaining and attracting investments by overseas biopharma companies, including by Bayer and Lilly in biotech start-ups and Lilly in manufacturing.

Strides is to supply semaglutide and liraglutide to generics companies amid global capacity constraints and drug shortages, ahead of loss of exclusivity. An ability to make drug-device combinations has meant it has contracts for seven of the eight GLP-1 agonists, and counting.

Strides is to supply semaglutide and liraglutide to generics companies amid global capacity constraints and drug shortages, ahead of loss of exclusivity. An ability to make drug-device combinations has meant it has contracts for seven of the eight GLP-1 agonists, and counting

Trevor Martin talked to In Vivo about the importance of sharing a strategic vision with partners, the company’s superpower, and how a PhD is the best prep for a startup.

Decentralized manufacturing methods for cell and gene therapies will be critical for improving patient access to treatments, but sponsors must prepare to demonstrate “comparability” with centralized manufacturing.

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.

CRN/Radicle Trailblazing Woman Award to ChromaDex’s Yasmeen Nkrumah-Elie; Nourish’s TV ad campaign features US soccer star Alex Morgan; Vitamin Shoppe BodyTech Elite Altered Strength line sponsors Team Red, White & Blues; contract pharma/consumer health product development firm LabConnect appoints Wesley Wheeler CEO; Avanos’ Game Ready is “Recovery Partner” of NFL’s Nick Bosa; Akita adds Robert Hanson to advisory board; and BODi has wrestler as brand ambassador

Manufacturers looking to change their device sterilization method as part of the move away from ethylene oxide (EtO) may be able to make use of the Predetermined Change Control Plan (PCCP) process, FDA officials said in a webinar this week.