article thumbnail

€30m raised for first-in-class in vivo cell reprogramming platform

Drug Discovery World

The company plans to submit an Investigational New Drug (IND) application to the FDA for AT-108 by 2026, expand and reinforce its research and development team, and fuel new reprogramming modalities and delivery platforms to strengthen the pipeline. This financing also follows a strong pre-clinical package providing PoC for AT-108.

article thumbnail

Analysis Chemical Thank You How states are looking to control PFAS through different legislative models

Agency IQ

As of January 1, 2026, the law will implement a variety of new prohibitions on intentionally added PFAS in products, including in cookware, cosmetics, cleaning products, and most textiles. Recently enacted legislation Maine: On April 16, 2024, Maine Governor JANET MILLS approved L.D.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Article Periodic Thank You Why comprehensive state-level bans on PFAS in products are faltering

Agency IQ

Under the law, beginning in January 2026, manufacturers who sell products in Minnesota with intentionally added PFAS must submit a significant amount of information regarding the product.

article thumbnail

FDA Issues Long-Awaited QMSR Final Rule

FDA Law Blog: Biosimilars

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

FDA 59
article thumbnail

Transitioning to eCTD v4.0

The Premier Consulting Blog

Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5 Implementation Package v1.5 Module 1 Implementation Package FDA eCTD v4.0 How can you prepare? How can you prepare? ICH electronic Common Technical Document – eCTD v4.0 FDA eCTD v4.0

article thumbnail

Elliott Advisors (UK) letter to GSK

The Pharma Data

At its Investor Update, GSK announced a package of new financial outlooks and ambitions. Adjusted operating margins are expected to improve from the current mid-20s level to over 30% by 2026. Cash generated from operations is expected to exceed £10 billion by 2026.

article thumbnail

Analysis Chemical Thank You California publishes draft regulations for landmark plastic pollution reduction act

Agency IQ

Background: SB 54 and its requirements On June 30, 2022, Governor Gavin Newsom signed into effect SB 54, the Plastic Pollution Prevention and Packaging Producer Responsibility Act. Cutting waste: By 2032, SB 54 requires that the state cut the use of single-use packaging and food service ware by 25%.