The Medicines and Healthcare products Regulatory Agency explains how it would deal with pediatric investigation plans if the UK leaves the EU with no deal.

First suit challenging biosimilar litigation settlements ratchets up pressure on AbbVie's "patent thicket" and licensing strategy.

Clonal neoantigen immunotherapy developer Achilles Therapeutics tells the Pink Sheet how the regulatory landscape for advanced therapies might not be as tricky as it used to be.

Draft guidances reflect the agency’s thinking on when patients with HIV/hepatitis infection, brain metastasis, organ dysfunction or prior malignancies, as well as pediatric patients, should be enrolled in cancer trials; FDA also finalizes recommendations on adolescent enrollment in adult studies of oncology drugs.

Faced with a proposed regulation that aims to eliminate rebates and an upcoming hearing on Capitol Hill, US pharmacy benefit managers including OptumRx are working to validate the concept of rebates when redirected to patients at the point-of-sale. 

Amgen seeks a preliminary injunction to halt US sales by Cipla and says it will take steps to stop Piramal’s sales; in its antitrust lawsuit, Cipla alleges Amgen paid to license Teva products under the companies’ patent settlement, which resulted in Teva pulling its generic off the market shortly after launch.

Assessing how closely GSK's OTC brands including Panadol compete with Pfizer's Robitussin and other OTC brands is the aim of investigation by Australia's Competition and Consumer Commission into the pharma giants' proposed consumer health joint venture. ACCC states particular interest in importance of Panadol, Voltaren and Advil brands, and whether GSK and Pfizer compete closely in supply of pain relief, gastrointestinal and cold and flu relief products.

FDA commissioner discloses effort underway to tighten oversight of changes to active pharmaceutical ingredient manufacturing processes by rewriting parts of its drug GMP regulation.

Once a gene therapy product begins to show promise in clinical trials, the next step is deciding how the product is to be manufactured. Options are to make the product in house, contract out the manufacturing, or to combine the two approaches. An industry representative discussed some of the advantages and disadvantages of each approach and what to look for in the site selection process if the company decides to build out.

Company argues there is a clinical need for its ready-to-use, preservative-free compounded formulation of vasopressin but agency says Vasostrict is available in a dose without the preservative.