Brazil's drug regulator ANVISA will require more experience in dealing with adaptive trial designs before issuing guidance; translating older ICH guidelines remains a barrier to their implementation; and industry is asked to be more transparent in sharing their confidential information among drug regulators to facilitate convergence.

The use of biosimilars is growing in Italy, but the authorities want their market share to rise further and so the regulator has set up a dedicated webpage to explain the biosimilar concept more clearly to doctors and the general public and to help dispel any remaining doubts about their safety and efficacy. The aim is to increase awareness and use of biosimilars and rationalize state spending on biologic medicines.

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

Congressional hearings on the recent outbreaks of measles and other vaccine-preventable diseases offered a positive theme for the industry during the ongoing drug pricing debate.

FDA officials said manufacturers of complex generic drugs submitted more approvable requests for pre-submission meetings for FY 2018. Official also clarifies at recent meeting when it's best to request a pre-ANDA meeting and when to submit a controlled correspondence.

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.

Challenges ranging from fear of QC job loss to training requirements and discovery of surprise impurities confront effort to expand the use of powerful test methods for release of biopharmaceuticals.

Yet another valsartan approved as quality/shortage crisis unfolds, while warning letters hit firms on poor root cause investigations and supply chain issues, and FDA investigators procure shirt-button candid cameras.

FDA officials said manufacturers of complex generic drugs submitted more approvable requests for pre-submission meetings for FY 2018. Official also clarifies at recent meeting when it's best to request a pre-ANDA meeting and when to submit a controlled correspondence.