New guidance from the UK covers the recognition of EU approvals, accelerated assessment, rolling reviews, and much else besides.

An EU public-private collaborative project is seeking validation from regulators and health technology assessment bodies regarding its proposed best practice approach to conducting patient preference studies.

Novartis seems to have accepted the fact that the indication granted for Piqray in the EU means there is little scope for the advanced breast cancer drug to be used in markets such as the UK.

Product review report reveals multiple delays and missteps on route to market, holding valuable lessons for other gene therapy developers but also evidencing an ultimately welcoming environment.

CDER has ‘turned the corner’ on hiring during 2020, acting Director tells stakeholders – though the added workload from COVID-19 makes that hard to see.

As companies undergo pharmacovigilance inspections from a growing multitude of regulatory authorities from around the globe, a senior pharmaceutical industry executive discusses how her company has been handling this complex and challenging task.

CMS final rule for hospital payment in 2021 includes enhanced payment for six novel antibiotics – including one that is not yet approved by FDA. New policies to encourage antibiotic innovation are clearly having an impact in the context of Medicare payments.

But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.

Germany uses government facilitated price negotiations between publicly funded insurers and manufacturers that are based on an independent assessment of how much added value a drug provides.

With some studies about to finish and others on clinical hold, the coronavirus vaccine field approaches an inflection point as the US FDA prepares for its first advisory committee on the topic. Our charts and graphics offer a quick look at what stands where.

US FDA must rethink guidance on maintaining placebo-control in COVID-19 trials after any vaccine gets an EUA, companies say, arguing current proposal may not be ethical or feasible. Disease organizations who agree with the hurdles to preserving placebo-control maintain this is a reason why any EUA must meet a very high standard.

Acquisition is based on the prospects for Immunomedics’ Trodelvy, but regulatory changes, manufacturing challenges, and research dynamics could upset even the best-laid plans.

As CEO Erck touts that its COVID vaccine has the 'best data,' Novavax prepares to enter Phase III trials and inks deal with Serum Institute to boost production even as its 'almost a perfect flu vaccine' remains on hold.

Join Anju Ghangurde and Vibha Ravi in this recorded session from Informa Pharma Intelligence's recent 24-hour webinar series on COVID-19: Lessons Learned And A Path Forward.

Expert outlines how pharma can create resilient and secure supply chains and some benefits of localization.

Wholesalers are given three more years to set up electronic systems to verify saleable returns under another reprieve from the FDA. Yet the reprieve does not extend to manufacturers, who must respond within 24 hours to wholesalers’ requests to manually verify that a returned product is not suspect.

Agency explains how it will model vaccine authorization process on its licensing process for matters like inspections and lot release.