The three-day advisory committee was intended to ‘put companies on notice’ about the importance of confirmatory trials. The result? Mission accomplished.

This year’s Pangea operation has led to the seizure of millions of falsified medicines and other products and the closure of 113,000 websites.

The European Medicines Agency has added 13 new drugs to its list of products that are under review for potential pan-EU marketing approval.

A sweeping "anti-blocking" law, patent legislation, gene therapy study guidance and new regulations on inspections are all within a flurry of regulatory activity in China.

Health advocates hail the move but the EU and UK still insist a waiver is not the solution to boosting the availability of coronavirus vaccines.

Expectations will be high after the COVID-19 product IP waiver plan took a big step forward and G7 leaders prepare for discussions on the global recovery from coronavirus, tackling climate change and other weighty subjects.

Health advocates hail the move but the EU and UK still insist a waiver is not the solution to boosting the availability of coronavirus vaccines.

Study will assess responses of cancer survivors and caregivers to disclosures that a drug received accelerated approval. FDA analysis found that 73% of 26 accelerated approval drugs cited approval pathway on product websites.

The Russian Direct Investment Fund says it has 20 technology transfer and production agreements in place in 13 countries across the world.

The European Medicines Agency has accepted Larimar’s potential treatment for Friedreich’s ataxia onto its PRIME scheme for helping to get medicines for unmet medical needs to patients faster.

While regulators are steaming ahead to accelerate clinical trial and product approvals, China's pharma industry still lacks innovation. Underlying the hot investment, multi-million deals and IPOs is a lingering reliance on 'fast-following,' regulators and pharma execs tell the DIA China meeting.

Medicare patients fared worse than pivotal trial populations on cancer drugs, two recent papers conclude, offering more ammunition for an increased regulatory focus on more generalizable trial populations. Current drug labels may portray an inaccurate risk-benefit calculation in older populations, which account for most cancer cases.

Five years after European licensure and launch, and 30 months after FDA approval, Vaxelis enters the US market offering an advantage of fewer shots than current pentavalent vaccines for protection against six diseases in children six weeks to four years old.

BARDA’s suspension of funding for COVID-19 therapeutics risks repeating mistakes of past pandemics as it may cause industry to pull out of the development space, experts say. Industry sources are concerned the Biden administration is focusing on funding NIH at the expense of BARDA.

Investors are trying to wrap their minds around exactly how big Pfizer’s COVID vaccine business will end up being. But they also have questions about Pfizer’s prospects at the opposite end of the patient-population spectrum.

Selective whistleblower allegations, investigative reports hint at drug GMP issues awaiting US FDA inspection resumption; GSK sotrovimab EUA gets root cause provision; API GMP compliance work acknowledged; Aziyo recalls bone matrix associated with tuberculosis outbreak, and other matters in this latest update.

President Biden’s 100-day plan relies on Defense Production Act authorities to increase resilience of critical domestic pharmaceutical supplies.

The Russian Direct Investment Fund says it has 20 technology transfer and production agreements in place in 13 countries across the world.