When patients should receive the RSV prevention treatment was the subject of much debate even as the Antimicrobial Drugs Advisory Committee voted nearly unanimously that it should be approved for infants and neonates.

Iilun Murphy, a 15-year agency veteran, takes helm of OGD. Jacqueline Corrigan-Curay to assume oversight of the office and report to CDER director.

Promising early clinical trial results from Rocket and Abbisko respectively helped the companies secure their places on the European Medicines Agency’s priority medicines scheme, which aims to help speed up the development and regulatory review of treatments for unmet medical needs.

A new report says that pharma firms are finding it difficult to recruit staff with experience in emerging scientific technologies, particularly in areas such as regulatory and quality assurance. COVID-19, Brexit and competition for talent with other countries and industry sectors are cited as key factors.

US FDA will ask its advisory committee to weigh anti-amyloid drug’s benefit-risk in populations at higher risk for adverse events, but agency says lecanemab’s risks ‘do not appear to preclude traditional approval’ and the CLARITY AD trial demonstrated clinical efficacy and a reduction in brain amyloid.

France is piloting a new approach that will allow innovative products to be accessed by patients before a reimbursement price has been agreed.

Saudi Arabia’s medicines agency says its membership of the international Pharmaceutical Inspection Co-operation Scheme will contribute to developing and raising inspectors' efficiency.

France is piloting a new approach that will allow innovative products to be accessed by patients before a reimbursement price has been agreed.

Coming less than three months before the statutory deadline for CMS to publish the initial list of drugs, Merck’s lawsuit calls US Medicare drug price negotiations ‘extortion’ in a complaint that could be the first of more legal pushback to follow.

Promising early clinical trial results from Rocket and Abbisko respectively helped the companies secure their places on the European Medicines Agency’s priority medicines scheme, which aims to help speed up the development and regulatory review of treatments for unmet medical needs.

A new report says that pharma firms are finding it difficult to recruit staff with experience in emerging scientific technologies, particularly in areas such as regulatory and quality assurance. COVID-19, Brexit and competition for talent with other countries and industry sectors are cited as key factors.

Digital health, AI, real-world evidence and “proactive learning” are key components of the EU’s proposals for new ways of regulating novel medicines, but only time will tell which products might benefit from the flexibilities offered by the “regulatory sandbox.”

Plus, Roche talks about why it wants to partner with firms that have machine learning expertise as the BIO International Convention continues in Boston.

On the first day of the BIO International Convention, our reporters hear from industry leaders about tough financing, when to go public, and why ‘there shouldn't be 700 listed biotechs in the US.’

From ACIP to Part D to data transparency, GSK has several policy asks as it prepares to launch its new RSV vaccine for older adults. The Pink Sheet spoke with GSK’s vaccine policy lead about the firm’s new data platform and the worrisome US vaccination trends following the Covid pandemic.

Saudi Arabia’s medicines agency says its membership of the international Pharmaceutical Inspection Co-operation Scheme will contribute to developing and raising inspectors' efficiency.

Academic expert provides insight into the economic and quality challenges behind generic drug shortages, and what to do about it.

The publication of two major reports has led the UK government to announce a £650m “Life Sci for Growth” package to bolster the life sciences sector.