To get regular approval, the Alzheimer’s treatment could see tightened labeling on the need to test for ApoE ε4 status given advisory committee recommendations. Some panelists also raised concerns around use with anticoagulants and in patients with cerebral amyloid angiopathy.

With regulatory science research already funded for generic drugs and biosimilars, CDER Director Patrizia Cavazzoni wants a program for prescription drugs considered for the next user fee renewal.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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.

Amgen's Prolia appears to be the biggest drug on the list of products incurring price inflation penalties in Part B; many of the others have relatively low sales to Medicare.

Canada’s health technology appraisal body is to increase its industry fees well beyond inflation for conducting reviews and scientific advice. It says it will also improve its drug reimbursement review process.

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

With regulatory science research already funded for generic drugs and biosimilars, CDER Director Patrizia Cavazzoni wants a program for prescription drugs considered for the next user fee renewal.

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.

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.

A new voluntary certification from the AMR Industry Alliance and the British Standards Institution will assess pharmaceutical firms’ responsibility and sustainability when it comes to manufacturing antibiotic drugs, in an attempt to control the spread of antimicrobial resistance.

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.