Pink Sheet reporters and editors discuss the US FDA decision to lower the eligibility age for the Pfizer/BioNTech COVID-19 vaccine, CMS drug pricing project plans, and mid-stream standard of care changes in drug development.

Some ACIP members argued woman older than 50 should also be singled out in warning for Johnson & Johnson’s COIVD-19 vaccine and said that people need to be more clearly told they can get alternative vaccines that don’t have this risk.

Incorporation of the Ped-PRO-CTCAE instrument would help inform short-term tolerability and long-term effects of treatment, particularly newer immunotherapy agents, but there are logistical and operational challenges to overcome, advisory committee members said.

Agency more interested in switching to remote methods or imputing data than reducing sample size or duration of cell/gene therapy trials, official tells ASGCT.

A new study shows that the immune response to Pfizer/BioNTech’s Comirnaty in elderly people is 3.5-fold greater when the second dose is given after 12 weeks rather than three. The WHO has OKd the emergency use of a Chinese vaccine.

Updated guidance on the UK’s new licensing pathway for biosimilars – which will typically not require comparative efficacy data – has been published by the MHRA after a stakeholder consultation. It has been warmly welcomed by the off-patent industry both locally and internationally.

Pfizer has been unsuccessful in its appeal against the health technology assessment body’s rejection of the rare heart disease drug, Vyndaqel. Meanwhile, Dr Falk Pharma has received the all-clear to make Jorveza (budesonide) available on the National Health Service for eosinophilic esophagitis.

Without giving ACIP a chance to vote on the change or providing additional data, CDC announces new guidance allowing coadministration of COVID-19 vaccines with other immunizations. Needless to say, the decision raised a few eyebrows.

IP experts share views on a range of critical issues around the proposed US-backed patent waiver for COVID-19 vaccines. Proprietary materials once public can’t be pulled back, one cautioned, while others indicated the waiver risk may be the stick that pushes companies to toe the tech transfer line.

Increasing number of product development meetings suggests that many complex generics remain in the development stages.

Companies wanting to get involved in long-running plans to overhaul the EU orphan drugs and pediatric medicine legislation can make their contribution through a public consultation that began on 10 May.

 Advicenne withdrew its orphan drug designation application for Sibnayal over concerns that a key study was not designed to compare the product to standard of care.

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.

Due to need to plan for potential vaccine boosters now, administration is focusing on contracting with the companies whose shots are already being given in the US, David Kessler tells the Senate health committee. Data on whether it is ok to ‘mix and match’ vaccine types with boosters should be available in a few months.

US FDA will ask advisory committee whether data from the trial supporting full approval of Merck’s Keytruda for second-line setting can be used to confirm clinical benefits for earlier setting of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy following a failed confirmatory study. Genentech’s Tecentriq is also at risk of losing its accelerated approval in that space but it could buy some time as its confirmatory study is not yet complete. New competitor entrant since accelerated approvals also lessens degree of unmet need.

Generics industry and FDA also debated inspection policies in lieu of travel and safety restrictions mandated by the pandemic.

Due to need to plan for potential vaccine boosters now, administration is focusing on contracting with the companies whose shots are already being given in the US, David Kessler tells the Senate health committee. Data on whether it is ok to ‘mix and match’ vaccine types with boosters should be available in a few months.

Pink Sheet reporters and editors discuss the potential for the US and other governments to waive IP protections for COVID-19 vaccines, the FDA’s inspection backlog during the pandemic, and potential reimbursement changes for CAR-T therapies.