As the World Health Organization brands the Indian virus a “variant of concern,” the UK is planning to use a lab-grown virus variant in challenge trials of current and new vaccines, and is also investing in new variant vaccine testing facilities. A new study will use Oxford Immunotec’s T cell test to monitor people’s immunological response to infection or vaccination.

Following a memorable cancer drug advisory panel meeting where FDA explained how accelerated approvals may be more at risk due to changing standard of care, ChemoCentryx’s ANCA-vasculitis treatment runs into trouble because of another drug’s changing indication during their Phase III study.

AstraZeneca and Novavax have not filed EUAs for their vaccines, and they never might. The pathway remains viable in the short-term, but as BLAs are approved and supplies are no longer short, the window may close.

Calls grow for a relaxation of IP on COVID-19 vaccines as interest groups pile the pressure on the UK government and the Pope gives his blessing to the proposed waiver.

Advisory committee will discuss ways to encourage inclusion of the Pediatric PRO-CTCAE tool in cancer trials on 11 May, followed the next day by a discussion on real-world data sources that could inform the efficacy and long-term safety of pediatric cancer treatments.

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.

Horning describes challenges of moving from tenured professor to industry executive in accepting the award from the Healthcare Businesswomen’s Association. She is recognized for her ‘epic tenacity’ in advancing medicines and commitment to patients. Pfizer’s Rod MacKenzie receives honorable mentor award.

A 2008 law that limited exclusivity for certain antibiotics to three years does not apply to Allergan’s Avycaz, which combines an approved old antibiotic active moiety and a new active moiety, CDER exclusivity board concludes.

Regeneron and Eli Lilly have seen limited uptake for their COVID treatments; CMS payment increase addresses concerns that inadequate reimbursement has hampered use of the monoclonal antibody drugs.

Horning describes challenges of moving from tenured professor to industry executive in accepting the award from the Healthcare Businesswomen’s Association. She is recognized for her ‘epic tenacity’ in advancing medicines and commitment to patients. Pfizer’s Rod MacKenzie receives honorable mentor award.

Pfizer disclosed that a Phase III trial for the gene therapy has been unable to start in the US because of questions from the FDA, even while enrollment in 15 sites outside the US is under way.

Near tie goes to the US FDA? While almost every member of the Arthritis Advisory Committee agreed with agency’s assessment that ChemoCentryx’s trial of avacopan for ANCA vasculitis was poorly designed, making it hard to tease out the drug’s benefit-risk profile, about half were in favor of approval due to the potential to spare patients from the adverse effects of steroids. Others said the sponsor didn’t meet the agency’s standard for approval off just one pivotal study.

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.

Similarities to AstraZeneca blood clots are clear, but more research needed before any ‘class effect’ conclusions can be drawn.

ICER President Steve Pearson expresses interest in setting drug costs for accelerated approval drugs low with price increases based on confirmatory evidence ahead of upcoming white paper from the group.

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.

Regulatory flexibilities such as rolling review, conditional marketing authorizations and possibly an EU emergency use authorization will play a key part in the EU’s plans to identify and approve promising new coronavirus treatments.

The pharmaceutical industry in Europe has attacked the US decision to come out in support of a relaxation of IP rights that is designed to boost global production of COVID-19 vaccines. But the move by the Biden administration could well cause other countries to rethink their opposition to the move.