COVID-19 And Its Implications

The European Medicines Agency believes Idorsia’s Jeraygo should be approved for use in the EU at two different doses rather than just the one approved by the US Food and Drug Administration last month.

A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.

The FDA’s decision to end litigation challenging an agency communication that tried to tackle COVID-19 misinformation leaves an appeals court opinion in place that could haunt it later. But continuing to fight the case could have left the agency in a far worse position.

After making the COVID-19 vaccines available, multiple presentations based on age and vaccination status created confusion that likely hindered uptake, said OVRR Director David Kaslow.

The body that is steering the talks on a future pandemic treaty says it wants to focus on areas where consensus has been reached in order to maximize the chances of agreement by the end of May.

Thomas Cueni is stepping down after seven years at the helm of the International Federation of Pharmaceutical Manufacturers and Associations. In an interview with the Pink Sheet ahead of his retirement, he reflects on the proposed pandemic treaty, what still needs to be done to ensure equitable access to medicines, the importance of tackling AMR, moves towards regulatory reliance – and what his post-IFPMA life might look like. 

FDA’s efforts to tackle misinformation may face fewer legal obstacles moving forward, following oral arguments at the Supreme Court on a case that could have broad ramifications for how the government communicates public health information.

As talks restart this week on a future pandemic accord, the international drug industry body, the IFPMA, has reiterated its concerns over the negotiating text, saying some measures could “severely hinder responses to future pandemics.”

A complex transformation is underway as client proposes to acquire CDMO facilities that vaccinated the world against the COVID-19 pandemic for pivot to the obesity epidemic.

HHS Secretary Becerra challenges the commercial price Pfizer chose for its COVID-19 therapeutic as the government transitions from being the primary US customer for the drug.

The WHO sees the HTAP as an important step in securing more equitable access to a wide range of health products by sharing intellectual property and scientific knowledge. But the pharmaceutical industry wants to see more detail and has warned against a global “one-size-fits-all approach” to the licensing of medicines and vaccines.

As discussion continues on the role of artificial intelligence in tackling misinformation and who gets to decide what information AI synthesizes, Califf and CBER’s Peter Marks call on clinical and biomedical community to dilute misinformation about vaccines with large amounts of scientific evidence.

The request from House Energy and Commerce Committee Republicans states they are worried about retaliation against career agency staff.

COVAX, a global initiative that was established to provide equitable access to COVID-19 vaccines worldwide, will end on 31 December, freeing up funds for new inoculation equity schemes across the globe.

Artificial intelligence, real world evidence and point of care manufacturing are top priorities for the International Coalition of Medicines Regulatory Authorities, says the coalition’s chair, Emer Cooke.

A WHO advisory group says that while no change is warranted in the antigen composition of COVID-19 vaccines, more data are needed on immune responses in different populations and the circulation of variants of the SARS-CoV-2 virus.