COVID-19 And Its Implications
Pandemic Treaty Talks Go Up To The Wire
The talks are still tough, with the Pathogen Access and Benefit Sharing proposal proving the most difficult aspect of the treaty, but there is cautious optimism that some form of agreement may be reached this week.
Updated COVID-19 Vaccines Should Target New JN.1 Variant, Says EMA
Variant vaccine approvals can be based on manufacturing/quality and non-clinical data as long as data on earlier vaccines support the predictability of clinical immunogenicity and reactogenicity.
US FDA’s Vaccine Office Emerges From Non-COVID-19 Backlog
The Office of Vaccines Research and Review's delayed receipt policy ended in 2023, but took another two months to fully unwind, Director David Kaslow said.
Idorsia’s Novel Hypertension Pill Among Eight New Drugs To Win EMA Nod
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.
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
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.
Ivermectin Settlement Brings Relief And Worry For US FDA Communications
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.
Quick And Flexible Vaccine Approval Must Include Postmarket Simplicity, US FDA’s Kaslow Says
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.
WHO Allots Extra Time To Get Pandemic Treaty Talks Over The Line
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.
'Don't Compromise The Pharma Innovation System,' Says Outgoing IFPMA Head Thomas Cueni
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.
US FDA’s Anti-Misinformation Campaigns Look Safer After Supreme Court Oral Arguments
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.
Disputes Over Access & Benefit Sharing Dog Pandemic Treaty Talks
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.”
From COVID Cliff To GLP-1 Ramp: Novo Takes Catalent Plants For Next Public Health Crisis
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.
Letting Paxlovid Go: HHS Seeking To Buffer Drug’s Sticker Shock In ‘Cold’ Commercial World
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.
WHO Announces ‘More Attractive’ Successor To COVID-19 Technology Access Pool
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.
Combatting Misinformation: FDA’s Califf On Use Of Facts, Opinion And Emotion
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.
House Lawmakers Could Receive A Mountain Of Docs On US FDA Scientific Disagreements
The request from House Energy and Commerce Committee Republicans states they are worried about retaliation against career agency staff.
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