COVID-19 And Its Implications
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.
WHO Reflects On ‘Plethora Of Learnings’ From COVAX As Initiative Ends
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.
ICMRA Chief On The Future Of Regulatory Collaboration & The Move Towards Convergence
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.
WHO Advises On Composition Of COVID-19 Vaccines After Assessing Latest Data
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.
Time Pressures May Result In Diluted Global Pandemic Treaty
The pressure of having to reach agreement on a global pandemic treaty by May 2024 could mean countries end up opting for a less far-reaching version than originally planned. A group of European parliamentarians has called on the EU to take a stronger stance.
Bigger Trials, More RWE Needed for Future Crisis Response, Say EU Regulators
A report from the EU medicines regulatory network looks at what was done well in the response to the COVID-19 pandemic, and what needs to be improved if we are to be better prepared next time.
The Opportunities & Challenges Of Local mRNA Vaccine Production In Africa
Building new local manufacturing facilities raises issues such as regulatory complexity, the supply of raw materials and what to do with “ever-warm” production sites outside health crisis situations, a conference heard this week.
WHO Working On ‘Evolved’ Model For COVID-19 Licensing Platform
With companies still reluctant to share their IP and knowledge via the C-TAP platform, stakeholders will be offered the chance to comment on a proposed new model that is expected to cover drugs for other high-priority diseases.
WHO Still Backs Paxlovid In COVID-19 But Advises Against New Antiviral Deuremidevir
The limitations of vaccines against COVID-19 mean that there is a need for new treatments for the disease, according to the organization.
IP Rights, Benefit Sharing And R&D Dominate Talks On WHO Pandemic Treaty
A lot of work needs to be done, and many compromises struck, if talks on the proposed pandemic accord are to be completed in time for the May 2024 deadline.
England’s NICE Formalizes Faster Approach To Appraisals
NICE, the health technology appraisal body for England and Wales, has published the first update to its health technology evaluations manual setting out two of the pathways that form part of its new proportionate approach to assessments.
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