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IP is no barrier to COVID vaccine access, says industry

pharmaphorum

While proponents argue waiving IP on COVID-19 vaccines would better enable low- and middle-income countries to inoculate their populations, the pharma industry has called the proposals “unnecessary and harmful to innovation”. Since then, then IP framework has “fallen victim of political posturing”, it claims. Accelerating roll out.

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Regulators commit to collaborating on RWE integration

European Pharmaceutical Review

Both the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have endorsed a statement calling for international collaboration on integrating real-world evidence (RWE) into regulatory decision-making. Related regulatory news: EU proposes new blood, tissues and cells Regulation.

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Axsome bounces back as FDA clears depression drug

pharmaphorum

The biotech hasn’t revealed much information about the reasons for the delay in getting approval, but said in an SEC filing in June this year that it had agreed to “post-marketing commitments” proposed by the FDA, without going into details.

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The Pandemic Treaty and the opportunity to end ‘vaccine apartheid’

pharmaphorum

During a recent address at a conference on the lessons learned from COVID-19, the WHO regional director for Europe, Hans Kluge, outlined a global target for an approach called 7-1-7, which he noted had received ‘significant interest’. The aim of this initiative is to speed up the response to potential threats.

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Biogen finally publishes its phase 3 Aduhelm data

pharmaphorum

The antibody reduced amyloid beta plaque levels out to week 132 of treatment, and also cut plasma levels of a biomarker protein called p-tau181 at week 128, according to a presentation of the data at the International Conference on Alzheimer’s and Parkinson’s Diseases. There are signs of opposition to that stance.

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FDA head Califf on tighter accelerated approvals and lower drug prices at JP Morgan

Pharmaceutical Technology

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. Accelerated approvals are really important to society and patient populations, and industry,” Califf told the JP Morgan Conference. “[But]

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Eureka Institute to show what translational medicine can do for digital health

pharmaphorum

They hope the conference will provide an opportunity to get their message out to a new group of influencers in the ongoing digital transformation of healthcare. “So, And this is what we call, not policymaking for sure, but it’s creating sufficient critical mass to help in shaping policy.”.

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