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COVID-19 Vaccine Sponsors’ Pledge To Wait For Phase III Helps US FDA

 
• By Derrick Gingery

The move reduces the pressure on the companies to rush development, but also relieves burden on the FDA to approve a candidate too soon.

Coronavirus
The coronavirus vaccine development pledge should not have been necessary, said Paul Offit of Children's Hospital of Philadelphia. • Source: Shutterstock

The pledge by multiple coronavirus vaccine developers to follow high development standards may alleviate as much pressure on the US Food and Drug Administration as it does on the individual companies pushing to make their products available.

Nine vaccine sponsor CEOs announced a non-binding commitment 8 September (see box) to always make the safety and well-being of vaccinated individuals a top priority, continue to adhere to high scientific and ethical standards for the conduct of clinical trials and the rigor of manufacturing processes, work to “ensure a sufficient supply and range of vaccine options,” and

Companies Signing The Coronavirus Vaccine Development Pledge

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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
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Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

340B Not Designed To Pass Savings Directly To Patients, Hospitals Tell Senate Committee

 
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Respondents to a Senate investigation that could re-energize 340B reform efforts said hospitals offer patient assistance programs and use 340B revenue for “capital improvement projects” and “community benefit programs,” though they do not account for specific program revenue allocations.

Kiji CEO On EU HTA Regulation, Hospital Exemption And The Future Of ATMPs

 
• By Eliza Slawther

Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.

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What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
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During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

What MAHA Means For US FDA: Prevention Is Not What You Think

 
• By Michael McCaughan

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.