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Taking full control of partner Translate Bio means that Sanofi is the only big vaccine company with a wholly-owned mRNA platform in-house but observers say it is too early to declare that the Paris-headquartered group has bagged itself a bargain.
Japanese firm again links with an earlier venture capital partner and some familiar faces to progress its norovirus vaccine outside Japan.
HIV PrEP and treatments saw increases in sales, though the US treatment market’s recovery was slower than expected and may need “several” quarters to return to pre-pandemic levels.
TB Alliance CEO Mel Spigelman discusses a range of new and evolving aspects pertaining to the three-drug BPaL regimen for highly drug-resistant TB, including the ZeNix trial results and adding a licensee for pretomanid. He also notes how COVID-19 has had a “terrible impact” on efforts to tackle the TB pandemic.
Doctors and patients need to be persuaded of the benefits of switching from familiar oral therapies to Cabenuva, the once-monthly anti-HIV injection.
With fast-tracked development and deployment of COVID-19 vaccines yielding results, experts call for similar urgency and funding impetus to progress new vaccines for TB, which still claims 4,000 lives daily. Over 15 candidates have been in development for years, with hope now abounding around the potential of new platforms like mRNA to accelerate efforts.
A new UK company, Poolbeg Pharma, has been set up to develop new anti-infectives in an efficient manner, and already has a repositioned MAP kinase inhibitor for the treatment of severe influenza ready for Phase II studies.
A potential next-generation, 24-valent, pneumococcal vaccine in development by Affinivax and Astellas has shown strong immunogenicity in a Phase II study and is preparing to enter pivotal Phase III trials; if successful, it will target a growing market currently dominated by big pharma players.
Comirnaty and Spikevax to get EU label update on cardiac safety, Japanese filing for REGEN-COV, plus vaccine progress for ReiThera and Genexine.
US regulators indicate that authorizing booster shots is not a priority - but Pfizer still plans to seek an EUA in the fall.
The company could have a significant competitive position thanks to the ability to rapidly develop and combine vaccines using mRNA technology.
This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.
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