Pascal Soriot, AstraZeneca CEO (Chris Ratcliffe/Bloomberg via Getty Images)
While Europe is in the midst of a massive fourth Covid-19 surge, the UK has largely avoided the high levels of hospitalizations and deaths seen on the rest of the continent. And AstraZeneca CEO Pascal Soriot suggested Tuesday the reason for Britain’s better fortunes could be his company’s vaccine.
In a one-on-one interview with BBC Radio 4, a reporter asked Soriot whether he was disappointed over the UK’s decision not to use the AstraZeneca/Oxford shot as a booster. Soriot responded by touting the vaccine’s T cell response, saying some data have shown it may be more durable than mRNA shots in older people, where the focus had largely been on antibodies.
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Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs
Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.
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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.
Joan Perelló, Sanifit CEO
Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.
Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.
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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)
As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.
GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.
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Peter Ding, Allorion Therapeutics co-founder and CEO
Precision-med biotech Allorion Therapeutics is expanding — and now has tens of millions of dollars more to work with.
The Natick, MA-based company announced in a statement this morning that it closed a Series A round, bringing in $40 million. Shanghai VC Qiming Venture Partners led the round, which also includes a number of both new and old investors — Octagon Capital, IDG Capital and TF Capital, to name a few.
Most people know if they’re ‘Team Pfizer’ or ‘Team Moderna,’ but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.
And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novovax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as ‘Covid-19 Vaccine Janssen.’
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In an effort to up its development of microbial-derived proteins, Swiss CDMO Lonza will invest in its manufacturing capacities in its home country.
The extension will be good to go by the end of this year, the company said. The expanded development will strengthen the upstream, downstream and process analytics support for new projects. The microbial footprint at its Visp site will be consolidated, and new high-throughput equipment and automation processes will be added to increase efficiency and project delivery. That will include three liquid handling workstations, and the upgrades will help improve data generation.
The FDA’s backlog of drug manufacturing facility inspections continues to be a sore spot for the agency, as FDA said Monday that a total of 52 new drug (but no biologics) applications still remain delayed due to the backlog from the pandemic.
And while the agency has maintained that it won’t issue a CRL for a delayed inspection, the number of delayed applications is rising as FDA said in May that 48 new drug applications have been delayed due to FDA’s inability to conduct pre-approval, pre-market, or pre-license inspections as of last March.
Stephen Hahn and Donald Trump, AP Images
The House Select Subcommittee on the Coronavirus Crisis on Monday questioned former FDA commissioner Stephen Hahn on whether he acquiesced to political pressure in authorizing the use of hydroxychloroquine and convalescent plasma early in the pandemic, despite limited evidence of their effectiveness.
Hahn publicly disavowed any political interference in any of his agency’s EUA decisions, but behind the scenes, the pressure clearly caught up with him.
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Ugur Sahin (L) and Özlem Türeci (Bernd von Jutrczenka/picture-alliance/dpa/AP Images)
Pfizer and BioNTech are planning to file for full approval of their Covid-19 vaccine for all of those over the age of 12 after they said longer-term analysis of the vaccine in teens continued to show strong protection against symptomatic cases of Covid-19 more than four months after the second dose.
With no serious safety concerns at least 6 months after the second dose for those ages 12 through 15, the companies said the data will form the basis for a planned upgrade from EUA to supplemental Biologics License Application (sBLA).
https://endpts.com/did-europe-blunder-in-its-covid-19-vaccine-picks-pascal-soriot-points-to-a-potential-mistake-and-gets-a-little-payback/
