In an effort to combat rising Covid-19 cases worldwide, the World Health Organization has struck a deal to license serological technology for antibody testing and provide it royalty-free to low- and middle-income countries in the hopes of boosting production.
The WHO’s Covid-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) finalized the deal with the Spanish National Research Council (CSIC), a public research institute, on Tuesday. It’s the first test license signed by the MPP, a United Nations-backed public health organization, and included in the WHO pool, according to the organizations. It covers all related patents and biological material necessary for manufacturing the tests, and CSIC has agreed to provide know-how and training.
So far, CSIC’s technology has resulted in four antibody tests, including one that can distinguish the immune response of Covid-infected individuals from vaccinated individuals.
‘This is the kind of open and transparent license we need to move the needle on access during and after the pandemic,’ WHO director-general Tedros Adhanom Ghebreyesus said in a statement. ‘I urge developers of COVID-19 vaccines, treatments and diagnostics to follow this example and turn the tide on the pandemic and on the devastating global inequity this pandemic has spotlighted.’
The move marks the latest in a string of efforts to contain the pandemic in lower income countries, where vaccines are sorely needed. Back in September, the US government said it would buy 500 million more doses of Pfizer’s vaccine to donate to countries in need. It also dumped more $200 million over the summer into a South African manufacturing plant to boost access to J&J’s vaccine. However, the New York Times reported in August that many of those doses had been exported back to Europe.
CSIC president Rosa Menéndez emphasized that technology related to Covid-19 should reach all countries, adding: ‘In this sense, we would like this action by CSIC, of taking part in the international initiatives of MPP and WHO, to become an example and a reference for other research organizations in the world.’
US government fights to uphold workplace vaccine mandate
The US government is fighting to keep an Occupational Safety and Health Administration (OSHA) rule in place that requires workers to be vaccinated for Covid-19 or tested weekly, according to court documents.
The OSHA rule, which was issued Nov. 5 and requires businesses with at least 100 employees to comply by early next year, was initially shot down in the US 5th Circuit Court of Appeals in New Orleans. OSHA estimated that the rule would save a minimum of 6,500 lives and prevent over 250,000 hospitalizations over the next six months. But challengers called the standard ‘staggeringly overboard,’ Reuters reported.
Now, the US government is asking a Sixth Circuit federal appeals court to ‘immediately’ lift the 5th Circuit’s stay, according to court documents filed Tuesday.
‘A court order blocking the Standard is a far greater affront to sovereign prerogatives. Such an order would also threaten deaths and hospitalizations that employers wish to prevent. Those interests, and the government’s interests in protecting employees and employers while this case proceeds, vastly outweigh petitioners’ asserted harm,’ the motion states.
The news comes as Covid-19 cases rise in the US, despite more than 82% of adults having gotten at least one dose of a vaccine. Last Friday, the FDA announced that all adults who received two doses of an mRNA Covid-19 vaccine are now eligible for a booster shot.
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If both its BioNTech-partnered Covid-19 vaccine and in-house antiviral live up to their full promises, Pfizer may be sitting on a $100 billion goldmine in 2022.
That’s according to SVB Leerink analyst Geoffrey Porges, who released his latest forecast early Tuesday complete with a lengthy breakdown of all the intricate factors going into his calculation. Bottom line: universal boosting and pediatric recommendations will shore up global Covid vaccine sales to $59 billion in 2021 and $48 billion in 2022, or $107 billion in cumulative sales.
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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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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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Supply chain issues and an inspection backlog have hindered manufacturing’s seemingly endless boom, following an influx of money. But a new threat looms over the industry: a strain of Windows malware.
BIO-ISAC, an international organization that addresses threats to the bio economy, issued the warning on its website Monday, saying that a ‘large biomanufacturing facility’ was involved in an attack in spring 2021, and the same malware was noticed at a second facility in October 2021. The organization expedited the threat advisory in the public’s interest and has issued a statement to manufacturers: Assume that you are a target, and review security protocol accordingly.
Neil Desai, Aadi Bioscience CEO (via YouTube)
The FDA on Tuesday approved Aadi Bioscience’s first drug and the first treatment approved specifically for patients with an ultra-rare and aggressive form of sarcoma that occurs mostly in women.
The approval of the drug, known as Fyarro, is for those with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), and is based on a Phase II trial.
Results showed an overall response rate as assessed by independent review of 39% (12/31), with two patients achieving a complete response after prolonged follow up, Aadi said. The company also said that among responders, 92% had a response lasting greater than or equal to six months; 67% had a response lasting greater than or equal to 12 months; and 58% had a response lasting greater than or equal to two years.
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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