Kodiak Sciences announced today positive follow-up data from its Phase 1b APEX study of KSI-101, showing ≥90% of MESI patients achieved absence of retinal fluid at week 20, supporting advancement to Phase 3 trials.
Wednesday, November 5, 2025
'UK facing alarming loss of scientific talent overseas'
A report has suggested the UK is seeing an exodus of skilled science, technology, engineering, and mathematics (STEM) workers to other countries, placing the country's economic future at risk.
The survey (PDF) by STEM workforce consultancy SThree found that nearly a quarter (23%) of STEM employers have already seen talent move to new jobs abroad in the past 12 months, reflecting a "dynamic new phase" in global competition for workers.
"This is no longer a passive competition for talent, but an active, employee-led migration, with the USA emerging as the primary destination," according to the new report, which sees similar patterns in other European countries, including Germany and the Netherlands.
It also found that one in three STEM professionals in the UK have been approached by a foreign employer in the last 12 months, while 13% are in the process of moving or making plans to do so, and another 25% would consider moving abroad "if the right opportunity came along."
Nearly 10 million people are employed in jobs related to STEM in the UK, according to SThree.
The findings chime with another just-published report from the Science and Technology Committee of the House of Lords, which portrays the UK's science base as "bleeding to death" as a result of the loss of skilled workers and a failure to scale startup science and technology companies.
"The UK's inability to retain economic benefits of its R&D is a fatal flaw to any growth strategy," according to the document, which calls for the creation of a National Council for Science, Technology and Growth to coordinate actions to reverse the decline and break the country out of a "doom loop."
The conclusions are thrown into stark relief by the recent decisions by AstraZeneca, MSD, and Eli Lilly not to proceed with planned investments in the UK, plus a stream of startups abandoning the London stock market in favour of listing in the US.
If those trends continue, the UK risks becoming little more than an 'incubator economy' in areas like life sciences, according to the committee's report.
Visa clampdown may compound the problem
Alongside the loss of home-grown workers, there are also concerns that the minimum salary threshold for a skilled worker visa in the UK – which has risen in the last two years to a current level of at least £41,700 per year – will further weaken the UK's competitiveness.
Nearly two-thirds (62%) of STEM professionals said that this visa requirement will be an impediment to the sector, while the House of Lords committee has called it an "absurd act of national self-harm."
"Skilled immigration is crucial to the UK's economic future. Yet UK businesses now face stricter sponsorship rules just as global competition for STEM talent intensifies," commented Rakesh Patel, SThree's managing director for the UK and the rest of Europe.
"Without the right STEM talent, we cannot deliver on net zero and digital transformation, nor remain competitive in vital sectors such as life sciences, technology and engineering, all of which underpin the government's Industrial Strategy."
https://pharmaphorum.com/news/uk-facing-alarming-loss-scientific-talent-overseas
Google Maps to get Gemini-powered upgrade
Alphabet Inc.'s Google announced on Wednesday that its navigation tool Google Maps will be upgraded to include the company's generative artificial intelligence (AI) chatbot Gemini.
According to Google's official statement, users will now be able to search for locations in Google Maps hands-free, by asking vocally. They will also be able to, in the same way, report incidents, such as road accidents, and add events to the Calendar applications.
"Gemini in navigation starts rolling out in the coming weeks on Android and iOS everywhere Gemini is available, with Android Auto on the way," Google said.
https://breakingthenews.net/Article/Google-Maps-to-get-Gemini-powered-upgrade/65125011
France moves to suspend Shein
The French government announced on Wednesday that it has begun the process to suspend the e-commerce app Shein. The platform will be blocked temporarily until it demonstrates that it fully complies with French regulations, according to the Ministry of Economy. A first progress report on the matter will be compiled within 48 hours.
Shein faced controversy in France recently after authorities opened an investigation into "childlike" sex dolls that were sold on the app. A day later, the company opened its first physical location in the country, in the BHV department store in Paris, provoking protests.
https://breakingthenews.net/Article/France-moves-to-suspend-Shein/65124601
Shein halts third-party seller products in France
The Chinese online sales platform Shein announced on Wednesday the suspension of sales on its marketplace in France, referring to products offered by third-party sellers.
Shein made this decision "following concerns related to certain listings made by independent third-party sellers," according to a company statement. "This measure allows for a thorough review to ensure full compliance with French law and the highest standards in terms of consumer protection."
This decision comes just minutes after the government initiated proceedings to suspend the site over "pedopornographic" sex doll sales.
https://breakingthenews.net/Article/Shein-halts-third-party-seller-products-in-France/65125166
Amazon, Whole Foods debut new purchase model
Amazon.com Inc. announced on Wednesday a new purchase model available at its affiliate Whole Foods Market Inc.'s concept store in Plymouth Meeting, Pennsylvania.
Customers will now be able to shop for products from Whole Foods Market and national name-brand groceries and other utilities from Amazon in one location, at the same time. The orders can be made as online deliveries or in-store pickups.
In its official statement, Amazon expressed hope that it will expand the service to more stores in the future.
https://breakingthenews.net/Article/Amazon-Whole-Foods-debut-new-purchase-model/65125251
FDA Overruled Reviewers in Approving Stealth’s Barth Syndrome Treatment
According to reporting from Reuters, reviewers at the agency pointed to an inability to differentiate from placebo to justify rejecting the drug, but an FDA office director approved the drug anyway.
The FDA overruled its reviewers when approving Stealth Biotherapeutics’ Barth Syndrome drug, despite questions about the efficacy achieved in a 10-patient clinical trial, according to documents related to the approval.
That approval came in September after Stealth had unsuccessfully tried to get elamipretide, now sold under the brand name Forzinity, across the finish line for years. Documents from the FDA show that Hylton Joffe, the FDA’s director of the office of cardiology, hematology, endocrinology and nephrology, signed off on the drug under the accelerated approval pathway. The approval was based on a 10-person study that showed the drug improved knee strength.
However, reviewers at the FDA pointed out that the study, which was not placebo-controlled, did not directly link Forzinity to the patient improvements. Reviewers also pointed out that in the TAZPOWER trial, patients taking placebo improved about as much as those taking the drug in a test of how far they could walk in six minutes.
Charu Gandotra, a cardiologist and FDA clinical team leader, also recommended against approving Forzinity to Joffe.
The FDA’s actions were first reported Wednesday by Reuters.
The feelings at the FDA seemed to be broadly mixed in parallel with the drug’s years-long journey to approval. The FDA declined to consider the drug for full approval back in 2021. In 2024, an advisory committee voted 10-6 in favor of supporting the drug for approval, though even the committee members who were in favor were equivocal in their support.
“This was just impossible,” Gerard Berry, professor of Pediatrics at Harvard Medical School and one of the members who voted in favor of the drug, said at the time. “As a pediatrician and metabolic specialist who’s cared for these patients, to deprive somebody of being able to get the medicine that might help is just untenable for me.”
Stealth was again rejected by the FDA in May, but the agency suggested the company resubmit under the accelerated pathway. Stealth did so, without submitting new data but addressing manufacturing and safety concerns brought up by the FDA in its prior review.
Barth Syndrome is an ultra-rare disease affecting 150 people in the entire U.S. It arises from a genetic mutation affecting patients’ mitochondria, resulting in cardiac abnormalities that lead to muscle weakness and debilitating fatigue. Most patients die by the age of five. Forzinity is the first ever approved treatment for the condition.
The Trump administration has repeatedly advocated for getting more approvals for rare diseases, and the Barth Syndrome patient community rallied to support Forzinity .
“We have everything at stake in this,” Kate McCurdy, board chair at the Barth Syndrome Foundation, told BioSpace in September. “It’s not just hearsay or sort of wishful thinking that we see the benefits of this drug. We can see it.”
This is not the first time that an FDA head has approved a contentious drug for a disease lacking treatment options. In 2023, Peter Marks, the former head of the agency’s Center for Biologics Evaluation and Research, approved Sarepta Therapeutics’ Elevidys for Duchenne muscular dystrophy, despite recommendations from reviewers to decline the treatment.
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