| |   | Good morning, all. Damian here with a less-than-optimistic look forward, a curious Covid-19 vaccine update, and more trouble for GlaxoSmithKline. | | | Earnings season probably won’t save biotech Biotech, a sector desperate for news that might change investor sentiment, would benefit if the coming spate of quarterly earnings calls brought news of unexpectedly booming business and up-sized expectations for the full year. Unfortunately, that’s probably not going to happen.
According to analysts at Cowen, over the past year, the only companies to consistently “beat and raise” have been those with Covid-19-related revenue, like Moderna, Gilead Sciences, and Regeneron Pharmaceuticals. For everyone else, earnings have been flat or falling, leading to declining fortunes for the likes of Biogen, Amgen, and Vertex Pharmaceuticals.
Making matters worse, even Covid sales might not help in 2022. Omicron has decimated the demand for many once-lucrative treatments, and Johnson & Johnson’s recent decision to pull its full-year vaccine revenue forecast suggests the market for booster doses might be drying up. | Novavax remains puzzling Novavax, the company that has repeatedly failed to meet self-imposed deadlines with its powerful Covid-19 vaccine, has again paired promising science with questionable execution.
Yesterday, the company presented early data on a combination vaccine for Covid-19 and seasonal influenza, suggesting the company could be the first to market with such a product, beating its competitors at Moderna.
But that would require the timely execution of clinical trials and regulatory filings, which has not been Novavax’s strength over the past two years. The company has not yet received an emergency use authorization for its Covid-19 vaccine, and yesterday’s comments from an FDA official suggest the agency is still waiting on data from Novavax. That might spell yet another delay for a company accustomed to them. | Join STAT on May 3 in Boston to explore the challenges, and the unique opportunities for new approaches, solutions, and partnerships, of the drug development process. This in-person program will bring together a diverse group of individuals to share their perspectives about the drug development process. Stay once the conversation is complete for a networking and cocktail reception with STAT and your fellow attendees. Get your ticket now (and save 40% as a STAT+ subscriber). | ALS patient: Two FDA wrongs don’t make a right The outrage over the FDA’s approval of Biogen’s Alzheimer’s disease treatment Aduhelm has cast a shadow over the agency’s neurology division, one that threatens an unrelated medicine that promises hope for patients with a fatal disease.
That’s according to Bernard Zipprich, a patient diagnosed with ALS who watched in shock last month as an FDA advisory committee voted narrowly against approving a novel treatment called AMX0035 from the company Amylyx Pharmaceuticals. “Although Aduhelm was barely mentioned during the hearing on AMX0035 … its shadow was apparent as reviewers emphasized shortcomings in the Amylyx study instead of its strengths,” Zipprich writes in STAT.
To Zipprich, while the FDA may have erred in approving Aduhelm, rejecting AMX0035 won’t do anything to calm the controversy or restore the agency’s reputation. “What it will do is keep people with ALS from accessing a promising treatment because of cost, ensuring that when the Phase 3 results are finally revealed, many won’t be alive to see them,” he wrote.
Read more. | ‘New GSK’ has a labor issue GlaxoSmithKline, beset by activist shareholders, skeptical investors, and a shrinking stock price is now staring down a labor strike.
As the Financial Times reports, hundreds of the company’s U.K. employees have voted to go on strike unless GSK offers them a raise that outstrips the rate of inflation. According to the union representing the company’s manufacturing employees, the vote follows a painful 2021 negotiation in which GSK initially refused to grant raises but offered a 2% pay increase under threat of a strike.
Meanwhile, CEO Emma Walmsley is working to sell the world on what the company calls “New GSK,” which is what will be left after the firm spins out its consumer products division. The company promised to increase revenue from vaccines and drugs by 5% over five years and 38% by 2031. Activist investors, led by the hedge fund Elliott Management, are less than sold on the plan and are agitating for changes to GSK’s leadership. | More reads - Pfizer faces criticism for arguing that intellectual property for its Covid-19 pill is a human right. STAT+
- How Gilead, Regeneron and other top biopharmas used political connections to hurry their Covid-19 products. Endpoints
- Brewing Alzheimer’s drug plan fights rest in patients’ hands. Bloomberg
| Thanks for reading! Until tomorrow,  | | | |
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