February 12, 2024

The need-to-know this morning

Pfizer ran a Super Bowl ad that celebrated its 175-year history and a commitment to finding new treatments for cancer. The soundtrack was Queen's "Don't Stop Me Now," lip synced by animated portraits, sculptures and sepia-toned photos of Pfizer founders Charles Pfizer and Charles Erhart, along with Rosalind Franklin, Sir Isaac Newton, Hippocrates, Rosalind Franklin, Albert Einstein, Katalin Karikó and others. Really good ad, probably won't make a bit of difference.
Travis Kelce, a pitchman for Pfizer's Covid-19 and flu vaccines, won the Super Bowl.
AN2 Therapeutics said a blinded analysis of a Phase 2 study evaluating its drug epetraborole in an infectious lung disease showed "potentially lower-than-expected efficacy." As a result, the company is pausing enrollment in an ongoing Phase 3 study.
Larimar Therapeutics reported results from a Phase 2 study evaluating its drug nomlabofusp for Friedrich's Ataxia.

research integrity

Universities scrambling to keep up with scientific misconduct

Evidence of scientific misconduct is growing exceedingly common, STAT reports — with allegations, as reported to the NIH, having more than doubled from 2013 to 2022. Dana-Farber Cancer Institute is investigating potential discrepancies involved in about 60 papers coauthored by four of its top researchers over a 15-year period.

Part of the reason that errors and data manipulation are becoming more apparent? The internet. Anyone who might have the time and interest can probe published studies and flag any discrepancies.

"Honestly, if there's someone out there watching and getting us to correct the literature, good. Bring it on," one research integrity officer told STAT. "What isn't OK is that the volume has increased so substantially, and our people power has not increased. Everything piles up behind us. The frequency of these has just exploded. You can't respond with panic."

psychedelics

Psychedelic investment continues to ramp up

Funding for biotech startups developing mental health treatments derived from psychedelic drugs continue to raise a great deal of money, the Financial Times writes. Just last month, companies working with the hallucinogens MDMA, psilocybin, and DMT raised at least $163 million. It's the second-highest month of fundraising in this space, after March 2021. And the sector is expected to continue expand, as data continues to validate the potency of these medicines.

Compass Pathways, a Nasdaq-listed group backed by investors like Peter Thiel and Christian Angermayer, will likely publish phase 3 data from an 800-subject trial showing synthetic psilocybin's efficacy in treatment-resistant depression.

"Much of the stigma in investing circles has started to dissipate," Compass CEO Kabir Nath told the Financial Times, adding that recent FDA guidance on psychedelic study has made the field "made it a lot more straightforward" for investors.

generics

Some production halted at generics maker Aurobindo

U.S. inspectors found nine different quality control issues at an Aurobindo plant in India, causing the generic drug maker to halt manufacturing on some of its production lines. Aurobindo is one of the largest generic drug makers, and this news underscores the ongoing issue of drug shortage and quality from some suppliers.

"At this point in time, we don't foresee any material impact on the business," Aurobindo said in a filing with the Bombay Stock Exchange. But the site, which is in Telangana, India, manufactures more than 150 products, including essential injectables and eye drops for the U.S. market. The facility also makes about 30 products for sale by other companies, including Walgreens and McKesson. At least six products are on the FDA's shortages list, including dexamethasone sodium phosphate and methylprednisolone acetate injections.

obesity

The safety profile of weight loss drugs

New drugs treating obesity have exploded in popularity, but questions remain over their safety profile in the longer term. Nature has published a very handy review of the safety profile of weight loss medicines — ranging from the newer GLP-1 medicines to older approaches like phentermine.

Drugs like semaglutide, liraglutide, tirzepatide, orlistat, and naltrexone combined with bupropion can have issues that range from headache and vomiting to acute kidney injury, the review shows. It finds that data supports using the gut-hormone receptor analogues to treat the obesity epidemic, but that continuous surveillance of side effects is critical moving forward — the data that cinched their approval "may have been insufficient to unveil all the safety issues," the paper says.

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