| | | |   | Hey, it’s Meghana. Hope you’re enjoying these waning days of summer. Today, we get a sneak peak of late-breaking ESMO abstracts, learn about the WHO’s new guidelines for Ebola, and more. | | | A quick look at ESMO’s late breakers The European Society for Medical Oncology briefly published the titles of late-breaking abstracts before taking them offline again, Evaluate Pharma writes — offering the earliest clues on what’s on tap at the upcoming oncology conference. Most notably, perhaps, are three pivotal studies that track how anti-PD1 monoclonal antibody drugs perform against hepatocellular cancer. Merck’s Keytruda is already known to have failed, but camrelizumab from Jiangsu HengRui Medicine Co. and Beigene’s tislelizumab show promise. Evaluate has a handy guide to some of the abstracts that we already have been briefed about — and notes that ESMO, which kicks off Sept. 9 in Paris, “is shaping up to be full if catalysts.” If you’d like a more complete list of what’s to come, head on over to Twitter. And don't forget to sign up for STAT's pop-up newsletter from the conference. | A new drug for major depressive disorder approved The FDA has approved a new, fast-acting antidepressant from Axsome Therapeutics called Auvelity. It’s a combination of dextromethorphan, which is found in cough medicine, and buproprion, which is the generic form of the depression drug Wellbutrin. Patients taking the combo pill charted a 15.9-point improvement on a 60-point scale of depression severity. Patients taking placebo saw, on average, a 12.1-point benefit. Auvelity works on the brain’s NMDA receptors, and is the first pill of its kind approved to treat major depressive disorder. A nasal spray from Johnson & Johnson called Spravato, approved in 2019, works similarly. Axsome’s share price rose 40% on the news, bringing its valuation to $2.5 billion. Analysts project $2 billion in revenues at peak. Read more. | Modern collaboration, free for emerging biotechs Collaborating with distributed teams and CROs is mission critical for getting treatments to patients faster. Egnyte’s modern collaboration platform is purpose-built for today's life sciences companies – simple to deploy and easy to maintain data integrity, across any partner, anywhere. And now, early-stage biotechs will get a full year’s subscription -- free. Find out if you qualify. | WHO releases first guidelines for Ebola drugs In its first set of therapeutic guidelines for Ebola, the WHO has issued “strong recommendations” to use two monoclonal antibody drugs to treat the virus. The first is ansuvimab, sold under the brand name Ebanga, which is made by Ridgeback Therapeutics. The other is Inmazeb, from Regeneron Therapeutics. After a systematic review and meta-analysis of the drugs’ efficacy, the global health organization is calling for an increase in access to the two life-saving medications. “Ebola virus used to be perceived as a near certain killer. However, that is no longer the case,” one of the authors of the WHO guidelines said. “Provision of the best supportive medical care to patients, combined with monoclonal antibody treatment — MAb114 or REGN-EB3 — now leads to recovery for the vast majority of people.” | Inconsistencies abound at generics maker Sun Pharma An FDA inspection report shows that India’s Sun Pharmaceutical, one of the world’s largest generic drug makers, allegedly falsified several documents at one of its plants. When investigating discrepancies in a batch of medicines, FDA inspectors found records that seemed to be backdated by quality assurance and quality control employees. They also found that building access records showed an employee, who was responsible for collecting samples, didn’t enter the buildings where documents show the samples had been collected. In a notice filed with the Bombay Stock Exchange, Sun Pharmaceutical said it’s preparing a response to the findings, which will be submitted to the FDA. These sorts of manufacturing issues are not new, particularly in India: In a high-profile scandal a few years back, another large generics maker, Ranbaxy Laboratories, also falsified data. It was eventually acquired by Sun Pharmaceutical. Read more. | More reads - FDA asks Pfizer to test second Paxlovid course in patients with Covid rebound, Reuters
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- The Inflation Reduction Act: One step closer to pharmacoequity? STAT
| Thanks for reading! Until tomorrow,  | | | |
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