| |   | Hey, it’s Friday! Before you dive back into the weekend, we’ve got a Theranos conviction, a NASH redo, and a pretty cool podcast for you. Enjoy!
- Meghana (with some help from Jason Mast) | | | Theranos's Balwani convicted on all counts A federal jury yesterday convicted former Theranos executive Sunny Balwani, finding him guilty on all 12 felony counts of defrauding both investors and patients.
The verdict was more severe than the one handed down to Elizabeth Holmes, the disgraced former CEO of the blood-testing unicorn, who was convicted on four counts of fraud and acquitted of four others in January. Holmes’ sentencing is slated for Sept. 26; Balwani’s sentencing date has been set for Nov. 15. Read more. | A setback for Legend Biotech Five years ago, a little-known Chinese biotech called Legend Biotech turned heads at ASCO when it reported that its CAR-T treatment sent 33 out of 35 multiple myeloma patients into complete remission — a nearly unheard of result in oncology, given that just slowing a tumor’s path for a few months in a fraction of patients is often regarded as a victory. That CAR-T is now an FDA-approved therapy in massive demand, and Legend is confronting the question every biotech unfortunate enough to get a drug over the finish line faces: Can it do it again? Yesterday, the company announced a setback in that effort, cuttinga U.S. trial for a CAR-T for a form of lymphoma after a similar product it was developing failed to benefit patients in a Chinese study. Although a blow, the biotech — which has significantly reshuffled its leadership — has set up plenty of other opportunities to repeat its surprise success. Alongside efforts to move the approved multiple myeloma therapy, called Carvykti, into more patient settings, trials are ongoing for CAR-Ts in other blood cancers and solid tumors and for an off-the-shelf version of Carvykti. In June, the Food and Drug Administration authorized a trial of a CAR-T targeted against a protein found on pancreatic, gastric and esophageal tumors. | Democrats' Last Chance for Drug Pricing Reform? The drug pricing debate remains a central conversation in Congress. On July 20, STAT sits down with key decision-makers about the latest developments from Capitol Hill and the White House. Join them. | NASH gearing up for FDA redemption Intercept Pharmaceuticals’ experimental NASH treatment achieved its primary goal for efficacy, a re-analysis of its data shows.
The company’s initial submission for a marketing application for the drug, called obeticholic acid, was rejected by the FDA two years ago, STAT's Adam Feue. The company intends to use this fresh look at a large clinical trial to reapply — though whether it’ll be approved this time is a subject of hot debate. Regulators had worried back in 2020 that the efficacy analyses gleaned from liver biopsy slides had been conducted by a single physician and were too unreliable. After extensive negotiation, however, the FDA and Intercept agreed that the same liver biopsy slides would be reexamined by more physicians. The new results show that 22.4% of patients receiving a high dose of the drug saw a significant reduction in liver fibrosis, compared to 9.6% of placebo. Read more. | How can biotech innovate in bear market The biotech market has plunged, sparking concern among the R&D set. Is it possible to maintain innovation in a bear market?
Yes, but biotech leaders must proceed with caution — and “focus on the aspects of their business they can control to safeguard their companies and development pipelines,” opines one former investment banker, who works now as a biotech CFO. This will involve tightening up the fiduciary ship — being intentional about operations and financial management. And with access to equity become increasingly uncertain, biotech leadership needs to look at other forms of raising capital, including debt, to continue pressing forward. Read more. | Is the era of the unicorn over? What’s gotten into the FDA? And will a NASH drug ever work? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Allison DeAngelis joins us to explain how the prolonged downturn for biotech stocks is stoking anxiety among venture capitalists. We also discuss an FDA plot twist for a novel ALS treatment, a second shot for a once-promising liver drug, and the latest in the Covid-19 pandemic. Listen here. | More reads - Merck Is in advanced talks to acquire biotech firm Seagen. Bloomberg
- Remote technology could nudge patients to join cancer clinical trials. STAT
- Scientists explore 'mosaic' nanoparticles, inhaled COVID-19 vaccine options. FierceBiotech
| Thanks for reading! Until next week,  | | | |
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