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The Readout Damian Garde & Meghana Keshavan

A biopharma turnaround team is going after Shkreli

Martin Shkreli is still somehow managing his company from the confines of a prison cell. And it’s not doing well: Revenue’s down by half, it’s facing a spate of civil lawsuits, and the federal government is working hard to shutter what was once known as Turing Pharmaceuticals.

A team of dissident shareholders is trying to seize control of the company, which is now called Phoenixus, STAT’s Damian Garde exclusively reports. The first step would be to undo the 4,000% price increase of daraprim, the HIV drug that made Shkreli infamous. 

“I want to right the wrongs,” Jason Aryeh, a health care investor who specializes in company turnarounds, told STAT. “I want to throw the bad guys out. There isn’t a bigger, badder guy than Martin Shkreli.” 

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Recurrent BRCA breast cancer prevented by PARP inhibitor

Lynparza, a PARP inhibitor drug from AstraZeneca and Merck, reduces breast cancer recurrence in patients who carry BRCA mutations, new data from ASCO show. The results are quite striking, STAT’s Matthew Herper writes — and several experts intend to change their course of treatment for patients with this genetically driven form of breast cancer.  

“These results are so important, since about 5% of all breast cancers are associated with the BRCA1 or BRCA2 mutations,” said ASCO President Lori Pierce. “I think this further highlights the importance of genetic testing in appropriate patients, so that we know which patients will benefit from this therapy.” 

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Post-surgical immunotherapy proves fruitful

Keytruda given immediately after tumor resection surgery substantially reduces the risk of kidney cancer relapse, Merck said at ASCO on Thursday. New trial results show that Keytruda is the first immunotherapy to prove beneficial this early in a patient’s treatment: Typically such checkpoint inhibitors are used in patients with more advanced cancers, STAT’s Adam Feuerstein writes

But this positive data doesn’t necessarily mean treatment protocols for kidney cancer will change overnight. Survival data are still immature, so it’ll take some more time before physicians know whether their patients could live longer or better after being given immunotherapy early in their course of treatment. But oncologists are optimistic: 

“Are these results practice-changing? I think the answer is yes,” one kidney cancer expert said. “There will always be a debate, especially this being the first readout from an interim analysis, but when we put these Keytruda data against adjuvant Sutent — which is FDA-approved for adjuvant kidney cancer — this is remarkably better than Sutent.”

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Will a lower dose increase the use of Regeneron's Covid-19 antibody?

Monoclonal antibodies have been authorized to prevent hospitalization in patients with Covid-19, but the drugs are not being as widely used as experts hoped. One reason: they are difficult to give, requiring an IV infusion. On Friday Regeneron announced that the Food and Drug Administration has changed the authorization for its antibody cocktail, cutting the dose in half. It will also allow the dosage to be given as four injections, in the upper thighs, back of upper arms, or quadrants of the abdomen, instead of intravenously.

"Unfortunately, to date only a fraction of patients eligible for antibody treatments have received [antibodies], which we hope will change based on this updated FDA authorization." said George D. Yancopoulos, Regeneron's president and chief scientific officer. He also emphasized that, because of resistant variants, the Regeneron antibody cocktail is the only monoclonal antibody treatment for Covid currently available in all 50 states.

Who is Anthony Fauci emailing at 3 a.m.? 

Does the FDA leave legible tea leaves? And what's it like to cover an international science scandal? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we discuss why it's so hard to predict FDA decisions, and why the latest big deal in biotech left investors cold.

Then, STAT Washington correspondent Nicholas Florko joins us for a dive into the thousands of emails from Anthony Fauci that were made public this week, complete with a top-five countdown of messages both impactful and absurd. Finally, longtime Associated Press medical reporter Marilynn Marchione retired last week, and she calls in to talk about the biggest stories of her career.

Listen here.

More reads 

  • Verily’s new big hire, Amy Abernethy, on her plans to transform clinical trials — and bring in money. (STAT)
  • With a souped up synthetic genome, scientists make bacteria impervious to viral attack. (STAT)
  • Former Celgene shareholders claim Bristol Myers reaped a $6.4 billion windfall by delaying a drug approval. (STAT)

Thanks for reading! More next week,


Friday, June 4, 2021


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