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Jim Wilson's dark side, a new schizophrenia pill, & a Lumakras fail

  

 

The Readout

In today's installment, we have an investigation into Jim Wilson's pioneering gene therapy program at Penn, the likely birth of a new antipsychotic blockbuster, and much more.
- Meghana

At Penn gene therapy center, Jim Wilson presided over toxic, abusive workplace, staffers say

(Mike Reddy for STAT)


The University of Pennsylvania’s Jim Wilson has been, without question, a pioneer in gene therapy. But workplace toxicity and mismanagement have been pervasive at his research center, Penn’s Gene Therapy Program, a new STAT investigation finds.

In interviews, current and former employees of the program, most of whom were granted anonymity due to fears of retaliation, said Wilson and other senior managers fostered and condoned an abusive workplace culture where bullying and harassment were commonplace. The result: In the span of just three years, 126 employees resigned or were fired from the lab — about half the program's workforce.

Wilson himself has the reputation of being genuinely passionate about patients, staffers said, but abrasive to his employees. “You can catch him at a moment where he’s getting emotional talking about a patient’s condition,” one scientist said. “And then another moment where he’s tearing someone apart in a data presentation and mocking what they had done.”

Read more.

Drug pricing reform is happening 

After years of debate on Capitol Hill and fierce resistance from the pharmaceutical industry, drug pricing reform is happening, ready or not.

Senate Democrats yesterday advanced a substantive package that would allow Medicare to negotiate some drug prices, cap Medicare beneficiaries’ costs at $2,000 per year, and impose penalties on drugmakers that hike prices faster than inflation. The package, part of a massive health and climate bill, was passed 51-50 on a party-line vote.

As STAT's Rachel Cohrs reports, the legislation was narrowed in the process, but it still represents a major defeat for the pharmaceutical industry. The next stop for the legislation is the House of Representatives, which is expected to pass the bill after it comes into session on Friday.

Karuna’s new schizophrenia pill quite effective

A novel combination pill from Karuna Therapeutics reduced psychosis, hallucinations, and delusions in patients with schizophrenia, hitting the primary endpoints in a Phase 3 trial. The drug, which targets the muscarinic acetylcholine receptors, also improved issues like social withdrawal and cognition.

The Boston biotech will use the new data to pursue a marketing application with the FDA next year. If the drug, called KarKT, is approved, it will represent a new class of medicines for the disease.

Existing antipsychotic drugs have hard-to-manage side effects — but since there have been no other options for people with schizophrenia and related disorders, analysts project that KarXT sales could reach into the billions of dollars. The drug is also being investigated for psychosis associated with Alzheimer’s.

Read more.

Lumakras fails in combination approach

Amgen’s KRAS-targeting cancer drug, Lumakras, caused serious side effects in the liver when combined with other immunotherapies, the company said.

Lumakras was approved last year for lung cancer, but sales haven’t been particularly significant because it’s only effective in a narrow slice of the patient population. The hope had been to widen that pool with a combination therapy.

“Drug development is a daily exercise in humility,” Amgen’s R&D chief told STAT. “Mother Nature is telling us things. We need to learn from that and figure out how to optimize therapy for these patients.”

Read more.

More reads

  • AstraZeneca’s Enhertu wins keenly anticipated U.S. breast cancer nod, Reuters
  • Eli Lilly expanding outside of Indiana over state’s abortion law, Fox Business

Thanks for reading! Until tomorrow,

@megkesh
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Monday, August 8, 2022

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