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The Readout Damian Garde

Exclusive peak at a price-fixing lawsuit

Several states have alleged that generic drug makers schemed to fix prices for years. But many passages in their lawsuit, which involves 47 states lodging complaints against 17 companies, two executives, and dozens of medicines, have remained redacted. STAT’s Ed Silverman got ahold of an unredacted copy, and writes that the full complaint sheds light on all kinds of examples of alleged price-fixing.   

For (egregious) example, former Heritage Pharmaceuticals president Jason Malek allegedly accused an employee to contact a competitor, Dr. Reddy’s laboratories: 

“Would like you to have a call with (J.A., Vice President, Sales & Marketing at Dr. Reddy’s), on Zoledronic (the generic name). Right now, only us and DRL have a tentative on the 5mg (version). Need to know if he’s going to be there day one and see if he’s willing to discuss strategy at all. This is huge right now if it’s only a two player market and we need to lock in our strategy.”

Read more.

CRISPRing vaccine alternatives

Vaccination has given us a remarkable tool to curb the spread of human disease, but it’s far from foolproof. Immunocompromised individuals can’t be inoculated; furthermore, there are dozens of diseases that just don’t have workable vaccines. Enter CRISPR. A handful of labs are using the genome-editing tool to genetically reprogram B cells, prompting them to produce disease-fighting antibodies into perpetuity, STAT’s Sharon Begley writes.

It's early days for this work, and the method wouldn’t necessarily replace traditional vaccines — that would be economically prohibitive — because the B cells would have to be CRISPRed individually, patient by patient. But there are talks of developing “universal donor” B cells that could be implanted into just about anyone. 

Read more.

Insulin price hiking: Who's at fault?

Insulin prices may have increased, like, tenfold in the past decade and change — and drug makers are facing a lot of heat. But it’s not just the pharma companies that are at fault, STAT’s Nicholas Florko writes. Generic drug makers, doctors, and even the FDA all share in the blame.

Congress will soon investigate the broken biopharma market, and lawmakers have identified the three main insulin suppliers — Sanofi, Novo Nordisk, and Eli Lilly — as top targets for questioning. But why aren’t other players, including federal drug regulators, also up for scrutiny? 

“Everyone is at fault, which is makes it hard to figure out how to fix it,” Dr. Walid Gellad, who heads the University of Pittsburgh’s Center for Pharmaceutical Policy and Prescribing, told STAT.

Read more.

New combo therapy for advanced kidney cancer

Looks as though there may be a new standard of care for metastatic kidney cancer: Avelumab, a PD-L1 immunotherapy sold by Pfizer and Merck under the trade name Bavencio, significantly improved the progression-free survival of advanced renal cancer patients when combined with chemotherapy agent axitinib, according to a new (Pfizer-and Merck-sponsored) study in the New England Journal of Medicine. 

Control patients were treated with the chemotherapy drug sunitinib, which to date has been the standard treatment for the disease. Tumors shrank at a higher rate with the combination therapy than with sunitinib, researchers found.

"This is certainly better than sunitinib — hopefully this will lead to Food and Drug Administration approval soon," the study’s senior author said in a statement

More reads

  • Research on rare disease can provide insights into more common ones. (Washington Post)
  • Move clinical trial data sharing from an option to an imperative. (STAT)

Thanks for reading! More tomorrow,


Tuesday, February 19, 2019


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