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Faulty chemotherapy, data from Cassava, and a new biotech VC

January 25, 2023
Biotech Correspondent
Hi there. Today, a deep and rather disturbing dive into the global scandal brewing around a chemotherapy for childhood cancer, we see Cassava's bold claims of cognition improvement in Alzheimer's dashed, and more. 

global health

Faulty chemotherapy could harm children globally

Asparaginase, an important chemotherapy drug used to treat childhood cancers, has been at the heart of global scandal. It began in Brazil, when physicians found that the drug, when sold under the brand name Leuginase, wasn't nearly as effective as it should have been. Although five years ago a Brazilian court ordered that Leuginase be removed from hospital shells, the issue snowballed internationally. 

A report the Bureau of Investigative Journalism, in partnership with STAT, shows that at least a dozen brands of asparaginase have been found to be of poor quality — even though 10 are still on the market globally. In addition to not doing what it's supposed to — that is, stopping cancer cells from dividing and growing — some versions have been found to have contaminants like bacteria that could be harmful to patients. The vast majority of the patients receiving this drug are children in low-income countries. 

"What's happening here is a disaster," said Vaskar Saha, director of a cancer research center in India. "This is an issue of money, resources, and equity." 

Read more.


adam's take

Cassava's Alzheimer's drug tantamount to placebo

Although Cassava Sciences has long claimed that its drug, simufilam, could improve cognition in Alzheimer's patients, mid-stage study results show otherwise. The cognition in patients taking the drug seems no better than placebo. 

The company said last August that the first 100 patients in the study had improved cognition — something that no other drug has yet accomplished. But, according to STAT's Adam Feuerstein, a wide divergence between the first and second cohorts of patients undermines the company's credibility. Since there hadn't been a placebo arm in the earlier study, the boost in cognition might even be attributed to a sort of placebo effect.

A pair of forthcoming phase 3 trials will confirm whether or not there's any hope for an improvement in cognition with Cassava's drug.

Read more.



Closer Look

Doc group files complaint about 60 Minutes Wegovy special

A recent 60 Minutes segment on Wegovy was no better than an extended advertisement for the weight-loss drug, a physicians' group argues. The Physicians Committee for Responsible Medicine has filed a complaint about the Novo Nordisk drug with the FDA, claiming that the 13-minute segment "extensively promoted" Wegovy but "offered a negligible reference to the drug's 'complications and adverse impacts." The group also said that 60 Minutes aired comments from experts who worked as paid consultants for Novo Nordisk, receiving more than $100,000 over the years. 

"The content was promotional rather than educational, as it excluded other experts, other points of view, other approaches to obesity, and other products," the group wrote. "Although this promotion constituted a broadcast advertisement, the content failed to comply with FDA regulations on prescription drug advertising, particularly those related to disclosure of risks and contraindications."

Read more.


Venture capital

Dimension: A spanking-new life sciences venture capital firm

Zavain Dar, Adam Goulburn, and Nan Li were some of the most senior investors with an eye on the biotech industry at their previous VC firms. But those firms' investments spanned technology apps, meat alternatives, therapeutics companies, aerospace startups, and more. Now, the three are going all in on life sciences.

The investors are officially launching Dimension, a new venture capital firm, with $350 million for its first fund today. Dimension's plan is to cover everything from drug R&D software to manufacturing. One of its early investments is in a software as a service, or SaaS, company called Kaleidoscope. 

Read more.


More around STAT
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More reads

  • Promising gene therapy delivers treatment directly to brain, STAT

  • Many pediatric drug study results were never posted to a U.S. government database, STAT

  • Microbiome firm Finch Therapeutics cuts 95 percent of its workforce, Boston Globe

  • Eli Lilly to invest $450 million more to expand capacity as obesity drug decision looms, Reuters


Thanks for reading! Until tomorrow,


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