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Tuesday, May 4 2021

Full Issue

Illegal Drug MDMA Proves Useful Against PTSD In New Study

In other pharmaceutical news, promising results come from a new treatment for Duchenne muscular dystrophy; Gilead sues Russia over a government-okayed remdesivir clone; and the EU fines drugmaker Merck over a merger deal.

The New York Times: A Psychedelic Drug Passes a Big Test for PTSD Treatment

In an important step toward medical approval, MDMA, the illegal drug popularly known as Ecstasy or Molly, was shown to bring relief to those suffering from severe post-traumatic stress disorder when paired with talk therapy. Of the 90 people who took part in the new study, which is expected to be published later this month in Nature Medicine, those who received MDMA during therapy experienced a significantly greater reduction in the severity of their symptoms compared with those who received therapy and an inactive placebo. Two months after treatment, 67 percent of participants in the MDMA group no longer qualified for a diagnosis of PTSD, compared with 32 percent in the placebo group. (Nuwer, 5/3)

Stat: Sarepta’s More Potent Duchenne Treatment Shows Promise, Greater Toxicity

Sarepta Therapeutics said Monday that a second-generation medicine for patients with a certain type of Duchenne muscular dystrophy showed improved performance in laboratory tests over the biotech’s marketed treatment. In a small clinical trial, a monthly infusion of the new Sarepta drug, called SRP-5051, produced eight times more of the muscle protein dystrophin compared to weekly infusions of Exondys 51, the company’s existing product. (Feuerstein, 5/3)

In pharmaceutical news from around the globe —

Stat: Gilead Sues Russia Over A Compulsory License Issued For Remdesivir

Amid worldwide clamoring for Covid-19 vaccines and other therapies, Gilead Sciences (GILD) last month filed a lawsuit against the Russian government for allowing a domestic company to manufacture and market its remdesivir treatment, which is also known as Veklury. The move came after the government late last year issued a compulsory license to a company called Pharmasyntez, which unsuccessfully approached Gilead about obtaining a license to produce a version of the medicine. At the time, the health minister pursued the step “in the interest of national security,” and the company indicated plans to sell its version about half the cost. (Silverman, 5/4)

Stat: Merck KGaA Unit Fined For Providing Misleading Info Prior To A Merger

The European Commission fined a unit of Merck KGaA $9 million for providing incorrect or misleading information during an investigation of a deal in which the drug maker spent $17 billion to acquire Sigma-Aldrich, which was a U.S. supplier of laboratory testing materials. The EC, which is the executive arm of the European Union, had approved the deal in June 2015, but only on the condition that the companies agreed to sell certain portions of their lab chemicals business. At the time, there were concerns the merger would reduce competition, because Merck (MKKGY) and Sigma-Aldrich were the two leading suppliers of solvents and inorganics. (Silverman, 5/3)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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