Today has been marked by a wide range of life science and biopharma stories. Here’s a broader look at some of the top stories.
Today has been marked by a wide range of life science and biopharma stories. Here’s a broader look at some of the top stories.
Novartis’ Mayzent (siponimod), recently approved for relapsing types of multiple sclerosis (MS), also showed improvements and prevented deterioration of cognitive processing speed in patients with secondary progress MS. Cognitive problems affect about 50-70% of MS patients, with processing speed the most commonly affected area. The EXPAND Phase III trial was focused primarily on other benefits, but the trial also showed improved cognitive processing speed.
Chimerix announced it is restructuring and cutting more than 50% of its staff. It also indicates it plans to “pursue external opportunities to build its pipeline of product candidates.” This is the result of discontinuing all ongoing human clinical trials for brincidofovir (BCF) because of low patient recruitment. The company suffered a massive public relations hit in 2014, when the company denied a 7-year-old access to the drug under compassionate use, arguing that it wouldn’t help the child.
A study by the U.S. Food and Drug Administration (FDA) found a link—granted, a very rare link—between a class of diabetes drugs called SGLT2 inhibitors and a deadly genital infection called Fournier gangrene. The FDA, using a database of adverse events, identified 55 cases of Fournier gangrene in patients taking SGLT2 inhibitors from March 2013 and January 2019. All patients became severely ill, had surgery to remove the damaged tissue, and three died. Well-known SGLT2 inhibitors include Johnson & Johnson’s Invokana, Eli Lilly’s Jardiance and AstraZeneca’s Farxiga. The research was published in the Annals of Internal Medicine.
Researchers with the University of Pittsburgh in Pennsylvania used a genetically modified bacteriophage—a type of virus that infects bacteria—to successfully treat 15-year-old Isabelle Carnell, a British girl with cystic fibrosis who had been fighting a drug-resistant Mycobacterium abscessus infection half her life. Her physician, Helen Spencer, with London’s Great Ormond Street Hospital, was out of options and reached out to Graham Hatfull at U of P. Their approach appeared to work, although they caution that because it was outside a controlled clinical trial, there may be other factors to their patient-specific cocktail. She continues to receive the treatments, which haven’t cured the infection, but appears to have it under control. The research was published in the journal Nature Medicine.
Elizabeth Holmes, former chief executive officer and founder of Theranos, is back in the news again. Holmes and the company’s former chief operating officer, Ramesh Balwani, are facing a massive fraud trial. From 2013 to 2015, the two raised more than $700 million from investors through what the SEC called “years-long fraud” where they lied or exaggerated the efficacy of the company’s technology and the state of its finances. Recent court filings by Holmes and Balwani outline a possible defense strategy, according to The New York Times: “put the government on trial by claiming that regulators improperly brought actions against the company for its blood analysis technology.” They are also alleging that The Wall Street Journal reporter John Carreyrou, who wrote a book, “Bad Blood: Secrets and Lies in a Silicon Valley Startup,” had interactions with the Centers for Medicare and Medicaid Services (CMS) that influenced the regulatory process that, according to the filing, “warped the agencies’ focus on the company and possibly biased the agencies’ findings against it.”
Senator Elizabeth Warren (D-MA), who is running for president, is donating $4,500 to offset political contributions made to her Senate campaign over the years by the Sackler family, who owns Purdue Pharma, maker of OxyContin. She has also proposed a plan to combat the opioid epidemic, spending $100 billion over 10 years. It is modeled on a 1990 law that was used to fight AIDS. The proposal would be funded by taxing the wealthiest Americans.
Gilead Sciences announced a generic version of HIV drug Truvada, which will be available in September, a year earlier than expected. Truvada is used as a prophylactic, to prevent the transmission of the disease. It is dubbed pre-exposure prophylaxis, or PrEP. Douglas Brooks, Gilead’s executive director for community engagement, in an email shared by advocacy group PrEP4All to NBC News, wrote, “Gilead reached an agreement with Teva Pharmaceuticals in 2014 to allow the early launch of a generic version of Truvada into the market in 2020, a year earlier than required.”
After a raid on its headquarters by the FBI, microbiome-testing company uBiome told customers this week that it was suspending the sale and testing of its two main tests. The FBI raided its offices in San Francisco in late April as part of an investigation into the company’s billing practices. Company co-founders and co-CEOs Jessica Richman and Zac Apte were placed on administrative leave. The company’s tests sequence the microbiome, the trillions of bacteria, fungi and other microorganisms that live in the human body. The tests include SmartJane, which evaluates the vaginal microbiome for sexually transmitted diseases and chronic vaginal infections, and SmartGut, which tests for gut conditions and metabolic disorders. The company indicates it won’t run the tests on any sent in recently and will refund customers for the canceled tests. The company will continue to offer a direct-to-consumer test called Explorer. John Rakow, uBIome’s general counsel, is acting as interim CEO and plans an independent investigation overseen by the board of directors.
