| |   | Hiya! It's Meghana. Lots to unpack today in the medical device breakthrough realm, so be sure to check out STAT's comprehensive investigation! | | | Who actually benefits from a device breakthrough? The FDA launched the Breakthrough Devices Program five years ago, aimed at speeding up the development of potentially lifesaving medical devices — ostensibly in order to get them quickly to the patients who need them. But manufacturers may have benefited more from the breakthrough program than patients, a STAT investigation finds. Many breakthrough recipients use the label to promote their products and reel in investment — making it a business imperative in the medical device world. About 650 products have been granted breakthrough status thus far, with 213 earning the label in 2021 alone. “The number of breakthrough device designations have gone up so much, I think it’s pretty clear that definition has been applied very loosely,” one health policy researcher told STAT. Since the FDA doesn’t usually disclose which device makers have been granted breakthrough status, STAT scoured hundreds of press releases, social media posts, and regulatory announcements to build the most comprehensive public database of breakthrough-designated devices. Read the full investigation here. See the breakthrough device database here. And see what questions still remain here. | Accounting for sex differences in medicine There is growing evidence that immune responses to Covid-19 vaccines vary between men and women. This isn’t exactly surprising — plenty of drugs are metabolized differently depending on sex, but unfortunately, “sexism has deep and twisted roots that have tainted science and medicine for a long time,” opines science journalist Dawn Sinclair Shapiro. Scientific research needs to broadly shift gears, she writes, to make up for these biological differences between the sexes. The NIH is already scaling up efforts to address this, and the NHS in the United Kingdom will begin requiring “sex to be specified in the experimental design of grant applications involving animals, and human and animal tissues and cells.” Sex should always be considered a biological variable in preclinical research, she says. Read more. | A conversation with the STAT Madness crowd favorite Each year, universities and research institutions across the country compete in STAT Madness, a bracket-style tournament, in order to be recognized as having produced the top biomedical innovation or discovery of the year. Register for a virtual event on April 20 to hear researchers from the winning team discuss their work. | BMS throwing in the billion towel with Nektar Last week we perhaps heard the shuddering last gasps of Nektar Therapeutics. After two more late-stage clinical trials failing, it looks like Bristol Myers Squibb’s $1 billion upfront gamble on the Nektar drug PEGylated IL-2 will not pay off. So BMS and Nektar have decided to break up — discontinuing future studies of Nektar’s drug in combination with BMS’s Opdivo. This is one of the biggest bets that Thomas Lynch, BMS’s chief scientific officer, has ever taken, FierceBiotech points out. It also calls into question whether there is a future for the IL-2 field. After all, in addition to PD-1 and CTLA-4, the IL-2 cytokine has been one of the major pillars of immuno-oncology — but has long been viewed as too toxic for practical use. Nektar’s drug was meant to offset this. Those interested in IL-2 will pay extra attention to Sanofi, which dropped $2.5 billion in 2020 to buy Synthorx, whose recombinant IL-2 molecule THOR-707 delivered early clinical data that analysts dubbed “intriguing.” | Bill Gates on hastening drug development Bill Gates was surprised at how long it took to develop therapies for Covid-19, he writes in an op-ed for the New York Times. And it wasn’t for a lack of trying: Plenty of existing and novel compounds have been tested over the past two years, with varying degrees of success. Gates, who famously predicted that a pandemic would rip through the world well before 2020 hit, writes, "The next time we’re faced with a contagion, scientists will need to develop treatments as fast as possible, much faster than they did for Covid." He says that investing in large drug compound libraries is key — particularly broad-spectrum antibodies or drugs that can treat a wide variety of pathogens. He also thinks there needs to be more work in learning how to activate the innate immune response. Tools like organs-on-chips will be particularly useful, he posits, along with using artificial intelligence and machine learning to target weak spots on pathogens. “This will require substantial investment to bring together academia, industry, and the latest software tools,” he writes. “But if we succeed, the next time the world faces an outbreak, we’ll save millions more lives.” | More reads - FDA authorizes first Covid-19 breath test. (CNN)
- TG Therapeutics retracts FDA request for combo therapy due to death risk. (FierceBiotech)
| Thanks for reading! Until tomorrow,  | | | |
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