| | By Elizabeth Cooney | Good morning. Voting is now open for STAT Madness, our bracket-style competition modeled on college basketball’s March Madness tournaments. Find out more here. | | UC Berkeley loses CRISPR patent case, invalidating gene-editing licenses Is it really over? The U.S. Patent and Trademark Office issued a decision yesterday in a long-running dispute over which team of scientists was first to get the genome-editing technology CRISPR to work in eukaryotic cells (cells with a nucleus). Yesterday the office ruled that the Broad Institute of Harvard and MIT was the first to make this crucial step toward translating CRISPR into treatments for human disease. It’s a huge blow to the University of California and biotech companies that had licensed the technology, including Intellia Therapeutics and CRISPR Therapeutics. They will now have to negotiate with the Broad Institute for the right to use CRISPR for human therapies. And it’s also a loss for 2020 Nobel laureates Jennifer Doudna of UC Berkeley and Emmanuelle Charpentier of the Max Planck Institute for Infection Biology. STAT’s Megan Molteni has more in STAT+. | Pfizer Covid vaccine less effective in kids 5 to 11 than over 12 years old, study finds Newly emerging data suggest the Pfizer-BioNTech Covid vaccine did not perform nearly as well at preventing infection and hospitalizations in children aged 5 to 11 as it did in those aged 12 to 17 — raising questions about whether the companies chose the wrong dose for the younger children. The study, based on data from the New York State Department of Health and posted yesterday on a preprint server, has not been peer reviewed. It follows disappointing results from Pfizer trials of an even lower vaccine dose in children under the age of 5. Pfizer would not say if it is exploring the possibility that the dose used in children might be too low, but said it is “confident in the protection and safety” of its Covid-19 vaccine. STATs Helen Branswell has more. | Breast cancer is overdiagnosed in 1 of 7 cases — fewer than previously thought Catching cancer early in a mammogram can be lifesaving — smaller tumors are easier to remove surgically, and therapy often has a much greater effect. But paradoxically, breast cancer screening also sometimes picks up tumors that would have caused less harm if they’d remained hidden. These cases, known as “overdiagnoses,” may never go on to pose a threat to a patient’s health for a number of different reasons. A new study in Annals of Internal Medicine suggests they occur in 1 of 7 breast cancer cases detected during screening. That new estimate comes as a relief to breast cancer clinicians, who say that the study should reinforce the idea that the benefits of mammography generally outweigh its risks. Still, experts said, it doesn’t minimize the real danger of overdiagnosis or the need to effectively communicate the risks and benefits of screening to patients. STAT’s Angus Chen has more. | The leading modalities for ex-vivo cell therapy manufacturing As biopharma executives build out their cell and gene therapy processes, top investors want to know which manufacturing technologies are set up to emerge within the competitive landscape, and which modalities will carry the industry forward into its next phase of growth. Be a “fly on the wall” for KOL conversations that dive into these themes and more in “Tegus Insights: Cell and Gene Therapy.” Download a copy. | Closer look: Strong evidence = good business for mental health tech startups (adobe) Interest in the mental health tech space is booming, as more stakeholders warm to the idea that software could be used to meet soaring demand for mental health treatment at a reasonable cost. But as smartphone apps to treat mental health conditions become more common, the companies making them are grappling with a growing imperative: If they want to succeed, they need to get a lot better at producing more compelling evidence. So far, that evidence hasn’t been enough to convince health insurers and providers they should prescribe or pay for digital therapeutics. There are several reasons why: The regulatory landscape means strong research isn’t always required to go to market, disincentivizing such studies. It’s also challenging to design comprehensive clinical studies, especially for novel treatment approaches, and expensive to run them. STAT’s Mario Aguilar has more for STAT+ subscribers. | People worry about Covid restrictions — both ending them and keeping them Now that the Omicron surge is subsiding, a national KFF poll out today finds a partisan divide in what worries Americans just as Covid restrictions are being lifted across the country. Overall about two-thirds of people say they are worried about restrictions hurting the mental health of school-age children (73% of Republicans, 56% of Democrats) and damaging businesses (74% R vs. 56% D). About 6 in 10 are also concerned about immunocompromised people falling ill with Covid (30% R vs. 82% D). And nearly half of respondents think more people might die (23% R vs. 70% D) or fail to get the medical help they need from overwhelmed hospitals (22% R vs. 66% D). Most Republicans (65%) and unvaccinated adults (60%) think it is safe to resume normal activities now while fewer Democrats (11%), independents (38%), and vaccinated adults (26%) would agree. | Alexa, call a doctor Amazon is teaming up with telemedicine provider Teladoc Health to launch a 24/7 voice-activated way to call for medical help without actually calling on a phone. It’s not intended to replace 911, but people who aren’t experiencing medical emergencies though still need care can tell Alexa they’d like to talk with a doctor. That will connect them to a Teladoc call center and a physician who will call them back the same day, depending on the availability of doctors where the patient is located, Teladoc spokesman Chris Savarese told the Associated Press. Without insurance, the calls cost $75. Savarese also said Amazon will not be able to access, record, or store the content of the ensuing call. | | | What to read around the web today - Biden to launch overhaul of nursing home standards, safety. Associated Press
- When an ancestry search reveals fertility fraud. New York Times
- FDA approves second CAR-T cancer therapy to treat multiple myeloma, opening the door for greater access. STAT+
- Possible case of deer-to human Covid infection identified in Canada. The Guardian
- Intellia Therapeutics shows improved, sustained effect from in vivo CRISPR treatment. STAT+
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