• A new nasal vaccine for whooping cough shows promise in protecting individuals and preventing the transmission of the disease by clearing the bacteria from the respiratory tract.
• A Stanford Medicine study showed that CAR-T cell therapy shrank brain tumors and restored function in children, offering new hope for treating deadly pediatric brain tumors.
• Researchers at UC San Diego have developed a wearable ultrasound patch for continuous, noninvasive blood pressure monitoring, offering improved cardiovascular health tracking.

Recent News

• Jazz Pharmaceuticals receives FDA approval for biliary tract cancer treatment
  Reuters – November 20, 2024
  The U.S. Food and Drug Administration approved Jazz Pharmaceuticals’ , opens new tab drug for the treatment of a type of biliary tract cancer, the company said on Wednesday. The drug zanidatamab-hrii, sold under the brand name Ziihera, is approved for use in previously treated adults with metastatic HER2-positive biliary tract cancer. HER2 is a protein that stimulates quick growth of cancer cells. Its presence in solid tumor form includes biliary tract, bladder, cervical, endometrial, ovarian and pancreatic cancers.
• Medtronic scores FDA clearance for smart insulin pen app aimed at multiple daily injections
  Fierce Biotech – November 20, 2024
  With a new smartphone app clearance from the FDA, Medtronic said it has all the pieces necessary to deliver a complete diabetes management system aimed at people taking multiple insulin injections per day. The companion app for the InPen digital insulin pen is designed to connect with the company’s latest Simplera continuous glucose monitor, offering users personalized dosing suggestions based on real-time blood sugar readings. Medtronic also said the app will be the first on the market to provide alerts for potentially missed or inaccurate doses—including for boluses taken before meals. The company estimates that people with diabetes may regularly miss as many as one out of every three insulin doses, which can lead to blood sugar spikes after eating.
• Researchers Develop Clinically Validated, Wearable Ultrasound Patch for Continuous Blood Pressure Monitoring
  UC San Diego – November 20, 2024
  A team of researchers at the University of California San Diego has developed a new and improved wearable ultrasound patch for continuous and noninvasive blood pressure monitoring. Their work marks a major milestone, as the device is the first wearable ultrasound blood pressure sensor to undergo rigorous and comprehensive clinical validation on over 100 patients. The technology, published on Nov. 20 in Nature Biomedical Engineering, has the potential to improve the quality of cardiovascular health monitoring in the clinic and at home. “Traditional blood pressure measurements with a cuff, which are limited to providing one-time blood pressure values, can miss critical patterns.
• CDC encouraging older adults to get vaccinated twice as COVID cases rise again
  FOX 23 – November 20, 2024
  COVID-19 cases are rising again just in time for the holidays. The Tulsa Health Department said new guidelines encourage older adults to get vaccinated twice. FOX23 learned what you need to know as you make holiday plans. If you’re traveling or getting together with family for Thanksgiving, your biggest problem may not be awkward small talk. “Anytime you’re seeing people gathering together with others it involves travel or indoors with Thanksgiving celebrations we do see an increase,” said Madison Thomas, Tulsa Health Department.
• Rapid growth spurt for UCB’s Bimzelx continues with hidradenitis suppurativa nod marking 5th FDA approval
  Fierce Pharma – November 20, 2024
  It was only last October that UCB’s up-and-coming immunology powerhouse Bimzelx first crossed the FDA finish line in psoriasis after an initial delay. Now with a new nod in hidradenitis suppurativa (HS), the drug seems to be carving the path to blockbuster land with five approved indications. Bimzelx, which is the first to selectively inhibit IL-17F as well as IL-17A, was cleared to treat adults with moderate to severe forms of the disease after proving it could help patients significantly reduce signs and symptoms of the condition. HS is characterized by chronic and recurring painful nodules, abscesses and pus-discharging fistulas that can have a major impact on quality of life.
• J&J pill clears skin in two late-stage psoriasis studies
  BioPharma Dive – November 19, 2024
  An experimental pill developed by Johnson & Johnson and Protagonist Therapeutics significantly cleared skin in most people with moderate-to-severe plaque psoriasis who enrolled in a Phase 3 trial run by J&J. Treatment with the drug, called icotrokinra, led to clear or almost clear skin in about two-thirds of participants after four months of testing. Just under half experienced a 90% or greater reduction in their scores on another measure of psoriasis plaque coverage and severity. Only 8% and 4%, respectively, of study participants on placebo hit those same marks. Responses to icotrokinra improved further through six months and, according to a Monday statement from J&J, a similar percentage of participants in both trial groups experienced side effects. The company plans to present detailed results at an upcoming medical meeting.
• New nasal vaccine shows promise in curbing whooping cough spread
  Medical Xpress – November 18, 2024
  As whooping cough cases rise in the U.S., a new nasal vaccine developed by Tulane University may hold the key to reducing the spread of the highly contagious respiratory disease. Current pertussis vaccines are widely used and effective at preventing whooping cough, caused by the Bordetella pertussis bacteria. However, the vaccines fail to clear bacteria from the upper respiratory tract, allowing even vaccinated individuals to spread the disease. The new vaccine combines the traditional pertussis antigens with an innovative adjuvant called T-vant, which boosts the body’s immune response specifically in the respiratory tract.
• Syndax wins U.S. approval for leukemia treatment
  Stat News – November 18, 2024
  The Food and Drug Administration approved a new drug developed by Syndax Pharmaceuticals to treat patients with a genetically defined form of advanced leukemia. The pill, called Revuforj, is the first medicine in a class of drugs called menin inhibitors to reach the market. Revuforj was approved to treat adults and children with relapsed or refractory leukemias that have a genetic “rearrangement” called KMT2A. This particular genetic type of leukemia is present in approximately 10% of cases, and is difficult to treat, leading to high relapse rates and survival of less than a year.
• PTC wins US approval of gene therapy for fatal enzyme disorde
  BioPharma Dive – November 14, 2024
  PTC Therapeutics won Food and Drug Adminitration approval for Kebilidi, the first gene therapy cleared in the U.S. for direct administration to the brain. The treatment is designed for patients with aromatic L-amino acid decarboxylase, or AADC, deficiency, a condition that affects the way neurons transmit information to other cells. The potentially fatal disorder typically manifests in the first six months after babies are born and affects all aspects of their lives, both physical and mental. Kebilidi is designed to deliver a functioning DDC gene into the body, correcting the genetic defect that causes the disorder. It’s administered by a neurosurgeon in four infusions in one session.
• Cell therapy fights lethal childhood brain cancer in clinical tria
  Stanford Medicine – November 13, 2024
  An immune-cell therapy shrank children’s brain tumors, restored neurologic function and—for one participant in a Stanford Medicine clinical trial—erased all detectable traces of a brain cancer typically considered incurable. The trial, among the first successes against solid tumors for engineered immune cells known as CAR-T cells, offers hope for children with a group of deadly brain and spinal cord tumors, including a cancer called diffuse intrinsic pontine glioma, or DIPG. The findings were published online Nov. 13 in Nature. In October, this therapy received a regenerative medicine advanced therapy designation from the U.S. Food and Drug Administration, which gives the researchers access to a fast-tracked version of the FDA approval process.
• Combination approach shows promise for treating rare, aggressive cancers
  UCLA Health – November 12, 2024
  A research team led by UCLA Health Jonsson Comprehensive Cancer Center investigators has shown that that combining pembrolizumab, an immunotherapy drug, with standard chemotherapy can improve treatment outcomes for patients with small cell bladder cancer and small cell/neuroendocrine prostate cancer. Small cell carcinomas can arise in various tissues—including the bladder, prostate, lung, ovaries and breast—and are known for their rapid progression, tendency to relapse after initial treatment and poor overall survival rates. The survival time for patients with advanced small cell bladder cancer is only about 7 to 13 months and only 7 to 9 months for patients with small cell/neuroendocrine prostate cancer.
• Nasal spray made from stem cell-derived vesicles could treat Alzheimer’s disease
  Medical Xpress – November 7, 2024
  A new therapy may delay Alzheimer’s disease progression by years, according to a study by researchers at Texas A&M University College of Medicine. Published in the Journal of Extracellular Vesicles, the research aims to explore treatment options for Alzheimer’s, which constitutes the most common form of dementia and is a leading cause of death among those aged 65 or older, afflicting nearly 7 million Americans. Utilizing a nasal spray to non-invasively target cells perpetuating chronic neuroinflammation, researchers found decreased inflammation in the brain and a reduction in the build-up of plaques and proteins thought to be linked to the progressive loss of neurons in the brain, characteristic of Alzheimer’s.
• Intra-Cellular’s unstoppable Caplyta nails another trial, this time for relapse prevention in schizophrenia
  Fierce Pharma – November 5, 2024
  Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial. In a statistically significant showing, treatment with Caplyta led to a longer time to relapse than placebo in schizophrenia patients, Intra-Cellular said, citing top-line results from a phase 3 trial.  Caplyta showed a 63% reduction in the risk of relapse versus placebo during a 26-week double-blind treatment phase, according to the company. Eighteen relapses (a rate of 16.4%) occurred in the Caplyta group versus 44 incidents (38.6%) in the placebo group.