Innovations and Impacts
🧬The Latest Life Science Innovations Changing Patients Lives | October 30, 2024
October 30, 2024

The California Biotechnology Foundation is committed to keeping you up to date about the latest breakthroughs in biotech treatments and the impact of one of California’s largest industries in the state and beyond. This newsletter edition, as of October 30, 2024, brings you updates directly from the forefront of medical innovation. Among the notable advancements featured are:
- The FDA has expanded approval of Pfizer’s RSV vaccine to include adults aged 18-59 at risk, broadening RSV protection in the U.S.
- Novocure’s new electric field device, Optune Lua, received FDA approval to treat non-small cell lung cancer.
- The FDA has approved Healgen’s ‘Rapid Check’ at-home test for COVID-19 and flu detection, marking a first for over-the-counter testing with full regulatory clearance ahead of flu season.
Recent News
- Ozempic linked to lower risk of Alzheimer’s diagnosis in observational study
Stat News – October 24, 2024
Novo Nordisk’s drug Ozempic was linked to a lower risk of getting diagnosed with Alzheimer’s among people with type 2 diabetes, an analysis of medical records found, supporting the case for further research of the blockbuster GLP-1 drug in neurodegenerative diseases. Among the over 1 million people with diabetes whose records were included in the study, the overall risk of developing Alzheimer’s was already very low. But researchers found that semaglutide, the scientific name of Ozempic, was associated with a 40% to 70% lower risk of an Alzheimer’s diagnosis over three years compared with other diabetes treatments such as insulin, metformin, SGLT2 inhibitors, and older GLP-1 drugs. - Pfizer’s RSV vaccine cleared by FDA for use in some younger adults
Biopharma Dive – October 23, 2024
The Food and Drug Administration expanded the approval of Pfizer’s RSV vaccine Abrysvo to include adults aged 18 to 59 years who are at an increased risk of disease from respiratory syncytial virus. The vaccine was previously cleared in adults aged 60 years and older, as well as in pregnant women who are between 32- and 36-weeks gestation. With the latest expansion granted by the FDA, Pfizer claims its vaccine now holds the “broadest” indication for adults. In June, the Centers for Disease Control and Prevention tightened its guidance for RSV vaccination in older adults and delayed making recommendations for adults younger than 60. - FDA grants de novo clearance to airway stent covered with human tissue
Fierce Biotech – October 22, 2024
The FDA has granted a de novo clearance to a new type of stent designed to hold open the passages down the windpipe and into the lungs, among patients that may have their airways pinched and blocked by growing cancers. Peytant Solutions’ minimally invasive AMStent system includes a metal frame encased in a material sourced from human amnion, the pliable membrane that helps form the amniotic sac. Processed amnion has been used in several medical specialties for years, including in the treatment of chronic wounds, burns and skin ulcers. - Oral version of Novo diabetes drug protects heart health in large study
Biopharma – October 21, 2024
Novo Nordisk’s diabetes pill Rybelsus cut the risk of heart attacks, strokes and cardiovascular death by 14% in a Phase 3 trial of people with diabetes and established heart or kidney disease, the company said. The study, called SOUL, tested Rybelsus against a placebo in trial participants already receiving standard medications. Novo intends to ask the Food and Drug Administration around the end of 2024 to approve the medication to protect the heart health of people with diabetes. Should the FDA agree, Novo’s pill would join diabetes medicines like Boehringer Ingelheim and Eli Lilly’s Jardiance and AstraZeneca’s Farxiga, which are proven to have similar benefits. - US FDA expands use of Avadel’s sleep disorder drug to ages 7 and up
Reuters – October 17, 2024
The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals’ sleep disorder drug for children aged 7 years and older, broadening its use and heating up competition for popular treatments from Jazz Pharmaceuticals. Avadel said the drug, called Lumryz, was now approved to treat pediatric patients with sudden muscle weakness called cataplexy or for excessive daytime sleepiness (EDS), both symptoms of narcolepsy. It was approved for adults in 2023. Narcolepsy is a chronic neurological disorder that impacts the brain’s ability to regulate sleep and wake cycles, with 70% of patients also experiencing cataplexy. - 3rd time’s the charm: AbbVie scores FDA nod for continuous Parkinson’s disease therapy Vyalev
FiercePharma – October 17, 2024
AbbVie made history in 2015 with its Parkinson’s disease infusion pump therapy Duopa, kicking off a trend of delivery system innovation in the space as drugmakers sought to avoid the common pitfalls associated with oral treatments. Now, after multiple delays, the Illinois pharma giant has a new offering on the table as it has scored FDA approval for its more convenient, subcutaneous follow-up Vyalev. Vyalev, previously known as ABBV-951, features foscarbidopa and foslevodopa, which are the prodrugs for standard-of-care medicines carbidopa and levodopa. Prodrugs are drug derivatives that become active after entering the body. The therapy is delivered as a 24-hour continuous infusion to treat motor fluctuations in adults with advanced Parkinson’s. AbbVie already markets a carbidopa and levodopa combination with Duopa. - Novocure wins FDA approval for electric field device in lung cancer
Biopharma Dive – October 16, 2024
The Food and Drug Administration approved a new device to treat non-small cell lung cancer, Novocure’s Optune Lua, which creates electric fields that its manufacturer says disrupts malignant cell division. The FDA cleared the device for use with immunotherapy or chemotherapy in people whose cancer has spread and progressed following chemo. Approval was based on results from “Lunar,” a Phase 3 trial in which people who used the device with standard therapies had a 26% reduced risk of death over a median follow up of around 10 months. - Pfizer drug for hemophilia approved by FDA
Biopharma Dive – October 14, 2024
The Food and Drug Administration approved a new kind of medicine for hemophilia, clearing Pfizer’s Hympavzi for people with either the “A” or “B” forms of the inherited bleeding condition. Adults and children 12 years of age or older who haven’t developed proteins, or “inhibitors,” that prevent clotting drugs from working well are eligible to receive Hympavzi, the FDA said. The drug is taken once per week via an under-the-skin injection. Typically, medicines for hemophilia replace the blood clotting factor that people with the disease lack. By contrast, Hympavzi works by reducing activity of an anticoagulatory protein called tissue factor pathway inhibitor, or TFPI. This increases enzymes that help blood clump together, which in turn can prevent bleeding from occurring. - Adaptive deep brain stimulation trial results poised to “transform” Parkinson’s disease
Clinical Trials Arena – October 10, 2024
A new type of self-adjusting neuromodulation is poised to transform the landscape of neurology, as per analyst reaction to results from two studies evaluating the technology. The pair of studies, conducted at University of California, San Francisco (UCSF), tested what it calls ‘intelligent brain pacemakers’ – an implant that uses an approach called adaptive brain stimulation (aDBS). This method involves using artificial intelligence (AI) to spot changes in patient symptoms via brain activity monitoring and then delivering personalized care. “As the landscape of medical treatment evolves, particularly with these sophisticated systems, a promising shift is being witnessed towards more personalized and effective treatment strategies for neurological conditions,” Says GlobalData medical device analyst Cynthia Stinchcombe. - FDA clears at-home COVID/flu combo test with eye on fall seaso
Fierce Biotech – October 8, 2024
The FDA has given a green light to an at-home test that checks for both COVID-19 and the flu—a first for the agency, outside of the additional authorities that it received during the coronavirus pandemic. Previous over-the-counter combination tests had been granted Emergency Use Authorizations. The Rapid Check test from Healgen received a de novo clearance through the FDA’s traditional product review pathways, allowing its use without a prescription—marking a milestone in OTC tests for influenza, as well. The antigen test was brought up through the National Institutes of Health’s Independent Test Assessment Program, part of the pandemic-era Rapid Acceleration of Diagnostics initiative known as RADx. The 15-minute nasal swab screener detects the bug behind COVID-19 as well as influenza A and B. - GSK says RSV vaccine protects against disease over three seasons
Biopharma Dive – October 8, 2024
Vaccine maker GSK unveiled new data showing its respiratory syncytial virus vaccine Arexvy protected older adults over three seasons against disease caused by infection. Across the entire time period, one dose of Arexvy was 63% effective against RSV broadly, and 67% effective against severe disease, GSK said. However, the shot’s efficacy waned, falling to an estimated 48% in the third season alone. Currently, the Centers for Disease Control and Prevention doesn’t recommend a second RSV vaccine dose. While GSK described the three-season data as evidence of the shot’s “significant health impact,” it said that “over time, revaccination is expected to be required to maintain an optimal level of protection.” - Exact Sciences wins FDA approval for improved stool-based colon cancer test
Stat News – October 4, 2024
Exact Sciences won Food and Drug Administration approval for an improved version of a stool-based screening test for colon cancer that should result in fewer cancer-free patients receiving unnecessary follow-up colonoscopies. The FDA approved the test, Cologuard Plus, for adults 45 and up with an average risk of cancer based on results from a large clinical trial, dubbed Blue-C, which recruited more than 20,000 participants. Earlier this year, Exact reported in the New England Journal of Medicine that the new test detected 94% of cancers and 43% of advanced precancers, abnormal cell growths that often precede disease. The company also reported that Cologuard Plus correctly returned a negative result in 91% of participants who didn’t have colon cancer or advanced precancer, a test feature known as specificity.
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