• The U.S. FDA recently approved updated COVID-19 vaccines from Moderna and Pfizer/BioNTech to combat the latest variants.
• UC San Diego recently opened the Goeddel Family Technology Sandbox, a cutting-edge facility that will serve as a hub for partnerships with the life sciences industry.
• UCLA Health launched a first-of-its-kind clinical trial to evaluate a cancer vaccine targeting a highly aggressive brain tumor, typically found in adolescents and young adults.

Recent News

• FDA signs off on updated COVID-19 vaccines from Moderna and Pfizer/BioNTech
  CNN – August 22, 2024
  As a summer wave of COVID-19 continues to hit the United States, the US Food and Drug Administration signed off on updated COVID-19 vaccines from Moderna and Pfizer/BioNTech. Moderna and Pfizer said updated mRNA shots will be available in pharmacies and clinics in the days ahead. “Vaccination continues to be the cornerstone of COVID-19 prevention,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
• In launching epinephrine nasal spray, ARS Pharma has a ‘blue sky opportunity,’ analyst says
  Fierce Pharma—August 21, 2024
  Gaining FDA approval for its epinephrine nasal spray came nearly a year later than expected for ARS Pharmaceuticals. But after the recent approval of neffy, the San Diego drugmaker is poised for an October launch and a “blue sky opportunity,” according to analysts at Leerink Partners. By offering a needle-free alternative, ARS has a chance to gain users among the 13.5 million in the United States who have been diagnosed with type 1 allergic reactions and who do not have current epinephrine prescriptions, according to a Leerink note. Another potential group of users is the 3.3 million patients who have let their prescriptions lapse over the last three years.
• Lilly’s Zepbound slashed risk of developing diabetes
  STAT—August 20, 2024
  Eli Lilly’s obesity drug Zepbound significantly cut the risk of developing type 2 diabetes, showing the benefits of long-term use of the blockbuster therapy. In a Phase 3 trial that lasted over three years, people with pre-diabetes taking Zepbound had a 93% lower risk of progressing to diabetes compared with people on placebo, Lilly said. The company did not report absolute risk rates. The new results add to the body of data showing that continued use of the class of GLP-1 obesity drugs can help prevent other health problems.
• J&J drug combo for lung cancer approved by FDA
  Biopharma Dive—August 20, 2024
  A new FDA approval has vaulted a Johnson & Johnson lung cancer drug combination into a key territory already dominated by AstraZeneca’s Tagrisso. The J&J combination contains Rybrevant and a new drug called Lazcluze, or lazertinib. J&J said the FDA has approved the regimen for newly diagnosed non-small cell lung cancer patients with one of the two common EGFR mutations at exon 19 or exon 21. J&J has high hopes for the lung cancer combination, having put its peak sales potential at above $5 billion.
• The Long Road to the Sandbox: An Unlikely Journey to a World-Class Technology Hub
  UC San Diego Today—August 19, 2024
  When the Goeddel Family Technology Sandbox opens its doors on the UC San Diego campus, the cutting-edge facility will immediately take its place as a unique world-class resource for science, education and training. A gathering point for top-flight scientific instruments, the Technology Sandbox also is a nexus for partnerships with the life sciences industry, including Thermo Fisher Scientific and Nikon Instruments. The inaugural faculty member charged with leading the new facility comes to UC San Diego with an extraordinary background. School of Biological Sciences Assistant Professor Uri Manor’s journey to the Goeddel Family Technology Sandbox is a winding path filled with challenges, including a hearing disability that sometimes led to bullying, social neglect and educational hurdles. Now he has flipped the script. It’s his turn to invite others to join him in the Sandbox to play with science’s most advanced “toys.”
• FDA clears its first at-home blood test for syphilis
  Fierce Biotech—August 16, 2024
  The FDA granted a green light to its first at-home, over-the-counter test to detect a person’s exposure to syphilis, offering a private option to help detect the sexually transmitted infection. Developed by NOWDiagnostics, the First To Know rapid test captures antibodies in the bloodstream that can be linked to the bacteria behind the disease, delivering a result within about 15 minutes using a drop of blood from a fingerstick. The FDA’s de novo clearance follows up on the authorization of its first mail-in test for home-collected samples to screen for chlamydia and gonorrhea—the agency’s first at-home diagnostic kit for a sexually transmitted infection other than HIV.
• Gilead wins U.S. approval for drug to treat autoimmune liver disease
  STAT—August 14, 2024
  The Food and Drug Administration approved a new treatment for primary biliary cholangitis, an autoimmune liver disease mainly affecting women that causes decreased liver function, debilitating itching, and fatigue. The drug, called Livdelzi, will be sold by Gilead Sciences, following the $4.3 billion acquisition of its developer, CymaBay Therapeutics. Regulators cleared Livdelzi for patients with primary biliary cholangitis, or PBC, that doesn’t respond adequately to initial treatment with a commonly used medicine.
• Could This New Drug Turn Back the Clock on Multiple Sclerosis
  UC San Francisco—August 6, 2024
  Multiple sclerosis (MS) degrades the protective insulation around nerve cells, leaving their axons, which carry electrical impulses, exposed like bare wires. This can cause devastating problems with movement, balance and vision; and without treatment, it can lead to paralysis, loss of independence and a shortened lifespan. Now, scientists at UC San Francisco and Contineum Therapeutics have developed a drug that spurs the body to replace the lost insulation, which is called myelin. If it works in people, it could be a way to reverse the damage caused by the disease. The new therapy, called PIPE-307, targets an elusive receptor on certain cells in the brain that prompts them to mature into myelin-producing oligodendrocytes. Once the receptor is blocked, the oligodendrocytes spring into action, wrapping themselves around the axons to form a new myelin sheath.
• UCLA Health launches clinical trial using personalized cancer vaccine to tackle aggressive brain tumors in adolescents and young adults
  UCLA Health—August 5, 2024
  In an effort to combat one of the most lethal forms of pediatric brain cancer, researchers at the UCLA Health Jonsson Comprehensive Cancer Centerare launching a first-of-its-kind clinical trial to evaluate the safety and effectiveness of a cancer vaccine targeting H3 G34-mutant diffuse hemispheric glioma, a highly aggressive brain tumor that is typically found in adolescents and young adults. This type of brain tumor is primarily characterized by a particular mutation of the H3-3A gene, which encodes an important regulatory component on histone H3.
• FDA signs off on Adaptimmune’s Tecelra as the first engineered cell therapy for a solid tumor
  Fierce Pharma—August 2, 2024
  Adaptimmune has won accelerated FDA approval for Tecelra (afami-cel), a treatment for metastatic or unresectable synovial sarcoma. Tecelra’s approval comes with several firsts. It’s the first engineered cell therapy for a solid tumor, the first TCR-T therapy to enter the market, and the first new treatment in the indication in more than a decade. It also is the initial approval for the 16-year-old company, which has attracted and lost partnerships with several pharma giants—including GSK, Astellas and most recently Roche—who were drawn to the potential of Adaptimmune’s unique engineered T-cell receptor (TCR) platform.