• The FDA approved Novartis’s targeted therapy for certain early-stage breast cancers, significantly expanding the number of patients who will have access to this type of drug.
• Gilead Science’s new drug, lenacapavi, was found to be 96% effective in preventing HIV infections.
• UC Davis School of Medicine’s external research awards exceeded $1 billion for research on ultra-rare diseases and most common ones, like diabetes, cancer and heart disease.

Recent News

• UCB rapidly bolsters blockbuster potential for Bimzelx with 3 new FDA approvals
  Fierce Pharma – September 23, 2024
  Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease treatment. The FDA cleared Bimzelx to treat adults with active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS). The med is the first IL-17A/F inhibitor approved to treat the three indications, UCB noted in a press release. “In psoriatic arthritis and across the spectrum of axSpA, clinical study results and real-world experience outside the U.S. have highlighted that Bimzelx can help patients achieve high thresholds of clinical response that are rapid in onset and sustained up to two years,” the company’s chief commercial officer, Emmanual Caeymaex, said in the release.
• FDA designates devices for heart surgery, smart knee implant as ‘breakthroughs’
  STAT News – September 19, 2024
  The latest medical devices to receive breakthrough status from the Food and Drug Administration range across conditions, with several treating cardio and neurovascular conditions. The FDA’s breakthrough devices program is designed to speed the path to market for novel, potentially lifesaving products. It gives manufacturers better access to regulators and the ability to design more flexible clinical trials.
• GE HealthCare claims FDA clearance for amyloid imaging software in Alzheimer’s disease
  Fierce Biotech – September 18, 2024
  GE HealthCare’s recently acquired MIM Software division has secured an FDA clearance for a tool to help quantify the density of amyloid plaque in the brains of people with Alzheimer’s disease. The automated MIMneuro program analyzes PET images from any scanner boosted by injectable radioactive tracer agents with the goal of providing a standardized metric for one of the main facets of the condition’s pathology.
• FDA awards Novartis expanded approval for breast cancer therapy
  STAT News – September 17, 2024
  Kisqali, a key targeted therapy for breast cancer from Novartis, until now has been indicated only for patients with metastatic disease. But, the Food and Drug Administration approved Kisqali in combination with hormone therapy for patients with certain early-stage breast cancers, significantly expanding the number of patients who will have access to this type of drug.
• This preventive drug could be a ‘game changer’ in ending the HIV epidemic
  NPR – September 17, 2024
  Can we eliminate the HIV epidemic? It’s a question that dates back to the start of the epidemic in the 1980s. With 1.3 million new infections a year, the epidemic continues … and the world is not on track to meet the ambitious U.N. goal of ending HIV/AIDS by 2030. But now there’s rising optimism among leading infectious disease experts after the latest groundbreaking clinical trial results for a drug called lenacapavir which have shown it to be capable of virtually eliminating new HIV infections through sex.
• What to know about the vaccines available this respiratory virus season
  CNN Health – September 16, 2024
  Covid-19 levels in the United States are high and rising, flu season is approaching quickly, and RSV cases are already starting to tick up. Forecasts from the US Centers for Disease Control and Prevention suggest that this respiratory disease season will be similar to last year’s — which brought more than 20 hospitalizations for every 100,000 people in one week at its peak — and far worse than in pre-pandemic years. There’s a chance that the burden of disease could be lower, however, and vaccination rates will be a key factor in that trajectory.
• Lilly’s immunology unit scores another FDA nod with eczema treatment Ebglyss
  Fierce Pharma – September 16, 2024
  Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S. regulator has signed off on IL-13 inhibitor Ebglyss to treat atopic dermatitis (AD). The endorsement covers adults and patients between the ages of 12 and 18 who weigh at least 88 pounds. It is for those who have a moderate-to-severe form of the disease and don’t achieve an adequate response with prescription topical treatments.
• School of Medicine leads in external research funding for UC Davis
  UC Davis News – September 11, 2024
  In fiscal year 2023-24, UC Davis’ external research awards exceeded $1 billion, surpassing last year’s total by $33 million. The School of Medicine was once more the top recipient with $400 million, the highest among all UC Davis colleges. “For the third consecutive year, UC Davis has set the bar high for research funding,” said Chancellor Gary S. May. “This investment will empower our university to continue transformative research confronting the world’s most persistent challenges from climate change to child welfare, generating unprecedented opportunities for individuals both here in California and across the globe.”
• Novartis builds out radiopharma production with expansion, new factory
  Biopharma Dive – September 4, 2024
  Novartis is expanding a manufacturing site in Indianapolis and building a new plant in California in anticipation of growing demand for radiopharmaceutical therapies to treat cancer. The company said it has already broken ground on a new facility at its Indianapolis site, where Novartis plans to produce the radioisotopes that are a critical part of the therapies. The company received Food and Drug Administration approval to manufacture its Pluvicto treatment at its 70,000-square-foot site in Indianapolis. At the same time, Novartis is expanding to the West Coast with a new production site in Carlsbad, California.