Carolyn Bertozzi Returns to Eli Lilly and Company Board of Directors 2025
oncodaily - Eli Lilly and Company has announced the election of Carolyn R. Bertozzi, Ph.D., as a returning member of its Board of Directors, effective December 8, 2025. In her renewed role, […]
AI Summary: Eli Lilly has announced the return of renowned scientist Carolyn Bertozzi to its Board of Directors. Her comeback underscores the company’s commitment to a research‐intensive strategy and reinforces its focus on cutting–edge oncology and other therapeutic innovations.
FDA approves 1st gene therapy for Wiskott-Aldrich syndrome
Ella Jeffries / beckershospitalreview - The FDA has approved Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskott-Aldrich syndrome, a rare and life-threatening immune disorder. Waskyra is indicated for pediatric patients 6 months and older, as well as adults with Wiskott-Aldri…
AI Summary: In a landmark decision, the FDA approved Waskyra – the first gene therapy for Wiskott‐Aldrich syndrome – offering new hope for patients with this rare and life‐threatening immune disorder. The agency’s flexible approach in handling rare disease treatments marks a turning point in precision medicine.
Zoliflodacin shows promise as single-dose treatment for gonorrhea
A Phase III trial has demonstrated that zoliflodacin – a single-dose oral antibiotic – is highly effective against drug‐resistant gonorrhea, offering an innovative solution to a mounting public health threat. The encouraging results suggest a potential game‐changer in the fight against antibiotic-resistant infections.
Adding Tucatinib to First-line Maintenance Therapy Delayed Disease Progression in HER2-positive Metastatic Breast Cancer in HER2CLIMB-05 Trial
Kathleen Medora / aacr - Benefit was seen across all subgroups, including in patients with brain metastasis SAN ANTONIO – Adding tucatinib (Tukysa) to first-line maintenance therapy with trastuzumab (Herceptin) and pertuzumab (Perjeta) delayed disease progression in patients with…
AI Summary: A phase III trial—part of the HER2CLIMB-05 study—showed that adding tucatinib to first‑line maintenance therapy with trastuzumab and pertuzumab significantly delayed disease progression in patients with HER2‑positive metastatic breast cancer, with benefits observed across key subgroups including those with brain metastases.
Sacituzumab govitecan-hziy led to similar progression-free survival as standard of care for some breast cancers: Trial
medicalxpress - Patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancers had similar progression-free survival (PFS) whether they were treated with sacituzumab govitecan-hziy (Trodelvy) or standard-of-care chemotherapy as the first treatment af…
AI Summary: Trial results indicate that patients with HR‑positive, HER2‑negative advanced breast cancers treated with sacituzumab govitecan‑hziy experienced similar progression‑free survival to those receiving standard care. Two reports from the same trial underlined these findings, reinforcing the therapy’s potential for endocrine therapy‑refractory tumors.
Novel Endocrine Therapy Giredestrant Improves Disease-free Survival Over Standard of Care for Patients With Early-stage Breast Cancer in Phase III lidERA Trial
Kathleen Medora / aacr - SAN ANTONIO – The investigational, oral selective estrogen receptor degrader (SERD) giredestrant given as an adjuvant therapy showed significant improvement in invasive disease-free survival (iDFS) compared with the current standard-of-care endocrine ther…
AI Summary: An international Phase III trial led by UCLA reveals that giredestrant, a novel endocrine therapy, significantly reduces recurrence risk in early‐stage breast cancer compared with standard care. The robust findings promise to shift hormonal treatment paradigms—even if skeptics may raise a wry eyebrow at yet “another” incremental advance in a crowded field.
CVS Health agrees to pay $37.8M to settle fraud allegations over insulin pens
fiercehealthcare - CVS Health agreed to pay $37.76 million to settle allegations that it dispensed too many insulin pens to patients and improperly billed federal healthcare programs for those prescriptions.
AI Summary: CVS Health has agreed to pay approximately $38 million to settle allegations that it improperly dispensed insulin pens and misbilled federal health programs, resolving accusations of fraudulent practices and restoring trust in its operations.
Startup Protego Bio Lands $130M for First-in-Class Drug’s Pivotal Test in Rare Plasma Disorder
Frank Vinluan / medcitynews - Protego Biopharma’s lead program is a potential treatment for the rare disease light chain amyloidosis. The startup says the novel mechanism of its oral small molecule should have better outcomes than antibodies from AstraZeneca and Prothena that failed t…
AI Summary: Two reports reveal that Protego Bio has raised $130M to fund pivotal clinical testing of its novel therapy for AL amyloidosis, a rare plasma disorder. This funding milestone, backed by industry leaders, marks a significant advance in treatment options for a challenging condition.
UK and US agree zero-tariff deal on pharmaceuticals
go - Officials say the U.K. has sealed a deal securing a 0% tariff rate for all U.K. medicines exported to the U.S. for at least 3 years, in return for the U.K. spending more on new medicines
AI Summary: In a twist worthy of a Hollywood trade drama, officials announced that the UK and US have struck a deal to impose zero tariffs on UK‐made medicines destined for the US. As part of the arrangement, the UK must shell out considerably more for drug pricing—a move set to avoid tariffs that could soar as high as 100%—with the agreement effective for at least three years.
FDA approves all ages gene therapy for spinal condition
Ella Jeffries / beckershospitalreview - The FDA approved Novartis’ Itvisma (onasemnogene abeparvovec-brve), the company’s first and only gene replacement therapy for spinal muscular atrophy in children 2 and older, as well as for teens and adults. The therapy is designed to address the genetic …
AI Summary: The FDA has given the green light to Novartis’ gene replacement therapy Itvisma for the treatment of spinal muscular atrophy, a development that extends its use to patients of all ages. The approval, which responds to long‐standing concerns over safety and patient eligibility, marks a significant milestone in SMA care.
Novo submits high-dose Wegovy for FDA approval using voucher
Max Bayer / endpoints - Novo Nordisk submitted a higher dose of its obesity drug Wegovy for FDA approval and is using a recently-won voucher to expedite the review. The company said Wednesday that it submitted ...
AI Summary: Novo Nordisk has formally submitted its application to the FDA to approve a higher-dose formulation of its flagship obesity drug, Wegovy. Leveraging a recently secured priority voucher, the filing is set to potentially expand treatment options for weight management as the review process begins.
CASSANDRA-PACT-21 Trial Update: Preoperative PAXG vs mFOLFIRINOX in Resectable and Borderline Resectable PDAC
oncodaily - The landscape of early-stage pancreatic ductal adenocarcinoma (PDAC) continues to evolve as clinicians move from surgery-first strategies toward perioperative treatment. Neoadjuvant and perioperative approaches have shown growing promise, yet no […]
AI Summary: New findings from the CASSANDRA study indicate that a neoadjuvant quadruplet PAXG regimen significantly improves event‐free survival versus traditional mFOLFIRINOX in patients with resectable or borderline resectable pancreatic ductal adenocarcinoma, suggesting a potential shift in treatment guidelines.
Novo Nordisk GLP-1 fails to slow Alzheimer’s in trials
Ella Jeffries / beckershospitalreview - Novo Nordisk’s GLP-1 drug semaglutide did not demonstrate a statistically significant effect in slowing progression of Alzheimer’s disease in two late-stage clinical trials. According to a Nov. 24 news release from the company, two double-blinded, placebo…
AI Summary: Novo Nordisk’s much‑talked‑about GLP‑1 drug, famed for its weight‐loss benefits, has hit an unexpected wall in Alzheimer’s trials. In two separate reports – one on the standard injectable and another on a pill form – semaglutide showed no statistically significant impact on slowing brain decline. Who knew obesity meds couldn’t multitask?
FDA Approves Pembrolizumab + Enfortumab Vedotin-ejfv for Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
oncodaily - What Does FDA Approval Mean? The U.S. Food and Drug Administration (FDA) evaluates new cancer therapies to determine whether they are safe and effective for clinical use. Approval is based […]
AI Summary: The U.S. Food and Drug Administration has approved a combination of pembrolizumab (Keytruda) and enfortumab vedotin (Padcev) for patients with muscle‐invasive bladder cancer who cannot tolerate cisplatin. Both agents—which have individually transformed treatment paradigms—are now linked in a perioperative setting that could alter outcomes for this aggressive cancer.
New nasal nanodrops wipe out brain tumors in mice
sciencedaily - A new nasal-delivered nanotherapy shows promise against aggressive glioblastoma tumors. By activating the STING immune pathway using gold-core spherical nucleic acids, researchers were able to reach the brain without invasive surgery. When paired with dru…
AI Summary: A novel nasal‐delivered nanotherapy that triggers the STING immune pathway via gold‐core nanoparticles has been shown in mice to nearly wipe out aggressive brain tumors. This noninvasive approach offers hope for a radically new treatment modality in glioblastoma.
FDA Approves Ziftomenib for Relapsed or Refractory Acute Myeloid Leukaemia with a NPM1 Mutation
esmo - Evidence for efficacy is based on the results from the KO-MEN-001 study
AI Summary: The FDA has granted full approval for ziftomenib—a novel agent aimed at treating relapsed or refractory acute myeloid leukemia, especially in patients with NPM1 mutations. Backed by the KO‐MEN‐001 trial data, this decision marks a significant step forward for a patient group in dire need of new therapeutic options.
Novo Nordisk rolls out lower prices for Ozempic and Wegovy
medicalxpress - People paying out of pocket for Ozempic or Wegovy may soon see lower costs, as Novo Nordisk rolls out new price discounts for its popular GLP-1 medications.
AI Summary: In a bid to ease the financial burden on self‐pay patients, Novo Nordisk has unveiled deep price cuts for its flagship GLP-1 drugs, Ozempic and Wegovy. The new pricing strategy comes amid intensifying market pressures and aims to broaden access to these critical therapies for weight management and type 2 diabetes.
Mikael Dolsten removes himself from board candidacy at Novo; Bavarian Nordic chairman resigns
Alex Hoffman / endpoints - → In what appears to be another blow to Novo Nordisk, ex-Pfizer CSO Mikael Dolsten has withdrawn his nomination to join the company's board of directors due to ...
AI Summary: Merck has made a blockbuster move by finalizing a $9.2 billion deal to acquire Cidara Therapeutics’ late‐stage anti‐influenza candidate. This acquisition underscores Merck’s commitment to expanding its antiviral portfolio and marks a key strategic investment in advancing flu prevention amid evolving global health threats.
F.D.A. Will Remove Black Box Warnings From Hormone Treatments for Menopause
Roni Caryn Rabin / nytimes - The benefits of hormone replacement have been underappreciated, Dr. Marty Makary, the agency’s commissioner, said on Monday. Critics described evidence for the change as insufficient.
AI Summary: In a bold policy pivot, the FDA will lift long‑standing black box warnings on hormone treatments for menopause. The decision – made without an official advisory committee’s input – updates labeling to better reflect current risk–benefit assessments, leaving critics to wonder if caution has finally given way to progress.
FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths
go - The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year
AI Summary: The FDA has revised the label for Sarepta’s Duchenne muscular dystrophy gene therapy, adding a boxed safety warning and stricter usage conditions following reports of two patient deaths. The update reflects mounting safety concerns that have prompted closer regulatory oversight.