Intratumoral Bacterial Burden Drives Immunotherapy Resistance in Head and Neck Cancer
oncodaily - Immune checkpoint blockade (ICB) benefits only a subset of patients with head and neck squamous cell carcinoma (HNSCC), and commonly used biomarkers (PD-L1, TMB) remain imperfect in this setting. This […]
AI Summary: Researchers reveal that an increased bacterial burden within head and neck tumors may undermine the efficacy of immune checkpoint blockade treatments. Detailed investigations indicate that intratumoral bacteria could be a pivotal factor in treatment resistance, opening new avenues for overcoming these challenges in managing advanced head and neck cancers.
Judge blocks 340B rebate pilot program
Ella Jeffries / beckershospitalreview - A federal judge granted a temporary restraining order blocking the Department of Health and Human Services from launching its 340B Rebate Model Pilot Program, which was scheduled to begin Jan. 1, 2026. U.S. District Judge Lance Walker of the District of M…
AI Summary: A federal judge has temporarily halted the rollout of a 340B rebate pilot program designed to reshape drug pricing ahead of its January start. The ruling challenges the current administration’s approach to reforming pricing models, casting uncertainty on the initiative’s future.
Advocates Applaud DEA’s Fourth Extension of Remote Prescribing Flexibilities
Marissa Plescia / medcitynews - The DEA extended telemedicine prescribing flexibilities for controlled substances through the end of 2026, drawing praise from telehealth advocates who are urging a permanent solution.The post Advocates Applaud DEA’s Fourth Extension of Remote Prescribing…
AI Summary: The Drug Enforcement Administration has extended telemedicine prescribing flexibilities for controlled substances through 2026, maintaining the COVID-era approach. Telehealth advocates are cheering the move as it cements remote care as a long-term fixture, even as regulators and critics continue debating its broader safety implications.
AstraZeneca bets up to $2B on Jacobio’s pan-KRAS inhibitor for cancer
Ayisha Sharma / endpoints - AstraZeneca is spending $100 million upfront to secure ex-China rights for an early-stage cancer drug developed by Jacobio Pharma. The UK drugmaker will be responsible for advancing and selling the oral pan-KRAS inhibitor, JAB-23E73, in ...
AI Summary: Reports indicate that AstraZeneca has struck a global licensing agreement with Jacobio Pharma for its investigational pan‑KRAS inhibitor. With a deal value of up to $2 billion and an upfront commitment, the move is set to reinforce AstraZeneca’s oncology pipeline with next‑generation targeted therapy.
Sanofi buys hepatitis B vaccine maker Dynavax for $2.2B; gets CRL for MS drug
Elizabeth Cairns / endpoints - Sanofi is set to supplement its vaccine offering with the acquisition of Dynavax Technologies for $2.2 billion in cash, the companies said Wednesday. Separately, Sanofi said the ...
AI Summary: Two separate reports confirm that Sanofi has completed a $2.2 billion deal to acquire Dynavax Technologies. This strategic move strengthens Sanofi’s vaccine lineup by adding a commercially proven hepatitis B vaccine and a clinical‐stage shingles candidate, positioning the company for enhanced market competitiveness amid global pressures.
Novo Nordisk’s Wegovy Pill Becomes First FDA-Approved Oral GLP-1 Drug for Weight Loss
Frank Vinluan / medcitynews - Beyond weight reduction and long-term maintenance of weight loss, the FDA decision for oral Wegovy covers use of the once-daily pill for reducing the risk of major cardiovascular events. Novo Nordisk expects the Wegovy tablet will launch in early January.…
AI Summary: The FDA has given its nod to Novo Nordisk’s oral GLP‑1 receptor agonist for chronic weight management – a historic first for an anti‑obesity pill. The approval offers patients a non‑injectable alternative, potentially transforming obesity care in a market hungry for innovation.
FDA Approved Rucaparib for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
oncodaily - On December 17, 2025, the FDA issued a regular approval for rucaparib (Rubraca®), marking the formal conversion of its earlier accelerated authorization into full approval for BRCA-mutated metastatic castration-resistant prostate […]
AI Summary: The FDA has granted full approval to rucaparib (Rubraca®) for treating adults with BRCA‐mutated metastatic castration‐resistant prostate cancer, converting its prior accelerated approval into standard approval. This landmark decision offers a new treatment option for patients with this genetic profile.
FDA Removes Key Limitation on the Use of Real-World Evidence in Regulatory Reviews
oncodaily - On December 15, 2025, the U.S. Food and Drug Administration (FDA) announced a significant update to its regulatory approach regarding the use of real-world evidence (RWE) in drug and medical […]
AI Summary: The FDA has dramatically loosened its long‐standing limitations on the use of real‐world evidence in regulatory reviews, signaling an era where big data may facilitate quicker approvals for innovative drugs. Officials are also urging early-phase trials reform to better capture real‐world outcomes.
Optum Rx: 100% of network community pharmacies shift to cost-based model
fiercehealthcare - Earlier this year, Optum Rx announced that it would shift to a cost-based model, which would boost reimbursements for brand-name drugs at community pharmacies.
AI Summary: In a significant payment model overhaul, Optum Rx has moved 100% of its community and independent pharmacies to a cost‐based model, a change aimed at aligning reimbursements with actual expenses and enhancing pharmacy viability in a challenging market.
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.