F.D.A. Decisions on Abortion Pill Were Based on Science, New Analysis Finds
Pam Belluck / nytimes - A study of more than 5,000 pages of agency documents on mifepristone over 12 years found that agency leaders almost always followed the evidence-based recommendations of scientists.
AI Summary: New in‑depth analyses of internal FDA documents reveal that regulatory decisions on the abortion pill mifepristone were firmly based on thorough evidence rather than political pressure, dispelling common misconceptions about politicized review processes.
#JPM26: Day 1 at the JP Morgan Healthcare Conference
ENDPOINTS / endpoints - It’s day 1 at the JP Morgan Healthcare Conference, and the mood heading into the week is one of cautious optimism. Biotech fundraising was off to a hot start in 2026. There ...
AI Summary: At the 2026 JP Morgan Healthcare Conference, several industry leaders showcased cutting‐edge sessions. Presentations covered AI enhancements in EHRs, real‑time prior authorization solutions, and strategic partnerships from major players including Moderna, Elation Health, and CommonSpirit, reflecting finance–tech convergence in healthcare innovation.
No Link Between Acetaminophen in Pregnancy and Autism, a New Study Finds
Azeen Ghorayshi / nytimes - The review looked at more than three dozen studies and found no evidence that acetaminophen increased the risk of neurodevelopmental disorders in children.
AI Summary: A new comprehensive review of more than three dozen studies found no evidence that taking acetaminophen during pregnancy increases the risk of neurodevelopmental disorders such as autism, ADHD or intellectual disabilities. Despite lingering public anxiety and the occasional skeptical quip, expectant mothers can take a breath of relief.
Life-extending prostate cancer drug to be offered to thousands in England
bbc - Abiraterone will be available in a matter of weeks and will be offered to 7,000 men a year.
AI Summary: Health authorities in England have announced that nearly 7,000 additional men with hormone‐sensitive prostate cancer will soon be eligible for abiraterone—a breakthrough treatment that extends survival. The drug is expected to be available within weeks, marking a significant step forward in targeted prostate cancer care.
FDA rejects cancer therapy for rare post-transplant disease
Ella Jeffries / beckershospitalreview - Atara Biotherapeutics received a second complete response letter from the FDA for its biologics license application for Ebvallo (tabelecleucel). The letter, received Jan. 9, said the FDA no longer considers the single-arm ALLELE trial adequate to support …
AI Summary: The FDA has again rejected Atara’s cell therapy aimed at treating rare post‐transplant complications linked to Epstein–Barr virus. Despite high hopes for this innovative approach, regulatory concerns remain over its safety and efficacy—clearly a “repeat performance” in the world of breakthrough therapies.
Compounding pharmacy sues Eli Lilly, Novo Nordisk over GLP-1 access
Ella Jeffries / beckershospitalreview - Strive Compounding Pharmacy filed a federal antitrust lawsuit Jan. 14 against Eli Lilly and Novo Nordisk, alleging the two drugmakers used their market power to restrict access to compounded GLP-1 medications and suppress competition. The lawsuit, filed i…
AI Summary: A compounding pharmacy has taken legal aim at industry giants Eli Lilly and Novo Nordisk, alleging an anti‑competitive scheme designed to restrict access to their blockbuster GLP‑1 therapies. The lawsuit puts the pharmaceutical titans on the defensive as antitrust concerns mix with therapeutic access debates.
NVIDIA and Eli Lilly Launch $1B AI Co-Innovation Lab to Reinvent Drug Discovery
oncodaily - Dave Ricks, Chair, CEO at Eli Lilly and Company, shared Eli Lilly and Company‘s post on LinkedIn, adding: “Exciting news from the JPMorgan Healthcare Conference: Lilly and NVIDIA are joining […]
AI Summary: Eli Lilly and Nvidia have teamed up to invest up to $1 billion in a brand‑new AI lab aimed at reinventing drug discovery. This collaborative venture promises to streamline R&D with cutting‑edge artificial intelligence while hinting that pharma’s reliance on tech is evolving – and it’s not all sci‑fi smoke and mirrors.
FDA moves to remove suicide warnings from GLP-1 weight loss drugs
medicalxpress - Federal health regulators say popular weight loss drugs like Wegovy and Zepbound do not increase the risk of suicidal thoughts, and they have asked drugmakers to remove those warnings from medication labels.
AI Summary: In a surprising twist, the FDA has decided that the long‐rumored risk of suicidal ideation on popular GLP‑1 weight‐loss drugs may have been overblown. Regulators have now asked drugmakers – including Lilly and Novo Nordisk – to scrub these warnings from product labels, a move that is sure to spark both relief and raised eyebrows among critics.
Merck Could Strike 30 Billion Deal for Revolution Medicines
oncodaily - According to the Financial Times, Merck is in talks to acquire Revolution Medicines, a Redwood City, California-based cancer drug developer, in a deal that could value the company at roughly […]
AI Summary: Merck is reportedly in advanced talks to acquire Revolution Medicines—a Redwood City–based cancer drug developer—in a deal that could be worth around $30 billion. A separate report adds speculative color, reinforcing market buzz about this strategic move in oncology.
Aktis Has First Biotech IPO of 2026, Raising $318M to Expand the Reach of Radiopharmaceuticals
Frank Vinluan / medcitynews - Aktis Oncology’s IPO will support a pipeline of “miniprotein” radioconjugates that could offer advantages over other targeted radiation cancer treatments. In addition to its internal pipeline, Aktis has a discovery partnership with Eli Lilly. The post Akt…
AI Summary: Aktis Oncology’s debut on the public market raised $318M, buoyed by a 25% first‐day bounce. The IPO not only generated strong investor enthusiasm for biotech in 2026 but also signals the company’s ambitious plans to extend its portfolio of innovative miniprotein radioconjugates for targeted cancer therapy.
FDA rejects Corcept’s cortisol-targeting drug for Cushing’s syndrome
Ayisha Sharma / endpoints - Corcept Therapeutics failed to secure US approval for its drug candidate as a hormonal disorder treatment. The FDA rejected Corcept’s selective cortisol modulator relacorilant for Cushing’s syndrome, according to a company
AI Summary: Corcept Therapeutics has hit a regulatory roadblock as the FDA rejected its cortisol‐targeting relacorilant, intended for hormonal disorders. The decision forces the company to reassess its strategy, highlighting the challenges inherent in advancing novel hormonal therapies amid strict regulatory scrutiny.
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.