FDA flags misleading claims for cancer drug by biotech billionaire Patrick Soon-Shiong
abcnews - Federal health officials have issued a warning about controversial statements made by biotech billionaire Dr. Patrick Soon-Shiong about one of his company's cancer drugs
AI Summary: The FDA issued warnings over promotional materials and public statements related to a cancer drug associated with a biotech entrepreneur, finding claims that could mislead patients and investors. The agency asked the company to correct materials and refrain from unsubstantiated efficacy or safety assertions while oversight and compliance reviews continue.
FDA Approval for Denali Therapeutics Blazes a New Trail for Brain-Penetrating Drugs
Frank Vinluan / medcitynews - Denali Therapeutics’ Avlayah received FDA approval for treating Hunter syndrome, a rare neurological disorder. The biologic medicine uses Denali’s proprietary drug delivery technology to cross the protective blood-brain barrier. The post FDA Approval for …
AI Summary: Regulators granted Denali accelerated approval for a brain‑penetrant therapy, recognizing promising early efficacy in a rare neurological indication and addressing unmet needs in CNS drug delivery. The pathway requires confirmatory trials to verify clinical benefit while enabling earlier patient access to a novel mechanism targeting central nervous system disease.
FDA approves 1st weekly basal insulin for Type 2 diabetes
Ella Jeffries / beckershospitalreview - The FDA has approved Novo Nordisk’s Awiqli (insulin icodec-abae), making it the first once-weekly basal insulin available in the U.S. for adults with Type 2 diabetes. Awiqli is indicated as an adjunct to diet and exercise and is intended to reduce injecti…
AI Summary: The FDA approved the first once‑weekly basal insulin for adults with Type 2 diabetes, providing an alternative to daily injections and aiming to improve adherence and glycemic control. Regulators based the decision on trials showing comparable efficacy and safety to daily basal insulins, potentially reshaping diabetes management.
FDA approves Rocket's gene therapy for ultra-rare immune disease
Lei Lei Wu / endpoints - A rare disease gene therapy from Rocket Pharmaceuticals has garnered FDA approval after an earlier rejection for manufacturing problems. The FDA on Thursday granted accelerated approval to Rocket Pharma’s gene therapy ...
AI Summary: The FDA granted approval to Rocket’s gene therapy for a pediatric immune disorder, marking the first regulatory ok for this specific treatment class in children and offering a one‑time corrective option for affected patients. The decision opens access while raising expectations for long‑term follow‑up and real‑world safety monitoring.
Merck’s $6.7B Terns Acquisition Positions It to Challenge a Blockbuster Novartis Cancer Drug
Frank Vinluan / medcitynews - Merck has been acquiring assets that could help make up for the coming revenue decline as its top product, the cancer drug Keytruda, drops off the patent cliff. Terns Pharmaceuticals’ lead product candidate, in development for treating a type of leukemia,…
AI Summary: Merck announced a definitive deal to acquire Terns Pharmaceuticals for about $6.7 billion, gaining a promising leukemia drug candidate and bolstering its oncology pipeline. The transaction aims to combine Merck’s late‑stage development and commercialization capabilities with Terns’ targeted therapy assets to compete in hematologic malignancies.
Pfizer Lyme vaccine candidate heads to FDA
Ella Jeffries / beckershospitalreview - Pfizer and Valneva’s investigational Lyme disease vaccine candidate, PF-07307405 (LB6V), demonstrated more than 70% efficacy in preventing Lyme disease among individuals age 5 and older, according to topline phase 3 trial results. The prespecified analysi…
AI Summary: Pfizer is advancing a Lyme disease vaccine toward FDA submission despite a messy late‑stage picture: efficacy signals above 70% were reported while a pivotal trial missed its primary endpoint and struggled with low case numbers. Regulators must weigh public health need against statistical nuance as the company pushes for licensure.
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
Ayisha Sharma / endpoints - Novartis has budgeted $2 billion upfront to buy a more selective PI3Kα inhibitor for breast cancer. The Swiss pharma already has Piqray with a similar target, but drugmakers are now entering the next-generation era as ...
AI Summary: Novartis agreed to pay $2 billion upfront to acquire Synnovation’s mutant‑selective PI3Kα inhibitor, a bet to revive and strengthen PI3K‑targeting combination strategies in breast cancer. The deal swaps in external innovation for internal development speed, shoring up the company’s oncology pipeline while quietly admitting buying is sometimes faster than building.
TerraPower Isotopes Invests $450M in Actinium-225 Production Facility
oncodaily - TerraPower Isotopes (TPI), the Bill Gates-founded nuclear science company, unveiled plans on March 17, 2026 to invest $450 million in a state-of-the-art actinium-225 (Ac-225) manufacturing facility in Philadelphia’s Bellwether District. The 250,000-square…
AI Summary: TerraPower announced a $450 million investment to construct a commercial Actinium‑225 production facility to supply alpha‑emitting radioisotopes for targeted cancer therapies. The plan tackles chronic supply shortages, strengthens domestic radiopharmaceutical capacity and positions the company at the center of growing demand for targeted‑alpha therapeutics — and yes, investors are watching.
This common vaccine cuts heart risk nearly in half in new study
sciencedaily - A shingles vaccine might double as a powerful heart protector. In people already at high risk, it cut major cardiac events by 46% and deaths by an impressive 66% within a year. Scientists think preventing shingles may also stop clot-related complications …
AI Summary: New research finds that receipt of a common shingles vaccine is associated with roughly a 50% reduction in serious cardiac events in the studied population. Investigators propose immune‑modulating mechanisms may underlie the protective effect; if confirmed, the vaccine could offer a tidy twofer—preventing shingles and cutting heart risk—proof that prevention sometimes moonlights as cardiology.
Updated: Lilly’s triple-G comparable with Mounjaro, first Phase 3 diabetes data suggest
Elizabeth Cairns / endpoints - Eli Lilly’s so-called triple-G reduced blood sugar levels in patients with type 2 diabetes by up to 1.9% in a late-stage trial — a similar margin as Mounjaro achieved in its pivotal diabetes study. The triple-G ...
AI Summary: Eli Lilly’s third‑generation GLP‑1 candidate reported Phase 3 data demonstrating significant weight loss and A1C reductions, with efficacy appearing comparable to existing therapies like Mounjaro. The results sharpen competition in the GLP‑1 market and raise questions about pricing, access and who gets first dibs on the next blockbuster injection.
- At clinics: GLP‑1 demand reshaping access, care and pricing (5)
- In labs: oral pills and novel GLP‑1 delivery approaches (4)
- On the ground: Lilly's triple‑G rivaling Mounjaro in trials (3)
- Other: clinical oddities, surgical implications and pipeline setbacks (5)
At clinics: GLP‑1 demand reshaping access, care and pricing
In labs: oral pills and novel GLP‑1 delivery approaches
On the ground: Lilly's triple‑G rivaling Mounjaro in trials
Other: clinical oddities, surgical implications and pipeline setbacks
‘Lack of Substantial Evidence’ Leads to FDA Rejection of Aldeyra Dry Eye Disease Drug
Frank Vinluan / medcitynews - Aldeyra said the FDA did not ask for another clinical trial for reproxalap in dry eye disease, but the drug’s mixed record in clinical testing warrants exploration about the reasons for failure, which could identify the appropriate patients for the eye dr…
AI Summary: The FDA has rejected Aldeyra’s reproxalap application, citing a lack of substantial evidence—marking the company’s third setback. Regulators did not demand a fresh, large trial but flagged inconsistent results, prompting investor angst and a slide in the stock. The decision underscores the gap between hopeful early data and regulatory standards.
Neoadjuvant GOLP Prolongs EFS Among Patients with Resectable High-Risk Intrahepatic Cholangiocarcinoma
esmo - Findings from the ZSAB-neoGOLP study
AI Summary: The ZSAB‑neoGOLP trial shows that giving a four‑drug neoadjuvant regimen—gemcitabine, oxaliplatin, lenvatinib and toripalimab—before surgery prolongs event‑free survival for patients with resectable, high‑risk intrahepatic cholangiocarcinoma. The finding suggests preoperative systemic therapy can downstage aggressive tumors and delay recurrence, potentially changing treatment sequencing for this challenging disease.
NRG-LU005 Trial: Atezolizumab Plus Chemoradiotherapy in Limited-Stage Small Cell Lung Cancer
oncodaily - A major international clinical trial, NRG-LU005, has provided important new insight into how immunotherapy should be used in limited-stage small cell lung cancer (SCLC). While immune checkpoint inhibitors have significantly […]
AI Summary: A major international trial tested whether adding the PD‑L1 inhibitor atezolizumab to concurrent chemoradiotherapy for limited‑stage small‑cell lung cancer would boost outcomes. The study found no significant survival benefit, prompting clinicians to rethink the timing and role of immune checkpoint blockade in curative‑intent SCLC rather than assuming more drugs always means better results.
FDA Drug Approval Marks a First for a Disease — But It’s Not Autism
Frank Vinluan / medcitynews - Leucovorin is now approved for cerebral folate deficiency months after FDA Commissioner Marty Makary claimed the decades-old generic drug had promise for treating autism. The FDA’s review was based on published literature and real-world evidence.The post …
AI Summary: The FDA has granted traditional approval to leucovorin for cerebral folate deficiency, formalizing a decades‑old generic’s role in a rare metabolic disorder. The decision comes amid earlier agency notes that evidence for autism benefit was weak and debate over expanding use without fresh trial data — cue the policy hot takes.
A new triple negative breast cancer target: Why HORMAD1 could guide treatment choices
medicalxpress - A gene that is typically active only in reproductive cells may hold the key to new treatments for triple negative breast cancer, according to new research published in the journal Nature Communications. Scientists from the Breast Cancer Now Toby Robins Re…
AI Summary: Researchers have identified HORMAD1, a normally reproductive‑cell gene, as a vulnerability in some triple‑negative breast cancers. Preclinical work suggests exploiting this target could guide patient selection and novel therapies, opening a promising — if early‑stage — route for a tumor type that desperately needs smarter options.
- HORMAD1: reproductive gene reveals vulnerability in triple‑negative breast cancer (3)
- New insights into why aggressive breast cancers grow and spread (3)
- OTHER: related cancer research and approvals outside this TNBC angle (5)
- All Other Stories
HORMAD1: reproductive gene reveals vulnerability in triple‑negative breast cancer
New insights into why aggressive breast cancers grow and spread
OTHER: related cancer research and approvals outside this TNBC angle
All Other Stories
Alfasigma Pays $300M for Rights to GSK Rare Liver Disease Drug On Track for FDA Decision
Frank Vinluan / medcitynews - GSK licensed to Alfasigma global rights to linerixibat, a drug developed to treat the rare liver disease primary biliary cholangitis (PBC). The move follows Alfasigma’s 2025 voluntary market withdrawal of Ocaliva, a PBC drug that had sparked safety concer…
AI Summary: GSK has licensed its investigational drug linerixibat to Alfasigma for $300 million upfront, transferring global rights as the therapy nears regulatory decisions for cholestatic liver itch. The deal accelerates Alfasigma’s rare-disease ambitions while allowing GSK to reposition its pipeline — a tidy corporate shuffle with real implications for patients with debilitating pruritus.
Roche’s big hope breast cancer drug fails in crucial first-line trial
Elizabeth Cairns / endpoints - Roche’s breast cancer pill, which the company recently said had the potential to become its biggest-ever selling drug, has failed in what is arguably its most important Phase 3 trial. The persevERA ...
AI Summary: Roche’s experimental breast cancer oral agent failed to meet its primary endpoint in a pivotal first‑line trial, dashing expectations that it would become a major new therapy. The negative readout forces a strategic rethink for the program and raises questions about near‑term prospects for what had been touted as a potential blockbuster.
‘They Need Each Other’: Why Hims & Hers and Novo Nordisk Made Up
Marissa Plescia / medcitynews - Novo Nordisk dropped its lawsuit against Hims & Hers and launched a new collaboration. The deal is advantageous for both companies, experts say.The post ‘They Need Each Other’: Why Hims & Hers and Novo Nordisk Made Up appeared first on MedCity News.
AI Summary: Novo Nordisk has dropped its legal fight with Hims & Hers and struck a business-friendly truce: Hims will sell Novo’s branded weight‑loss medications on its platform. The abrupt move turns courtroom theatrics into commercial collaboration, smoothing distribution while leaving regulators and competitors to enjoy the schadenfreude.
Antonio Calles: RECITE Trial Findings on Romiplostim for Chemotherapy-Induced Thrombocytopenia
oncodaily - Antonio Calles, Medical Oncologist at Hospital General Universitario Gregorio Marañón and faculty member of the Lung and Other Thoracic Tumours faculty group of the ESMO, shared a post by NEJM, […]
AI Summary: A global phase 3 trial shows romiplostim markedly reduces chemotherapy‑induced thrombocytopenia, cutting severe low‑platelet events and helping patients stay on planned treatment schedules. The finding promises to lower bleeding risk and avoid dose delays, a relief for clinicians and patients alike — and for anyone tired of rescheduled infusions.
Ipsen pulls cancer drug Tazverik from market over safety risks
Nicole DeFeudis / endpoints - Ipsen is pulling its cancer drug Tazverik from the market after an independent data monitoring committee found safety concerns in a confirmatory trial. The committee reported cases of secondary cancers that begin in blood-forming tissue ...
AI Summary: Ipsen has removed its EZH2 inhibitor Tazverik (tazemetostat) from the U.S. market after safety issues flagged by an independent monitoring review. The withdrawal forces clinicians to pivot to alternative therapies and triggers regulatory and clinical re‑examination of the drug’s benefit‑risk profile for patients previously depending on it.