Helixgate https://validator.w3.org/feed/docs/rss2.html STAT+: The FDA’s rebuilding effort is running into a new challenge STAT+: England to cover AstraZeneca breast cancer drug, a result of U.K.-U.S. drug pricing deal STAT+: FDA has too few staffers to hire more staff STAT+: Pharmalittle: We’re reading about FDA hiring delays, a new Bavarian Nordic CEO, and more Sleep deals cluster in narcolepsy and sleep apnea Science Spotlight: A macrophage-recruiting bispecific, plus new tactics against TCR-T escape and tumor stroma Oncology biotech news: key moves to watch in September 2026  Legend Biotech names Novartis veteran Ingrid Zhang as new CEO Ori locks down $120M pact to deploy automated production platform for unnamed commercial cell therapy Standout pharma marketing takes the stage at the 2026 Fierce Pharma Marketing Awards Reckitt allots $600 million in upgrade of its U.S. operations BMS, Ono take Amgen to task as FDA’s Opdivo biosimilar decision looms Cellares links with GenomeFrontier to test automation approach for virus-free CAR-Ts FDA drops warning letter on Bausch & Lomb, citing contamination concerns Ex-PHM CEO Andrea Palmer takes top job at Assembled Intelligence AZ, Daiichi’s Enhertu scores long-awaited NICE blessing in HER2-low breast cancer Vera’s strong phase 3 IgAN data for Trutakna intensify kidney disease rivalry Lifecycle Approach Could Solve CGT Scale-Up Challenges Red Light Supercharges Anti-Obesity Drug Precursor GSK lays off 650 staffers amid closure of German vaccine manufacturing site Choice of Excipients Dramatically Affects Antibody Solubility Rare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meeting STAT+: Pharmalittle: We’re reading about faster FDA approvals, access to experimental drugs in Montana, and more AI is changing the talent biotech companies compete to hire Cellares and GenomeFrontier Therapeutics Partner to Advance Automated Manufacturing of GF-CART01 Prime Assembly Expands Genome Editing with Precise, Large-Scale DNA Integration STAT+: Sen. Warren demands to see Trump drug-pricing pharma contracts, accuses RFK Jr. of hiding them Sling banks $123M for an experimental thyroid eye disease pill Novartis to pay $125M for blood-brain barrier crossing platform Prime assembly can correct multiple mutations at once, pointing toward universal gene therapies Device simulates natural conditions to grow biofilms and test their antibiotic susceptibility more accurately A versatile nanopore identifies four classes of analytes simultaneously FDA opens Operation TrialBlazer for applications, hoping to reshore early trials For many, the retirement goal posts are shifting FDA approves pioneering breast cancer drug that nips resistance in the bud Eli Lilly and QurCan sign genetic medicine deal Gilead and PAHO agree to expedite lenacapavir access for HIV prevention Novartis pays Sironax $125M to acquire platform for crossing the blood-brain barrier Sling reels in $123M series C to fund oral Tepezza rival through phase 3 trial Corbus Pharmaceuticals Announces Positive Topline Data from CANYON-1 Study of Daily Oral CRB-913 for the Treatment of Obesity Novartis ends ALS program after phase 2 flop, adding to R&D woes Sling catches $123M series C for thyroid eye disease pill FDA warning letter accuses Bausch & Lomb of lacking commitment to remediation Prophylactic Phage Therapy Protects Mice Against Oral Salmonella Infection Stakeholders urge FDA to define data, treatment standards as psychedelic drugs near market FDA hears input on psychedelics, PDUFA, lung cancer’s next-gen therapies boost survival Brain Protein in Mice Offers Insights Into Brain Development and ADHD Novartis halts TREM2 targeting ALS program in 4th trial stumble in a month Deep dive: Psychedelics back on FDA’s doorstep Home