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Tentative FDA OK for Lutathera Generic — Lantheus Locked in Patent War
The FDA has issued a tentative approval for Lantheus’ PNT2003, a generic version of Novartis’ radioligand therapy Lutathera (lutetium Lu 177 dotatate), even as Novartis pursues multi‑patent...
HER2 ADC Posts >50% Response in Bladder Cancer – Phase 2 Data
Phase 2 results presented at ASCO Genitourinary show the HER2‑targeted antibody‑drug conjugate disitamab vedotin (DV) delivered confirmed overall response rates above 50% in both HER2‑positive and...
Cadonilimab Combo Improves Outcomes in Advanced Cervical Cancer — Phase 3
COMPASSION‑16, a Phase 3 trial, showed that adding cadonilimab to first‑line chemotherapy, with or without bevacizumab, improved outcomes for patients with advanced cervical cancer. The trial’s...
Novel Diketopiperazine Alkaloids Discovered via Heterologous Expression
Researchers identified a new class of diketopiperazine alkaloids from the endophytic bacterium Kitasatospora sp. CPCC204717 by expressing a previously silent biosynthetic gene cluster in a...
Antibody‑siRNA Conjugate Reaches Muscle — Promising Data in Myotonic Dystrophy
Phase I/II MARINA trial data published in the New England Journal of Medicine report that the antibody‑siRNA conjugate delpacibart etedesiran (del‑desiran, AOC‑1001) successfully delivered siRNA...
Targeting P3H1 Slows Pancreatic Cancer Growth and Reprograms Tumor Immunity
New preclinical work identifies prolyl 3‑hydroxylase 1 (P3H1) as a driver of pancreatic cancer progression and a modulator of the tumor immune microenvironment. Genetic or pharmacologic inhibition...
TYK2 Implicated in TDP‑43 Neuroinflammation in Alzheimer’s — New Therapeutic Angle
A Nature Communications study linked TYK2 activation to neuroinflammatory cascades in Alzheimer’s disease brains exhibiting TDP‑43 pathology. The authors show that TYK2 mediates inflammatory...
Wireless High‑Resolution Sensor Promises Continuous Hemodialysis Access Monitoring
Researchers published a Nature Communications paper describing a wireless, noninvasive high‑resolution 'thrill' sensor for continuous monitoring of arteriovenous access in hemodialysis patients....
High‑Throughput SPR Moves Upstream in Drug Discovery — Carterra’s Vega
Carterra’s Vega platform expands surface plasmon resonance (SPR) throughput to tens of thousands of compounds per day, enabling label‑free kinetic and affinity screening early in drug discovery....
Orphan Drug Sales to Top $400 Billion by 2032 — Evaluate Forecast
Evaluate’s 2026 Orphan Drugs Report projects global orphan drug sales will reach roughly $409 billion by 2032, up from about 15% of prescription sales in 2022 to more than 21% a decade later. The...
CAR-T Persistence... Cytokine scaffold extends durability
Researchers at Albert Einstein College of Medicine reported a new manufacturing strategy that generates longer-lived CAR‑T cells by linking IL‑7, IL‑15 and IL‑21 into a single protein scaffold...
Antibody‑siRNA Conjugate – First clinical signs of muscle delivery
A Phase I/II trial reported in the New England Journal of Medicine shows delpacibart etedesiran (del‑desiran, AOC‑1001), an antibody–siRNA conjugate, can deliver siRNA to skeletal muscle and...
Doxorubicin biosynthesis unlocked – Engineered bacteria scale production
An international consortium published complementary papers in Nature Communications describing engineered bacterial strains that overcome long‑standing biosynthetic bottlenecks in doxorubicin...
Lutathera generic... FDA tentatively clears ANDA amid patent fight
Lantheus scored a tentative FDA approval for an ANDA for PNT2003, a generic version of Novartis’ radioligand Lutathera (lutetium‑177 dotatate), while Novartis maintains active patent litigation...
Old drug, new label: FDA okays leucovorin for cerebral folate deficiency
The FDA approved leucovorin for treatment of cerebral folate deficiency (CFD) after reviewing published literature and real‑world evidence; the decision follows public attention when then‑FDA...
Frozen brains revived – Vitrification restores activity in mouse tissue
A team in Germany reported a method using vitrification and optimized thawing that preserved neuronal firing, metabolism and some plasticity in whole mouse brains, published in Proceedings of the...
SPR goes high‑throughput: Vega brings binding data to early screening
Carterra’s Vega platform expands surface plasmon resonance (SPR) from low‑throughput validation to primary screening, enabling tens of thousands of binding measurements per day, the company says...
Orphan drugs to $409B by 2032 – Evaluate projects rare market surge
Evaluate’s 2026 Orphan Drugs Report forecasts global orphan drug sales will exceed $400 billion by 2032, estimating $409 billion annually and a rising share of total prescription revenue. The lead...
Cadonilimab combo improves first‑line outcomes in cervical cancer
COMPASSION‑16 Phase 3 data showed cadonilimab added to chemotherapy, with or without bevacizumab, improved outcomes for first‑line treatment of advanced cervical cancer. Investigators presented...
Insilico joins Hang Seng... AI biotech hits index milestone
Insilico Medicine, an AI‑driven clinical‑stage biotech, was added to the Hang Seng Composite Index (HSCI) and became eligible for the Stock Connect program, expanding its investor access in Hong...