Merz Therapeutics and Kvvit Partner to Advance Inbrija in Mainland China, Hong Kong and Macao
Merz Therapeutics has licensed its inhaled levodopa product Inbrija to Chinese biotech Kvvit for exclusive commercialization in mainland China, Hong Kong and Macao. The agreement assigns Merz responsibility for drug supply, global quality oversight and holding the overseas registration certificate, while Kvvit becomes the domestic responsible person, steering local development, regulatory filings and market launch. Financial terms include an upfront cash payment, milestone fees and tiered royalties linked to commercial performance. Inbrija targets intermittent OFF episodes in Parkinson’s patients already on oral levodopa therapy.
STAT+: Eli Lilly to Buy Three Small Vaccine Developers
Eli Lilly announced it will acquire three early‑ and mid‑stage vaccine developers—Curevo, LimmaTech Biologics and Vaccine Company—for a combined price of nearly $4 billion. The deals expand Lilly’s pipeline into vaccines targeting pathogens that cause long‑term health complications. Funding comes from the...
Arthrosi Drug Trial in Gout Delivers for New Owner Sobi
Swedish biotech Sobi’s $1.5 billion acquisition of Arthrosi is yielding results as its gout drug pozdeutinurad met primary goals in the phase 3 REDUCE‑2 trial. The URAT1 inhibitor lowered serum uric acid to ≤6 mg/dl in 69.2% of patients at a 75 mg dose...
Nanoscale Drug Delivery Systems for Ovarian Cancer: Targeting Strategies, Theranostic Platforms, and Translational Challenges
A new review maps the evolution of nanoscale drug delivery systems (DDS) for ovarian cancer, shifting focus from blunt chemotherapy to precision nanomedicine. It outlines three core design strategies—active targeting, microenvironment‑responsive release, and theranostic integration—across carriers such as liposomes, polymeric...
EU Approves Wegovy 7.2 Mg Pen Amid Expert Warnings of Bone Loss
The European Medicines Agency’s CHMP has recommended approval of Novo Nordisk’s Wegovy 7.2 mg single‑dose pen, which delivered a 20.7% average weight loss in trials. At the same time, orthopedic experts caution that rapid weight loss from GLP‑1 drugs can erode muscle...
A Photothermally Triggered Cascade Nanodelivery Platform for On‐Demand Nitric Oxide Release in Targeted Hepatocellular Carcinoma Therapy
Researchers have engineered a gold nanocage‑based nanoplatform (GIL9R) that co‑encapsulates indocyanine green and L‑arginine and is surface‑functionalized with the HCC‑targeting peptide 9R‑P201. Upon near‑infrared irradiation, the platform produces localized heat, reactive oxygen species, and catalyzes nitric‑oxide release, delivering combined photothermal,...
AstraZeneca Secures Positive EU CHMP Opinion for Camizestrant Combo in Advanced Breast Cancer
AstraZeneca announced that the European Medicines Agency’s CHMP has issued a positive opinion on camizestrant combined with a CDK4/6 inhibitor for ER‑positive, HER2‑negative advanced breast cancer with ESR1 mutations. The Phase III SERENA‑6 trial showed a 56% reduction in disease progression...
Will Lab-Grown Sperm Let Infertile Men Have Children of Their Own?
A US start‑up, Paterna Biosciences, says it can turn testicular stem cells into sperm in the lab, potentially offering a solution for men whose infertility cannot be treated with existing methods. The company claims the technique could enable almost all...
Northern Irish Health Tech Expands in the US After FDA Win
Neurovalens, a Belfast‑based health‑tech startup, received FDA De Novo clearance for its Modius Spero wearable that treats PTSD with low‑level electrical stimulation. The company will begin prescribing the device to U.S. veterans through the Department of Veterans Affairs in July, marking...
Pierre Fabre’s Braftovi Gains CHMP Positive Opinion for mCRC
The European Medicines Agency’s CHMP issued a positive opinion on Pierre Fabre’s Braftovi (encorafenib) combined with cetuximab and Folfox as a first‑line treatment for metastatic colorectal cancer (mCRC) harboring BRAFV600E mutations. The Phase III BREAKWATER trial demonstrated a 51% reduction in...
Pierre Fabre’s Braftovi Gains CHMP Positive Opinion for mCRC
The European Medicines Agency’s CHMP issued a positive opinion for Pierre Fabre’s Braftovi (encorafenib) combined with cetuximab and Folfox as a first‑line treatment of BRAFV600E‑mutant metastatic colorectal cancer. The Phase III BREAKWATER trial showed a 51 % reduction in death risk, extending median...
The European CDMO Model, Powering Biologics Innovation
European contract development and manufacturing organisations (CDMOs) are becoming pivotal as biologics grow in complexity, and 3PBIOVIAN exemplifies this shift with a pan‑European, end‑to‑end model. The company operates GMP‑certified facilities in Pamplona, Spain, and Turku, Finland, offering microbial, mammalian, viral...
Does Ceramide Lipid Metabolism Affect Response to Prostate Cancer Drugs?
Researchers discovered that ceramide lipid metabolism varies by genetic ancestry and influences response to androgen‑receptor pathway inhibitors in metastatic castration‑resistant prostate cancer. Black patients entered treatment with lower total ceramides but higher C24‑to‑C16 ratios, a pattern that flipped during therapy....
AstraZeneca Receives the CHMP Positive Opinion for Camizestrant to Treat Advanced Breast Cancer
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on AstraZeneca’s oral selective estrogen receptor degrader camizestrant, to be used with a CDK4/6 inhibitor for ER‑positive, HER2‑negative advanced breast cancer harboring ESR1 mutations....
Amgen Drug Reviewed Amid Deaths
Amgen’s rare‑disease drug Tavneos (avacopan) resumed sales in Japan after a new warning label was added following 20 reported deaths linked to liver injury. The drug, acquired when Amgen bought ChemoCentryx in 2022, generated $459 million in 2025 sales. In the...
Follow the Money: AI Drug Design Engine, Treating Multiple Myeloma, Quantum Healthcare Platform
Isomorphic Labs closed a $2.1 billion Series B to scale its AI drug‑design engine, while CellCentric secured $220 million to push its oral myeloma candidate, inobrodib, into Phase 3 trials. NVision raised $55 million Series B to merge quantum computing with its POLARIS MRI platform, aiming...
REGENXBIO, Novartis, Dyne Near FDA Submissions in Muscular Dystrophies
A wave of near‑term regulatory activity is reshaping the muscular dystrophy landscape. REGENXBIO reported mixed Phase 3 data for its gene therapy RGX‑202, achieving 93% microdystrophin expression but raising safety flags, while targeting a 2027 launch. Novartis’ $12 billion acquisition of Avidity...
Can Fast, Nimble Clinical Trials Deliver a Drug to Halt the New Ebola Outbreak?
The World Health Organization and African health agencies have launched an adaptive, randomized clinical trial in the Democratic Republic of the Congo to evaluate two therapies—remdesivir and the experimental antibody cocktail MBP134—against the Bundibugyo strain of Ebola. The protocol draws...
Noxopharm Studies Confirm Cancer-Fighting Potential of Sofra Platform
Australian biotech Noxopharm announced new data on its Sofra platform, a TLR8‑activating oligonucleotide technology that could enhance cancer immunotherapy. Preclinical studies demonstrated up to a 200‑fold boost in TLR8 activity in human skin biopsies and nearly three‑fold activation in animal...
Gilead's Trodelvy Wins CHMP Positive Opinion for First‑Line Metastatic Triple‑Negative Breast Cancer
The European Medicines Agency’s CHMP has issued a positive opinion on Gilead’s Trodelvy for first‑line treatment of metastatic triple‑negative breast cancer (mTNBC) in patients who cannot receive PD‑(L)1 inhibitors. The recommendation follows the ASCENT‑03 trial, which showed a 38% reduction...
FDA Grants Priority Review to Bayer's Finerenone for Type 1 Diabetes Kidney Disease
The U.S. FDA accepted Bayer's supplemental NDA and granted priority review to finerenone (Kerendia) for chronic kidney disease in adults with type 1 diabetes. The decision follows a phase‑3 trial that cut urine albumin‑to‑creatinine ratio by about 25% in 242 patients,...
NeuroScientific Hails 80% Clinical Response in Crohn’s Stem Cell Program
NeuroScientific Biopharmaceuticals reported that four of five patients with fistulising Crohn’s disease showed a clinical response to its StemSmart mesenchymal stem cell therapy, an 80% response rate. All participants experienced symptom improvement and no serious adverse events were recorded. The...
Vividthree Warns of FY26 Revenue Decline and Net Loss
Vividthree Holdings Ltd. announced that its unaudited FY26 results will show a net loss driven by reduced revenue, goodwill impairments from recent acquisitions, and fair‑value losses on investments. The board urged shareholders to exercise caution while the company finalises its...
Caliway Secures FDA IND Clearance, Launches Global Phase 3 Trial for CBL‑514
Caliway Biopharmaceuticals received U.S. FDA clearance of its IND for CBL‑514, enabling a global Phase 3 study that will enroll about 320 participants across the United States, Canada and Australia. The trial’s rigorous MRI‑based endpoints aim to set a new efficacy...
SPARK Microgravity to Launch Live Cancer Cells in Microgravity Test Flight
SPARK Microgravity is set to launch a micro‑payload containing live triple‑negative breast cancer cells aboard an SSC Space rocket from Esrange, Sweden, in May 2026. The mission, the company’s first oncology‑focused flight, seeks to prove that cancer cells can be...
Eli Lilly's VERVE-102 Gene Therapy Cuts PCSK9 and LDL‑C in Phase 1b Heart‑2 Trial
Eli Lilly announced that a single infusion of its investigational base‑editing therapy VERVE-102 produced dose‑dependent reductions in circulating PCSK9 protein and LDL‑C in the Phase 1b Heart‑2 trial of adults with heterozygous familial hypercholesterolemia or premature coronary disease. The FDA...
New Maternal RSV Vaccine Lowers Infant Hospitalization Rates, but Accessibility May Be Limited, Study Finds
A new maternal RSV vaccine introduced in fall 2023 reduces infant hospitalizations, with the Dallas study showing zero hospitalizations among vaccinated infants versus 3% among unvaccinated. Vaccination rates varied sharply by insurance type and race, with private‑insured mothers at 37%...
Peptides / Bioregulators
Therapeutic peptide development has accelerated over the past decade thanks to new synthesis, modification, and analytical platforms, positioning peptides as a fast‑growing drug class. While FDA‑approved peptides remain limited to GLP‑1 analogues and a handful of niche indications, a flood...
Response to Comments on "Aluminium Adjuvants in Vaccines and Potential Health Effects: Systematic Review"
The authors of a BMJ systematic review on aluminium adjuvants in vaccines rebut criticisms by highlighting methodological flaws in cited studies and reaffirming that no causal association has been identified. They note that the Joura 2015 HPV vaccine trial cannot...
Nanotech Drug‑Delivery Market Set to Hit $179 B by 2033, DataM Reports
DataM Intelligence announced that the global nanotechnology‑enabled drug delivery devices market, valued at $54.22 billion in 2024, is projected to climb to $179.12 billion by 2033, expanding at a 12.6% compound annual growth rate. The forecast underscores accelerating commercial interest in precision‑medicine...
Roswell Park Scientists Present Five Key Cancer Studies at Clinical Meeting
Roswell Park Comprehensive Cancer Center will showcase five of its own studies at the ASCO 2026 Annual Meeting in Chicago, alongside additional research presented by its faculty and fellows. Highlights include a real‑world analysis of GLP‑1 receptor agonists on hormone‑receptor‑positive breast cancer,...
World Blood Cancer Day 2026: New FDA Approvals and Phase III Readouts
World Blood Cancer Day 2026 highlights a projected 180,000 new U.S. blood‑cancer cases, underscoring the disease’s growing burden. The FDA granted several approvals, including an all‑oral decitabine/cedazuridine‑venetoclax regimen for older AML patients and Beqalzi for relapsed mantle‑cell lymphoma. Janssen’s Tecvayli...
AstraZeneca, Daiichi Drug Approved as New First-Line Therapy for Tough Type of Breast Cancer
The FDA granted accelerated approval to Datroway (DS‑1062), an antibody‑drug conjugate co‑developed by Daiichi Sankyo and AstraZeneca, as a first‑line therapy for metastatic triple‑negative breast cancer (TNBC). Phase 3 data showed Datroway reduced the risk of disease progression or death by 43%...
ATP2B4 Boosts Chromatin Compaction, Worsens Pancreatic Cancer Radiotherapy Resistance
Researchers have identified the calcium pump ATP2B4 as a driver of chromatin compaction that shields pancreatic tumor DNA from radiation damage. Elevated ATP2B4 levels were detected in roughly two‑thirds of pancreatic ductal adenocarcinoma samples, correlating with poorer radiotherapy outcomes. Genetic...
Shanghai Center Reports First‑in‑China CAR‑T Success for Pakistani Lymphoma Patient
Jiahui International Cancer Center in Shanghai treated a 36‑year‑old Pakistani lymphoma patient with a customized CAR‑T therapy, leading to rapid pain relief and tumor shrinkage. The case underscores the growing role of Chinese CAR‑T programs in serving international patients with...
FDA Grants Accelerated Approval to Gilead’s Hepcludex, First U.S. HDV Therapy
The U.S. FDA has granted accelerated approval to Gilead Sciences' Hepcludex (bulevirtide‑gmod) 8.5 mg, creating the first FDA‑cleared therapy for chronic hepatitis delta virus (HDV) in the United States. The decision rests on Phase 3 MYR301 data showing virologic and biochemical improvements,...
Discovery of Novel 11 Beta-Hydroxysteroid Dehydrogenase Type 1 Inhibitor by Machine Learning Enabled Large-Scale Virtual Screening
Researchers applied a machine‑learning‑driven virtual screening workflow to the Mcule catalog of roughly 139.6 million compounds, ultimately identifying a single top candidate, MCULE‑6869845113, as a potent 11beta‑HSD1 inhibitor. The Gradient Boosting Classifier achieved an AUC of 0.88 and Matthews Correlation Coefficient...
Thioflavin-T Derivatives: Novel One- & Two-Photon Amyloid Markers
Researchers have unveiled a new class of thioflavin‑T derivatives that function as both one‑photon and two‑photon fluorescent markers for amyloid aggregates. The compounds exhibit markedly higher quantum yields, expanded two‑photon cross‑sections, and superior photostability compared with the classic Thioflavin‑T dye....
Four Decades of Glioblastoma Targeted Therapy: A Bibliometric and Pharmacological Perspective on Translational Failure and Future Directions
Over the past four decades, more than 5,000 studies have examined targeted therapies for glioblastoma (GBM), yet clinical success remains elusive. The United States and China dominate the research output, with the field progressing through four phases: molecular discovery, first‑generation...
Hyperbranched Biorefinery Molecule‐Regulated Switchable Adhesion and Noninvasive Healing
Researchers have created a reversible biomedical adhesive using a hyperbranched polysaccharide produced via microbial fermentation. The nanoconfined structure supplies abundant dynamic disulfide bonds, delivering both high adhesive strength and a broad, controllable adhesion range (296 N/m down to 17 N/m). In animal...
Fragments in the Clinic: VVD-214
Vividion’s covalent WRN inhibitor VVD‑214 evolved from a vinyl‑sulfone fragment hit (compound 1a) to a clinically viable candidate through a series of empirical SAR steps. Introducing a methyl group (2a) boosted stability and sub‑micromolar cellular potency, while a tert‑butyl cyclopentyl...
REGENXBIO's RGX-202 Gene Therapy Hits Pivotal Efficacy Endpoint in Duchenne Trial
REGENXBIO announced that its one‑time AAV microdystrophin therapy RGX-202 met the primary endpoint in the pivotal phase III AFFINITY DUCHENNE trial, with 93% of evaluable patients showing at least 10% protein expression at week 12. The result positions the company...
Tri‑complex RAS Inhibitors: 40k Compounds,
Came across this great talk from $RVMD's Adrian Gill on @drughunter_com about the development of probably one of the most important oncology drug classes in history : Tri-complex RAS inhibitors. It's not too technical so non-chemists can follow as well. Synthesized...
Single VERVE-102 Dose Slashes PCSK9 and LDL
we live in the future - the next step is designing large gene insertions and fine scale editing with AI 👀 @ProfluentBio “One dose of VERVE-102 (in vivo base editor) led to dose-dependent, substantial, and sustained reductions in PCSK9 and...
One-and-Done Heart Disease Prevention? Scientists Show It May Be Possible.
Scientists reported that a single infusion of an experimental gene‑editing drug lowered LDL cholesterol by up to 62 percent in an interim analysis of 35 patients. The reduction remained durable in a subgroup treated 18 months earlier, suggesting a potentially...
Lilly's Verve Gene Editor Cuts Cholesterol, but Delays Loom
Eli Lilly $LLY says Verve’s gene editor lowers cholesterol levels in early, but development timelines have slipped. https://t.co/fuJOPyDwQb via @Jasonmmast
Agios Reports the EC Approval of Pyrukynd for Anemia in Alpha or Beta Thalassemia
The European Commission has granted approval for Agios' oral pyruvate kinase activator Pyrukynd (mitapivat) to treat anemia in adults with both non‑transfusion‑dependent and transfusion‑dependent alpha‑ or beta‑thalassemia. The decision follows positive results from the global Phase III ENERGIZE and ENERGIZE‑T trials,...
Eli Lilly’s Retatrutide Delivers up to 30% Weight Loss in Phase 3 Trial
Eli Lilly announced that its experimental triple‑agonist retatrutide produced an average 28.3% weight loss (about 70 lb) in the highest dose group of its Phase 3 TRIUMPH‑1 trial, with nearly half of those participants shedding at least 30% of body weight. The result...
Eisai Sets FY2028 Revenue Goal of ¥1 Trillion ($6.7B) on Oncology, Dementia Growth
Japanese drugmaker Eisai announced a FY2028 revenue target of ¥1 trillion (about $6.7 bn), underpinned by projected sales of its Alzheimer’s antibody Leqembi, insomnia drug Dayvigo and cancer therapy Lenvima. The guidance marks a steep climb from FY2025 and signals confidence in...
Pharming Reports the EC Approval of Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS)
The European Commission has granted marketing authorization for Pharming’s oral PI3Kδ inhibitor Joenja (leniolisib) to treat patients aged 12 and older with activated phosphoinositide 3‑kinase delta syndrome (APDS) across all 30 EEA states. Approval is based on a Phase II/III...