Merck Announces First Patient Dosed in Phase 3 Study for Investigational Antibody-Drug Conjugate in Colorectal Cancer
Merck has dosed the first patient in the Phase 3 PROCEADE‑CRC‑03 trial of Precem‑TcT, the company’s inaugural anti‑CEACAM5 antibody‑drug conjugate (ADC) featuring an exatecan payload for metastatic colorectal cancer (mCRC). In Phase 1, the ADC achieved a 20.7% confirmed objective response rate and a median progression‑free survival of 6.9 months. The global study will enroll roughly 1,020 heavily pretreated mCRC patients across about 165 sites in 20 countries, testing the ADC alone or with bevacizumab. Merck reported 2025 sales of €21.1 billion, roughly $23 billion.
ASCO 2026: Bayer to Present New Data Across Oncology Portfolio
Bayer announced that it will unveil 16 new oncology abstracts at the ASCO 2026 meeting in Chicago, spanning prostate, breast, lung, renal‑cell, colorectal and salivary‑gland cancers. The headline presentation will feature Phase II head‑to‑head data comparing NUBEQA (darolutamide) with enzalutamide in...
AI‑Designed PE8 Editors Boost Prime Editing Efficiency
Today in @NatureBiotech we report a new suit of PE8 prime editor proteins. PE8 variants were developed from laboratory-evolved PE6 proteins using AI-guided protein redesign. This approach combines recent advances in computational protein design and directed evolution to increase prime...
Fixing Medication Adherence In Clinical Trials: How Technology Stops Data Corruption
Medication adherence in clinical trials is notoriously difficult to measure, with self‑reports often exceeding 90% while biomarker data reveal far lower rates. Traditional methods such as dosing diaries and pill counts are vulnerable to patient error and intentional manipulation, compromising...
Avaí Bio, Austrianova Advance Α-Klotho Cell Therapy Manufacturing Step
Avaí Bio and Austrianova have finished a GMP‑compliant master cell bank (MCB) of genetically engineered cells that overexpress the anti‑aging protein α‑Klotho. The bank will now undergo independent viral and adventitious‑agent testing before a working cell bank is created for...
ImmunityBio’s ANKTIVA + BCG Gets FDA Supplemental BLA Acceptance, Decision Set for Jan 6 2027
ImmunityBio announced that the FDA has accepted its supplemental biologics license application to expand ANKTIVA + BCG into BCG‑unresponsive non‑muscle invasive bladder cancer with papillary disease only. The agency set a PDUFA target action date of Jan. 6 2027, and the filing is backed...
How Eli Lilly's Next-Gen Obesity Drug Is 'Raising The Bar' In Weight Loss
Eli Lilly’s next‑generation obesity drug retatrutide delivered dramatic weight loss in the Phase 2 Triumph‑1 trial, with participants shedding an average 28.3% of body weight (about 70 lb) after 80 weeks and up to 30.3% (≈85 lb) in a 104‑week extension. Nearly half of...
Bayer Secures FDA Priority Review for Kerendia in Type 1 Diabetes‑Related Kidney Disease
Bayer AG announced that the U.S. FDA has granted priority review to its supplemental New Drug Application for Kerendia in adults with type 1 diabetes and chronic kidney disease. The decision follows positive Phase III FINE‑ONE data showing a significant reduction in...
M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)
The ICH has issued the M11 Template — Clinical Electronic Structured Harmonised Protocol (CeSHarP) – a draft guidance released in June 2025. The template standardizes the format, table of contents, and common headers for clinical trial protocols, while the accompanying Technical Specification defines...
Economic and Market Impact of the PRRS-Resistant Pig
In April 2025 the FDA cleared Pig Improvement Company’s gene‑edited PRRS‑resistant pig, a breakthrough against the disease that costs the global pork sector billions annually. Dr. Jayson Lusk of Oklahoma State University built an economic model to simulate adoption scenarios across...
Eli Lilly Reports P-III (TRIUMPH-1) Trial Data on Retatrutide for Weight Management
Eli Lilly’s phase‑III TRIUMPH‑1 trial showed its triple‑agonist retatrutide produced dramatic weight loss in adults with obesity and at least one weight‑related comorbidity. Across 80‑week endpoints, the 12 mg dose cut mean body weight by 28.3% and waist circumference by 24.1 cm, with...
Fixed-Duration AV Is a Compelling Option, With Important Caveats: Adam Kittai, MD
In a follow‑up interview, Dr. Adam Kittai of NYU Langone compares fixed‑duration acalabrutinib + venetoclax (AV) with continuous Bruton tyrosine kinase (BTK) inhibitor therapy for chronic lymphocytic leukemia (CLL). The AMPLIFY trial showed AV’s safety advantage—atrial fibrillation in 0.7% and major hemorrhage...
Retatrutide Delivers up to 30% Weight Loss in Phase 3 Trials
Retatrutide just delivered some very impressive phase3 results for $LLY at 4mg, 9mg and 12mg -- https://t.co/7sKbaDoInq Retatrutide is their GLP-3 ie triple agonist which hits the GLP, GIP and Glucagon receptors. At the primary endpoint of 80 weeks... patients on 4mg,...
Retatrutide Delivers Record 28% Weight Loss, Raises Safety Concerns
Retatrutide, a triple receptor drug for GLP-1, GIP, and glucagon, is the most powerful weight loss drug yet. A significant issue is too much weight loss among the trial participants. New randomized trial results announced today with 28% body weight...
Infex Chases After Insmed with Bronchiectasis Trial Win
Infex Therapeutics announced that its anti‑PcrV antibody RESP‑X (INFEX702) successfully completed a Phase 2a trial in patients with non‑cystic fibrosis bronchiectasis (NCFB) colonised by Pseudomonas aeruginosa. The study demonstrated early efficacy signals, a favorable safety profile and a 28.8‑day half‑life supporting...
Intellia Files First CRISPR‑Based BLA, Testing FDA’s New Post‑Approval Guidance
Intellia Therapeutics has filed a biologics license application for its in‑vivo CRISPR therapy targeting transthyretin amyloidosis, becoming the first CRISPR‑based product to be reviewed under the FDA’s September 2024 draft guidance on post‑approval monitoring. The move pits the company against...
Secret World of Cellular Communication Visualized in 3D Thanks to New Nanoscopy Method
Australian National University researchers unveiled RO‑iSCAT, a label‑free nanoscopy method that captures living cells in three dimensions over days. By rotating illumination and stacking images, the technique amplifies weak light signals tenfold, revealing dynamic, thread‑like nanoscale bridges that mediate cell‑to‑cell...
How Ossium Health Is Building an Off-the-Shelf Bone Marrow Transplant Model
Ossium Health is developing an off‑the‑shelf bone‑marrow product sourced from deceased organ donors, aiming to eliminate the timing and dose constraints of traditional live‑donor transplants. The company’s first‑in‑human PRESERVE I trial has treated about 25 patients with cryopreserved marrow and...
AIM ImmunoTech Secures $2.4 Million via Direct Share Offering and Warrant Placement
AIM ImmunoTech Inc. entered definitive agreements for a registered direct offering of 7.51 million shares at $0.325 per share, targeting roughly $2.4 million in gross proceeds. A concurrent private placement of Series I warrants for up to 15.04 million shares will also raise capital,...
What Does the Regulatory Landscape Look Like From the Other Side of FDA?
Harpreet Singh, MD, former FDA Oncology Division Director and now chief medical officer at Precision for Medicine, explains that industry sponsors find the oncology regulatory landscape more navigable when they leverage insider experience. He stresses three pillars: early and frequent...
Looking for a Lifeline: New Compounds Show Promise Against AMR
Scientists at Umeå University have created a new class of synthetic tricyclic compounds, called TriPcides, that effectively kill MRSA strains resistant to earlier GmPcide antibiotics. By redesigning the molecular scaffold to evade the lmrB efflux pump, the compounds prevent the...
Bayer Gets Swift Review for Kerendia in Type 1 Diabetes
Bayer has applied to the FDA for a label extension of its mineralocorticoid receptor antagonist Kerendia to treat chronic kidney disease in type 1 diabetes patients. The agency granted priority review, promising a decision within six months. Phase 3 FINE‑ONE data showed...
ATS 2026: Long-Term Data Show Durable Benefit of Trikafta for Cystic Fibrosis
At the 2026 American Thoracic Society conference, a German single‑centre cohort of 106 adults with cystic fibrosis and at least one F508del allele reported four‑year outcomes on Trikafta (elexacaftor/tezacaftor/ivacaftor). Patients showed a 0.5 L (15.6%) rise in FEV1, a 28.9% drop...
MHRA Proposes New Regulatory Pathway for Rare Disease Therapies
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on a new, technology‑agnostic regulatory pathway for rare disease therapies. Central to the proposal is an Investigational Marketing Authorisation (IMA) that merges clinical trial approval with a...
Infex Reports Phase IIa Win for Anti-Pseudomonas Antibody
Infex Therapeutics announced positive Phase IIa results for RESP‑X, its first‑in‑class anti‑virulence monoclonal antibody targeting PcrV in Pseudomonas‑colonised non‑cystic fibrosis bronchiectasis. The randomized, double‑blind trial demonstrated safety, tolerability and a 28.8‑day half‑life supporting quarterly dosing. While the study was not powered...
Eli Lilly Acquires Engage Biologics for ~$202M
Eli Lilly announced the acquisition of Engage Biologics for roughly $202 million in cash, integrating Engage’s Tethosome non‑viral DNA delivery platform with Lilly’s growing genetic‑medicine portfolio. The deal includes an upfront payment and milestone‑based earn‑outs tied to development progress. Tethosome combines engineered DNA...
Genetic Insights From 619,372 Metabolic Profiles
A landmark study examined 619,372 metabolic profiles linked to genetic data, creating the largest metabolomics‑genomics dataset to date. Researchers uncovered more than 1,200 genetic loci that modulate circulating metabolite concentrations, many of which map to pathways implicated in cardiometabolic disease....
The Next Era of Healthcare Is Personal
In this episode, McKinsey’s Eric Kutcher talks with Moderna CEO Stéphane Bancel about how mRNA technology and AI are reshaping healthcare from rapid vaccine development to truly personalized medicines. Bancel explains that mRNA is an "information molecule" that can be programmed...
Targeting Inflammation in Depression: A Proof-of-Concept Worth Following
A proof‑of‑concept randomized trial examined a single intravenous dose of tocilizumab, an IL‑6 receptor blocker, in 29 adults with treatment‑resistant major depressive disorder and low‑grade inflammation (CRP ≥ 3 mg/L). The drug safely reduced CRP levels, but the primary outcome—somatic depression symptoms—did not...
Imperagen Raises £5 Million to Use Quantum Physics, AI on Enzyme Engineering
Imperagen, a Manchester‑spun biotech founded in 2021, closed a $6.7 million seed round led by PXN Ventures, bringing total funding to $11.42 million. The startup combines quantum‑physics simulations, custom AI models, and robotic closed‑loop experimentation to accelerate enzyme engineering. It aims to...
Algae‑Powered Robot Swarms Heal Wounds Using Light
Living #Robot swarms built from algae can split, merge, and target wounds with light by Neetika Walter @IntEngineering Learn more: https://t.co/eFL1uXG9hg #MedTech #Healthcare #HealthTech #Tech #TechForGood https://t.co/P2jlormizm
Lantern Pharma Gets FDA Type C Clearance for LP-300 Phase 2 Trial in Never‑Smoker NSCLC
Lantern Pharma announced that the FDA issued a successful Type C meeting response, clearing protocol amendments for its LP-300 Phase 2 HARMONIC trial. The agency raised no objections to focusing enrollment on EGFR exon 21 L858R‑mutant never‑smokers and extending treatment...
Flatiron Health Launches AI Platform Flatiron Telescope to Deliver Oncology Insights in Minutes
Flatiron Health introduced Flatiron Telescope, an AI-powered platform that generates oncology insights in minutes, leveraging data from over 5 million patient journeys. The tool promises to cut study feasibility timelines from months to minutes, offering real‑time cohort building and analytics for...
Achieve Life Sciences Presents 52‑Week Cytisinicline Safety Data Ahead of FDA Decision
Achieve Life Sciences disclosed 52‑week safety results from its ORCA‑OL trial of Cytisinicline, a nicotine‑dependence therapy, at the ATS 2026 meeting. The data reinforce long‑term tolerability as the company approaches a June 20, 2026 FDA PDUFA deadline for its New...
Did a Boy’s Life-Saving Gene Therapy Cause His Brain Tumour?
A five‑year‑old who received adeno‑associated virus (AAV) gene therapy for a rare genetic disorder developed a brain tumor four years later. Genetic analysis traced the tumor to integration of the viral vector into the child’s genome, suggesting a causal link....
Atyr Pharma Launches Global Phase 3 Trial C-006 of Efzofitimod for Pulmonary Sarcoidosis
Atyr Pharma announced the start of a global Phase 3 trial (C-006) of its anti‑inflammatory drug efzofitimod in pulmonary sarcoidosis, prioritizing forced vital capacity as the primary endpoint. The move follows a Type C meeting with the FDA that reshaped...
Surveillance: Post Drug-Approval Activities
The FDA’s Center for Drug Evaluation and Research (CDER) oversees post‑marketing surveillance to ensure that drugs remain safe and effective after approval. Through mandatory adverse‑event reporting and targeted monitoring programs, the agency can identify unexpected risks. When serious concerns arise,...
GLP-1s Show Promise for Glaucoma, AMD, Other Eye Diseases
GLP‑1 receptor agonists, long used for diabetes and obesity, are emerging as potential treatments for several eye conditions. Recent reviews cite modest reductions in intra‑ocular pressure and lower incidence of primary open‑angle glaucoma among users. The data on diabetic retinopathy...
Eton Pharmaceuticals Secures U.S. Rights to IMPAVIDO, Adds 2026 Leishmaniasis Launch
Eton Pharmaceuticals announced an exclusive U.S. commercialization agreement for IMPAVIDO, the only FDA‑approved oral treatment for multiple forms of leishmaniasis, with rights effective Sept. 26, 2026. The deal adds a new 2026 launch to Eton’s rare‑disease pipeline and is tied to a...
Collaborative Drug Discovery Inks Deal with Eli Lilly to Accelerate Biotech Innovation
Eli Lilly’s TuneLab AI platform will be embedded into Collaborative Drug Discovery’s (CDD) Vault system, giving biotech companies access to Lilly’s proprietary ADMET predictive models. The integration will appear in both the core and AI modules of CDD Vault, allowing researchers...
HELIX AI Model Accurately Predicts RNA Splicing, Unlocks Precision Medicine
Researchers at the Chinese Academy of Sciences unveiled HELIX, an AI framework that predicts RNA splicing and isoform usage with unprecedented accuracy. By combining DNA sequence data with expression profiles of 1,499 RNA‑binding proteins, the model outperforms existing tools across...
Abbreviated New Drug Application (ANDA)
On October 3, 2025, the FDA unveiled a pilot program that fast‑tracks the review of abbreviated new drug applications (ANDAs) submitted by generic manufacturers that test and produce their products in the United States. The initiative is designed to spur...
Longevity Biotech Matures: Precise Indication‑Focused Drug Development
The longevity biotechnology field is coming of age in the best possible way. A recent analysis captures how the sector has learned to speak pharma’s language fluently—moving from broad claims about “slowing aging” to precise, indication-focused drug development with conventional endpoints,...
IL-6 Blocker Shows Promise for Treating Depression
Would depression respond to an anti-inflammation drug (interleukin-6 blocker)? A small pilot, placebo-controlled randomized trial suggests this might be possible https://t.co/zKO76yvRAo https://t.co/e8K9YLEAQj
STAT+: Biotech Execs, Academic Expert Lament Impact of FDA Turnover on Rare Disease Drug Development
Biotech leaders and an academic expert warned that recent turnover among senior FDA officials is creating heightened uncertainty for rare‑disease drug developers. At the STAT Breakthrough Summit West, Mahzi Therapeutics CEO Yael Weiss described constant investor inquiries and a “roller‑coaster”...
FDA Clears INTERACT Meeting for Glafabra’s Fabry Gene Therapy, Paving Way for Single‑Shot Treatment
The U.S. Food and Drug Administration accepted Glafabra Therapeutics’ request for a face‑to‑face INTERACT meeting on July 16, 2026, to discuss its lead Fabry disease gene therapy GT-GLA‑S03. The meeting, granted to only about 30% of applicants, moves the company...
FDA Clears Johns Hopkins AI Tool that Cuts Sepsis Deaths by 20%
The U.S. Food and Drug Administration gave clearance to an AI‑driven early‑warning system from Johns Hopkins University that identifies sepsis up to 48 hours before clinicians suspect it. Early data show a near‑20% reduction in sepsis‑related deaths across dozens of...
Activist Targets 80%-Down Biopharma at Cash‑Discount
Clinical-stage biopharma down 80% after a failed trial, now at a massive discount to net cash Biopharma activist just took a sizeable position via 13G. Mgmt has prior wind-down and sell experienc. Clear path: halt trial, strategic review, re-rate higher. Full pitch on...
Parabilis Raises $800M, Eyes IPO to Tackle Undruggable Targets
After raising $800M, Parabilis seeks an IPO to pursue ‘undruggable’ targets https://t.co/hKprr9rkJ4 @ByJonGardner $PBLS #biotech #IPO
Monopar's ALXN1840 Cuts Copper in Wilson Disease Phase 2 Trial
Monopar Therapeutics announced that its experimental drug ALXN1840 achieved rapid, statistically significant copper reduction in a nine‑patient Phase 2 trial for Wilson disease. The open‑label study, published in Hepatology Communications, marks a key milestone for the first‑in‑class ATC activator. The data...