Generative AI System Could Cut Animal Testing by Up to 50% in Preclinical Research
Researchers at Goethe University Frankfurt, Philipps University of Marburg and the Fraunhofer Institute for Translational Medicine and Pharmacology have unveiled genESOM, a generative AI tool that creates synthetic preclinical data. Trained on small experimental sets, it can mimic real laboratory results and cut the number of animals used in drug testing by 30‑50%. The system addresses growing ethical and scientific pressure to replace animal experiments. The findings appear in Pharmacological Research.
AstraZeneca Follows Merck with Phase 3 Win in Bladder Cancer
AstraZeneca announced that its checkpoint inhibitor Imfinzi, co‑developed with Pfizer, combined with Astellas’ antibody‑drug conjugate Padcev, significantly extended overall survival in a Phase 3 trial for advanced bladder cancer. The regimen outperformed the current standard of care, marking the company’s second...
MacroGenics Sells Manufacturing Arm; West Pharma Discloses Cybersecurity Attack
MacroGenics announced the sale of its GMP‑manufacturing operations to Bora Pharmaceuticals, shifting its focus back to early‑stage antibody development. The transaction, terms undisclosed, transfers a fully qualified production suite and associated staff. In parallel, West Pharma disclosed a recent cybersecurity...
AstraZeneca Reports the P-III (VOLGA) Trial Data on Imfinzi + Enfortumab Vedotin (EV) for Muscle-Invasive Bladder Cancer
AstraZeneca presented Phase III VOLGA data showing that the combination of Imfinzi (durvalumab) and Enfortumab Vedotin improves event‑free survival and overall survival in muscle‑invasive bladder cancer patients who cannot receive cisplatin. The trial enrolled 695 patients undergoing radical cystectomy and compared two...
Why AI Fails in Drug Development and How to Build Tools That Actually Deliver Real Value
Artificial intelligence can add real value to drug development only when it is tightly woven into existing expert‑led workflows and respects real‑world constraints. The authors, drawing on their experience at Intrepid Labs and Quotient Sciences, illustrate how AI tools that...
BeOne Wins Mantle Cell Lymphoma Approval, Opening New Therapy Class
The FDA granted accelerated approval to BeOne Medicines’ BCL2 inhibitor sonrotoclax, marketed as Beqalzi, for patients with relapsed or refractory mantle‑cell lymphoma who have failed at least two prior therapies, including a BTK inhibitor. The drug is the first BCL2...
STAT+: Biogen’s Tau-Targeting Alzheimer’s Drug Posts Mixed Results in Mid-Stage Study
Biogen’s Phase 2 trial of the tau‑targeting Alzheimer’s drug diranersen (BIIB080) showed that the compound lowered tau protein in cerebrospinal fluid and brain tissue and was linked to a modest slowing of cognitive decline. The study evaluated three escalating dose levels,...
FDA Hands BeOne, Taiho Approvals for Blood Cancers
BeOne Medicines’ BCL‑2 inhibitor Beqalzi (sonrotoclax) earned FDA accelerated approval as a third‑line treatment for mantle‑cell lymphoma, marking the first U.S. approval of a BCL‑2 drug for this indication. The approval is based on a phase 1/2 trial showing a 52%...
Regulatory Round-Up: A Month of Key FDA Approvals for Cancer Drugs
The FDA approved four oncology drugs in May 2026, marking a focused regulatory push in cancer therapeutics. Taiho Oncology received clearance for the oral Inqovi‑venetoclax regimen for elderly acute myeloid leukemia patients, while BeOne Medicines earned accelerated approval for Beqalzi...
BeOne’s Next-Gen BCL2 Inhibitor Wins FDA Approval, Taking Aim at Venclexta
BeOne Medicines received accelerated FDA approval for sonrotoclax, its next‑generation BCL‑2 inhibitor, for mantle cell lymphoma. The decision rests on a single‑arm trial that delivered a 68% overall response rate in heavily pre‑treated patients. Sonrotoclax is positioned to compete directly...
AZ Cues up Broader Use of Imfinzi in Bladder Cancer
AstraZeneca’s immunotherapy Imfinzi (durvalumab) demonstrated a significant survival benefit in the phase‑3 VOLGA trial for muscle‑invasive bladder cancer (MIBC) patients who cannot receive platinum chemotherapy. The study combined Imfinzi with Pfizer‑Astellas’ antibody‑drug conjugate Padcev before surgery, extending both event‑free and...
From MSCs to iPSCs: Building the Cell Therapy Future
In a live session at the ISCT annual meeting, Miguel Forte and Jon Ellis discussed the evolving roles of mesenchymal stem cells (MSCs) and induced pluripotent stem cells (iPSCs) in cell‑therapy development. They examined the scientific advantages of each platform, highlighted persistent...
Osel and Partners Launch Phase IIb FLIP-2 Trial of Lactin-V
Osel, Imperial College London and the March of Dimes have launched the Phase IIb FLIP‑2 trial to evaluate Lactin‑V, a live‑biotherapeutic containing Lactobacillus crispatus, for preventing preterm birth in high‑risk pregnancies. The study will enroll 360 women across four UK maternity...
Pfizer Receives EC Approval for Hympavzi to Treat Haemophilia
Pfizer secured European Commission marketing authorisation for Hympavzi (marstacimab) to treat hemophilia A or B patients with factor inhibitors aged 12 and older who weigh at least 35 kg. The once‑weekly subcutaneous therapy eliminates routine lab monitoring and delivered a 93%...
Pfizer Receives EC Approval for Hympavzi to Treat Haemophilia
Pfizer secured European Commission marketing authorisation for Hympavzi (marstacimab) to treat hemophilia A or B with inhibitors in patients aged 12 years and older weighing at least 35 kg. The once‑weekly subcutaneous therapy showed a 93% reduction in mean annualised bleeding rate versus on‑demand...
PreVenTB Trial: A Critical Appraisal
WHO’s technical advisory group welcomed the PreVenTB phase 3 trial results but warned that the interpretation may be flawed. The letter points out that the study emphasized per‑protocol analyses despite the protocol designating a modified intention‑to‑treat (mITT) analysis as primary, which...
Dare Bioscience Inc (DARE) Q1 2026 Earnings Call Transcript
Daré Bioscience announced the imminent commercial launch of its DARE to PLAY sildenafil cream through a 503B outsourcing facility in December 2025, providing a near‑term revenue stream while full FDA approval is pursued. The company highlighted a strong cash position...
Pelthos Therapeutics Inc (PTHS) Q1 2026 Earnings Call Transcript
Pelthos Therapeutics reported a record Q1 2026, with U.S. BRIUMVI net product revenue of $195 million, 63% year‑over‑year growth, and total revenue of $205 million. The company raised its full‑year U.S. revenue outlook to $885‑$900 million and global guidance to about $925 million, nearing...
Jasper Therapeutics Inc (JSPR) Q1 2026 Earnings Call Transcript
Agios Therapeutics reported first‑quarter 2026 net revenues of $20.7 million, a 138% year‑over‑year increase driven by the U.S. launch of AQVESME for thalassemia. The company recorded 242 prescriptions by REMS‑certified physicians, indicating rapid early adoption. Management announced plans to file an...
Atrium Therapeutics Inc (RNA) Q1 2026 Earnings Call Transcript
Sarepta Therapeutics reported Q1 2026 revenue of $731 million, a modest 2% decline, while posting GAAP operating profit of $358 million and ending the quarter with $748 million in cash. The company reiterated full‑year revenue guidance of $1.2‑$1.4 billion and highlighted non‑cash collaboration income...
Navigating the Clinical Progress of Antibody-Drug Conjugates: Emerging Opportunities and Remaining Challenges
Antibody‑drug conjugates (ADCs) have become one of the fastest‑growing anticancer modalities, reaching 19 FDA‑approved products worldwide by the third quarter of 2025. The portfolio has expanded from hematologic indications to a broad array of solid tumors, driven by successful HER2‑targeted...
Sangamo Therapeutics Inc (SGMO) Q1 2026 Earnings Call Transcript
Sangamo Therapeutics announced that the FDA reaffirmed the use of eGFR slope as an endpoint for an accelerated Biologics License Application for its Fabry gene therapy ST-920, positioning a filing as early as Q1 2026. The STAR study showed a mean...
Pharma Leaders Hope Next FDA Head Calms Waters
PhRMA chief Steve Ubl urged the incoming FDA commissioner to restore certainty after a turbulent period marked by Marty Makary’s resignation and staff cuts. Executives from Bristol Myers Squibb and other majors echoed the need for a stable regulator to...
Recurrent Strokes Less Severe on Asundexian: OCEANIC-STROKE
The OCEANIC‑STROKE trial of 12,327 patients showed that the factor XIa inhibitor asundexian reduced recurrent ischemic strokes by 26% versus placebo in secondary prevention. Additional analyses revealed that strokes occurring on asundexian were less severe, with fewer NIHSS scores ≥8 and...
New Drug Candidate that Reprograms the Immune System Shows Promise as a Brain Cancer Treatment
McMaster University researchers have engineered a uPAR‑targeted CAR‑T cell that reprograms the immune system to attack glioblastoma. In preclinical mouse studies, a single infusion of 1 × 10⁶ engineered T cells eradicated established brain tumors and prevented recurrence, outperforming unmodified T cells....
Sonrotoclax Granted Accelerated Approval for R/R Mantle Cell Lymphoma
The FDA granted accelerated approval to BeOne Medicine’s sonrotoclax, marketed as Beqalzi, for adults with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior therapies, including a BTK inhibitor. In the single‑arm BGB‑11417‑201 trial of...
5 Key Regulatory Shifts From Makary's Era at the FDA
Former FDA commissioner Marty Makary reshaped U.S. drug regulation with five sweeping changes: the agency dropped the default two‑trial requirement, making a single pivotal study the norm for most new drugs; a new biosimilar guidance eliminates routine comparative efficacy trials,...
How Biologic Developers Are Using Optimized Platforms and Operations to Reach First-in-Human Trials
Catalent’s Emily Schirmer explains that early chemistry, manufacturing and controls (CMC) decisions and early engagement with a capable CDMO can dramatically shorten the path to first‑in‑human (FIH) trials. By evaluating the full supply chain—drug substance, product, fill‑finish and distribution—developers avoid...
Development of Local Anesthetic Drug Products With Prolonged Duration of Effect
The FDA released a draft Level 2 guidance (Docket FDA‑2023‑D‑0608) on developing local anesthetic products with prolonged duration of effect. The document outlines recommended development pathways, trial designs, and data requirements for future new‑drug applications. It aims to help sponsors generate evidence...
Cellares and ProTgen Automate Manufacturing of Progenitor T-Cell Therapy for Blood Cancer
Cellares, an integrated development and manufacturing organization, has partnered with ProTgen to automate the production and quality control of ProT-096, a personalized progenitor T‑cell therapy for refractory leukemia and other blood cancers. Cellares will deploy its Cell Shuttle and Cell...
Current Clinical Trials of Alzheimer’s Drugs
The 2026 annual report on Alzheimer’s drug development lists 158 therapies across 192 active clinical trials, enrolling 54,728 participants. Over the past decade the number of trials and tested agents grew by roughly 35% and 40%, respectively, with 59 new...
Adopting Creative Chemistry to Optimize Bioprocessing Workflow
Professor Sunny Zhou of Northeastern University argues that creative chemistry can mitigate unique bioprocessing challenges of antibody‑drug conjugates (ADCs). He highlights two major vulnerabilities: light‑sensitive payloads that cause aggregation and linker cleavage by host‑cell enzymes, both of which can compromise...
Lilly Data Point to ‘Maintenance’ Strategies for GLP-1 Weight Loss
Eli Lilly presented new data showing its GLP‑1 therapies can help patients maintain weight loss after injectable treatment. In the Surmount‑Maintain trial, patients who stayed on the highest Zepbound dose lost an additional two pounds over a year, while a reduced...
Cipla Bets on Fast-Growing Biosimilars Market, to Steadily Add Products: CEO
Cipla is accelerating its entry into the fast‑growing biosimilars space, planning to launch 1‑2 new products each year over the next five to six years. The strategy is anchored by a joint venture with contract manufacturer Kemwell Biopharma, which will...
AI Generates First Complete Models of Proteins in Motion
Scientists at EPFL have unveiled LD‑FPG, an AI‑driven generative framework that creates full‑atom, dynamic models of proteins, moving beyond static predictions like AlphaFold. The system leverages graph neural networks and latent diffusion to generate ensembles that capture side‑chain motions and...
Standard-Dose Ivermectin Superior to High Dose for Severe Scabies
A randomized, double‑blind trial published in the New England Journal of Medicine compared standard‑dose ivermectin (200 µg/kg) with a higher dose (400 µg/kg), each combined with 5 % permethrin, in 132 adults suffering from severe scabies. The standard‑dose regimen achieved an 82 % cure...
AstraZeneca Reports Positive Phase 3 Data for Eneboparatide in Chronic Hypoparathyroidism
AstraZeneca announced that its investigational PTH‑1 receptor agonist eneboparatide met the primary endpoint in the Phase 3 CALYPSO trial, with 31.1% of patients achieving normalized serum calcium and independence from active vitamin D and high‑dose calcium supplements at 24 weeks. The placebo...
STAT+: Gene Therapy Viruses Linked to a Boy’s Tumor
A recent investigation has linked a viral vector used in a gene‑therapy trial to a tumor in a young boy, marking the first documented case of a potential therapy‑induced cancer. The tumor was identified as a sarcoma arising at the...
The Changing Landscape of New Approach Methodologies
New Approach Methodologies (NAMs) have shifted from experimental curiosities to mainstream tools in pre‑clinical drug development, driven by a growing evidence base and sweeping regulatory reforms. In 2025, FDA and UK initiatives accelerated adoption, with organ‑on‑chip technologies seeing growth rates...
Molecular Grappling Hooks Improve Cancer Drug Targeting and Effectiveness
Scientists have engineered restricted interaction peptides (RIPs) that act as molecular grappling hooks, anchoring anticancer drugs to tumor cell membranes after activation by fibroblast activation protein. In mouse models, a RIP‑linked monomethyl auristatin E payload shrank tumors more effectively and with...
Millions for Preclinical Immunology: Boehringer Teams Up with Immunitas
Boehringer Ingelheim has signed a licensing deal with US‑based Immunitas Therapeutics that could be worth up to €407.5 million (approximately $445 million). The agreement grants Boehringer global rights to a preclinical antibody designed to selectively eliminate disease‑driving immune cells in chronic inflammatory...
Taiwan Renews Healthcare Innovation Partnership with U.K. Agency
Taiwan’s National Health Insurance Administration and the UK’s National Institute for Health and Care Excellence have renewed a two‑year partnership covering 2026‑2028. The agreement expands collaboration on health‑technology assessment, digital transformation, and talent development. It targets high‑cost innovations such as...
Novo Nordisk Data Shows Oral Semaglutide Delivers Significant Weight Loss in Phase 3 Trial
Novo Nordisk presented sub‑analyses of the phase 3 OASIS 4 trial at ECO2026, showing that oral semaglutide 25 mg tablets deliver substantial weight loss and functional gains for adults with obesity. Early responders—28.8% of participants—lost at least 10% of body weight by week 16...
A Plan to Make Drugs in Orbit Is Going Commercial
Varda Space Industries has secured United Therapeutics as its first commercial partner to test drug manufacturing in orbit. The collaboration will send United's pulmonary‑arterial hypertension medicines to microgravity to grow novel crystal forms that could improve stability and efficacy. Varda...
STAT+: Drug Meant to Make Gene Therapy Safer May Also Make It Less Effective
A trial by Encoded Therapeutics investigating a gene‑therapy for Dravet syndrome found that adding the immune‑suppressant sirolimus may blunt therapeutic benefit. The study enrolled 21 children, most of whom received standard steroids, while a high‑dose subgroup also received sirolimus. Researchers...
Alkermes Reports Encouraging Data From Phase III Study of Lumryz
Alkermes announced positive top‑line results from its Phase III REVITALYZ trial of extended‑release Lumryz (sodium oxybate) in adults with idiopathic hypersomnia. In a double‑blind withdrawal phase, participants who continued Lumryz maintained significantly lower Epworth Sleepiness Scale scores than those switched to...
TIL Therapies: The Impact on Cancer Research
In 2024 the FDA cleared Iovance Biotherapeutics’ TIL therapy Amtagvi (lifileucel), the first autologous, non‑CAR‑T cell treatment approved for a solid tumor—advanced melanoma. The therapy expands a patient’s own tumor‑infiltrating lymphocytes in the lab and reinfuses them, often with high‑dose...
Implantable Cytokine Factories Show Promise Against Advanced Ovarian Cancer
Researchers at Rice University and MD Anderson reported first‑in‑human results for AVB‑001, an implantable cell capsule that continuously secretes interleukin‑2 within the peritoneal cavity of patients with high‑grade serous ovarian cancer. In a Phase I dose‑escalation study of 14 platinum‑resistant...
Genprex Inc (GNPX) Q1 2026 Earnings Call Transcript
Genprex (GNPX) reported Papzimias generated $21.6 million in net product revenue for Q1 2026, up from $3.4 million in the prior quarter, driving total revenue to $23.3 million. The therapy now enjoys coverage for more than 90 % of insured U.S. lives and a permanent...
VTv Therapeutics Inc (VTVT) Q1 2026 Earnings Call Transcript
Travere Therapeutics announced the first full FDA approval of its kidney drug Filspari for focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome, expanding the product’s label beyond IgA nephropathy. In Q1 2026, Filspari net sales jumped 88% year‑over‑year to $105.2 million, driving...