Re: Alzheimer’s Drugs Targeting Amyloid Do Not Produce Clinically Meaningful Effects, Concludes Cochrane Review
A recent Cochrane review concluded that amyloid‑targeting drugs for Alzheimer’s disease do not deliver clinically meaningful benefits, prompting disappointment among researchers, investors, and caregivers. In a BMJ rapid response, emeritus professors Elaine and Robert Perry argue that cholinergic therapy—available for three decades—remains a viable option, citing improvements in cognition, behavior, and disease‑specific response patterns. They highlight advances such as drug‑specific efficacy differences, combination regimens with memantine, novel delivery routes, and natural‑product cholinesterase inhibitors. The letter also notes emerging strategies like muscarinic M1 agonists and deep‑brain stimulation of basal forebrain nuclei as future avenues.
Merck, Eisai’s Keytruda Triplet Fails to Improve Survival in Kidney Cancer
Merck and Eisai announced that their Phase 3 LITESPARK‑012 trial of a three‑drug regimen—Keytruda, Welireg and Lenvima—failed to improve overall survival or progression‑free survival in first‑line renal cell carcinoma. The control arm received the approved Keytruda‑Lenvima doublet, which also did not...
SaNOtize - 727784 - 04/17/2026
The U.S. Food and Drug Administration issued a warning letter to SaNOtize, the maker of “NOWONDER™ Nasal Cleanser,” on April 17, 2026. The agency determined the product is an unapproved new drug because its labeling and website claim nitric‑oxide‑based immune benefits, violating sections 505(a)...
Pro Numb Tattoo Numbing Spray, LLC - 722589 - 04/14/2026
The FDA issued a warning letter to Pro Numb Tattoo Numbing Spray, LLC for multiple Current Good Manufacturing Practice (CGMP) violations, including failure to test finished drug batches, inadequate raw‑material verification, and lack of stability data. The firm also marketed...
Neolaia Synthesizes New CD38 Inhibitors
Biohaven disclosed detailed preclinical data on BHV‑2100, a TRPM3 calcium‑channel modulator aimed at neuropathic pain. A new meta‑analysis concluded that anti‑amyloid therapies for Alzheimer’s have not demonstrated clinically meaningful benefits, intensifying debate over the approach. Jiangsu and Shanghai Hengrui patented...
What New Atopic Dermatitis Treatments Are in the Pipeline in 2026?
The atopic dermatitis pipeline in 2026 is dominated by next‑generation biologics and selective small molecules that aim to improve efficacy while reducing side‑effects. Connect Biopharma’s rademikibart achieved near‑complete skin clearance in a phase 3 trial, and Apogee’s extended‑half‑life zumilokibart showed durable...
Incyte Discloses New TYK2 And/Or JAK1 Inhibitors
Incyte announced the discovery of a new series of small‑molecule inhibitors that selectively target TYK2 and JAK1, two kinases central to cytokine signaling in autoimmune disorders. The compounds demonstrated sub‑nanomolar potency in cell‑based assays and favorable safety margins in early...
Pharma Exporters Facing Issues with Online National Drug Licensing System
Indian pharmaceutical exporters are encountering technical problems with the Online National Drug Licensing System (ONDLS), which issues Certificates of Pharmaceutical Products (COPP) under the WHO Good Manufacturing Practices scheme. The Pharmaceuticals Export Promotion Council (Pharmexcil) has launched a feedback drive...
Biocon Receives Health Canada Approval for Bosaya and Vevzuo (Biosimilars, Prolia and Xgeva)
Biocon has secured a Notice of Compliance from Health Canada for its denosumab biosimilars, Bosaya and Vevzuo, which mirror Amgen’s Prolia and Xgeva. The approval follows a comprehensive data package demonstrating comparable quality, safety and efficacy to the reference products....
This Biotech Firm Has Room to Run Despite Surging Nearly 500% in Past Year, Morgan Stanley Says
Arrowhead Pharmaceuticals’ stock has rocketed 473% over the past year, prompting Morgan Stanley to upgrade the shares to overweight and lift its price target to $100 from $78, indicating roughly a 44% upside. The firm is set to release Phase‑3...
Rethinking When to Start Long-Acting HIV Therapy
Real‑world data from the OPERA cohort of over 5,000 patients show that starting long‑acting cabotegravir plus rilpivirine (CAB+RPV LA) in individuals with detectable viral loads—about 11% above 50 copies/mL—can still achieve virologic suppression comparable to patients who begin treatment already...
Monopar Therapeutics Reports P-III (FoCus) Trial Data on ALXN1840 in Wilson Disease
Monopar Therapeutics reported Phase III FoCus trial results for ALXN1840, an oral copper‑binding agent, in Wilson disease patients with neurologic involvement. The study enrolled 77 patients on ALXN1840 and 35 on standard of care, showing neurologic worsening in only 9% versus...
STAT+: Tortugas Neuroscience Launches with Hopes to Develop Drugs for Brain Disorders, Other Conditions
Tortugas Neuroscience launched with a $106 million financing round led by Cure Ventures, The Column Group and AN Ventures. The startup has licensed two schizophrenia and tinnitus candidates from China’s Jiangsu Hansoh and two additional therapies for focal epilepsy and encephalopathies...
STAT+: BioAge Says Experimental Pill Aimed at Reducing Heart Risks Significantly Reduced Inflammation
BioAge Labs reported that its investigational cardiovascular‑risk pill BGE‑102 dramatically lowered inflammation in a Phase 1 trial. A 60‑mg dose cut high‑sensitivity C‑reactive protein (hs‑CRP) by 85% after one week, with the effect persisting through three weeks. The same reduction was...
Merck-Eisai’s Kidney Cancer Drug Combo Fail to Improve Survival in Late-Stage Trial
Merck and Eisai reported that their late‑stage trial of Keytruda plus Lenvima with Welireg, as well as a Lenvima‑MK‑1308A combo, failed to improve overall survival or progression‑free survival in clear cell renal cell carcinoma. The study enrolled 1,688 patients and...
Akeso Announces P-II (COMPASSION-26) Trial Results on Cadonilimab + CT in 1L PDAC
Akeso reported Phase II COMPASSION‑26 data showing its bispecific antibody cadonilimab combined with chemotherapy as a first‑line option for advanced pancreatic ductal adenocarcinoma. With a median progression‑free survival of 11.1 months and median overall survival exceeding 23 months, the regimen delivered 12‑month and...
How the Depo-Provera Brain Tumor Lawsuit Works
The Depo‑Provera brain tumor lawsuit alleges that the contraceptive shot’s manufacturer failed to warn users of an increased risk of meningiomas, a type of brain or spinal‑cord tumor. Plaintiffs must demonstrate a causal link through medical records, expert testimony, and...
Eli Lilly Doubles Down on in Vivo with $7bn Kelonia Buyout
Eli Lilly announced a deal to acquire Kelonia Therapeutics for up to $7 bn, securing its lentiviral‑based in vivo gene‑therapy platform iGPS and an early‑stage multiple‑myeloma asset, KLN‑1010. The transaction includes a $3.25 bn cash payment upfront and up to $3.75 bn in milestone payments...
Why Aspirin Is Becoming a Weapon Against Cancer
Aspirin, the 4,000‑year‑old painkiller, is now shown to cut colorectal cancer risk in high‑genetic‑risk patients. A 10‑year trial of 861 Lynch‑syndrome participants found a daily 600 mg dose halved cancer incidence, and a lower 75‑100 mg dose appears equally effective. The UK...
CPC Biotech Debuts Unified Bioprocess Fluid Portfolio
CPC Biotech, a new brand under Dover’s Pump Solutions Group, launched by merging CPC’s sterile connector expertise with PSG Biotech’s low‑shear pumps, flow meters and sensors. The unified portfolio offers biopharma manufacturers a single source for connectors, pumps, and measurement...
Atsena Secures DMC Approval for LIGHTHOUSE Trial
Atsena Therapeutics received a recommendation from its independent data monitoring committee to launch the pivotal Part C of the LIGHTHOUSE Phase I/II/III trial for ATSN‑201, its gene‑therapy candidate targeting X‑linked retinoschisis (XLRS). Part C will enroll 76 patients across Europe and North America,...
Eli Lilly to Acquire Kelonia Therapeutics for ~$7B
Eli Lilly announced a definitive agreement to acquire Kelonia Therapeutics for roughly $7 billion in cash, including an upfront payment of $3.25 billion. The deal brings Kelonia’s in‑vivo gene placement system (iGPS0) and its lead candidate, KLN‑1010, a one‑time IV gene therapy that...
AstraZeneca’s Ultomiris Cuts Urine Protein in Late-Stage Kidney Disease Trial
AstraZeneca announced that its rare‑blood‑disorder drug Ultomiris achieved the primary goal in a late‑stage trial for IgA nephropathy, a rare kidney disease. An interim analysis showed a statistically significant reduction in urine protein by week 34, with effects detectable as early...
Probiotics Shown to Relieve Constipation in Kids: Vietnam RCT
A Vietnam‑based randomized, double‑blind trial found that two Bacillus spore probiotic liquids, LiveSpo Kids and LiveSpo Preg‑Mom, significantly eased functional constipation in preschool children. Over four weeks, the probiotic groups experienced a 3.6‑ to 4‑fold reduction in low‑frequency bowel movements,...
APC-Deficient Cancer Cells Rely on Single Enzyme for Survival
Researchers have identified aldehyde dehydrogenase 2 (ALDH2) as a critical survival factor for colorectal cancer cells lacking functional APC. Computational screening and lab experiments show that pharmacological inhibition of ALDH2, using agents such as disulfiram, sharply reduces proliferation and induces...
Trial Shows Safety of Novel KIR-CAR T Therapy in Solid Tumors
A Phase I dose‑escalation trial of SynKIR‑110, a novel KIR‑CAR T therapy, demonstrated safety in nine patients with advanced ovarian cancer, mesothelioma or cholangiocarcinoma. The multi‑chain design uses NK‑cell receptors to provide an on/off switch, reducing T‑cell exhaustion and side...
CRISPR Screens Map Human T‑Cell Genes That Promote or Block HIV Infection
Researchers at Gladstone Institutes and UCSF used genome‑wide CRISPR activation and knockout screens in primary human CD4+ T cells to map host genes that either promote or restrict HIV infection. By optimizing infection rates to about 70%, they could perturb...
Trump’s Psychedelic Order Tests Review Norms
BioCentury’s website uses a tiered cookie system to support essential functions, personalization, marketing, advertising, and analytics. Strictly necessary cookies are always active, enabling authentication, registration, and navigation, while functional cookies enhance site features. Marketing and advertising cookies help tailor product...
Nektar’s Phase II Alopecia Extension Reveals Late Responders to IL-2 Therapy
Nektar Therapeutics reported results from a Phase II extension study of its interleukin‑2 (IL‑2) therapy for alopecia areata. The data revealed a subset of patients who did not respond initially but achieved meaningful hair regrowth after prolonged exposure, raising the...
Personalized CRISPR Therapies Could Soon Reach Thousands — Here’s How
The FDA has proposed a "plausible mechanism" pathway to streamline approval of personalized CRISPR gene‑editing therapies. The new framework would let developers test multiple patient‑specific guide RNAs within a single trial, potentially shrinking the approval timeline from four years to...
US Speeds Research Into Mind-Altering Drugs — Including Mysterious 'Ibogaine'
On April 18, President Donald Trump signed an executive order to accelerate U.S. research on ibogaine and other psychedelics, directing the FDA to fast‑track review and providing $50 million in federal funding to match state programs. The order aims to ease...
AI Model 'Reads' Protein Pairs, Unlocking New Insights Into Disease and Drug Discovery
Researchers at the National University of Singapore unveiled a paired protein language model (PPLM) that learns from two interacting proteins simultaneously, a departure from traditional single‑sequence AI approaches. Trained on more than 3 million protein pairs, the model powers three tools—PPLM‑PPI,...
Lab-Grown Mini Brain Models Offer New Hope for Diagnosing and Treating Alzheimer’s Disease
Johns Hopkins researchers created patient‑derived hindbrain organoids that faithfully reproduce Alzheimer’s molecular hallmarks. Using these mini‑brains, they tested the SSRI escitalopram, uncovering strikingly different serotonin‑signaling responses across individual organoids. Proteomic analysis of extracellular vesicles revealed disease‑related proteins that shifted with...
STAT+: At AACR, a Provocative Use of CAR-T, Merck’s New Thing and Cancer’s Geography Problem
At the AACR 2026 meeting, early‑phase data showed Merck‑partnered CAR‑T therapy Carvykti eliciting deep responses in 20 high‑risk smoldering multiple myeloma patients, suggesting a preventive angle for a precursor disease. The conference also featured Merck’s first glimpse of an oncology...
Trump Clears Path for Expanded Psychedelic Research to Treat Veterans’ PTSD
President Donald Trump signed an executive order directing the FDA to accelerate reviews of psychedelic therapies and earmarking at least $50 million for ibogaine research aimed at treating veteran PTSD. The order also creates a Right‑to‑Try pathway for severely ill patients...
Lilly Acquiring Kelonia In Largest Funded Biotech Startup Purchase In Years
Eli Lilly announced it will acquire Kelonia Therapeutics for up to $7 billion, marking the largest venture‑backed biotech purchase in years. The deal consists of $3.25 billion paid upfront with an additional $3.75 billion tied to clinical, regulatory and commercial milestones. Kelonia, founded only...
Delgocitinib Maintains QOL, Productivity Improvements at 52 Weeks in Chronic Hand Eczema
The open‑label DELTA 3 extension of the phase 3 delgocitinib trials shows that patients with moderate‑to‑severe chronic hand eczema who continued with twice‑daily or as‑needed delgocitinib cream for a full year maintained significant gains in disease‑specific and generic quality‑of‑life scores. Across 472...
How Trump's Psychedelics Executive Order Could Unlock Stalled Cannabis Reform
President Donald Trump signed an executive order that accelerates research, clinical trials, and Right‑to‑Try access for psychedelics such as psilocybin, MDMA and ibogaine, while leaving their scheduling unchanged. The order follows a prior, stalled effort to reschedule cannabis, highlighting the...
The ROI of Beating Cancer
A small early‑stage trial showed that a personalized mRNA vaccine triggered an immune response and extended survival for pancreatic cancer patients, a disease that kills over 90% within five years. Economists estimate that between 1988 and 2000, cancer detection and...
A Protein Engineering Method May Lead to More Exact Cancer Treatments
Researchers at the University of Texas at Dallas unveiled ProSSpeC, a machine‑learning model that predicts protease substrate specificity by mining evolutionary data from thousands of related enzymes. The model identified engineered synthetic proteases that outperformed the commonly used tobacco etch...
OpenAI Launches GPT Rosalind for Life Sciences Research
OpenAI has unveiled GPT Rosalind, a large‑language model tuned for life‑sciences research, designed to accelerate early‑stage drug discovery by automating literature review, evidence synthesis, hypothesis generation, and experimental planning. The model outperforms GPT‑5.4 on multiple chemistry, protein‑engineering and genomics benchmarks, and...
The BioPharm Brief: Oncology Innovations Continue with Durable Survival, In Vivo CAR-T, and Combination Therapies
Immunocore reported five‑year overall survival data confirming tebentafusp’s durable benefit in metastatic uveal melanoma, the first T‑cell receptor‑based therapy to show a clear survival advantage in this rare cancer. Eli Lilly announced the acquisition of Kelonia Therapeutics to accelerate in‑vivo CAR‑T...
STAT+: In Early Trial, CAR-T Results Raise Hope of Preventing Multiple Myeloma in High-Risk Patients
A phase‑I trial of CAR‑T therapy in high‑risk smoldering multiple myeloma reported that all 20 participants achieved undetectable disease after treatment. The results, presented at the AACR meeting, suggest the possibility of preventing progression to active myeloma, a deeper response...
ViewsML Secures $4.9 Million to Help Scientists Virtually Analyze Tissue Samples
ViewsML, a Vancouver AI startup, closed a C$4.9 million seed round (approximately US$3.6 million) to commercialize its virtual biomarker platform. The technology uses artificial intelligence to extract quantitative biomarker data from pathology images without traditional chemical staining. By turning a lab‑bound process...
AB Science: New Publication on Medrxiv Demonstrating Substantial Survival Benefits and Preserved Quality of Life with Masitinib in ALS Patients
AB Science announced a medRxiv preprint showing its tyrosine‑kinase inhibitor masitinib dramatically improves survival for amyotrophic lateral sclerosis (ALS) patients. The data reveal a 5‑year survival rate of 42.3% overall and 52.9% among those treated before complete functional loss, roughly...
Trump, FDA Plan to Expedite Psychedelic Development
President Donald Trump publicly endorsed psychedelic medicines as a breakthrough for severe mental health disorders, pledging to fast‑track their research and development. The White House announcement coincides with the FDA’s plan to create an accelerated review pathway for psychedelic drug...
FDA Grants Priority Review for Padcev Plus Keytruda in Bladder Cancer Treatment
The U.S. Food and Drug Administration has granted Priority Review to the peri‑operative combination of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) for muscle‑invasive bladder cancer (MIBC). The Phase 3 EV‑304 trial demonstrated a 47% reduction in recurrence, progression or death and a...
Novartis Cuts Two Programs in Cancer-Related Blood Clots
Novartis announced the termination of two late‑stage programs targeting cancer‑related blood clots after a pivotal trial demonstrated inferior efficacy versus existing anticoagulants. The candidates, one of which Novartis out‑licensed in 2019, were being developed to address the high unmet need...
Viatris Recalls Extended-Release Xanax over Dissolution Test Failure
Viatris has issued a Class II recall of a single batch of its extended‑release Xanax (Xanax XR) after dissolution testing showed the tablets did not meet release specifications. The affected bottles, each containing 60 3‑mg tablets, were manufactured in Ireland and are being...
Substack Live | Flagship Pioneering Announcement: Building on the Code of Life
Flagship Pioneering is hosting a Substack Live session on April 21 at 12:30 pm ET featuring origination partner Jake Rubens. The event will unveil a new initiative that leverages the "code of life" to advance synthetic‑biology‑based therapeutics. Rubens, an MIT‑trained synthetic biologist...