BMS’ Sotyktu (Deucravacitinib) Wins EC Approval to Treat Adults with Active Psoriatic Arthritis (PsA)
The European Commission has approved Bristol‑Myers‑Squibb’s oral drug Sotyktu (deucravacitinib) for adults with active psoriatic arthritis, either alone or with methotrexate. The decision follows positive Phase III data from the POETYK PsA‑1 and POETYK PsA‑2 trials, which enrolled over 1,200 patients and met primary endpoints of ACR20 response and minimal disease activity. Patients also experienced statistically significant improvements in SF‑36 physical component scores that persisted through week 52. The approval adds the first oral TYK2 inhibitor to the EU PsA therapeutic arsenal.
Patient Perspectives on Gene Therapies and Gene Editing for Familial Cardiomyopathies
Early‑phase trials are testing gene replacement and editing for hypertrophic and dilated cardiomyopathies, yet patient viewpoints remain understudied. Interviews with 21 adults (average age 57, 57% female) revealed four decision drivers: perceived disease severity, quality‑of‑life impact, treatment safety and delivery,...
CEAS Collective: Bridging Biotech Innovation and Consumer Wellness Through Direct-to-Patient Delivery
CEAS Collective is positioning itself at the intersection of biotech and consumer wellness by offering science‑driven products through a direct‑to‑patient delivery model. The company emphasizes rigorous quality control, sourcing botanicals with verified purity, and a digital logistics platform that bypasses...
Advances in RSV Vaccine Research and Development
Respiratory syncytial virus (RSV) remains a leading cause of acute lower‑respiratory infections, accounting for roughly 33 million cases and over 3 million hospitalizations each year, especially in children under five and older adults. Recent advances focus on stabilizing the prefusion F (preF)...
Hong Kong Outlines Strategy to Strengthen Global Health Innovation and Clinical Trials
Hong Kong announced a comprehensive strategy to become a regional hub for health innovation, focusing on expanding clinical trial capacity, regulatory reform, and research commercialization. The government unveiled the Greater Bay Area International Clinical Trial Institute, a “one institute, one...
Merck, Amgen Double Down on Bad Cholesterol to Vanquish Number 1 Killer
Merck’s oral PCSK9 inhibitor enlicitide cut LDL‑C by 64.6% in an eight‑week Phase III trial, outperforming other oral non‑statin drugs. Updated ACC/AHA lipid guidelines now require LDL‑C < 55 mg/dL for ASCVD patients, leaving roughly 70% of statin users above target. The tighter goals...
BeOne Medicines Recognized as "Outstanding Global Oncology Company of the Year" At HKCT Business Awards 2026
BeOne Medicines was named "Outstanding Global Oncology Company of the Year" at the 2026 HKCT Business Awards, recognizing its rapid R&D progress and manufacturing capabilities. The Swiss‑based firm now operates in more than 45 markets, employs over 1,200 oncology R&D...
Hong Kong Highlights Innovation and Greater Bay Area Collaboration at Hospital Authority Convention 2026
Hong Kong officials used the Hospital Authority Convention 2026 to unveil a suite of health‑innovation policies, including faster drug approvals, a new regulatory centre, and expanded AI use in hospitals. A Greater Bay Area Clinical Trial Collaboration Platform will allow...
StockWatch: EnGene Shares Crater on Declines in Complete Response Rates to Bladder Cancer Therapy
enGene (ENGN) shares plunged 83% after Phase II LEGEND trial data showed its gene therapy detalimogene achieved a 43% complete response at six months, far below the 62% benchmark previously reported. The updated data also revealed a 13.3% twelve‑month response and...
Certara Inc (CERT) Q1 2026 Earnings Call Transcript
Certara reported a record Q1 2021 with revenue of $66.7 million, up 16% year‑over‑year, and adjusted EBITDA rising 20% to $23.9 million. Bookings surged 34% YoY, driven by strong demand for both software and services, while services bookings jumped 39%. The company...
MOA Limits Animal Testing at Poorly Rated Institutions
Taiwan's Ministry of Agriculture announced stricter animal‑testing rules that will bar laboratories with poor welfare ratings from initiating new experiments until they pass a re‑inspection. Effective as early as July, all research animals must be sourced from accredited providers and...
Pooled Analysis Reveals Semaglutide Shows Good Efficacy in Older Adults Aged over 65 Years
A pooled analysis of Novo Nordisk's STEP trials examined semaglutide 2.4 mg in adults over 65 with obesity. The senior subgroup (n=358) lost an average of 15.4% of body weight over 68 weeks, compared with 5.1% on placebo, and showed marked...
Gallium‐Containing Agents for Tumor Diagnosis and Therapy: Current Status and Future Prospects
Gallium-based agents are emerging as powerful tools in tumor theranostics, combining diagnostic precision with therapeutic action. 68Ga-labeled PET probes have become routine for detecting prostate, neuroendocrine and other cancers, while gallium therapeutics target DNA metabolism, tumor immunity and angiogenesis. The...
Field‑Programmable Biofunctional Films: From Assisted Fabrication to Integrated Diagnostic‐Therapeutic Devices
Field‑programmable biofunctional films (FPBFs) are thin‑film platforms that can be programmed to react to a range of physical fields—thermal, mechanical, electrical, optical, magnetic and acoustic. Recent advances in single‑ and multi‑field‑assisted fabrication have expanded their structural tunability and functional density,...
Evaluating the Effectiveness and Safety of Digitalis Glycosides in Treating Heart Failure
A JAMA‑published trial presented at the ESC Heart Failure 2026 Congress found that adding digitalis glycosides to standard therapy lowered the combined risk of cardiovascular death and first worsening heart‑failure event in patients with HFmrEF and HFrEF. The reduction was...
The DASbox® Mini Bioreactor System: Small Scale. Big Results
Eppendorf’s DASbox Mini Bioreactor System lets researchers run up to 24 parallel bioreactors in a footprint of just 7.5 cm per unit. The platform supports 60‑250 mL working volumes, ideal for cell‑screening, media optimization, and early‑stage process development. Integrated DASware software provides QbD‑focused...
MoonLake Immunotherapeutics Announces Positive Outcome From Its Final Pre-BLA Meeting with the U.S. FDA and Reports First Quarter 2026 Financial...
MoonLake Immunotherapeutics reported a positive outcome from its final pre‑BLA meeting with the U.S. FDA, securing alignment on the submission plan and label strategy for sonelokimab (SLK) in hidradenitis suppurativa (HS). The FDA accepted MIRA trial data showing a ~43%...
Is Testosterone Therapy Safe and Effective? What We Know
A December FDA expert panel advocated expanding testosterone therapy beyond classic hypogonadism, branding it a multibillion‑dollar preventive‑care opportunity. Recent evidence, notably the 5,200‑patient TRAVERSE trial, found no rise in cardiovascular events among high‑risk men receiving therapeutic doses. However, high‑dose use—often...
How a Pill Approved 25 Years Ago Transformed Cancer Treatment
Gleevec, the brand name for imatinib, emerged from Dr. Brian Druker's vision of a targeted cancer therapy that switches off the BCR‑ABL enzyme driving chronic myeloid leukemia. After early‑stage trials showed 100% response with mild side effects, Novartis accelerated the...
Common Mistakes Avoided With Expert CMC Regulatory Consulting
Pharmaceutical and biotech firms increasingly turn to expert CMC regulatory consulting to avoid costly missteps that can stall product approvals. Common pitfalls include incomplete documentation, weak manufacturing controls, inadequate stability testing, delayed regulatory planning, and mismatched global requirements. Consultants bring...
Real World Outcomes Support the Benefits of Psychedelic Therapy for Severe Depression
A Swiss compassionate‑use program evaluated psychedelic‑assisted psychotherapy using either 100 µg LSD or 25 mg psilocybin in adults with treatment‑resistant depression or anxiety. More than a third of participants reported at least a 50% reduction in depressive symptoms within three months, and...
The Emerging Cancer Treatment That’s Exciting Scientists: ‘We’ve Just Scratched the Surface on What’s Possible’
CAR T-cell therapy, a genetically engineered immunotherapy, is gaining attention after Australian actor Sam Neill announced remission from stage‑three cancer following a clinical trial. Australia has approved four CAR T products since 2018, all targeting blood cancers, while researchers push the...
CRISPR Safeguard Changes How Engineered Microbes Can Be Controlled
Researchers have developed an irreversible CRISPR‑dCas9 base‑editing biocontainment system that disables essential genes in engineered microbes without causing DNA double‑strand breaks. By targeting the start codons of multiple essential genes, the platform permanently halts cell viability and dramatically lowers escape...
VIDEO: ‘New Era of Oral Therapies’ on Horizon in Psoriasis
At the American Academy of Dermatology meeting, data from phase 3 trials showed that next‑generation TYK2 inhibitors zasocitinib (Takeda) and envudeucitinib (Alumis) achieved significant plaque‑psoriasis reduction by week 24. These oral agents build on the earlier success of deucravacitinib, offering greater specificity...
Modicus Prime Announces $8M in Funding to Enable AI Audit Readiness Across Pharma
Modicus Prime announced it has closed an additional $4.5 million financing round led by Frist Cressey Ventures, bringing its total capital to $8 million. The funds will be used to scale its Trustworthy AI Compliance Software, which embeds a compliance layer into...
Queensland Funds New Biomedical Manufacturing Projects to Strengthen Sovereign Capability
Queensland has earmarked about US$133 million from its Sovereign Industry Development Fund for its first biomedical manufacturing projects. More than US$12.9 million will support AdvanCell’s Thorium‑228 radiopharmaceutical plant and US$1.6 million will fund Southern RNA’s semi‑automated sterile fill‑finish platform, together creating roughly 100...
New Combo Shows Promise for Unknown Primary Cancer
Researchers reported phase II results of the Fudan CUP‑002 trial, which combines an anti‑PD‑1 checkpoint inhibitor, nab‑paclitaxel chemotherapy, and bevacizumab anti‑angiogenic therapy for cancer of unknown primary (CUP). The triplet achieved higher objective response rates and longer progression‑free survival than historical...
Engaging Older Adults in Pragmatic Trial Research
A 2026 multi‑methods study published in BMC Geriatrics examined how researchers involve older adults in pragmatic clinical trials. Using interviews, focus groups and surveys, the authors identified facilitators such as dedicated PPI coordinators and barriers like limited funding and absent...
Asthma Medication Formoterol Shows Promise for Treating Fatty Liver Disease
Researchers at the Medical University of South Carolina found that the asthma drug formoterol reverses fatty liver in mouse models of metabolic dysfunction‑associated steatohepatitis (MASH) and is linked to lower liver‑related complications in retrospective patient data. The β‑2 adrenergic agonist...
What Does Cannabis ‘Rescheduling’ Mean for Science and Society?
In April 2026 the U.S. Department of Justice reclassified cannabis from Schedule I to Schedule III, ending a federal ban that has hampered scientific study for decades. The move clears a major regulatory hurdle, allowing federally funded researchers to conduct randomized controlled...
LSD Microdosing Linked to Acute Mood Improvements in Adults with Depression
A small open‑label pilot gave 19 adults with major depressive disorder sublingual LSD microdoses (4‑20 µg) over eight weeks. Participants reported acute spikes in creativity, energy and social connectedness on dosing days, with a 60% average reduction in overall depression severity...
The BioPharm Brief: Bispecifics, Biocatalysis, and Dual-Pathway Therapies
Harbour BioMed has secured FDA clearance to start a Phase I trial of its B7H4×CD3 bispecific antibody, HBM7004, in patients with advanced solid tumors. Merck published a scalable biocatalytic process for its oral PCSK9 inhibitor, enlicitide decanoate, showcasing a new route...
The Gates Foundation Is Funding A Startup’s Plan To Fight Malnutrition With Bacteria
The Bill & Melinda Gates Foundation has pledged new funding to Kanvas Biosciences to develop a synthetic microbiome pill aimed at treating environmental enteric dysfunction (EED), a gut‑inflammation disease that threatens roughly 150 million children worldwide. Kanvas uses machine‑learning‑driven microbiome mapping to...
Odyssey Completes Journey to NASDAQ: Public Equity Report
Odyssey Therapeutics completed its long‑awaited IPO and debuted on Nasdaq, after withdrawing a previous filing in June 2025. The immunology‑focused company priced its shares in early May 2026, marking a successful market entry. At the same time, three biotech firms—Cytokinetics,...
Tr1X: Inducing Long-Term Immune Tolerance with Allogeneic Tr1 Cells
BioCentury has updated its website privacy framework, detailing the use of strict, functional, marketing, advertising, and analytics cookies. The policy explains that essential cookies enable authentication, registration, and navigation, while functional cookies enhance personalization. Marketing and advertising cookies are used...
Brain Stimulation Boosts Willpower to Quit Smoking
A double‑blind, fMRI‑guided trial found that high‑frequency rTMS targeting the left dorsolateral prefrontal cortex (DLPFC) cut smokers’ daily consumption by about 11 cigarettes, outperforming sham and orbitofrontal cortex stimulation. The 15‑session protocol boosted prefrontal activity while suppressing reward‑related regions, correlating...
FDA Approves Ocrevus for Relapsing-Remitting MS in Children Aged 10 Years and Up
The U.S. Food and Drug Administration has approved Genentech's ocrelizumab (Ocrevus) for children aged 10 and older who weigh at least 55 lb, expanding its use beyond adult multiple sclerosis (MS) populations. The decision follows the OPERETTA II trial, which demonstrated superior...
Addressing Manufacturing and Access Barriers in Advanced Therapeutics
Advanced cell and gene therapies are moving from research to commercial markets, but their complex manufacturing creates variability that delays patient access. Industry leaders are deploying process analytical technologies (PAT) and artificial intelligence (AI) to gain real‑time insight and predictive...
Economic Assistance and Incentives for Drug Development
The FDA and other federal agencies offer a suite of pre‑approval assistance and post‑approval incentives to lower the financial risk of drug development. Programs such as the Orphan Products Grant, SBIR/STTR funding, and PDUFA fee waivers help sponsors fund clinical...
Odyssey’s IPO Brings In $304M for Quest to Develop Better Immunology Drugs
Odyssey Therapeutics priced 15.5 million shares at $18, raising $304 million including a $25.2 million private placement. The funds will finance Phase 2a/2b trials of OD‑001, an oral RIPK2 inhibitor for ulcerative colitis, and advance OD‑002, a SLC15A4 inhibitor, toward Phase 1/2a. Odyssey’s platform targets...
Exclusive-Kennedy's Health Officials Explored US Ban of some Widely Used Antidepressants, Sources Say
U.S. Health and Human Services officials recently examined whether to restrict certain selective serotonin reuptake inhibitors (SSRIs) such as Zoloft, Prozac and Lexapro, amid Health Secretary Robert F. Kennedy Jr.'s push to curb their use. Kennedy announced reimbursement guidelines for...
Entera Announces First Quarter 2026 Financial Results and Updates Across Its Oral Peptide Programs
Entera Bio reported Q1 2026 results, highlighting a streamlined Phase 3 protocol for its lead osteoporosis candidate EB613 and a completed Phase 1 bridging study that positions a single‑tablet formulation for the upcoming trial. The company also advanced its partnership with OPKO, securing...
Bristol Myers Squibb Accused of Buying Off Competitors to Delay Development of Generic Cancer Drugs
Centene Corp. filed a federal antitrust lawsuit accusing Bristol Myers Squibb (BMS) of conspiring with generic manufacturers to delay competition for lenalidomide and its brand version Revlimid. The complaint says BMS earned $5.2 billion in Revlimid sales in 2023 and raised...
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[Comment] Could Enpatoran Add to Our Therapeutic Toolbox in SLE?
Systemic lupus erythematosus (SLE) remains a heterogeneous disease with only two novel agents—BAFF and type‑1 interferon receptor inhibitors—approved since the 1950s. These drugs often fall short as stand‑alone treatments, are expensive, and are not uniformly accessible worldwide. Clinicians continue to...
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[Comment] RTS,S/AS01 Implementation Reduces Mortality in African Children
A recent Lancet analysis shows that the RTS,S/AS01 (Mosquirix) malaria vaccine rollout in Ghana, Kenya and Malawi cut child mortality by roughly 20% after three years of implementation. The program reached over five million children under five, integrating the vaccine...
Glint of Light in Therapy for Deadly ALS After Decades of Struggle
Researchers reported that tofersen, an antisense oligonucleotide targeting the SOD1 gene, dramatically slowed and even reversed disease progression in a subset of ALS patients with the rare SOD1 mutation. The phase‑III trial, published in JAMA Neurology, showed about a quarter...
Inclisiran Linked to Lower MACE, AMI Rates in High-Risk ASCVD Population
Inclisiran, added to maximally tolerated statins, lowered 4‑point major adverse cardiovascular events (MACE) from 22.7% to 14.6% in a real‑world ASCVD cohort. The therapy also reduced acute myocardial infarction (5.0% vs 8.5%) and all‑cause hospitalizations (20.8% vs 28.8%) over one...
Taking a Look at the Toxicity Trade-Offs of EPCORE FL-1
The phase 3 EPCORE FL‑1 trial added AbbVie/Genmab’s bispecific antibody epcoritamab to the rituximab‑lenalidomide (R²) regimen for relapsed or refractory follicular lymphoma. The triplet produced a 79% reduction in progression‑or‑death risk and lifted 16‑month progression‑free survival to 85.5%, nearly doubling the complete...
Search for Regulatory References | Drugs
The FDA has compiled a searchable reference guide that aggregates key regulatory resources for drug and biologics developers. It includes links to guidance on the BPCI Act’s license provision, Abbreviated New Drug Applications (ANDA), CDER small‑business assistance, and submission address...
STAT+: Capricor Therapeutics Accuses Nippon Shinyaku of Slow-Walking Plans on Duchenne Drug
Capricor Therapeutics has filed a lawsuit in New Jersey alleging that Nippon Shinyaku and its U.S. arm, NS Pharma, are deliberately stalling the U.S. launch of deramiocel, its experimental Duchenne muscular dystrophy therapy. The complaint highlights a pricing formula error...