Chlorine Dioxide, Raw Camel Milk: The FDA No Longer Warns Against These and Other Ineffective Autism Treatments
The FDA removed a consumer webpage that warned against chlorine dioxide, raw camel milk, chelation and hyperbaric oxygen as ineffective autism treatments, citing a routine cleanup of outdated content. The page, unchanged since 2019, remains only via the Internet Archive, leaving parents without an official federal warning. The removal occurs as HHS Secretary Robert F. Kennedy Jr. reshapes autism policy, appointing panel members who support unproven therapies. Advocacy groups fear this signals a broader retreat from evidence‑based guidance on dangerous autism remedies.
NICE Backs First Disease-Modifying Drug for ARG1 Deficiency
Immedica’s pegzilarginase (Loargys), the first enzyme replacement therapy for arginase‑1 (ARG1) deficiency, has received NICE endorsement for NHS use in the UK. The weekly IV or subcutaneous treatment cuts blood arginine levels by roughly 80% and is recommended for patients...
£20M Fund Backs UK Addiction Treatment Tech
The UK government, via Innovate UK, has launched a £20 million funding programme to accelerate development of medicines, medical devices, wearables, virtual‑reality therapies and AI‑enabled tools for drug and alcohol addiction. Grants of up to £10 million for late‑stage projects and up to...
Portal Diabetes’ Insulin Pump Receives FDA Breakthrough Device Designation
Portal Diabetes has secured FDA breakthrough device designation for its implantable Portal Pump, an insulin delivery system that pairs an abdominal pump with continuous glucose monitoring and concentrated insulin. The company also launched a Phase I study of temperature‑stable Portal Insulin...
Janux Commences Participant Dosing in Phase I JANX011 Trial
Janux Therapeutics has dosed the first participant in a Phase I, open‑label, dose‑escalation trial of JANX011, its inaugural candidate from the adaptive immune response modulator (ARM) platform. The bispecific antibody targets CD19‑expressing B cells to achieve a deep, lasting immune reset...
J&J’s Rybrevant Faspro Gains FDA Approval for New Dosing in NSCLC
Johnson & Johnson received FDA approval for a once‑monthly subcutaneous regimen of Rybrevant Faspro combined with Lazertinib for first‑line treatment of advanced EGFR‑mutated non‑small cell lung cancer. The new schedule delivers clinical outcomes comparable to the earlier bi‑weekly dosing while preserving...
Six Biotechs to Know in Barcelona
Barcelona is emerging as a premier European life‑sciences hub, contributing 7.6 % of Catalonia’s GDP and ranking sixth in scientific output. Six local biotech firms—Accure Therapeutics, Oryzon Genomics, SpliceBio, Peptomyc, Ona Therapeutics and Integra Therapeutics—are advancing diverse modalities from small‑molecule neuroprotectors...
Extens-Backed Orthalis Picks up Dentalsoft
Orthalis, backed by private equity firm Extens, announced the acquisition of Dentalsoft, a specialist orthodontic software provider. The purchase creates a new entity, SignalSoft Développement, focused on delivering software services to orthodontic professionals. By integrating Dentalsoft’s tools, Orthalis expands its...
AI and OCT Integration Highlights Promising Advances in Detecting Lipid-Rich Coronary Artery Plaques
Researchers at KAIST unveiled an AI‑driven method that extracts wavelength‑dependent information from standard optical coherence tomography (OCT) to automatically detect lipid‑rich coronary plaques. The weakly supervised deep‑learning model learns from frame‑level labels, eliminating the need for pixel‑wise annotations and works...
Collegium Pharmaceutical, Inc. (COLL) Gains Momentum on Jornay PM, Truist Highlights Robust Pain Portfolio
Collegium Pharmaceutical (NASDAQ:COLL) saw Truist Securities lift its price target to $58 and reaffirm a Buy rating, citing a strong pain‑management portfolio and growing momentum for its extended‑release opioid, Jornay PM. The company released its 2026 outlook, projecting total product revenue...
Amneal Pharmaceuticals, Inc. (AMRX) Added to S&P SmallCap 600 Index, Boosting Investor Visibility
Amneal Pharmaceuticals (AMRX) was added to the S&P SmallCap 600 Index on Jan. 29, giving the company heightened investor exposure. JP Morgan subsequently raised its price target by $4 while keeping a Buy rating, signaling analyst confidence. The firm also announced a...
Bank of America Cites Zoetis Inc.’s (ZTS) Strong Q4 Performance and Fiscal 2026 Outlook
Bank of America raised its price target for Zoetis Inc. (ZTS) to $140 from $135 while maintaining a Neutral rating, citing the company’s strong fourth‑quarter 2025 results and an upbeat fiscal 2026 outlook. Zoetis reported adjusted EPS of $1.48, topping...
AI-Powered Liquid Biopsy Advances Pediatric Brain Tumor Classification
Researchers at St. Jude Children’s Research Hospital introduced M‑PACT, an AI‑driven liquid‑biopsy platform that classifies pediatric brain tumors from cerebrospinal fluid with 92% accuracy. The deep neural network was trained on over 5,000 DNA methylation profiles covering about 100 tumor...
ScribeRyte ClickNote Seamlessly Flows AI-Generated SOAP Notes Into Browser-Based EMRs
ScribeRyte AI introduced ClickNote, a free Chrome extension that automatically inserts AI‑generated SOAP notes into any browser‑based EMR. The tool leverages ambient speech technology, multilingual support, and HIPAA‑secure protocols to streamline documentation. ScribeRyte claims providers can reclaim up to ten...
Kipu Health Launches Elevate 2026
Kipu Health announced Elevate 2026, a three‑day customer conference in Carlsbad, California, showcasing its AI‑native Kipu Helix Intelligent Operating System for behavioral health. The event gathers executives, operators and administrators to explore AI‑driven strategies, hands‑on programming and peer insights. Kipu...
Routes Healthcare Unifies a Complex SaaS and ERP Landscape with BPA Platform to Strengthen Operations and Continuity
Routes Healthcare, a leading health and social care provider in northern England, adopted the BPA Platform to integrate its Sage 200 ERP with a wide range of SaaS applications. The low‑code integration layer unified data, automated workforce communication, recruitment, and...
NHS Business Services Authority Improves Online Baby Loss Certification
The NHS Business Services Authority (NHSBSA) has completed a beta reassessment of its Baby Loss Certificate service, achieving compliance with all 14 government service standards. The digital service, created after the Pregnancy Loss Review, now offers bereaved parents formal recognition...
TheKey’s CEO Plots Home Health Expansion
TheKey, a Delray, Florida‑based home‑care provider, is moving to add private‑pay nursing services in four new states, aiming for a total of six states by the end of 2026. The company is finalizing licensure for the southern half of California...
Ongoing Regulatory Uncertainty Means Innovation Is Now Higher Risk
Regulatory uncertainty is rising as the FDA shifts leadership, adopts a single‑trial approval pathway, and tightens its benefit‑risk framework. While the one‑trial standard promises faster, cheaper market entry, recent surprise complete response letters (CRLs) show that even successful Phase 3 results...
Ionis Paves Its Own Path as Initial Tryngolza Launch Defies Expectations
Ionis Therapeutics announced that its GSK‑partnered antisense drug bepirovirsen achieved a statistically significant functional cure rate of roughly 15‑20% in a Phase 3 trial, far surpassing the 1‑3% rate of existing hepatitis B therapies. The company also reported a strong first‑year launch...
Proliferating Patents, Lawsuits Stave Off Pharmas’ Generic Competitors
A new analysis in Health Affairs Scholar reveals that brand‑name drugmakers are exploiting the Hatch‑Waxman framework through serial patent litigation and continuation patents to extend market exclusivity. By filing multiple overlapping patents, companies can repeatedly sue generic challengers, triggering 30‑month...
Low-Value X-Ray Imaging for Facial Trauma Still Prevalent, Despite CT’s Superiority
A new JAMA Network Open study of 281,000 U.S. facial‑trauma patients shows that 26% still receive plain X‑ray as the first imaging test, despite CT being the gold‑standard for fracture detection. Use of low‑value radiographs has fallen from 33% in...
ArgenTag, PacBio Partner on Long-Read Single-Cell Transcriptomics
ArgenTag, a Buenos Aires‑based startup, has entered PacBio’s Compatible Partner Program, confirming that its Single‑Cell RNA Library Kit works with PacBio’s Kinnex RNA kits for long‑read isoform sequencing. The partnership eliminates the need for expensive cell‑partitioning instruments by using ArgenTag’s...
NB Releases New Digital Health Strategy
New Brunswick’s government unveiled a comprehensive digital health strategy aimed at creating a modern, connected, and patient‑centred system. The plan expands the “digital front door,” modernizes electronic health records, and introduces AI‑driven tools to streamline provider workflows. It allocates a...
INOVAIT Announces Innovation Award Winners
INOVAIT announced the 2025/26 award winners at its Ottawa meeting, honoring Altis Labs with the Maple Leaf Award for AI imaging collaborations, Nova Scotia Health with the Aurora Borealis Award for industry‑academic synergy, and Profound Medical with the Mount Logan...
NWT Looks at Acquiring MRI Scanner
The Northwest Territories is conducting a feasibility study to install an MRI scanner at Yellowknife’s Stanton Territorial Hospital, aiming to end the practice of sending patients to Alberta for scans. Health Minister Lesa Semmler highlighted that the study will assess...
Infoway Pulls the Plug on PrescribeIT
Canada Health Infoway announced that its e‑prescribing platform PrescribeIT will be discontinued on May 29, ending a program that has cost more than $250 million since its 2017 launch. The service never achieved scale, with fewer than 5 percent of prescriptions routed through...
Bausch + Lomb Corp (BLCO) Q4 2025 Earnings Call Transcript
Glaukos Corp reported record fourth‑quarter 2025 sales of $143.1 million, a 36% year‑over‑year increase, and annual net sales of $507.4 million, up 32%. The company reaffirmed its 2026 revenue outlook of $600‑$620 million, indicating more than 20% growth. Growth was powered by the...
Sex Differences in Placebo and Antidepressant Response to Intranasal Esketamine for Treatment-Resistant Depression
A pooled analysis of five double‑blind, placebo‑controlled intranasal esketamine trials (n≈1,016) confirms that esketamine significantly reduces Montgomery‑Åsberg Depression Rating Scale (MADRS) scores versus placebo. Female participants showed larger total MADRS improvements at later visits (days 22 and 28) and greater reductions in...
Community Health Systems Inc (CYH) Q4 2025 Earnings Call Transcript
Community Health Systems reported a 2.1% year‑over‑year increase in same‑store net revenue for Q4 2025, driven by rate growth and higher acuity, while adjusted EBITDA reached $395 million with a 12.7% margin. The company continued its aggressive deleveraging, cutting net leverage...
Insulet Corp (PODD) Q4 2025 Earnings Call Transcript
Inspire Medical Systems reported a strong fourth‑quarter, with revenue rising 12% to $269 million and full‑year sales up 14% to $912 million, driven by existing and new center growth. The company set 2026 revenue guidance between $950 million and $1 billion, reflecting a 4%‑10%...
Ocular and Upstream Drop on Less-than-Wow Data; Compass Rallies on Second Phase III Win for Psilocybin
Ocular Therapeutix reported that its VEGF1/2/3 inhibitor Axpaxli outperformed aflibercept in the Phase III SOL‑1 trial, with 74.1% of patients maintaining visual acuity at 36 weeks versus 55.8% for the comparator. The study also met a 52‑week durability endpoint, showing 65.9%...
STAT+: At Drugmakers’ Forum, Oz Gets a Friendly Embrace, While Makary Faces Tough Questions
At a PhRMA‑hosted forum, CMS Administrator Mehmet Oz engaged warmly with Pfizer CEO Albert Bourla, championing vaccines and proposing closed‑door policy talks and even suggesting industry executives consider government jobs. In contrast, FDA Commissioner Marty Makary was sharply questioned by...
Oral SERD Spotlight. Plus: Setbacks at FDA— a BioCentury Podcast
The BioCentury This Week podcast highlighted the rapid expansion of oral selective estrogen receptor degraders (SERDs) as a leading application of targeted protein degradation, noting several candidates advancing toward late‑stage trials. Host Lauren Martz examined the competitive landscape and the therapeutic...
State Bills Target Nursing Home Transparency, Staffing and CNA Funding
Virginia lawmakers are debating a suite of bills aimed at improving nursing home oversight, staffing, and transparency. One proposal sets minimum nursing care hours at 3.08 per resident per day through 2027, rising to 3.25 by 2031 for facilities in...
‘We’re Not Through’: More Hybrid QM Data Collection Likely Ahead for Nursing Homes
The Centers for Medicare & Medicaid Services (CMS) is expanding its hybrid quality‑measure (QM) methodology, merging Minimum Data Set (MDS) information with Medicare claims to improve accuracy. Recent OIG reports on antipsychotic medication use and falls with major injury prompted...
Judge’s Ruling Expected On Whether To Block ACIP Meeting
A federal judge is set to rule this week on a lawsuit seeking to prevent the CDC’s Advisory Committee on Immunization Practices (ACIP) from convening. The plaintiffs argue the committee, whose members were appointed by HHS Secretary Robert F. Kennedy...
Rhododendron-Derived Drugs Now Made by Bacteria
Kobe University bioengineers have re‑programmed the gut bacterium Escherichia coli to synthesize orsellinic acid, the core of Rhododendron‑derived meroterpenoids, at 202 mg per liter—a 40‑fold increase over prior microbial attempts. This marks the first time the complex eukaryotic pathway has been...
Hospitals Mount Response as Site-Neutral Payment Policy Progresses
Hospital groups warn that expanding site‑neutral Medicare payment could slash revenues by $182 billion over the next decade, with rural facilities facing a $26.3 billion hit. The FTI Consulting report, commissioned by the Coalition to Strengthen America’s Healthcare, projects an 8% cut...
Doctors Tell Senators CMS Red Tape Is Driving Workforce Exodus, Threatening Access
Physicians, medical educators and health system leaders testified before the Senate Special Committee on Aging that escalating CMS regulations—particularly prior authorizations and Medicare quality reporting—are intensifying burnout and prompting many to leave clinical practice. The testimony highlighted that these administrative...
AI-Powered MRI Evaluations Predict STEMI Outcomes Better than Existing Risk Scores
A machine‑learning model that combines cardiac MRI data with clinical variables predicts long‑term major adverse cardiovascular events (MACE) in STEMI patients more accurately than the GRACE and TIMI scores. The study analyzed 1,066 patients, training on 682 cases and testing...
From Sensors to Smart Systems: The Rise of AI-Driven Photonic Noses
The 2025 review in *Microsystems & Nanoengineering* details how photonic noses combine optical sensing with AI to create highly selective, drift‑free chemical detectors. By leveraging colorimetric, refractive‑index, absorption and spectroscopy techniques, these devices generate rich spectral fingerprints that machine‑learning models...
Projecting Light to Dispense Liquids: A New Route to Ultra-Precise Microdroplets
Researchers at Southern University of Science and Technology have unveiled an optoelectrowetting platform that uses programmable light patterns to dispense nanoliter droplets with unprecedented precision. By projecting dynamic illumination onto a microfluidic chip, the system creates virtual electrodes that guide...
Gilead-Genhouse Tie-Up Among Several Spanning Pacific: Deals Report
Gilead Sciences has agreed to pay $80 million upfront to Suzhou Genhouse Bio for worldwide rights to GH31, a clinic‑ready oncology molecule. GH31 employs synthetic lethality to inhibit the MAT2A enzyme, a target implicated in several cancers. The deal follows regulatory...
Kolchinsky: Policy Constraints Holding Back Biomedical Innovation
In a BioCentury interview, RA Capital Managing Partner Peter Kolchinsky warned that staffing cuts and a growing conservative stance at the FDA are adding at least a three‑month delay to even the most promising drug programs. He says sponsors are now...
Pancreatic Cancer Cells Sense ECM to Switch Between Growth and Autophagy
Researchers at NYU Langone Health discovered that pancreatic ductal adenocarcinoma cells sense extracellular matrix (ECM) components via the surface protein integrin α3, which determines whether they adopt a proliferative or autophagic state. Cells anchored to laminin‑rich ECM keep autophagy low and...
Resources for Biomarker Requestors
The FDA’s Biomarker Qualification Program (BQP) offers a three‑stage pathway—Letter of Intent, Qualification Plan, and Full Qualification Package—to secure regulatory endorsement of biomarkers as drug development tools. Under the 21st Century Cures Act, the process has been modernized, allowing qualified...
Enlil Launches Milestone View for Its Medtech Product Lifecycle Traceability Software
Enlil unveiled Milestone View, the industry’s first evidence‑based milestone interface for medical device product development. The new capability embeds directly within Enlil’s unified traceability platform, linking each milestone to underlying requirements, design outputs, risk controls, change histories and regulatory evidence....
Timing Is Critical when Using Ultrasound for Pediatric UTI Cases
New research from the Advocate Aurora Research Institute suggests that the timing of renal and bladder ultrasounds in hospitalized infants and young children with febrile urinary tract infections (UTIs) significantly affects diagnostic accuracy. Ultrasounds performed within 24 hours of the last...
PCCI CEO Steve Miff on the 4 Pillars of a Trustworthy AI Framework
Parkland Center for Clinical Innovation (PCCI) unveiled a four‑pillar framework—prediction transparency, performance transparency, security transparency, and compliance—to ensure trustworthy AI throughout model lifecycles. The framework underpins 14 production models and several in testing, supported by tools like the Islet visualizer...