Drug-Resistant Fungi Prompt a Five-Step Global Plan Ahead of WHO's 2026 Update
An international consortium of 50 researchers led by Radboudumc has issued a five‑step plan to curb the rise of drug‑resistant fungi. The strategy—covering awareness, surveillance, infection control, optimized drug use, and investment—aims to shape the World Health Organization’s 2026 Global Action Plan on antimicrobial resistance. Researchers warn that resistance is spreading from agricultural fungicide use to hospitals, endangering immunocompromised patients. With only five new antifungal classes introduced in the past 75 years, prevention is now critical.
Deep Dive: Checking in with the FDA
The FDA’s 2025 turmoil included a 3,500‑person workforce cut, multiple leadership turnovers, and a surge in guidance reversals that delayed drug reviews. In 2026, the agency declined to file Moderna’s mRNA‑1010 flu vaccine, contradicting earlier guidance, underscoring regulatory uncertainty. Despite...
Common Osteoporosis Drugs Could Slow or Halt Aneurysm Progression
Researchers at Nagoya University discovered that clonal hematopoiesis, found in about 60% of aortic aneurysm patients, accelerates aneurysm expansion. In mouse models, Tet2‑mutant macrophages promoted elastin loss and matrix degradation via the RANK/RANKL pathway. Treatment with FDA‑approved osteoporosis drugs—anti‑RANKL antibodies...
GLP-1 Goes For The Middle
Indian pharmaceutical firms are rapidly converting the GLP‑1 hype into scale after Novo Nordisk’s semaglutide patent expired in March. Generics from Sun Pharma, Torrent, Zydus and others have already captured more than 15% of the market, pushing Novo’s share down...
Traws Pharma Inc (TRAW) Q4 2025 Earnings Call Transcript
Harrow Health reported Q4 2025 revenue of $89.1 million, a 33% year‑over‑year increase, and full‑year revenue of $272 million, up 36%. Management forecast 2026 revenue between $350 million and $365 million, with adjusted EBITDA of $80‑100 million, driven by sales‑force...
Consumers, Employers Make Joint Call For Price Transparency Reform
A coalition of consumer advocates, employers and health‑payer groups is urging Congress to pass a price‑transparency law that would require providers to disclose the true cost of treatments and prescription drugs at the point of care. The proposal also calls...
Psoriasis Paves the Way for Next-Generation TYK2 Inhibitors in Autoimmunity
Takeda and Alumis reported Phase III data for their next‑generation TYK2 inhibitors, zasocitinib and envudeucitinib, showing more than half of patients achieve PASI 90 in plaque psoriasis. The results close the efficacy gap between oral agents and injectable biologics, surpassing the 28%...
Phospholipid Asymmetry Helps Explain Extracellular Vesicle Surface Charge and Therapeutic Quality
Researchers led by Naohiro Seo and Takanori Ichiki published a review in ACS Nano Medicine that links extracellular vesicle (EV) surface charge to phospholipid asymmetry, especially the distribution of phosphatidylserine (PS). They show exosomes retain PS on the inner leaflet,...
CAR T Cell Therapy Biomanufactured by Cellares Infused Into First Two Patients
Cellares has successfully infused the first two patients with rese‑cel, Cabaletta Bio’s investigational autologous CAR‑T therapy, using its automated Cell Shuttle manufacturing platform. The product met all GMP release criteria, demonstrating that a low‑cost, high‑capacity process can produce clinical‑grade cell...
When Political Speech Becomes a Clinical Exposure
The letter highlights chronic underfunding of women’s health research and warns that high‑profile political statements can act as a clinical exposure, rapidly altering prescribing patterns. Data from the United States show a 10% drop in acetaminophen orders for pregnant women...
Adcendo Raises $75M to Advance Cancer Drug Pipeline
Adcendo, a Copenhagen‑Boston biotech focused on antibody‑drug conjugates (ADCs), announced a $75 million Series C financing led by Jeito Capital. The capital will accelerate Phase 1 trials for three lead ADC candidates targeting tissue factor, uPARAP, and a preclinical asset. The round attracted...
CDER SBIA Chronicles
The FDA’s CDER Small Business & Industry Assistance (SBIA) Chronicles newsletter delivers regulatory guidance to drug manufacturers through a series of podcasts and a searchable archive. The most recent episodes—released on Dec 13 2024, Nov 14 2024, and May 17 2024—cover centralized statistical monitoring for data...
Pharmacy's Rising Role in Cell and Gene Therapy: Zahra Mamoudjafari, PharmD, MBA
Cell and gene therapies (CGTs) are receiving approvals faster than health‑care institutions can operationalize them. Zahra Mahmoudjafari, a clinical pharmacy leader at the University of Kansas Health System, published a framework outlining eight interdependent domains needed for financially sustainable, patient‑accessible...
Helpful Webinars and Other Resources for Generic Drug Manufacturers
The FDA has compiled a suite of webinars, workshops and seminars aimed at helping generic drug manufacturers improve their abbreviated new drug application (ANDA) submissions. Topics span bioequivalence studies, inactive ingredient databases, sample retention, and product‑specific challenges for oral, inhalation,...
Hims & Hers Health, Inc. Dba Hers - 716825 - 09/09/2025
The FDA issued a warning letter to Hims & Hers Health, Inc., alleging that the company’s website falsely marketed its compounded semaglutide as equivalent to FDA‑approved products like Ozempic and Wegovy. The agency cites violations of FDCA sections 502(a), 502(bb)...
About the Quantitative Medicine Center of Excellence (QM CoE)
The FDA’s Center for Drug Evaluation and Research (CDER) has launched the Quantitative Medicine Center of Excellence (QM CoE) to centralize quantitative expertise across its offices. Governance includes senior leaders from the Offices of Generic Drugs, New Drugs, Pharmaceutical Quality,...
Cancer Dependency Map Consortium Launches Phase 3 to Accelerate Next-Generation Therapeutics
The Broad Institute’s Cancer Dependency Map Consortium (DMC) has entered Phase 3, expanding its mission beyond cataloguing tumor vulnerabilities to tackling drug resistance, surface‑protein targets, and high‑dimensional readouts. Backed by 23 pharma partners, the consortium builds on DMC 2.0’s expansion to over...
Elahere Combination Achieves 62.7% ORR in Phase 2 Trial for Platinum-Sensitive Ovarian Cancer at SGO 2026
AbbVie’s Elahere (mirvetuximab soravtansine) combined with carboplatin produced a confirmed objective response rate of 62.7% in patients with FRα‑positive, platinum‑sensitive ovarian cancer, meeting the primary endpoint of the Phase 2 IMGN853‑0420 trial presented at SGO 2026. The study enrolled 125 participants,...
GLP-1 Drug Improves Liver Health Independent of Weight Loss, Mouse Study Finds
Researchers at Toronto’s Sinai Health discovered that semaglutide, a GLP‑1 agonist, improves liver function by acting directly on liver sinusoidal endothelial cells, independent of weight loss. The study, published in Cell Metabolism, used mouse models of metabolic dysfunction‑associated steatohepatitis (MASH)...
FDA Bolsters Bespoke Therapy Framework with New Draft Safety Guidelines
The FDA’s Center for Biologics Evaluation and Research issued draft guidance to standardize safety assessments for genome‑editing therapies, covering both ex vivo and in vivo products that use next‑generation sequencing to detect off‑target effects. The recommendations target nonclinical studies supporting IND and...
Reproxalap Safe for Use in Patients With Dry Eye Disease
A Phase 3 trial of 0.25 % reproxalap eye drops in 757 dry‑eye disease patients found no serious treatment‑related adverse events. Mild ocular irritation was the most common side effect, occurring more often in older women. Visual acuity showed modest improvement, especially...
AWS Launches Amazon Bio Discovery for AI-Powered Scientific Experimentation
Amazon Web Services unveiled Amazon Bio Discovery, a cloud‑based platform that supplies scientists with a curated library of biological foundation models (bioFMs) for generating and evaluating drug molecules. The service lets researchers train custom models on their own experimental data...
Updated: FDA Asks for Data on Lilly’s Foundayo to Assess Heart, Liver Risks
The U.S. Food and Drug Administration has asked Eli Lilly for additional safety data on its newly approved obesity medication, Foundayo. The agency is specifically seeking information on any cardiovascular events and liver‑related adverse effects observed in clinical trials and post‑marketing...
Replimune Looks Ahead as Repeat CRL Speeds the Company's Decline
Replimune received a second complete response letter (CRL) from the FDA for its lead oncolytic cancer therapy, citing additional data gaps and manufacturing concerns. The regulatory setback triggered a wave of layoffs affecting roughly 30% of its workforce and pushed...
Max Hodak’s Science Corp. Is Preparing to Place Its First Sensor in a Human Brain
Science Corp, the neurotechnology startup founded by former Neuralink president Max Hodak, has recruited Yale neurobiologist Murat Günel as a scientific adviser to oversee its first U.S. human trials of a bio‑hybrid brain‑computer interface. The company recently closed a $230 million Series C...
In the Clinic for April 14, 2026
The "In the clinic for April 14, 2026" page serves as a centralized hub that aggregates the latest Bioworld data snapshots, special reports, and infographics across biopharma, medical technology, and emerging therapeutic areas. It links to analyses on mRNA vaccine...
Gaps in Persistence, Coverage Limit GLP-1 Impact in Obesity
Two AMCP 2026 posters highlighted persistent gaps in GLP‑1 therapy for obesity. A claims‑based analysis of 53,183 patients showed persistence falling from 65% at 120 days to 34% at one year, with higher out‑of‑pocket costs and fewer clinician visits driving...
Johnson & Johnson’s Spravato Sales Growth Signals Upside for Psychedelics Peers
Johnson & Johnson reported Spravato generated $468 million in Q1 2026, a 46% year‑over‑year increase that translates to an annualized run rate above $1.9 billion. Quarterly sales slipped 7% versus the prior quarter due to seasonal insurance resets, but the company reaffirmed guidance...
EU Sees 2025 Pharma Export Uptick Amid Competitiveness Concerns
EU pharmaceutical exports surged 16% in 2025, reaching €366.2 bn (≈$429 bn) and generating a record trade surplus of €220.5 bn (≈$257 bn). The United States remained the top destination, accounting for 44% of shipments – roughly €160.6 bn (≈$188 bn). Tariff pressures, including a 15%...
J&J Increasingly Confident It Can Manage Stelara Cliff, but Work Remains
Johnson & Johnson says the most intense biosimilar pressure on its blockbuster drug Stelara is largely behind it, and the company now projects robust growth through the late 2020s. Executives cite new therapeutic indications, expanded global reach, and strategic pricing...
Re: Weight “Regain” In Obesity Shifts Responsibility From Biology to Personal Inadequacy
The author agrees with recent criticism of the term “weight regain,” emphasizing that obesity is a chronic, biologically driven condition. She highlights that GLP‑1 receptor agonists cause loss of both fat and lean tissue, triggering adaptive reductions in energy expenditure...
Why Synthetic Data Is the Antidote to Clinical Trials
Synthetic data, digital twins, and AI are reshaping medical‑device trials by generating virtual patient cohorts that reduce enrollment needs and cut validation costs. The FDA’s in‑silico guidance and EMA’s acceptance of AI tools are paving regulatory pathways for these simulations....
Lilly Investing Billions to Prepare for Overseas Oral GLP-1 Launches
Eli Lilly announced a $3 billion investment in China and a $125 million spend in Japan to build capacity for its newly approved oral GLP‑1 drug, orforglipron. The moves aim to localize production, shorten lead times and hedge against geopolitical disruptions. Analysts see...
The US FDA New Drug Approvals in March 2026
In March 2026 the U.S. FDA approved five new therapies spanning hepatology, dermatology, rare genetics, oncology, and endocrinology. GSK’s Lynavoy treats cholestatic pruritus in primary biliary cholangitis, while Johnson & Johnson’s Icotyde targets moderate‑to‑severe plaque psoriasis. Denali Therapeutics earned accelerated...
Lilly Wants to Bridge Cancer Care Gap with $300M ADC Biotech Buy
Eli Lilly announced an acquisition of Houston‑based CrossBridge Bio, offering up to $300 million in cash and performance‑based biobucks. The early‑stage biotech is developing a dual‑payload antibody‑drug conjugate, CBB‑120, that targets the TROP2 protein found in many solid tumors. CrossBridge plans to...
This Biotech Firm Has Room to Run, Even as Its Drug Royalties Are Set to Shrink
Biogen was upgraded to overweight by Piper Sandler, which lifted its price target to $214, implying about 21% upside. The firm anticipates a dip in Ocrevus royalty income as exclusivity expires between 2028 and 2029, but expects new launches—Syfovre, Empaveli—and a...
STAT+: Pharmalittle: We’re Reading About an FDA Push for Trial Transparency, a Novo-OpenAI Deal, and More
The FDA has dispatched reminder letters to more than 2,200 companies and researchers, warning that failure to post required clinical trial results to the federal database could trigger fines. An internal review found that nearly 30% of studies likely subject...
Base Editing Repairs Mutation and Liver Function in Mouse Model of Zellweger Spectrum Disorder
Scientists at the Broad Institute and collaborators used a refined base‑editing system to correct a disease‑causing mutation in the PEX1 gene of mice that model Zellweger spectrum disorder. The edit restored peroxisome function and normalized liver biomarkers, demonstrating functional rescue...
Can Phage Therapy Answer the Booming Antibiotic Resistance Problem?
Antibiotic‑resistant infections cause nearly 5 million deaths annually, prompting renewed interest in bacteriophage therapy. Companies such as Armata Pharmaceuticals, TechnoPhage, and Locus Biosciences have reported positive clinical milestones, including Armata’s QIDP‑designated AP‑SA02 moving toward a phase 3 trial and TechnoPhage’s phase 2b study...
Psychedelic Therapy and Traditional Antidepressants Show Similar Results Under Open-Label Conditions
A meta‑analysis of 24 trials found that psychedelic therapy and open‑label antidepressants produce statistically indistinguishable reductions in depressive symptoms. The study compared 8 psychedelic trials (249 patients) with 16 antidepressant trials (7,921 patients) under equal unblinding conditions, revealing only a...
Helical Closes $10M Seed to Turn Bio Foundation Models Into Systems
Helical, a London‑based pharma‑AI startup, closed a $10 million seed round led by redalpine, with AI leaders from Cohere and HuggingFace among angel investors. The funding will expand its dual‑surface platform—Virtual Lab for biologists and Model Factory for data scientists—across more...
Helical Secures $10M to Advance Virtual AI Lab for Pharma Research
Helical, a biotech startup founded in early 2024, announced a $10 million seed round led by redalpine with participation from Gradient, BoxGroup, Frst and AI industry angels. The company’s virtual AI lab combines foundation model outputs with biological validation to create...
SynOx Therapeutics Reports Topline P-III (TANGENT) Trial Results on Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)
SynOx Therapeutics announced topline data from its global Phase 3 TANGENT trial, which evaluated emactuzumab (1,000 mg every two weeks for five doses) versus placebo in patients with tenosynovial giant cell tumor (TGCT). The study met both primary efficacy endpoints, showing a...
Parker Institute Doubles Down on Cancer Vaccines as Part of Ongoing Reboot
The Parker Institute for Cancer Immunotherapy announced a renewed focus on mRNA‑based cancer vaccines, launching a multi‑year program that will fund clinical trials and partner with biotech firms. The initiative includes a $200 million investment pool aimed at accelerating vaccine design,...
Exclusive: Redesign Health-Backed Starfire Launches to Help Pharma Commercialize Therapies
Starfire, backed by Redesign Health, has launched an agentic commercial intelligence platform aimed at helping pharmaceutical and biotech firms commercialize therapies. The AI‑driven system overlays both external and internal data to automate patient‑journey analyses, cost‑outcome models, and executive‑ready presentations. Redesign...
Vir Biotechnology Doses First Patient in Phase I VIR-5500 Trial
Vir Biotechnology has dosed the first patient in the expansion cohort of its Phase I trial of VIR‑5500, a PSMA‑targeted, dual‑masked T‑cell engager, for late‑line metastatic castration‑resistant prostate cancer (mCRPC). The cohort uses a step‑up regimen of 800/2000/3500 µg/kg every three weeks...
FDA Approves Travere's Filspari as First Drug for the Kidney Disease FSGS
The U.S. Food and Drug Administration has broadened the label for Travere Therapeutics' drug Filspari, adding a second kidney indication to its approval. Filspari, a dual endothelin‑angiotensin receptor antagonist, was already the first therapy cleared for primary focal segmental glomerulosclerosis...
Opinion: My Brother Can’t Access a Just-Approved Breakthrough Drug for His Rare Disease
A newly FDA‑approved breakthrough drug promises to address the neurological degeneration that has long plagued patients with Hunter syndrome, a rare lysosomal disorder. While the approval marks a scientific milestone, patients like the author’s 28‑year‑old twin brother still face barriers...
For Ben Sasse, Revolution Medicines’ Pancreatic Cancer Trial Felt Like His Best, only Option
Former U.S. senator Ben Sasse was diagnosed with metastatic pancreatic cancer in December and promptly enrolled in an early‑phase trial of Revolution Medicines' targeted drug daraxonrasib. The therapy, positioned as a first‑line option, aims to extend both the quantity and...
Travere Therapeutics Reports FDA Full Approval of Filspari for Proteinuria Reduction in FSGS
Travere Therapeutics announced that the U.S. Food and Drug Administration has granted full approval to Filspari (sparsentan) for reducing proteinuria in patients aged eight years and older with focal segmental glomerulosclerosis (FSGS) who do not have nephrotic syndrome. The approval...