Pharma News and Headlines
Pharma News and Headlines
Kyron.bio announced a strategic partnership with Servier to glycoengineer a Servier‑selected antibody using its precision glycosylation platform. Servier will fund the research and retain an option to pursue further development based on the results. The collaboration builds on Kyron.bio’s 2024 Servier Golden Ticket award and aims to improve efficacy, safety and scalability of next‑generation antibody therapeutics across multiple disease areas. Financial terms of the deal were not disclosed.
Under the Trump administration, the U.S. government slashed nearly $500 million in mRNA research funding, canceling 22 projects and a $766 million Moderna contract. The FDA’s initial refusal then reversal to review Moderna’s flu vaccine highlighted regulatory skepticism toward the platform. Private‑sector...
Arcutis Biotherapeutics reported record Q4 2025 results, with net product revenue of $127.5 million, an 84% year‑over‑year increase, and full‑year revenue up 123% to $372.1 million. Management raised its 2026 net product revenue guidance to $480‑$495 million, citing strong prescription growth, expanded Medicare...
Researchers at the University of Massachusetts Amherst have engineered a logic‑gated nanoparticle that releases a STING agonist only under acidic pH and hypoxic conditions typical of metastatic tumor sites. The dual‑stimuli‑responsive system triggers robust innate immune activation while sparing healthy...
Zevra Therapeutics reported Q3 2025 net revenue of $26.1 million, driven primarily by $22.4 million from its FDA‑approved NPC therapy MyPlayFa. The company narrowed its net loss to $0.5 million, a dramatic improvement from a $33.2 million loss a year earlier, while cash and...
Editas Medicine reported Q2 2024 progress on its gene‑edited cell therapy reni‑cel, presenting interim data from the RUBY sickle‑cell and EdiTHAL beta‑thalassemia trials. All 18 RUBY patients were free of vaso‑occlusive events, with hemoglobin levels above 14 g/dL and fetal hemoglobin exceeding...
Researchers have engineered a dual‑stimuli‑responsive nanoparticle that activates the STING pathway only when both acidic pH and hypoxic NQO1 activity are present, creating an AND‑logic release of the agonist MSA‑2. In preclinical models of lung carcinoma, triple‑negative breast cancer and...
Anixa Biosciences reported $131.7 million in cash, no debt, and a cash burn of $7.1 million in Q1 2026, extending its runway to over three years. Operating expenses fell sharply, with R&D down 55% YoY and G&A reduced by 32%, reflecting the end...
MacroGenics reported 2024 revenue of $150 million, up from $58.7 million, largely fueled by $85 million in milestone payments from its Incyte partnership. The company posted a net loss of $67 million versus $9.1 million a year earlier, while cash and marketable securities fell to...
ARS Pharmaceuticals reported a pivotal quarter, with U.S. Neffy net product revenue soaring to $31.3 million—a 2.5‑fold quarter‑over‑quarter increase that beat consensus. New prescriber market share reached 10.3% and provider adoption rose 85% since August, while the Get Neffy On...
The FDA has issued a final guidance titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.” The document outlines the agency’s scientific framework for establishing biosimilarity of therapeutic proteins submitted via the abbreviated licensure pathway. It details expectations for...
Researchers at Uppsala University reported that a single 30 mg/kg injection of the psychedelic N,N‑dimethyltryptamine (DMT) reversed depression‑like behaviors in mice subjected to chronic stress. The treated animals recovered their preference for sweetened water, displayed improved working‑memory performance, and showed reduced...
Researchers led by Dr. James Murrough and Dr. Emma Guttman‑Yassky identified the Th2 immune pathway as a contributor to major depressive disorder. Using proteomic profiling and computer modeling, they repurposed dupilumab—an IL‑4 receptor antibody approved for eczema—to target this pathway....
Researchers have identified lysophosphatidylcholine acyltransferase 1 (LPCAT1) as a driver of head and neck squamous cell carcinoma (HNSCC) by amplifying mitochondrial oxidative phosphorylation through the COX17 chaperone. Overexpression of LPCAT1 reshapes mitochondrial membrane lipids, stabilizing COX17 and boosting cytochrome c oxidase activity,...
Eli Lilly used an AI‑driven digital twin to dramatically increase manufacturing capacity for its high‑demand GLP‑1 drugs Zepbound and Mounjaro. The virtual factory model allowed real‑time optimization of equipment, process parameters, and defect detection, delivering production volumes the company says would...
A recent preclinical study shows that inhibiting interleukin‑2‑inducible T‑cell kinase (ITK) markedly improves the efficacy of anti‑CD19 CAR‑T cells. Researchers combined an ITK‑selective inhibitor with a second‑generation CD19‑CAR construct, observing enhanced cytotoxicity, reduced exhaustion markers, and prolonged persistence in mouse...
![[Comment] Aldosterone Synthase Inhibition in Resistant Hypertension: Promises and Unknowns](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/0a5065acfb3787a2e2e6999bae6248e9.webp)
Resistant hypertension affects up to 20 % of hypertensive patients and carries heightened cardiovascular risk. Recent phase‑3 studies of aldosterone synthase inhibitors such as baxdrostat and lorundrostat have demonstrated significant ambulatory blood‑pressure reductions, positioning them as potential fourth‑line agents beyond traditional...
Vinay Prasad, the FDA’s controversial biologics chief, has announced his departure, marking his second exit within a year. His resignation follows a public dispute over the agency’s handling of rare disease drug approvals, intensifying scrutiny of FDA decision‑making. Critics are...
A large observational study of 98,261 U.S. veterans with type 2 diabetes found that using GLP‑1 receptor agonists together with six to eight healthy lifestyle habits lowered major adverse cardiovascular events (MACE) by 43% compared with low‑habit, non‑GLP‑1 users. Both the...
Vinay Prasad, the controversial head of the FDA's Center for Biologics Evaluation and Research, will leave the agency in April after a tumultuous year marked by stricter vaccine guidelines and a new pathway for ultra‑rare gene therapies. His tenure saw...
Eli Lilly launched an Employer Connect platform on March 5, linking more than 15 independent program administrators with a nationwide pharmacy and telehealth network to broaden discounted access to its obesity drugs, notably the GLP‑1 Zepbound (tirzepatide) pen. The service targets employer‑sponsored...
Peptide therapies have moved from niche compounding to mainstream outpatient care, driven by telehealth platforms and rapid market growth. This expansion has attracted regulatory attention, with state boards and courts increasingly referencing USP and as compliance benchmarks. Non‑sterile peptide...
In February 2026 the FDA approved a suite of targeted therapies, including the HER2‑mutant NSCLC kinase inhibitor zognertinib and the first all‑oral acalabrutinib‑venetoclax combo for CLL/SLL, as well as a BRAF‑targeted encorafenib regimen for metastatic colorectal cancer. A portable tumor‑treating‑fields...
Geopolitical tensions between the U.S., Israel and Iran have rattled traditional safe‑haven assets, with gold and consumer staples slipping as oil prices breach $100 per barrel. UBS recommends pharmaceutical stocks as the new defensive refuge, citing their inverse link to...
EpiciphAI, a Chinese pre‑seed biotech, is building a liquid biopsy that reads histone modifications on cell‑free chromatin to pinpoint a fragment’s tissue of origin and its disease state. Unlike most epigenetic tests that focus on DNA methylation, this platform targets...
Canada’s Public Health Agency has signed a new agreement with CSL Seqirus to provide millions of doses of adjuvanted cell‑based influenza vaccine in the event of a WHO‑declared pandemic. The contract replaces a previous egg‑based arrangement and builds on the...
The FDA staged a media call where an anonymous senior official publicly criticized UniQure’s experimental Huntington’s disease gene therapy. The official, identified only as a practicing hematology‑oncology professor, framed his comments as serving the public interest while hinting at personal...
At AAAAI 2026, Novartis presented data confirming remibrutinib’s rapid and sustained efficacy in chronic spontaneous urticaria, with a 25 mg BID dose delivering significant UAS7 reductions. Phase 2 trials also demonstrated the BTK inhibitor’s potential in peanut allergy, achieving 86.7% tolerance at...
The FDA’s Drug Shortages portal aggregates letters, temporary import authorizations, and annual reports that detail current and historic medication scarcities. Recent communications include temporary import permits for Lederle Leucovorin, Tafenoquine, and Physostigmine to bridge supply gaps. The site also hosts...
The article outlines the legal requirement that U.S. wholesale drug distributors and third‑party logistics providers (3PLs) must hold a valid state license to handle prescription medications. It warns that unlicensed or unauthorized partners can expose patients to counterfeit, stolen, or...
Medochemie, Cyprus’s largest generic drug maker, has powered all nine of its GMP‑certified manufacturing sites with 100% renewable electricity as of 1 October 2025, covering roughly 18 million kWh annually and eliminating thousands of tonnes of CO₂. The transition aligns the firm with tightening...
Johnson & Johnson’s Tecvayli and Darzalex combination received FDA approval for second‑line multiple myeloma treatment, marking the third drug cleared under the Commissioner’s National Priority Voucher (CNPV) program. The decision was rendered in just 55 days after J&J’s filing, thanks...
The FDA has issued a draft Level 1 guidance (Docket FDA‑2025‑D‑1504) titled “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” The document targets both foreign and domestic manufacturers of human and animal drugs regulated by CDER,...
The March 3, 2026 AJMC/MHE webinar examined the Trump administration’s Great Healthcare Plan, focusing on most‑favored‑nation (MFN) drug pricing, the lapse of ACA marketplace subsidies, and the Inflation Reduction Act’s (IRA) impact on community oncology. Sixteen manufacturers have voluntarily adopted MFN pricing,...
Three biopharma firms—Bavarian Nordic, Sarepta Therapeutics, and Alkermes—announced the departures of long‑standing CEOs, prompting short‑term share declines. Bavarian Nordic’s Paul Chaplin steps down after a blocked $3 billion buyout, while Sarepta’s Doug Ingram leaves amid family health issues and recent product...
Immuneering Corporation announced its 2025 financial results, highlighting a 64% overall survival rate at 12 months for atebimetinib plus modified gemcitabine/nab‑paclitaxel in first‑line pancreatic cancer. The company secured FDA and EMA alignment on the design of its pivotal Phase 3 MAPKeeper 301...
Insilico Medicine and TaiGen announced that enrollment for the Phase‑I trial of ISM4808, an AI‑designed therapy for CKD‑related anemia, is now complete and the first patient has been dosed. The study comprises single‑ascending‑dose and multiple‑ascending‑dose cohorts evaluating safety and pharmacokinetics...
Private equity firms are actively pursuing growth in the active pharmaceutical ingredient (API) sector, with five recent transactions highlighted by Astorg, EQT, New Mountain Capital and TA Associates. The deals involve both acquisitions and divestitures of API manufacturing assets, reflecting...
Researchers have engineered a magnetic nanocarrier (IO@MBD) that combines γ‑Fe₂O₃ nanoparticles with a melamine‑based dendrimer to deliver doxorubicin. The platform achieves roughly 17 wt% drug loading, remains dispersible in water, and releases the drug preferentially under acidic conditions typical of tumor...
The latest generation of AI‑driven tools is transforming clinical trial data management by automating the build of electronic data capture (EDC) systems. Solutions such as CRScube’s AI‑led EDC builder can convert a PDF protocol into a structured database in hours...
Johnson & Johnson announced FDA approval of the Tecvayli (teclistamab) and Darzalex Faspro (subcutaneous daratumumab with hyaluronidase) combination for adults with relapsed/refractory multiple myeloma who have received at least one prior line of therapy. The approval is grounded in the Phase III...
Seqster has introduced 1‑Click DataLake, a real‑world data platform that aggregates anonymized electronic health‑record information from over 150 million patients and 200,000 clinicians across the United States. The solution delivers real‑time, longitudinal patient journeys to speed trial design, feasibility assessments, and...
Liberate Bio announced it has secured both exclusive and non‑exclusive licenses for patents covering chimeric antigen receptor (CAR) designs specifically engineered for myeloid cells such as monocytes and macrophages. The patents, obtained from Carisma Therapeutics and the University of Pennsylvania,...
The pharmaceutical industry has finally delivered an oral GLP‑1 weight‑loss pill, with Novo Nordisk launching an oral version of Wegovy earlier this year. Eli Lilly’s oral GLP‑1 candidate, orforglipron, is expected to receive approval imminently. Oral formulations overcome the injection barrier that...
Kainova Therapeutics, formerly Domain Therapeutics, announced a Series B funding round to advance its next‑generation GPCR‑modulating platform aimed at reversing tumor immunosuppression. The rebrand signals a strategic shift toward a broader oncology focus, leveraging GPCR pathways that control immune cell trafficking....
Harrison.ai has received U.S. FDA 510(k) clearance for its Acute Infarct Triage software, which analyzes non‑contrast CT brain scans to identify acute ischemic strokes. In validation studies the algorithm achieved roughly 89% sensitivity on thin‑slice CT and 86% on thicker...
Roche and Zealand Pharma disclosed Phase‑II (ZUPREME‑1) results for petrelintide, an amylin‑analog injected weekly, in 493 overweight or obese adults (mean BMI 37 kg/m²) with weight‑related comorbidities. The trial evaluated five dose levels against placebo over 42 weeks and met its primary endpoint,...
A recent double‑blind trial found that a combination of two GLP‑1 receptor agonists cut fat mass significantly while sparing lean muscle in adults with obesity. Over 24 weeks, participants lost an average of 5 % body fat, with lean mass decline...
Helus Pharma reported Phase II data for its psychedelic candidate HLP004, indicating symptom improvement in generalized anxiety disorder patients for up to six months. However, the trial’s low‑dose active control arm showed similar efficacy, making it difficult to isolate the...
Helus Pharma reported Phase II data for its psychedelic candidate HLP004 in generalized anxiety disorder, showing symptom improvement lasting six months. However, the trial’s active low‑dose control produced outcomes similar to the therapeutic dose, making it difficult to isolate the drug’s...
