Curated news and analysis on clinical trials, drug approvals, and medical research.
Invivyd reported progress in the Phase 3 DECLARATION trial of VYD2311, with top-line data now expected in Q3 2026 after a sample size increase of about 500 subjects. The company also aligned with the FDA on the LIBERTY Phase 3 study, a pediatric study plan for DRUMMER, and advanced measles antibody candidate VMS063.
Thermo Fisher Scientific entered a collaboration with Singapore's PRECISE to support the PRECISE SG100K biobank initiative. The company will supply proteomics capabilities for precision medicine research and biomarker discovery in Asia Pacific.
DexCom reported fourth-quarter 2025 revenue of US$1.26 billion and net income of US$267.3 million, with full-year sales of US$4.66 billion. The company reaffirmed 2026 revenue guidance of US$5.16–US$5.25 billion and targeted a non-GAAP operating margin of about 22–23%.
A 34-person trial found that a single 21.5mg intravenous dose of DMT with psychotherapy produced rapid antidepressant effects lasting three to six months. Separate brain-scan research across five psychedelics found a shared pattern of weaker within-network links and stronger communication between brain networks.
Iovance reported real-world data suggesting Amtagvi may have a best in class profile in advanced melanoma. The company posted $263.5 million in annual sales after 2024 approval, while pursuing broader use and facing regulatory and logistics risks.
Johnson & Johnson said revenue could reach about $100.5 billion at the midpoint in 2026 after 2024 net sales rose 6% to $94.2 billion. The company faces talc litigation, Stelara patent losses and U.S. drug price negotiations.
NASA’s Artemis II mission ended with a splashdown off California after a roughly 10-day crewed test flight around the Moon. The return tested Orion’s heat shield after issues seen on Artemis I and marked the first crewed lunar flyby in more than 50 years.
Orbicular and Apotex received tentative U.S. FDA approval for a generic Ozempic semaglutide injection. Apotex will commercialize the product in the United States as the ANDA applicant.
Pharma robots and clean room pass-through systems are projected to grow through 2035 as drugmakers increase automation and contamination control. Demand is being driven by biologics, cell and gene therapies, stricter sterile-manufacturing requirements, and investment in cleanroom infrastructure.
Bristol Myers Squibb said 2025 revenue was flat as a 17% increase in growth-portfolio sales offset a 15% decline in legacy drugs. The company expects legacy sales to fall another 12-16% in 2026, with newer products such as Opdivo, Reblozyl and Breyanzi supporting results.
An experimental ovarian cancer drug, elenagen, more than doubled median survival in a 30-patient mid-stage trial in Belarus. The drug was added to gemcitabine and reduced mortality risk by nearly 60%.
Knox County officials are seeking restrictions on cychlorphine after the synthetic opioid was detected in 41 overdose deaths in and around Knox County. The drug is described as extremely potent, not detectable through most test kits, and may require repeated naloxone doses in an overdose.
Q1 2026 sleep medicine trends include broader use of AI, expanding obstructive sleep apnea and narcolepsy treatments, and policy changes affecting reimbursement and access.
Scientists reported that psychedelics dampen visual processing and increase 5-Hz brain waves linked to memory recall. Real-time imaging in mice showed perception shifting from external input toward internally stored images.
Allogene Therapeutics said it will present interim futility analysis data from the Phase 2 ALPHA3 trial of cema-cel in first-line consolidation LBCL on April 13, 2026. The readout will assess day-45 MRD clearance in 12 patients per arm randomized to cema-cel or observation.
A FAERS database analysis identified 13 FDA-approved systemic medications with disproportionately high uveitis reporting signals among 7,301 events from 2003 to 2024. The strongest signals were for cidofovir and rifabutin, and the findings were described as hypothesis-generating rather than causal.
FDA debate over clinical trial reform is focused on continuous trials and faster, risk-based pathways for low-risk studies. Recent FDA remarks and existing guidance frame adaptive, seamless designs as compliant if trial integrity is maintained.
Johnson & Johnson shares hit a 52-week high after the company reported 2025 revenue of $94.19 billion and forecast 2026 revenue above $100 billion. The company also filed a shelf registration and said Innovative Medicine growth offset pressure from Stelara.
Replimune said the FDA issued a complete response letter for its RP1 plus nivolumab application in advanced melanoma. The company disputed the agency’s assessment and said it will cut jobs and scale back U.S. manufacturing.
Two phase 3 trials found upadacitinib 15 mg significantly improved facial and total repigmentation versus placebo at 48 weeks in nonsegmental vitiligo. The 614-patient studies also showed continued improvement over time and a safety profile consistent with prior use.
