Pharma News and Headlines
Pharma News and Headlines
Researchers identified a drug combination that enhances the brain's glymphatic system, improving clearance of Alzheimer‑related proteins. The regimen pairs a widely used sedative with a medication that prevents dangerously low blood pressure, showing safe and effective removal of amyloid and tau proteins in preclinical models. Modeling suggests the approach could delay Alzheimer’s onset by up to seven years. Experts say this could extend cognitive health for both patients and healthy adults.
On March 27, 2026, the U.S. Food and Drug Administration granted approval to Denali Therapeutics’ drug Avlayah for the treatment of Hunter syndrome, a rare lysosomal storage disorder. The decision arrives amid a recent wave of stricter FDA scrutiny of...
Host-cell proteins (HCPs) remain a persistent impurity risk in biomanufacturing, with regulators demanding levels below 100 ppm in final drug products. Traditional ELISAs measure total HCPs but cannot identify individual proteins, while conventional multiple reaction monitoring (MRM) suffers from retention‑time shifts...
Early-stage liver cancer survival hinges on timely diagnosis, yet ultrasound and AFP tests miss many cases. Helio Genomics has introduced the HelioLiver blood test, a multi‑analyte cfDNA and protein assay that flags tumor‑associated epigenetic signals earlier than imaging. A new...
Beam Therapeutics announced encouraging Phase 1/2 data for its base‑editing therapy targeting alpha‑1 antitrypsin deficiency (AATD). The trial demonstrated a 30% reduction in the disease‑causing SERPINA1 mutation and a 45% rise in functional protein levels, while confirming a clean safety profile....
The FDA released a draft guidance on using Bayesian methodology in clinical trials, outlining how sponsors should incorporate prior data, define success criteria, and document analyses. It emphasizes systematic prior construction, transparent operating characteristics, and extensive simulation documentation. The guidance...
The FDA has launched a Guidance Snapshot Pilot that distills complex guidance documents into visual, plain‑language one‑page snapshots complemented by podcasts, timelines, and social‑media links. The pilot targets cross‑cutting topics such as Bayesian trial methodology, decentralized clinical elements, and neonatal...
Boehringer Ingelheim announced it will maintain its high‑level R&D spending while exploring dealmaking opportunities in China to counteract mounting U.S. drug‑price pressure. The company is prioritising an obesity‑focused pipeline, betting on the fast‑growing weight‑loss market to sustain revenue. By keeping...
A post‑hoc analysis of the SOUL trial shows that once‑daily oral semaglutide (Ozempic pill) significantly improves several cardiometabolic risk factors in adults with type 2 diabetes at high risk for atherosclerotic cardiovascular disease. Compared with placebo, participants experienced a 3.2 mm Hg greater...
Rentsc hler Biopharma announced that its Milford, Massachusetts CDMO site has entered a new growth phase, adding a 22,000‑square‑foot cleanroom and four 2,000‑liter single‑use bioreactors. The expansion, the largest in the company’s 150‑year history, brings the U.S. facility to the...
Novo Nordisk announced that its triple‑agonist candidate UBT251 achieved a mean HbA1c reduction of up to 2.16% after 24 weeks in a phase‑2 study of Chinese patients with type‑2 diabetes. The trial, involving roughly 200 participants, underscores the drug’s potential...
Sarepta Therapeutics reported that early‑stage trials of two experimental drugs, SRP‑1001 and SRP‑1003, demonstrated safety and signs of efficacy for rare muscle‑wasting disorders. The data sparked a more than 20% surge in the company’s stock during early trading. The results...
UCB announced a $2 billion investment to build a 460,000‑square‑foot biologics manufacturing plant in Gwinnett County, Georgia, its first U.S. production site. The facility will create about 330 permanent jobs and over 1,000 construction positions, leveraging AI, robotics and automation. Georgia...
Xaira Therapeutics unveiled X-Cell, a 4.9‑billion‑parameter virtual cell model that predicts transcriptome‑level responses to genetic perturbations. The model leverages the company’s 25.6 million‑cell X‑Atlas/Pisces CRISPRi Perturb‑seq dataset and demonstrates zero‑shot performance on unseen T‑cell and iPSC contexts. X-Cell uses a diffusion...
GSK has accelerated its pipeline build‑out by pairing broad early‑stage partnerships with selective, later‑stage acquisitions such as the up‑to‑$950 million purchase of 35Pharma’s pulmonary‑hypertension candidate HS235. After spinning off Haleon, the company now leans on specialty medicines—accounting for over 40% of...
Maze Therapeutics reported Phase 2 results for its kidney drug MZE829, showing a 35.6% average reduction in proteinuria after 12 weeks and a 61.8% drop in the FSGS subgroup. The data were hailed as "overwhelmingly positive" but the stock fell more...
The U.S. Federal Trade Commission has filed a proposed settlement with CVS Caremark, accusing the pharmacy‑benefit manager of artificially inflating insulin prices and limiting patient access. The deal, which still requires FTC chair approval, mirrors a recent settlement with Cigna’s...
Terrestrial Bio, the microneedle vaccine patch pioneer originally founded as Vaxess Technologies, announced a $50 million Series B financing round to shift its focus from vaccines to GLP‑1 peptide delivery. The capital, led by a consortium of biotech investors, will fund clinical...
Japan’s Ministry of Health, Labour and Welfare approved Dupixent (dupilumab) for adults with moderate-to-severe bullous pemphigoid, marking the first targeted therapy for the disease in the country. The approval is based on the phase II/III ADEPT trial, which enrolled 106...
Maze Therapeutics reported that its Phase 2 trial of the genetic kidney disease candidate MZ‑001 achieved its primary efficacy and safety goals, showing a roughly 30% slowdown in eGFR decline versus placebo. The double‑blind study enrolled 150 patients with autosomal dominant...
WuXi Biologics reported record 2025 results, with revenue up 16.7% and IFRS gross profit climbing 30.9%, lifting its gross margin to 46%. The growth was driven by expanding research, development and manufacturing contracts and tighter cost control across its global...
Researchers at Baylor College of Medicine have identified a brain‑based pathway that underlies metformin’s glucose‑lowering effect. The study shows that metformin suppresses the Rap1 protein in the ventromedial hypothalamus, a region critical for whole‑body glucose regulation. Mice lacking hypothalamic Rap1...
Novo Nordisk and United Laboratories reported Phase‑II data for the GLP‑1 agonist UBT251 in 211 Chinese patients with type‑2 diabetes. Over 24 weeks, UBT251 achieved a 2.16 % HbA1c reduction, outperforming semaglutide’s 1.77 % and placebo’s 0.66 % from a baseline of 8.12 %....
Gilead announced a $2.1 billion acquisition of Ouro Medicines and its T‑cell engager OM336, planning to split the deal with long‑time partner Galapagos. Johnson & Johnson and Protagonist Therapeutics secured FDA approval for Icotyde, an IL‑23 receptor blocker that becomes Protagonist’s...
A genomic survey of over 18,000 *Escherichia coli* genomes has mapped 90 capsular K‑loci, revealing that five capsule types (K1, K5, K52, K2, K14) cause more than half of bloodstream and urinary‑tract infections in Europe. The study links these high‑risk...
Researchers at Australia’s Peter Doherty Institute have created a portable, CRISPR‑based diagnostic that simultaneously detects syphilis, HSV, chlamydia and gonorrhea in under an hour. The assay also identifies a key antibiotic‑resistance gene in gonorrhea, delivering 97‑100% accuracy compared with laboratory...
Merck (MSD) has entered a multi‑year research partnership with Quotient Therapeutics to uncover new drug targets for inflammatory bowel disease using Quotient’s somatic genomics platform. The deal provides Quotient with $20 million upfront and up to $2.2 billion in regulatory, development and...
Jacob Van Naarden, formerly COO of Loxo Oncology, joined Eli Lilly after its $8 billion cash acquisition of Loxo in 2018. He now serves as president of Lilly Oncology and head of business development, overseeing the company’s dealmaking and pipeline expansion. The purchase...
Ionis Pharmaceuticals received FDA acceptance of its new drug application for zilganersen and a priority‑review designation for treating Alexander disease, with a PDUFA target action date of September 22, 2026. The Phase III trial enrolled 54 patients aged 1.5 to 53...
French imaging contrast agent maker Guerbet is confronting a severe FDA warning after inspectors found significant good manufacturing practice violations at its Raleigh, North Carolina plant. The citation has already depressed Americas revenue by 4% year‑over‑year and reduced MRI‑related sales,...
Trace Neuroscience, launched Nov 2024, is developing an antisense drug, TRCN‑1023, to restore UNC13A protein function in ALS patients. The target emerged from parallel discoveries at UCL and Stanford, and the company plans intrathecal delivery and biomarker‑guided trials. Leveraging lessons...
Researchers at Trinity College Dublin have demonstrated that a single dose of interferon‑gamma can “train” human macrophages to more effectively kill drug‑resistant bacteria such as MRSA and Mycobacterium tuberculosis. The IFN‑γ‑trained cells undergo epigenetic reprogramming, rely on glutamine metabolism, and...
Researchers at the University of Illinois Chicago have repurposed the FDA‑approved cancer drug doxorubicin to combat drug‑resistant herpes simplex virus type 1 (HSV‑1). Using their AI‑driven platform HerpDock, they identified doxorubicin’s ability to block the PI3K‑AKT‑mTOR pathway that the virus exploits,...
The article outlines BioCentury’s cookie policy, detailing the categories of cookies used on its website—strictly necessary, functional, marketing, advertising, and analytics. Each type is described in terms of purpose, activation status, and impact on user experience. The policy emphasizes that...
Intelligent and miniaturized drug delivery devices (IMDDDs) combine biotechnology, AI, electronics, and novel materials to provide precise, programmable drug release inside the body. These platforms integrate real-time sensing with adaptive control, enabling dose adjustments based on biomarkers such as glucose...
The Federal Trade Commission and CVS Caremark have reached a settlement that resolves all claims alleging the pharmacy‑benefit manager inflated insulin prices through anticompetitive rebate practices. Court filings on March 23 indicate the agreement ends the FTC’s lawsuit in its...
Sen. Josh Hawley (R-MO) has demanded that Danco Labs, the maker of mifepristone and misoprostol, turn over any internal communications it has had with the FDA, telehealth providers, pharmacists, patients, state medical boards, and attorneys general concerning the safety of...
Doctors for America met with bipartisan lawmakers to flag several regulatory concerns at the FDA. The group warned that “America First” provisions in the upcoming PDUFA negotiations could increase user fees and hinder drug access, while the agency’s reliance on...
Absci Corporation announced that its AI‑designed antibody ABS‑201 has been dosed in the first three single‑ascending‑dose cohorts of the Phase 1/2a HEADLINE trial, showing favorable safety and early hair‑growth signals in human ex vivo studies. The company also unveiled Origin‑1, a generative‑AI...
Biomea Fusion announced its FY 2025 results, reporting $56.2 million in cash and a net loss of $61.8 million, roughly half the loss recorded a year earlier. The company highlighted durable 52‑week HbA1c reductions of 1.2 % from icovamenib in type 2 diabetes and launched...
Karyopharm Therapeutics announced top‑line data from its Phase III SENTRY trial, which evaluated selinexor combined with ruxolitinib in patients with myelofibrosis. The company reported that the regimen met its primary efficacy endpoints and demonstrated a manageable safety profile. Alongside the clinical...
A JAMA Network Open study examined 64 pharmaceutical kickback settlements from 2000 to 2025, uncovering $10.25 billion in penalties. The drugs at the center of those cases generated $458.6 billion in U.S. sales, meaning fines represented just 2.2 percent of related revenue. The...
CVS Health announced a proposed settlement with the Federal Trade Commission concerning its insulin pricing practices. The agreement, negotiated by CVS’s pharmacy benefit manager Caremark, is modeled after the FTC’s recent deal with Express Scripts, a Cigna subsidiary. While the...
Researchers analyzed real‑world claims data from 12,245 Crohn’s disease patients treated between 2016 and 2022 to compare safety outcomes across five advanced therapies, including TNF antagonists, vedolizumab, ustekinumab, risankizumab, and upadacitinib. Incidence rates for serious infections, major adverse cardiovascular events,...
Kintor Therapeutics announced that its oral JAK inhibitor KX-826 successfully met both primary and key secondary endpoints in a pivotal Phase III trial for alopecia areata. The double‑blind study enrolled 620 patients and showed statistically significant hair regrowth compared with...
The FDA sent a March 13 warning letter to ImmunityBio, a company controlled by biotech magnate Patrick Soon‑Shiong, after finding multiple false and misleading statements about its bladder‑cancer drug Anktiva. The agency highlighted that television ads and a podcast claimed the...
Yale and Cornell chemists have devised a metal‑free aminoxyl catalyst that oxidizes a single secondary alcohol in the macrolide antibiotic erythromycin A. The catalyst, paired with mCPBA, proved highly selective, but analogous macrolides clarithromycin and azithromycin required different reagents to achieve...
Ocugen announced that its investigational gene therapy for geographic atrophy, a leading cause of vision loss in age‑related macular degeneration, will move into a Phase 3 clinical trial. The company reported mixed Phase 2 results, showing a favorable safety profile but inconsistent...
Swiss biotech NanoZymeX has secured €160,000 (about $174,000) from Venture Kick to accelerate its lipid‑nanoparticle platform for enzyme replacement therapies. The technology, spun out of the University of Basel, seeks to improve delivery of therapeutic enzymes into muscle cells and lysosomes,...
The U.S. Food and Drug Administration issued a warning to ImmunityBio after a television ad and a podcast featuring billionaire biotech entrepreneur Patrick Soon‑Shiong suggested that the company’s bladder‑cancer drug Anktiva could cure or prevent all cancers. The FDA said...
