STAT+: Pharmalittle: We’re Reading About a Merck Acquisition, the Rise of Former Loxo Execs at Lilly, and 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 Express Scripts and signals intensified regulator focus on PBM pricing practices. The FDA also issued a warning letter to ImmunityBio, owned by Patrick Soon‑Shiong, for false and misleading claims about its bladder‑cancer drug Anktiva, including unsupported assertions that it treats all cancers. In a separate case, a New Jersey federal lawsuit alleges Novartis used hidden tracking pixels on its drug‑discount websites to transmit patients’ health information to Google and other advertising firms without consent.
Microneedle Vaccine Patch Company Raises $50M for Pivot to GLP-1 Delivery
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...
Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid
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 Meets Own Expectations in Phase 2 Kidney Disease Trial in the Same Arena as Vertex
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 Reports Record 2025 Annual Results, Operational Excellence Driven by Digital-Native Architecture
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...
Metformin’s Hidden Brain Pathway Revealed After 60 Years
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...
The United Laboratories and Novo Nordisk Report P-II Trial Data on UBT251 in Chinese Patients with Type 2 Diabetes
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’s Ouro Buy, J&J/Protagonist’s Approval, Aurinia’s Revamp, ACIP Confusion, More
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...
Genomic Mapping of E. Coli Capsules Identifies High-Risk Types for Vaccines
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...
World-First Portable Multi-Pathogen CRISPR Test Seeks to Improve STI Diagnostics
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...
MSD and Quotient Collaborate on IBD Drug Targets
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...
STAT+: How an Outsider Crept Into Eli Lilly’s Top Ranks — and Plans to Drive Its Business Forward
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’ Zilganersen Receives US FDA Priority Review for Alexander Disease
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...
Imaging Manufacturer Guerbet Faces Financial Challenges Following Recent FDA Warning
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 Unites ALS Teams Behind a Target That Could Broaden Treatment Access
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...
As Antibiotics Fail, a New Treatment Targets the Host, Not the Bacteria
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...
Cancer Drug Can Treat Drug-Resistant Herpes, Too
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,...
AL-S Pharma Tests How Far SOD1 Biology Extends Into Sporadic ALS
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...
Towards Intelligent and Miniaturized Drug Delivery Devices
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...
Proposed FTC, CVS Agreement Underway To Settle Inflated Insulin Costs Allegations
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...
Hawley Seeks Internal Data From Danco As Telehealth Abortions Rise
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 Raises PDUFA, CNPV, Bayesian, Supply Chain Concerns With Lawmakers
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 Reports Business Updates and Fourth Quarter and Full Year 2025 Financial and Operating Results
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 Reports Full Year 2025 Financial Results and Corporate Highlights
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 Inc. (KPTI) Discusses Top Line Results From Phase III SENTRY Trial in Myelofibrosis Transcript
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...
STAT+: Drug Company Penalties for Paying Kickbacks to Doctors Failed to Dent Bottom Lines, Analysis Finds
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 Reaches Insulin Pricing Settlement with FTC
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...
Safety Similar Across Advanced Crohn’s Disease Therapies
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’s KX-826 Meets Phase III Endpoints in Alopecia
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...
STAT+: FDA Slams Soon-Shiong and ImmunityBio for Making ‘False and Misleading’ Claims About a Drug
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...
Antibiotics Selectively Supercharged Against MRSA
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 Heads to Phase 3 with Gene Therapy for Geographic Atrophy
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...
NanoZymeX Secures €160K to Advance Lipid Nanoparticle Enzyme Therapies for Rare Diseases
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,...
FDA Warns ImmunityBio over Misleading Podcast with Patrick Soon-Shiong
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...
Optibrium Introduces Graphical Interface for QuanSA to Enhance Ligand-Based Affinity Predictions
Optibrium has released a new PyMOL plugin that adds a graphical user interface to its QuanSA ligand‑based affinity prediction tool. QuanSA uses physically‑motivated machine learning to deliver free‑energy perturbation‑level accuracy without needing a protein structure, dramatically lowering computational cost. The...
Karyopharm’s Mixed Myelofibrosis Data; Rezolute to Seek FDA Approval Despite Trial Failure
Karyopharm reported mixed results from its Phase 3 SENTRY trial of selinexor in myelofibrosis, achieving a statistically significant reduction in spleen volume but raising safety concerns. The data fell short of expectations for overall survival benefit. Meanwhile, Rezolute announced it will...
Seven T Cell Engager Companies You Should Know About
T‑cell engagers are bispecific antibodies that redirect T cells to destroy cancer cells and are being explored for autoimmune disorders. Seven companies are leading the field: Adaptin Bio secured FDA IND clearance for APTN‑101 in glioblastoma; Candid Therapeutics merged with...
Novartis Pledges $480M to Expand China Presence, Following Eli Lilly and AstraZeneca
Swiss drugmaker Novartis announced a $480 million investment to expand its manufacturing and R&D footprint in China. The plan allocates about $218 million to upgrade its Beijing Changping facility, which can produce up to 3 billion tablets annually, and $262 million to expand its...
STAT+: Pharmalittle: We’re Reading About a Trump Drug Pricing Flaw, a Gilead Deal, and More
A senior Trump administration health official warned that the president’s most‑favored‑nation (MFN) drug‑pricing strategy may unintentionally raise prices abroad rather than lower them in the United States. The flaw arises because manufacturers could postpone launching new drugs in foreign markets,...
Aardvark Pauses 2 Obesity Trials, Reveals New Details on Cardiac Concerns
Aardvark Therapeutics has paused two Phase 2 obesity trials, POWER and STRENGTH, after cardiac safety signals emerged in its lead compounds ARD‑101 and ARD‑201. The anomalies were observed in healthy volunteers receiving double the target dose, prompting a halt to the...
ImmuneBridge Secures $7.7M to Open Cell Therapy Manufacturing Platform to Biotech Partners
ImmuneBridge announced a $7.7 million second seed round, bringing its total seed capital to roughly $20 million, to commercialize its proprietary cell‑therapy screening and manufacturing platform for external partners. The platform combines machine‑learning‑driven donor selection with a unique small‑molecule that preserves stem‑cell...
Dual-Action Antiviral Treatments Offer A New Path Forward
Scientists at the U.S. Army Medical Research Institute of Infectious Diseases have engineered a dual‑action antibody that simultaneously targets two stages of Venezuelan equine encephalitis virus (VEEV) entry. The single‑molecule treatment protected animals even when given after exposure and neutralized...
Viz.ai and Alnylam Pharmaceuticals Partner to Launch AI Care Pathway for Cardiac Amyloidosis
Viz.ai and Alnylam Pharmaceuticals have teamed up to launch an AI‑driven care pathway targeting cardiac amyloidosis, a frequently underdiagnosed heart disease. The solution embeds the FDA‑cleared Us2.ai echocardiography algorithm and generative AI into hospital IT systems to automatically detect subtle...
Imaging Agent Granted FDA Fast Track Designation
FluoGuide A/S announced that the U.S. FDA has granted Fast Track designation to its intraoperative imaging agent FG001, targeting high‑grade glioma surgery. The designation recognizes the serious nature of glioblastoma and the agent's promise to improve tumor visualization during resection....
Quotient Therapeutics & Merck Enter ~$2.2B Partnership to Discover Novel Drug Targets in IBD
Quotient Therapeutics and Merck have signed a multi‑year collaboration to use Quotient’s somatic genomics platform for discovering new drug targets in inflammatory bowel disease. The agreement provides Quotient with $20 million upfront and includes milestone payments that could lift the total...
THE IMPACT OF ARTIFICIAL INTELLIGENCE ON PHARMACEUTICAL AND LIFESCIENCES INDUSTRY
Artificial intelligence is reshaping the pharmaceutical and life‑sciences value chain, from molecule discovery with generative and structure‑prediction models to clinical trial design, manufacturing, regulatory submissions, intellectual property and supply‑chain orchestration. Tools such as AlphaFold and de‑novo design engines accelerate lead...
Radiopharmaceutical Clinical Trials in 2026: How to De-Risk Isotope Supply, Imaging Variability, and Regulatory Pathways
Radiopharmaceutical clinical trials are becoming a high‑velocity segment in 2026, but they remain vulnerable to three predictable bottlenecks: isotope supply chain fragility, imaging variability, and regulatory pathway selection. Axcellant, a boutique CRO with an integrated imaging core lab, demonstrates that...
Synthetic DNA Manufacturing Hub Set Up in Boston by Artis BioSolutions
Artis BioSolutions, a San Diego‑based advanced therapies firm, has launched a synthetic DNA manufacturing hub in Boston using Syngoi Technologies' proprietary enzymatic platform. The new site complements its GMP manufacturing facility in Watertown, creating a bi‑continental network with an existing...
Biotech Investors Set to Meet with Key Congressional Panel
A bipartisan congressional commission focused on maintaining U.S. leadership in biotechnology will host a meeting with leading biotech investors next week. The investors, representing venture capital firms and industry funds, aim to discuss policy gaps, funding mechanisms, and regulatory hurdles....
Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)
Prestige Biopharma announced topline results from its phase‑III SAMSON‑II trial comparing HD204, a biosimilar to Avastin (bevacizumab), with the reference product in 625 patients with advanced non‑squamous non‑small cell lung cancer. The study demonstrated an objective response rate (ORR) of...