Pharma News and Headlines
Pharma News and Headlines
Voro Therapeutics has signed a research collaboration with Daiichi Sankyo’s San Diego research institute to create tumor‑activated antibody‑drug conjugates (ADCs) using Voro’s PrimeBody platform. The partnership will focus on masked ADCs that employ proprietary masking domains and protease‑cleavable linkers to achieve tumor‑selective activation and a higher therapeutic index. Voro will design and characterize ADC candidates against a chosen oncology target, building on its prior success with a CD47‑blocking program. The joint effort aims to expand treatment options for antigens that have been difficult to target with conventional ADCs.
Chinese researchers at Shandong University have engineered the probiotic strain Escherichia coli Nissle 1917 to synthesize and deliver the anticancer drug Romidepsin directly within breast‑tumor tissue in mice. The bacteria colonized the tumors, releasing the drug locally and achieving tumor‑inhibiting...
President Trump’s TrumpRx website claims to offer the world’s lowest prescription‑drug prices, but a New York Times analysis finds the opposite. The site lists only a few dozen negotiated U.S. prices, omitting widely used drugs such as statins and many high‑cost cancer...
Researchers have engineered lipid nanoparticles tethered with a prodrug that releases an IDO‑1 inhibitor while simultaneously delivering mRNA encoding interleukin‑12. The dual‑action formulation, administered intratumorally, generated robust CD8⁺ T‑cell responses, mitigated T‑cell exhaustion, and produced complete tumor regressions in several...
The U.S. Federal Trade Commission announced it is closely monitoring how pharmaceutical companies respond to the upcoming patent cliff affecting numerous blockbuster drugs. FTC antitrust director Dan Guarnera said the agency’s “laser focus” on healthcare will target any anticompetitive conduct...
Zymeworks will present Phase 1 data on its folate‑receptor‑alpha ADC ZW191 and preclinical results for a novel pan‑RAS inhibitor ADC platform at the AACR Annual Meeting. The oral presentation will detail dose‑escalation safety and efficacy in advanced solid tumours, while...
ORIC Pharmaceuticals announced that two preclinical abstracts on its PRC2‑targeting agent rinzimetostat (ORIC‑944) have been accepted for poster presentation at the 2026 AACR Annual Meeting. The data show rinzimetostat, an allosteric EED inhibitor, maintains potency against EZH1‑overexpressing complexes and key...
ArriVent BioPharma will showcase two preclinical posters at the 2026 AACR Annual Meeting, highlighting its EGFR inhibitor firmonertinib and the dual‑target tetravalent ADC ARR-002. Firmonertinib demonstrates high‑potency inhibition of both classical EGFR mutations and exon‑20 insertion variants, with strong brain...
A BMJ study of more than 600,000 Veterans Affairs patients with type‑2 diabetes found that glucagon‑like peptide‑1 (GLP‑1) drugs significantly lowered the risk of developing substance‑use disorders, including alcohol, cannabis, nicotine, cocaine and opioids. The analysis compared GLP‑1 therapy with...
A NIH‑backed multicenter trial of 140 pregnant adults found that weekly injectable extended‑release buprenorphine achieved significantly higher rates of illicit opioid abstinence than daily sublingual buprenorphine, while also reducing serious maternal adverse events. The study, published in JAMA Internal Medicine,...
ABIONYX Pharma filed its Universal Registration Document (URD) for the fiscal year 2025 with the French regulator AMF on March 17, 2026 (filing D. 26‑0099). The URD is now publicly available on both the company’s website and the AMF portal. The...
Sanofi unveiled pre‑clinical data for an in‑vivo CAR‑T platform that delivers mRNA via lipid nanoparticles (LNPs) and a CD8‑targeting VHH nanobody, eliminating the weeks‑long ex‑vivo manufacturing step. The approach achieved tumor suppression in mice with less than 5% liver uptake...
Biotech firm Bicycle Therapeutics announced it will lay off roughly 30% of its workforce, about 86 employees, as it deprioritizes its experimental ADC zelenectide‑pevedotin. Regulators expressed doubts that the Phase 2 Duravelo‑2 trial data will support accelerated approval for metastatic bladder...
Autologous CAR‑T therapies dominate the current market but face logistical and clinical challenges. Patients must undergo leukapheresis, endure long vein‑to‑vein times, and often need bridging therapy, which can cause adverse events. To address these issues, companies are shifting toward off‑the‑shelf...
On February 20, 2026, the FDA issued warning letters to 30 telehealth companies for misleading claims about compounded GLP‑1 weight‑loss drugs such as semaglutide and tirzepatide. The agency highlighted that compounded products are not FDA‑reviewed for safety, efficacy, or quality,...
Researchers introduced BQTML‑CB, an NQO1‑responsive prodrug that releases cytochalasin B inside tumor cells, disrupting actin filaments and halting migration and proliferation. The design exploits the enzyme NQO1, overexpressed in many aggressive cancers, to achieve tumor‑selective activation while sparing NQO1‑deficient cells and...
Researchers have engineered biomimetic nanocarriers that combine liposomal structures with Myxobacteria outer‑membrane vesicles (OMVs) to deliver antibiotics. The hybrid carriers achieve higher drug loading and can penetrate intracellular Gram‑negative pathogens, while native OMVs avoid immune clearance and sustain extracellular exposure....
The review highlights how bacterial membrane composition critically shapes the activity of antimicrobial peptides (AMPs) and outlines experimental and computational strategies for their rational design. By examining case studies, it maps structure‑activity relationships that govern membrane disruption versus intracellular targeting....
The FDA issued a third complete response letter rejecting Aldeyra Therapeutics' lead dry‑eye candidate, reproxalap, citing a lack of substantial evidence and inconsistent efficacy data. The agency noted the drug failed to demonstrate clear benefit in well‑controlled studies, though no...
Gifthealth unveiled an off‑the‑shelf platform that enables manufacturers to offer Most Favored Nation (MFN) pricing through direct‑to‑patient (DTP) programs. The solution leverages Gifthealth’s position as the nation’s largest DTP partner, handling over 90% of U.S. DTP volume and supporting more...
Bristol Myers Squibb faces a major patent cliff as flagship drugs like Revlimid, Pomalyst, Opdivo and Eliquis lose exclusivity, threatening its revenue base. To counteract the decline, the company is reshaping its pipeline through internal R&D and high‑profile acquisitions, emphasizing...
Persistent Systems has partnered with NVIDIA to bring Agentic AI to the healthcare and life‑sciences sector, focusing on computational drug discovery. Leveraging NVIDIA’s full AI stack—including AI Enterprise, BioNeMo, the NeMo Agent Toolkit, and NIM microservices—Persistent built GenMolVS, a generative...
In February 2026 the European Commission and the CHMP granted marketing authorisations and positive opinions for a slate of innovative therapies spanning COVID‑19, oncology, cardiology, immunology and rare diseases. Notable approvals include Moderna’s mNEXSPIKE COVID‑19 vaccine, Hansoh’s Aumseqa for EGFR‑mutated...
Pfizer disclosed topline Phase II (FOURLIGHT‑1) data showing that atirmociclib combined with fulvestrant outperformed fulvestrant alone or everolimus + exemestane in 264 HR+, HER2‑negative metastatic breast cancer patients previously treated with CDK 4/6 inhibitors. The trial met its primary endpoint, delivering a statistically significant...
Scientists are accelerating development of mRNA cancer vaccines, with more than 120 clinical trials targeting melanoma, brain, breast, lung and prostate tumors. Early studies, such as personalized vaccines for glioblastoma, demonstrate rapid immune activation and improved survival. Simultaneously, a false...
U.S. lawmakers warned that China dominates the supply chain for essential hospital and outpatient medicines, especially generic drugs that fill 90% of prescriptions. Witnesses at a Senate Aging Committee hearing highlighted that China controls roughly 90% of key starting materials...
Scientists from VIB and KU Leuven have identified the mechanism by which lecanemab (Leqembi) clears amyloid plaques in Alzheimer’s disease. Their study shows that the antibody’s Fc fragment engages microglia, reprogramming them to phagocytose and degrade plaques. Removing the Fc...
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The blog by HotSpot Therapeutics CEO Jonathan Montagu argues that China is no longer just a manufacturing hub but a burgeoning source of innovative drug candidates, evidenced by its 17% lead over the U.S. in Nature’s Index and nearly half...
The European Commission has granted approval for AstraZeneca’s Imfinzi (durvalumab) combined with FLOT chemotherapy as a perioperative treatment for resectable, early‑stage and locally advanced gastric and gastro‑esophageal junction (G/GEJ) cancers. The decision is based on the Phase III MATTERHORN trial, which...
GEN Pharmaceuticals received BEBO Foundation ethical approval to launch a Phase II proof‑of‑concept trial of its mitochondrial‑targeting drug SUL‑238 in Parkinson’s disease. The single‑centre, randomised, double‑blind, placebo‑controlled study, named SHEPHERD, will begin patient enrolment in Groningen in April 2026. Over a 28‑day...
Semaglutide’s patent will lapse in India on March 24, 2026, unlocking generic competition that could slash prices by up to 90%. The GLP‑1 drug, sold as Ozempic and Wegovy, has been shown to cut major cardiovascular events by 20%. Indian regulators, however,...
The White House is intensifying pressure on Congress to pass a “most‑favored nation” drug‑pricing bill that would cap U.S. medication prices at levels paid by peer nations. Administration officials say the proposal would overhaul pricing for providers, insurers, federal programs...
NeuroScientific Biopharmaceuticals has begun its first manufacturing run of the StemSmart mesenchymal stem cell therapy at Q‑Gen Cell Therapeutics in Brisbane, initiating a critical technology transfer. The engineering run will validate quality, potency and regulatory compliance ahead of a Phase 2...
Abeona Therapeutics reported its Q4 2018 results, highlighting progress on its lead cell therapy EB-101 for recessive dystrophic epidermolysis bullosa (RDEB). The Phase 1/2 trial demonstrated continuous type VII collagen expression for over two years, a favorable safety profile, and durable wound...
A systematic review published in Lancet Psychiatry, analysing 54 randomized controlled trials from 1980‑2025, found no evidence that medicinal cannabis treats depression, anxiety or PTSD. The paper highlights modest benefits for conditions such as epilepsy, multiple sclerosis spasticity, pain and...
Roche announced a new AI factory, adding 2,176 Nvidia Blackwell GPUs to its existing pool and bringing total GPU count above 3,500 – the highest in the pharmaceutical sector. The purchase, likely costing $65 million or more, aims to accelerate drug...
The TrumpRx website now lists 54 prescription drugs after adding seven products from GlaxoSmithKline and Amgen. The expansion pushes the total from 47 to 54, but health‑policy analysts note that the majority are older medicines nearing the end of their...
On July 23, 2020 the FDA issued new recommendations urging health‑care professionals to discuss and consider prescribing naloxone for any patient at heightened risk of opioid overdose. The guidance covers three groups: patients on opioid pain relievers, patients receiving medications...
The FDA is revising the boxed warning for every benzodiazepine product to explicitly list risks of abuse, misuse, addiction, physical dependence, and withdrawal. Updated patient Medication Guides will mirror these warnings, and prescribing information sections such as Warnings, Precautions, and...
The FDA has issued a series of safety communications and label updates for sedative‑hypnotic drugs, including a 2019 boxed warning for sleepwalking injuries and stricter dosing guidance for zolpidem products. Recent alerts also highlight the lethal risk of combining benzodiazepines...
The FDA has approved updated labeling for all pioglitazone‑containing medicines, adding a warning that use longer than one year may increase bladder cancer risk. Healthcare professionals are instructed not to prescribe pioglitazone to patients with active bladder cancer and to...
The FDA has approved label changes for general anesthetic and sedation drugs used in children under three, adding a warning that prolonged exposure—more than three hours or multiple procedures—may harm brain development. The revisions incorporate animal study data showing neuronal...
Scientists have engineered silica‑based nanoparticles that encapsulate rifampicin and release it only when exposed to low‑frequency ultrasound. The ultrasound both propels the particles through the protective matrix of bacterial biofilms and triggers cavitation that opens the particles, delivering the antibiotic...
GlaxoSmithKline replaced its Flovent HFA and Flovent Diskus inhalers with an identical authorized‑generic version priced substantially higher. The move was designed to sidestep Medicaid rebate requirements, prompting health plans and pharmacy benefit managers to erect new access hurdles. Senator Maggie...
NovaBridge’s VIS‑101, a dual VEGF‑A and angiopoietin‑2 inhibitor, delivered rapid and durable efficacy in a phase 2a trial of 38 wet AMD patients in China. Participants receiving 3 mg or 6 mg doses achieved mean visual gains exceeding 10 ETDRS letters and central...
Structure Therapeutics announced positive topline data from its ACCESS II trial of aleniglipron, an oral small‑molecule GLP‑1 receptor agonist. The study demonstrated statistically significant reductions in HbA1c and weight loss comparable to injectable GLP‑1 therapies. Safety signals were mild, with few...
CytomX Therapeutics’ shares surged 66% after the company released expansion data from its Phase 1 study of Varseta‑M, a masked antibody‑drug conjugate targeting EpCAM in late‑stage colorectal cancer. The trial evaluated three dose levels, with the two highest doses achieving response...
Sun Pharmaceutical's tildrakizumab (Ilumya) received FDA acceptance for a supplemental biologics license application to treat active psoriatic arthritis. The sBLA is backed by two Phase III INSPIRE studies involving more than 800 patients, which met primary endpoints with significant ACR20 improvements...
Researchers have identified that a surface‑defensive molecule on cancer cells not only sends a “don’t‑eat‑me” signal but also conceals an “eat‑me” cue that would normally trigger immune clearance. A newly engineered antibody can disrupt this masking interaction, making tumors visible...
