What's happening: Cell‑free PL‑display platform accelerates peptide screening ten‑fold
Researchers at the Innovation Center of NanoMedicine introduced PL‑display, a cell‑free system that immobilizes individual peptides on magnetic beads for rapid screening. The platform achieves more than ten‑fold efficiency gains over traditional cell‑based displays and remains functional under high‑temperature, high‑salt, or toxic‑protein conditions.
Also developing:

Kenco’s vice‑president of life sciences, Tim McClatchy, detailed how the firm is hardening cybersecurity across its manufacturer‑to‑home delivery network while deploying AI to streamline labor planning and route optimization. He explained the specific encryption and verification steps used at each handoff, and how recent FDA and HHS regulatory updates forced tighter data‑tracking protocols. McClatchy also projected that third‑party logistics providers will increasingly dominate home‑based care supply chains over the next decade, reshaping the industry’s operational model.
The iShares U.S. Pharmaceuticals ETF (IHE) is anchored by Johnson & Johnson and Eli Lilly, whose earnings per share have nearly doubled in the past year. IHE’s aggregate one‑year EPS growth estimate is an impressive 19.07% while trading at a modest...

President Trump’s "most‑favored nation" (MFN) drug pricing agreements, touted as a safeguard against excessive prescription costs, have been revealed to run for three years for several participants. SEC filings show that 16 pharmaceutical firms have entered these deals, each with...
Researchers have engineered size‑shifting lipid nanoparticles that grow from ~100 nm to >300 nm after intraperitoneal injection, exploiting a capsule‑filter mechanism that blocks entry into the liver and spleen while allowing passage to the pancreas. The enlarged particles deliver mRNA payloads—including CRISPR‑Cas9...
Eli Lilly unveiled LillyPod, a DGX SuperPOD built with 1,016 NVIDIA Blackwell Ultra GPUs delivering more than 9,000 petaflops of AI performance. The system powers genomics, protein‑diffusion, small‑molecule graph neural networks and foundation models, allowing billions of in‑silico experiments. Constructed...

The FDA approved Hernexeos through the national priority voucher program, a mechanism that fast‑tracks drugs addressing unmet medical needs. Industry leaders are evaluating direct‑to‑consumer (DTC) models to broaden access to HIV prevention tools, leveraging digital and telehealth channels. Additionally, the...
Three bispecific antibodies targeting PD‑1 and CTLA‑4—lorigerlimab, volrustomig, and cadonilimab—illustrate divergent engineering strategies. Lorig erlimab relies on a knob‑into‑hole heterodimer, volrustomig adopts a common light chain format, and cadonilimab incorporates Fc‑silencing mutations. Their distinct designs have produced markedly different safety...

Bayer's HYRNUO (sevabertinib) received accelerated FDA approval on November 19, 2025 for adult patients with HER2‑mutated, non‑squamous non‑small cell lung cancer who have progressed after prior therapy. The approval is based on the single‑arm SOHO‑01 trial, which enrolled 122 patients across 78...

A round‑up of leading experts highlights how cellular reprogramming has moved from a laboratory curiosity to a near‑clinical anti‑aging platform. Researchers describe partial, epigenetic‑focused approaches that can rejuvenate cells without erasing identity, and four biotech firms outline their distinct delivery...
The Inflation Reduction Act reshapes Medicare Part D by granting CMS authority to negotiate prices for high‑cost drugs and instituting a $2,100 annual out‑of‑pocket cap for beneficiaries starting this year. The first ten drugs, including Ozempic and Wegovy, will have negotiated...

The episode covers three main business stories: Tamarin Bio’s $13.6M Series A to build an AI model‑coordination platform that makes tools like AlphaFold accessible to wet‑lab biologists; the FDA’s reversal on Moderna’s mRNA‑1010 seasonal flu vaccine, spurring a modest stock...

AMSBIO (Oxford, UK) now provides ready‑to‑use lentiviral particles with titers exceeding 1×10⁷ IFU / mL, eliminating the need for in‑house virus production. The third‑generation self‑inactivating vectors are supplied in research‑grade and GMP‑grade formats, requiring only BSL‑2 containment. High‑titer, purified particles enable efficient...

A year-long trastuzumab emtansine (T‑DM1) regimen showed 98% three‑year invasive‑disease‑free survival in early‑stage HER2‑positive breast cancer, comparable to standard paclitaxel‑plus‑trastuzumab. The ATEMPT trial of nearly 500 patients found similar overall survival but markedly lower neuropathy and hair loss with T‑DM1,...
The FDA granted accelerated approval to Boehringer Ingelheim’s oral HER2 kinase inhibitor Hernexeos six weeks after the company filed its application, marking the second approval under the new Commissioner’s National Priority Voucher (CNPV) program. The decision expands Hernexeos use to...

Today’s brief highlights four pre‑clinical advances: Paratus Sciences unveiled PS‑1001, a pan‑inflammasome blocker targeting IL‑1β and IL‑18 for hidradenitis suppurativa; researchers identified the SCAN circuit as a core pathway disrupted in Parkinson’s disease; RX‑10616 demonstrated enhanced radiotherapy response in head‑and‑neck...
Prospect Therapeutics announced the identification of a new series of small‑molecule inhibitors targeting Janus kinase 1 (JAK1) and tyrosine kinase 2 (TYK2). The lead compounds demonstrate nanomolar potency and selectivity in biochemical assays and effectively suppress cytokine signaling in cellular...

Novo Nordisk’s CagriSema combination missed the primary non‑inferiority endpoint against Eli Lilly’s tirzepatide (Zepbound) in the 84‑week REDEFINE 4 obesity trial, posting 23.0% versus 25.5% weight loss. At the same time, Grail’s large NHS‑Galleri screening study failed to achieve its primary...
The Consolidated Appropriations Act of 2026 bans pharmacy benefit managers (PBMs) from receiving compensation tied to drug list prices and mandates 100% rebate pass‑through to plan sponsors by August 2028. The law also allocates roughly $190 million to the Centers for...

The FDA’s Drug Trials Snapshots program publishes concise, consumer‑focused summaries of the demographic makeup and outcomes of pivotal clinical trials for newly approved drugs. Launched in 2015, the tool covers only New Molecular Entities and original biologics approved after that...

Ionis Pharmaceuticals received FDA acceptance of its supplemental NDA for olezarsen and a priority‑review designation, with a PDUFA action date of June 30, 2026. The decision is backed by two Phase III CORE studies—CORE (n=617) and CORE2 (n=446)—that evaluated once‑monthly subcutaneous...

GSK’s depemokimab, marketed as EXDENSUR, received FDA approval on December 16, 2025 as a six‑month subcutaneous add‑on for severe eosinophilic asthma in patients aged 12 and older. Approval was based on two 52‑week, double‑blind, placebo‑controlled trials (SWIFT‑1 and SWIFT‑2) that...
Researchers highlight that senescent cells arising from DNA replication errors that generate whole‑chromosome duplications—polyploidy‑induced senescence (PIS)—are biochemically distinct from senescence caused by other stresses. Existing literature often fails to separate polyploid senescent cells from diploid counterparts, obscuring their unique roles...

Gilead’s U.S. HIV prevention VP Ashley Gildea unveiled a direct‑to‑consumer campaign for Yeztugo, the first twice‑yearly injectable PrEP. The campaign, anchored by a music‑driven “One2PrEP” spot, aims to lift awareness among the estimated 2.2 million Americans who could benefit from PrEP...
The FDA issued a suite of new guidance documents in early 2026 aimed at easing development of therapies for rare diseases, including the Rare Disease Evidence Pathway, Plausible Mechanism Pathway, and innovative trial designs for cellular and gene therapies. The...

Eli Lilly’s oral GLP‑1 small‑molecule orforglipron demonstrated greater A1C reduction and weight loss than oral semaglutide, while offering flexible dosing without fasting. GSK announced a $950 million acquisition of 35Pharma, securing HS235, an activin‑signaling inhibitor aimed at pulmonary hypertension. The deal taps...
Quotient Sciences has extended its commercial partnership with Ipsen to manufacture Sohonos (Palovarotene), the approved therapy for fibrodysplasia ossificans progressiva (FOP), an ultra‑rare disease affecting fewer than 1,000 people worldwide. The deal includes Ipsen's investment in a pneumatic closed‑transfer system...
Eli Lilly disclosed Phase III ACHIEVE‑3 results showing its oral GLP‑1 agonist orforglipron outperformed oral semaglutide in lowering A1C and inducing weight loss. The 52‑week, open‑label trial enrolled 1,698 patients across six countries and compared two doses of each drug. Orforglipron also...

Bayer announced that its phase‑III PEACE‑3 trial demonstrated a statistically significant overall‑survival benefit for the combination of Xofigo (radium‑223) and enzalutamide versus enzalutamide alone in patients with metastatic castration‑resistant prostate cancer (mCRPC) and bone metastases. Median overall survival extended to...
PMV Pharmaceuticals reported Phase I results of rezatapopt, a small‑molecule p53 reactivator, in 77 patients with advanced solid tumors carrying the TP53 Y220C mutation. The oral drug was generally well tolerated, with few dose‑limiting toxicities, allowing the selection of a...

The FDA has warned consumers against buying ULTRA ADVANC3 on Amazon and ULTRA ADVANC3 GOLD on NaturistaRex after laboratory tests revealed hidden prescription drugs. The supplements contain undeclared dexamethasone, diclofenac, and methocarbamol, each carrying serious health risks. The agency advises immediate discontinuation and...
Fulgent Genetics reported Q4 2025 revenue of $84.1 million, a sequential increase and strong year‑over‑year growth across its Precision Diagnostics and Biopharma segments. Non‑GAAP gross margin improved to 44.3% while operating expenses fell, delivering a $0.7 million adjusted EBITDA and a $4.5 million...
Senator Ron Johnson (R‑WI) is urging Congress to draft a “Right to Try 2.0” bill that would force the FDA to grant broader, faster access to experimental therapies for rare diseases. FDA Commissioner Martin Makary pushed back, defending the agency’s...

The U.S. Department of Justice filed an amicus brief supporting AbbVie in its effort to overturn a Colorado statute that prohibits pharmaceutical manufacturers from limiting discounts under the federal 340B drug pricing program when hospitals use contract pharmacies. The Colorado...

Researchers from Japan Tobacco and D‑Wave have unveiled a hybrid framework that merges deep generative models with quantum annealing to design drug‑like molecules. The system introduces a Neural Hash Function that enables binarisation for quantum processing while preserving gradient flow....
The FDA granted accelerated approval to zongertinib (Hernexeos) for adults with unresectable or metastatic non‑squamous NSCLC that carry activating HER2 TKD mutations, extending its use to treatment‑naive patients. The decision rests on the Beamion LUNG‑1 trial, which reported a 76%...
RIKEN scientists have shown that an intrinsically disordered region (IDR) of the DEAD‑box helicase DDX3X confers selective binding to specific mRNA structures, a mechanism uncovered using solution NMR spectroscopy. The discovery clarifies how DDX3X distinguishes target transcripts, linking its specificity...
ARUP Laboratories has unveiled the Innovation Central Laboratory, a dedicated hub for co‑development with pharmaceutical and biotech partners. The facility is designed to validate technologies and move next‑generation diagnostics from concept through to commercial readiness. It will host projects ranging...

The FDA approved KOMZIFTI (ziftomenib) on November 13 2025 as an oral 600 mg capsule for adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring an NPM1 mutation. Approval rests on the single‑arm KO‑MEN‑001 trial, which enrolled 112 participants across seven...

The January 2026 Patent Highlights roundup spotlights a wave of new intellectual‑property activity across several cutting‑edge drug discovery areas. Notable filings include lysine‑directed covalent inhibitor chemotypes, strategies to balance potency with drug‑like properties, refined target‑selection frameworks, dozens of Polθ synthetic‑lethal patents...
The Centers for Medicare & Medicaid Services entered the third year of its Medicare drug price negotiation program, selecting 15 drugs—including, for the first time, therapies covered under Medicare Part B. Patient advocacy groups have until March 1 to submit written comments...
Bristol Myers Squibb reported that its antibody‑drug conjugate iza‑bren, licensed from Chinese partner SystImmune, achieved statistically significant improvements in progression‑free and overall survival versus chemotherapy in a Phase III trial for advanced triple‑negative breast cancer. The study, conducted in mainland China...

An international team led by the University of Birmingham, University Hospitals Birmingham NHS Foundation Trust and Bristol Myers Squibb has produced the most detailed spatial atlas of pancreatic ductal adenocarcinoma (PDAC) to date. Using spatial transcriptomics and spatial molecular imaging...
Adding androgen deprivation therapy (ADT) to definitive radiotherapy improves overall survival for men with high‑risk prostate cancer, but its benefit when combined with postoperative radiotherapy (PORT) after prostatectomy is less clear. Randomised trials such as GETUG‑AFU 16, SPPORT, and the RADICALS‑HD...
Researchers at the University of Macau have demonstrated the first in‑situ synthesis of covalent organic frameworks (COFs) inside lysosomes of cancer cells, using acidic pH‑driven imine condensation of TAPB and DMTP. The crystalline UMCOF1 particles rupture lysosomal membranes, liberating ferrous...
The FDA announced it will default to a single pivotal trial for new drug applications, extending a practice long used in oncology and rare‑disease approvals. In 2024, 66% of new molecular entities were cleared based on one trial, signaling a...
The latest episode of BioSpace’s Denatured podcast spotlights a growing partnership between ALS patients and pharmaceutical developers, featuring insights from EverythingALS founder Indu Navar and VectorY Therapeutics CMO Dr. Olga Uspenskaya. The discussion highlights how patient‑driven collaborations are accelerating trial timelines...

Sarepta Therapeutics announced that CEO Douglas Ingram will retire by the end of 2026, triggering a formal succession search. The move follows a turbulent 2025 in which the company’s flagship gene therapy Elevidys was linked to two patient deaths, prompting...

The U.S. Food and Drug Administration rejected a rare‑disease cell therapy that had already secured approval in Europe, despite earlier internal support from the agency. The decision comes under the FDA’s new leadership and has sparked debate over whether the...

In Episode 9 of Drug Dealin, hosts Kenny and Shibu demonstrate how patients can use publicly available tools like ClinicalTrials.gov and AI language models to uncover novel treatment options, focusing on a hypothetical Parkinson’s disease case inspired by a TV...
Atara Biotherapeutics’ stock jumped 20% after STAT reported that internal FDA inconsistencies may have driven the rejection of its EBV‑positive PTLD cell therapy, Ebvallo. The FDA denied the U.S. application citing insufficient evidence of effectiveness, yet former reviewers said data...