Pharma News and Headlines
Pharma News and Headlines
Simulations Plus has launched strategic partnership programmes with three pharmaceutical companies to embed AI‑driven modelling into the drug development lifecycle. The collaborations will integrate Simulations Plus platforms—ADMET Predictor, GastroPlus, Thales and MonolixSuite—into model‑informed drug development (MIDD) workflows, enabling natural‑language interaction and automated multi‑engine simulations. By working with IT teams, the partners will establish governance, deployment and transparency standards for enterprise‑wide AI adoption. The goal is to translate AI efficiencies into reproducible, traceable outcomes across the industry.
HaemaLogiX, an Australian clinical‑stage biotech, is developing precision immunotherapies for multiple myeloma by targeting novel antigens KMA and LMA that appear only on malignant plasma cells. Peer‑reviewed research validates these targets, allowing the company to spare healthy plasma cells and...
Novartis announced a definitive agreement to acquire Excellergy, a private biotech developing next‑generation anti‑IgE therapies. The deal values Excellergy at up to $2 billion in upfront and milestone payments, with closing targeted for the second half of 2026. Exl‑111, Excellergy’s lead...
Insilico Medicine and Tenacia Biotechnology have expanded their AI‑driven partnership to create a second central‑nervous‑system (CNS) candidate, now advancing to the preclinical stage. The original March 2025 collaboration combined Insilico’s Pharma.AI platform with Tenacia’s expertise in blood‑brain‑barrier‑permeable small‑molecule inhibitors. Under...
Abcuro presented Phase II/III MUSCLE trial data for ulviprubart (ABC008) in inclusion body myositis (IBM) at the GCOM 2026 meeting. The study enrolled 272 patients who received either 0.5 mg/kg, 2 mg/kg, or placebo. Across the entire cohort the drug showed only...
AstraZeneca’s experimental antibody tozorakimab cut moderate‑to‑severe COPD flare‑ups in two phase‑III trials, meeting its primary endpoint. The drug showed a statistically meaningful reduction across both current and former smokers, including those with varying lung damage. The positive data lifted AstraZeneca...
Senior HHS official and Medicare administrator Chris Klomp warned that competition with China’s rapidly advancing biotech sector is “a war,” signaling heightened urgency in U.S. policy circles. He highlighted gaps in domestic research funding, manufacturing capacity, and talent pipelines that...
Innovent Biologics reported its first annual profit, propelled by strong demand for its weight‑loss medication. The Hong Kong‑listed company’s shares surged as much as 7.75%, the biggest jump since late October. The profit milestone underscores the rapid growth of China’s...
The FDA has granted approval to Rocket Pharma's gene therapy Kresladi for severe leukocyte adhesion deficiency type 1 (LAD‑1), an ultra‑rare immune disorder. The therapy was previously rejected in 2024 due to manufacturing concerns, but the agency cleared it after the...
Scientists at Shenyang Pharmaceutical University have engineered eye drops using exosomes derived from pig semen, loaded with a carbon‑dot nanozyme, to breach the retinal barrier in mice. The formulation halted retinoblastoma tumor growth and preserved normal vision over a 30‑day...
Mexico published the Rules of the Pharmaceutical Investment Promotion Committee on February 23, 2026, implementing a 2025 decree aimed at boosting pharmaceutical investment and domestic health‑supply production. The rules tie participation in certain public procurement procedures, such as direct awards...
Clarity Pharmaceuticals has signed a manufacturing supply agreement with Theragenics to scale up production of copper‑64, a radiometal used in its investigational prostate‑cancer tracer 64Cu‑SAR‑bisPSMA. The deal leverages Theragenics’ Atlanta‑area facility, which houses 14 cyclotrons capable of producing roughly 100...
Researchers at Helmholtz‑Zentrum Hereon and partners propose a payload‑driven approach to nucleic‑acid delivery, designing polymeric carriers that are chemically tuned to each DNA, RNA or mRNA payload. The strategy contrasts with the one‑size‑fits‑all lipid nanoparticles that dominate current vaccines and...
LeonaBio announced it has secured an exclusive global license for the Phase 3 lasofoxifene program, a novel selective estrogen receptor modulator aimed at ESR1‑mutated metastatic breast cancer, and raised $90 million in a private placement that could expand to $236 million with warrant...
Neion Bio, fresh from stealth mode, signed its first co‑development and supply agreement with a major global pharmaceutical company to produce recombinant biologics using its egg‑based Raptor™ platform. The deal provides upfront and milestone payments plus profit‑sharing after commercialization, delivering...
The FDA issued guidance clarifying how compounding pharmacies may use bulk drug substances, also known as active pharmaceutical ingredients. Under section 503A, state‑licensed physicians and pharmacists can compound with bulk substances that meet USP/NF monographs, are components of FDA‑approved drugs, or...
Pinnacle Medicines announced the closing of an oversubscribed $89 million Series B financing, co‑led by LAV and Foresite Capital. The biotech firm leverages a proprietary platform that blends physics‑based molecular simulations, AI‑driven design, and advanced peptide chemistry to create oral peptide therapeutics....
The FDA’s upcoming user‑fee framework, dubbed "America First," seeks to tighten eligibility for the small‑business waiver, limiting it to U.S.‑based applicants. Industry groups argue the change politicizes fee policy and could disadvantage foreign‑owned biotech firms that rely on the waiver...
Researchers applied a genome‑wide variance decomposition across TCGA’s 60,656 genes and 33 cancer types to prioritize therapeutic antigens, moving beyond traditional mean‑expression screens. The analysis yielded 17 candidates that met functional dependency, safety, and immune‑cold criteria, with three highlighted: CRIPTO/TDGF1,...
A new Biotechnology Innovation Organization poll of 1,000 U.S. voters shows eight in ten would back leaders who lower drug costs by reforming pharmacy‑benefit managers, insurers, and the 340B program. Across party lines, 88% support passing PBM rebates directly to...
Valneva SE announced its participation in the 26th World Vaccine Congress in Washington, D.C., from March 31 to April 2, 2026. The company’s CEO, Thomas Lingelbach, and senior executives will present data on the chikungunya vaccine IXCHIQ® and join a...
Transgene (Euronext: TNG) will deliver a 30‑minute oral presentation on its individualized neoantigen therapeutic vaccine TG4050 at the World Vaccine Congress in Washington, D.C. on April 1, 2026. TG4050, built on the AI‑driven myvac® platform, targets patient‑specific tumor mutations. Phase 1 data in...
The GLP‑1 drug semaglutide has entered the Indian market as generic versions after its patent expired last week, driving monthly prices down from roughly $144 to $36. The steep discount makes the medication affordable for a broader segment of diabetics...
Kodiak Sciences announced that its experimental eye drug Zenkuda (tarcocimab tedromer) achieved positive topline results in the GLow2 Phase 3 trial for diabetic retinopathy, outperforming sham treatment. The study met its primary endpoint, delivering a statistically significant gain in visual acuity...
Cryopreservation remains a linchpin for cell and gene therapy (CGT) manufacturing, yet frozen material is not inherently stable. Real‑world operations introduce transient warming events (TWEs) when products are moved, accessed, or shipped, silently degrading viability and potency. Traditional reliance on...
Dr. Emanuela Offidani, Tris Pharma’s Medical Director of Digital Health Strategy, highlighted that ADHD is increasingly recognized as a lifelong condition that often goes undiagnosed in women because symptoms are less overt. She explained that Tris Pharma’s proprietary LiquiXR delivery...
The Pistoia Alliance has published a peer‑reviewed best‑practice framework guiding ethical use of social‑media listening in drug development. The framework, co‑authored by experts from Bayer, Roche, Boehringer Ingelheim, Chiesi and Semalytix, outlines standards for data anonymization, bias mitigation, and AI‑driven...
Biotech start‑up Neion Bio is pioneering a method to turn chicken embryos into miniature drug factories. Scientists micro‑inject genetic constructs into three‑day‑old embryos, reprogramming the developing bird to synthesize pharmaceutical compounds within the egg. The approach promises faster, cheaper production...
Novocure disclosed topline Phase‑2 PANOVA‑4 data showing that Tumor‑Treating Fields (TTFields) combined with Tecentriq and gemcitabine/nab‑paclitaxel achieved a 74.4% disease‑control rate in metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial, enrolling 78 patients, outperformed the historical MPACT control arm’s 48% DCR. Secondary...
Pinnacle Medicines, a two‑year‑old biotech focused on oral peptide therapeutics, secured $89 million from a mix of U.S. and Chinese investors. The financing will fund its platform that converts injectable peptides into pill form, building on the recent success of Novo...
Otsuka Pharmaceutical presented Phase III VISIONARY trial data for Voyxact (sibeprenlimab‑szsi) in IgA nephropathy patients at risk of progression. At 48 weeks, 82.5% of patients receiving 400 mg subcutaneous Voyxact achieved negative microscopic hematuria versus 52.6% on placebo, with median time to...
Biogen has signed an exclusive license with South Korean biotech Alteogen for ALT‑B4, a recombinant hyaluronidase enzyme that facilitates subcutaneous administration of biologics traditionally given intravenously. The agreement provides Alteogen with $20 million upfront, a $10 million payment upon initiation of a...
Jiangsu Aidea Pharmaceutical, a Shanghai‑Star Market listed firm specializing in HIV/AIDS therapies, is preparing a Hong Kong IPO to fund its expansion into the United States and Europe. The company projects the global AIDS‑treatment market to exceed $1.45 billion by 2027...
Ascentage Pharma reported unaudited 2025 results, showing product sales surged 90% to $82.1 million while total revenue fell 41.5% after a $92.9 million drop in intellectual‑property income. Olverembatinib generated $62.2 million, up 81% YoY, and the newly launched Lisaftoclax contributed $10.1 million in its...
Lawrence Tallon, the MHRA chief, is set to oversee the launch of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 on April 28, 2026. The amendment represents the most extensive overhaul of U.K. clinical‑trial rules in two decades, targeting faster approval,...
The FDA’s Regulatory Education for Industry (REdI) Annual Conference will take place May 19‑20, 2026, offering both virtual and in‑person sessions at the White Oak Campus in Maryland. The two‑day program features three dedicated tracks—drugs, devices, and biologics—allowing participants to...
Denali Therapeutics received accelerated FDA approval for Avlayon (tividenofusp alfa‑eknm), the first enzyme replacement therapy designed to cross the blood‑brain barrier for Hunter syndrome. The approval is based on a phase 1/2 trial of 47 boys up to 18 years, showing...
The FDA’s Center for Drug Evaluation and Research released its FY 2025 GDUFA Science & Research Report, detailing more than 50 funded projects across eight priority scientific initiatives. The program targets bioequivalence, manufacturing standards, and advanced analytical methods to streamline abbreviated...
Under the Hatch‑Waxman law, generic manufacturers must file a Paragraph IV certification asserting that a listed patent is invalid, unenforceable, or not infringed to obtain FDA approval. The first substantially complete ANDA with such a certification secures a 180‑day exclusivity period,...
Researchers at Longeveron reported that a single infusion of laromestrocel, a mesenchymal stem‑cell therapy derived from donors aged 14‑18, significantly boosted mobility in frail seniors. In a double‑blind trial of about 150 participants aged 70‑85, the highest dose (200 million cells)...
The FDA announced new guidance that expands flexibility in chemistry, manufacturing, and controls (CMC) for cell and gene therapies (CGTs) across their development lifecycle. Sponsors can now defer full cGMP compliance until later trial phases and make iterative manufacturing changes...
The FDA granted accelerated approval to Avlayah (tividenofusp alfa‑eknm), a weekly IV infusion, for treating neurologic manifestations of Hunter syndrome in pediatric patients weighing at least 5 kg. The approval is based on a phase 1/2 trial that demonstrated a 91% average...
Researchers at the University of Guelph announced that their sugar‑based vaccine candidate against Campylobacter jejuni demonstrated safety and immunogenicity in a small Phase 1 human trial. Participants experienced only mild side effects, and the formulation generated measurable antibody responses even at...
Anavex Life Sciences withdrew its European marketing authorisation application for blarcamesine, an add‑on therapy for early‑stage Alzheimer’s, after the EMA’s CHMP signaled a likely negative opinion. The committee criticized the trial’s efficacy data, methodological flaws, and safety reporting, including concerns...
The FDA’s Center for Drug Evaluation and Research (CDER) released its FY 25 Drug Quality Sampling and Testing results, showing that the vast majority of tested pharmaceuticals met USP specifications. The program uses a risk‑based, data‑driven approach introduced in 2018 to...
At the ACS Spring 2026 meeting in Atlanta, the Medicinal Chemistry division unveiled six new drug candidates transitioning from discovery to clinical testing. The molecules, presented by researchers from Biohaven, Bristol Myers Squibb, Regor Therapeutics, Olema Oncology, FoRx Therapeutics, and Iambic Therapeutics,...
Seaport Therapeutics is embedding a fail‑safe mechanism into its Phase 2b trial of SPT‑300, an experimental therapy for major depressive disorder. The study will enroll roughly 300 patients at multiple U.S. sites and uses an adaptive design that can halt...
