The synergy – or lack of it – between knockdown drugs and stabilizers in treating transthyretin (TTR)-mediated amyloid cardiomyopathy (ATTR-CM) became one of the topics for debate in the aftermath of the phase III fizzle with gene silencer Wainua (eplontersen), advanced by Astrazeneca plc and Ionis Pharmaceuticals Inc.
The synergy – or lack of it – between knockdown drugs and stabilizers in treating transthyretin (TTR)-mediated amyloid cardiomyopathy (ATTR-CM) became one of the topics for debate in the aftermath of the phase III fizzle with gene silencer Wainua (eplontersen), advanced by Astrazeneca plc and Ionis Pharmaceuticals Inc.
The U.S. FDA declined to approve, for a third time, an investigational liver cancer drug regimen comprising HLB Co. Ltd.’s rivoceranib and Jiangsu Hengrui Pharmaceutical Co. Ltd.’s camrelizumab, reportedly citing issues from a drug manufacturing facility inspection.
Alongside its duties in evaluating safety and effectiveness of drugs and their postmarketing monitoring, the U.K. Medicines and Healthcare products Agency (MHRA) has now been handed a further brief to support economic growth.
Med-tech M&As through the first half (H1) of 2026 reached $75.73 billion in collective value, the highest H1 total since 2022’s $120.4 billion and well above every other year in BioWorld’s records. June contributed $12.21 billion, a rebound from May’s relatively quiet $1.51 billion.
Cancer researchers are increasingly turning to the microbiome to understand why some patients respond well to treatment while others face severe complications. Gut microbial communities shift during intensive therapies such as bone marrow transplantation, and those changes influence infection risk, immune recovery and long‑term survival. New advances in microbial sequencing and engineering redefine this community as a measurable clinical parameter that can be monitored, modeled, and even therapeutically reshaped to improve outcomes in oncology and other conditions.
The U.S. SEC reached a settlement with Weiguo Zhai resolving insider trading charges related to Astrazeneca plc’s $1.1 billion acquisition of Icosavax Inc. in 2023.
Of all the U.S. SEC’s recent proposed rules to make going, and staying, public more attractive, perhaps the most beneficial for biopharma and med-tech startups is the amendment that would give public companies the flexibility to file semi-annual rather than quarterly reports, Ben Bradford, head of...
The April 2024 full U.S. FDA approval of Pfizer Inc. and Genmab A/S’ tissue factor-targeting antibody-drug conjugate Tivdak (tisotumab vedotin) for cervical cancer sparked interest from drug developers in the strategy, which has been known about for a while.
Biopharma financings across all categories totaled $59.76 billion on 567 deals in the first half (H1) of 2026, more than double H1 2025’s $29.53 billion across 501 transactions.
To Ivan Oransky, China’s paper-mill problem is best understood as an incentives story. “This is literally organized crime,” the Retraction Watch co-founder told BioWorld. “Follow the money. When there’s an opportunity to make money, they will find it, and if your whole career is based on how...
For decades, treatment options for osteoarthritis have followed a familiar path: As cartilage deteriorates and pain worsens, conservative therapies eventually give way to joint replacement surgery. Australian regenerative medicine company Integrant Pty Ltd. wants to change that trajectory. Rather...
After decades of clinical research and false starts, have Brain-Computer Interface (BCI) systems finally arrived? With developments accelerating in the field, BioWorld's special series explores the advancements in the space, looking at the implanted technologies, their potential to transfer care,...
Veterans in the U.S. suffering from post-traumatic stress disorder (PTSD) now have access to Neurovalens Ltd.’s Modius Spero, a wearable neuromodulation device, which can reduce their symptoms in as little as four weeks. The treatment, designed for at-home use of 30-minute daily sessions, was...
A year and a half from its formation, Oblenio Bio has generated positive nonhuman primate data for LBL-051 in chronic autoimmune diseases and closed a $62 million series B to move the trispecific T-cell engager into the clinic.
Bionyra Pharma has emerged with a $165 million oversubscribed series A and a portfolio of three antibodies with extended half-lives that are designed to offer improvements over existing classes of monoclonal antibodies for treating chronic inflammatory diseases.
Ethyreal Bio Inc. has come out of stealth mode in order to disclose preclinical data for ETHY-001, its monoclonal antibody targeting thyroid stimulating hormone receptor, at the Endocrine Society’s 2026 annual meeting on June 15.
Modulating G protein-coupled receptors (GPCRs) is one of the major challenges in biomedicine. These are flexible proteins with small, deep binding pockets. The scientific community has explored small molecules, antibodies and nanobodies to develop ligands. Skape Bio Inc. is betting on creating...
Oorja Bio Inc., named after the phonetic spelling of “energy” in Sanskrit, secured $30 million from founding investor Westlake Biopartners in a series A financing round to advance its in-licensing approach to develop drugs for idiopathic pulmonary fibrosis (IPF) and other fibrotic and...
While biomedical resources in the form of specialized tools, hundreds of thousands of published papers and huge repositories of ‘omics, health records and other data, are growing exponentially, discovery is getting slower and more expensive. That is the perspective from which scientists at Stanford...
Following an initial rebuff in February 2026, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is recommending approval of Acadia Pharmaceuticals Inc.’s Daybu (trofinetide) for treating neurobehavioral symptoms of Rett syndrome, after it took another look at the file.
Ready or not, the future has arrived. Novel AI and brain-computer interface (BCI) systems are no longer confined to the realm of science fiction. As an increasingly intertwined human-machine model moves closer to adoption in real-world clinical and military practice, technological advances are...
Johnson & Johnson this week launched its dual-energy Thermocool Smarttouch SF platform in Europe bringing another option to physicians looking to enhance their electrophysiology procedures. The system combines radiofrequency (RF) and pulsed field ablation in one device to treat atrial fibrillation,...
Island Pharmaceuticals Ltd. has secured government and ethics approvals to deploy its investigational antiviral galidesivir in patients infected during the escalating Bundibugyo Ebola outbreak in Africa, giving the small Australian biotech a rare...
Pending talks with regulators, Satellos Bioscience Inc. may seek accelerated approval in Duchenne muscular dystrophy (DMD) for SAT-3247, which yielded positive results in the adult phase II Trailhead study. Shares of Toronto-based Satellos...
Roche Holding AG’s Genentech unit achieved superior phase III results with its KRAS G12C inhibitor divarasib over approved therapies in previously treated non-small-cell lung (NSCLC) cancer patients.
The data mill continues to churn out encouraging results in pancreatic ductal adenocarcinoma (PDAC), with shares of Ramat Gan, Israel-based Can-Fite Biopharma Ltd. benefiting from the latest, phase IIa dispatch that pushed shares (NYSE:CANF) up...
Top-line phase III Palisade-4 results of Vistagen Therapeutics Inc.’s fasedienol showed the intranasal pherine candidate failed to hit primary and secondary endpoints in the acute treatment of social anxiety disorder (SAD), issuing a near death...
Wall Street breathed easier, and shares of Abivax SA found relief as further phase III data from the Abtect maintenance trial were disclosed with obefazimod in ulcerative colitis (UC).
Breakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.