Roche Holding AG has rapidly developed a research-use only molecular PCR test to detect the rare Ebola Bundibugyo virus, to support response efforts amid the ongoing outbreak in the Democratic Republic of Congo and Uganda. The test comes as commentary in The Lancet this week underscored the urgent need for a fit-for-purpose diagnostic test, as it warned that the absence of reliable testing is hampering efforts to ascertain the scale of the epidemic and understand the transmissibility of this strain of Bundibugyo virus.
Roche Holding AG has rapidly developed a research-use only molecular PCR test to detect the rare Ebola Bundibugyo virus, to support response efforts amid the ongoing outbreak in the Democratic Republic of Congo and Uganda. The test comes as commentary in The Lancet this week underscored the urgent need for a fit-for-purpose diagnostic test, as it warned that the absence of reliable testing is hampering efforts to ascertain the scale of the epidemic and understand the transmissibility of this strain of Bundibugyo virus.
The U.S. FDA’s year-old Commissioner’s National Priority Voucher (CNPV) pilot program played to mixed reviews at the agency’s June 4 listening session intended to get various stakeholders’ perspective on the ultra-accelerated review process being offered to qualifying drugs.
After a major breach of trust when its data were advertised for sale in China, the UK Biobank will now attempt to recall data previously downloaded by legitimate researchers and seek assurances information has been deleted from local servers.
Agios Pharmaceuticals Inc.’s potential $665 million deal for Oscotec Inc.’s cevidoplenib, a phase III-ready oral SYK inhibitor to treat immune thrombocytopenia, marks a new chapter of development focused on cancer therapy resistance for Oscotec, CEO Yoon Tae-young said.
If the 2026 American Society of Clinical Oncology (ASCO) annual meeting in Chicago from May 30 to June 3 demonstrated anything about the evolution of China’s biotechnology sector, it was that the industry’s center of gravity is shifting. While Chinese companies once relied heavily on PD-1 antibodies and licensing deals to gain international visibility, this year’s oral presentations showcased a broader innovation base.
TRIM21, an enzyme involved in intracellular substrate degradation, can recognize viruses and bacteria that enter the cytosol when they are coated with antibodies. Just as it tags complex molecules for elimination, it can direct these infectious microorganisms to lysosomes through a mechanism its discoverers have termed antibody-directed xenophagy (ADX). Scientists at the Medical Research Council (MRC) Laboratory of Molecular Biology (LMB) in Cambridge, U.K., have identified the genes involved in this antibody-dependent degradation pathway, which acts as an antimicrobial process, and reported their findings in Molecular Cell on June 4, 2026.
Total biopharma financing through the first five months of 2026 reached $49.46 billion, the third-highest total for the period in the dataset and more than doubling of 2025’s $21.4 billion over the same stretch.
The opioid crisis may not be front and center anymore, but it’s raging still. Elysium Therapeutics Inc. CEO Greg Sturmer talks about his firm’s candidate for a solution to the medical and societal problem.
The BioWorld Neurological Diseases Index (BNDI) ended May up 12.29% for the year, outpacing both the Nasdaq Biotechnology Index (up 4.95%) and the Dow Jones Industrial Average (up 6.18%), a reversal from 2025 when the BNDI trailed both broader benchmarks.
Oppenheimer analyst Jay Olson trumpeted “a new era” in pancreatic ductal adenocarcinoma (PDAC) after Revolution Medicines Inc.’s data splash with daraxonrasib at the American Society of Clinical Oncology meeting in Chicago – but he wasn’t talking about only that company. Combined with other recent...
BioWorld tracked 143 clinical trial readouts across phases I through III in April 2026, down from 209 in March, but roughly in line with 152 in February and 144 in January. By phase, April’s readouts included 47 from phase I, 59 from phase II and 37 in phase III. Among phase III programs, 15 trials...
The BioWorld Drug Developers Index (BDDI) outpaced both the Nasdaq Biotechnology Index and the Dow Jones Industrial Average throughout the first four months of 2026. Starting the year in step with the broader indices, the BDDI pulled ahead steadily – climbing 4.41% year-to-date through January,...
Antibody-drug conjugate (ADC) specialist Ona Therapeutics SL has closed an oversubscribed series B at $86.6 million, as clinical development of the lead program ONA-255 in advanced treatment-resistant breast cancer gathers steam.
Rather than reinventing the wheel for every gene therapy that uses genome editing, the U.S. FDA is advising sponsors on leveraging existing knowledge, be it publicly available or platform-based, to more efficiently advance their products across multiple stages of development.
The Trump administration’s efforts to ensure U.S. federal grants align with its policies may soon be coming to fruition. The White House Office of Management and Budget released a proposed rulemaking to revise its Guidance for Federal Financial Assistance.
Abbott Laboratories received CE mark approval for two dual glucose and ketone sensing systems, bringing to the market sensors that could be transformational to the lives of people with diabetes at risk of diabetic ketoacidosis.
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...
Curacle Co. Ltd. inked a potential $1.07 billion deal with U.S.-based “newco” Memento Medicines on May 10, granting the latter exclusive global rights to develop and commercialize preclinical TIE2/VEGF-directed bispecific antibody MT-103 for retinal disorders.
The classic origin story for a biotech startup is that of a scientist who nurtures his work out of a university and to commercial success. For Link Biologics Ltd. and its TSG6-based pipeline, the story is the other way around; it began with now-CEO Reuben Dawkins meeting University of Manchester...
Sonire Therapeutics Inc. initiated a U.S.-based Sunrise II study of Suizenji, its novel ultrasound-guided high-intensity focused ultrasound (HIFU) system designed to ablate pancreatic tumors, after closing an $18 million series A financing round April 15.
Pilatus Bio Inc. is working to address a major under-addressed target of current checkpoint inhibitors: metabolic stress within solid tumors. “Traditional immunotherapies release immune ‘brakes,’ but they do not address the underlying metabolic stress in tumors,” Pilatus CEO and cofounder Raven Lin...
Achieving high marks in the phase II Amplify-BD trial for bipolar I and II depression, Autobahn Therapeutics Inc.’s elunetirom, a brain-penetrant central nervous system thyroid hormone receptor agonist, or thyromimetic, is moving toward a registrational path and a clinical readout in major...
New data from Grail Inc.’s randomized study of its Galleri multicancer early detection test could not alter the fact that the U.K. trial missed the primary endpoint of reducing the number of cancers diagnosed at stage III and stage IV. But the company is now suggesting that discounting the initial...
The much-awaited phase III readout from Oculis Holding AG’s OCS-01 in diabetic macular edema (DME) fell short of expectations, delaying the possibility of a topical eye drop option for DME patients and prompting the company to shuffle its pipeline priorities, with a focus on late-stage programs...
GSK plc has announced a breakthrough in the treatment of chronic hepatitis B, reporting a functional cure rate of 19% across two phase III trials of its antisense oligonucleotide bepirovirsen.
Innovent Biologics Co. Ltd.’s Claudin18.2-targeted antibody-drug conjugate (ADC), arcotatug tavatecan (IBI-343, TAK-921), met the primary endpoint in the international multicenter phase III G-Hope-001 trial in advanced gastric cancer, according to...
Turn Therapeutics Inc. made public strongly positive findings from an interim analysis that involves the first 50 subjects in the ongoing phase II atopic dermatitis (AD) trial with IL-36 inhibitor GX-03.
“I need to be honest with you about something important. Most previous Ebola outbreaks in the Democratic Republic of Congo (DRC) were caused by a virus called Ebola Zaire, for which we have vaccines and treatments. This outbreak is caused by a...
Bristol Myers Squibb Co. disclosed in March 2026 that the phase III portion of the seamless phase II/III Successor-2 study testing mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) in patients with relapsed or refractory...
D&D Pharmatech Inc. announced May 27 positive top-line tissue biopsy results of zabopegdutide (DD-01) from a 48-week phase II study of metabolic dysfunction-associated steatohepatitis (MASH), pushing company shares up 30% on the day.
Apogee Therapeutics Inc. loaded up on what could total as much as $1.3 billion in financial fuel from Blackstone Life Sciences funds that will be used to propel zumilokibart (zumi), which yielded positive phase II results in atopic dermatitis...
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.