Pfizer Inc. is paying Innovent Biologics Co. Ltd. $650 million up front and up to $9.85 billion in milestones, plus royalties, to collaborate across 12 early stage and de novo antibody-drug conjugates (ADCs) and multispecific antibodies for oncology.
Pfizer Inc. is paying Innovent Biologics Co. Ltd. $650 million up front and up to $9.85 billion in milestones, plus royalties, to collaborate across 12 early stage and de novo antibody-drug conjugates (ADCs) and multispecific antibodies for oncology.
Industry watchers will be tracking closely Replimune Group Inc.’s latest attempt to secure U.S. FDA approval of its advanced melanoma candidate, RP-1 (vusolimogene oderparepvec). The company announced Friday it had reached alignment for resubmitting the twice-rejected BLA with the agency, which it said has pledged to prioritize the review.
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 multiple myeloma was successful. Nearly three months later, the magnitude of success for its Pomalyst (pomalidomide) successor is clear.
“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 different virus called Ebola Bundibugyo. There are currently no approved vaccines or treatments for it.” This was the stark message from Tedros Adhanom Ghebreyesus, director general of the World Health Organization (WHO) in an open letter to the people of the DRC, as he traveled to the country on Friday, May 29.
China’s National Medical Products Administration has issued final implementation measures for drug trial data protection that mark a significant step toward aligning China’s pharmaceutical intellectual property framework with global standards.
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 reported positive results and two failed to meet primary endpoints.
The human pancreas often contains lesions that are common in the population and that, although they can become malignant, usually do not. To understand when this occurs and how these pancreatic cancer precursor lesions, known as pancreatic intraepithelial neoplasias (PanIN), evolve, scientists at the University of Michigan analyzed their gene expression patterns and their cellular microenvironment.
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 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,...
There are initial signs that President Donald Trump’s most-favored nation (MFN) policy may be further delaying access to new drugs in Europe, as companies hold off commercializing in these countries to avoid lower European prices being referenced in the U.S.
The “deep dive” April 8 by Ovid Therapeutics Inc. into potassium-chloride co-transporter 2 (KCC2) research included company officials and independent experts in the space, where a handful of drug developers are known to be working. New York-based Ovid owns a portfolio of potential first-in-class...
Upbeat phase II news lately from Spyre Therapeutics Inc. in inflammatory bowel disease (IBD) perked not only the company’s stock but also wider interest in the buzzing space, where developers big and small are trying to tackle such chronic bedevilments as Crohn’s disease and ulcerative colitis (UC).
Chinese biotech Longbio Pharma Co. Ltd. announced its IPO on the Hong Kong Stock Exchange to raise HK$1.362 billion (US$174 million) to progress its lead candidate, LP-003, a next-generation anti-IgE antibody.
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.
Insulet Corp. has initiated a voluntary medical device correction affecting insulin pump pods in its Omnipod product lines after discovering a manufacturing issue that could lead to the leaking of insulin and the under-delivery of doses in some patients. The company said that some pods from...
Artificial intelligence, remote monitoring and need-based innovation are beginning to reshape Australia’s medtech sector’s devices, as well as the way health care itself is delivered, according to speakers at the 2026 Ausmedtech conference in Perth May 19-20.
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...
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.
Infex Therapeutics Ltd. has published positive phase IIa data for its lead program, RESP-X, in the treatment of exacerbations of chronic respiratory infections caused by Pseudomonas aeruginosa and is now laying the ground for phase IIb development, after raising £4.3 million (US$5.8 million) in new...
Data from the All Women clinical trial, which looked at the Allegra transcatheter aortic valve replacement (TAVR) system compared to balloon-expandable valves (BEV) in women with aortic stenosis, showed that Allegra delivered lower mean gradients and less prosthesis-patient mismatch than BEVs. The...
Elixir Medical Corp. reported four-year data from the Bioadaptor randomized controlled trial presented at the EuroPCR conference in Paris, which showed that patients with coronary artery disease treated with its Dynamx coronary drug-eluting bioadaptor system experienced significantly lower event...
Posting another win for its triple G agonist, Eli Lilly and Co. rolled out top-line phase III data from Triumph-1 showing that all doses of retatrutide met primary and key secondary endpoints for obesity, with participants losing on average...
Shares of Immunovant Inc. (NASDAQ:IMVT) gained 35% after the firm disclosed early but “compelling” data from a phase IIb study testing next-generation FcRn inhibitor IMVT-1402 in patients with difficult-to-treat rheumatoid arthritis (D2T RA),...
Vincentage Pharma Co. Ltd.’s once-daily oral small-molecule GLP-1 receptor agonist, VCT-220, met the primary endpoints in a pivotal phase III trial in overweight or obese patients in China. Based on the top-line data, the Chengdu, China-based...
Showing a significant efficacy signal in a phase II trial, Relay Therapeutics Inc.’s zovegalisib (RLY-2608) achieved a 60% volumetric response in patients with PIK3CA-driven vascular anomalies (VAs). The isoform-selective PI3Ka inhibitor is in...
How the U.S. FDA might view the latest Duchenne muscular dystrophy (DMD) phase III data with gene therapy RGX-202 became the question for Regenxbio Inc., shares of which (NASDAQ:RGNX) closed May 14 at $6.25, down 38%, or $3.80, after the results...
Biogen Inc. has decided to advance diranersen (BIIB-080) into registrational trials for early Alzheimer’s disease, even though the antisense oligonucleotide therapy, originally discovered by Ionis Pharmaceuticals Inc., missed its phase II primary...
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.