Positive data from Novo Nordisk A/S’s pivotal phase IIIa study of once-weekly and once-monthly doses of its hemophilia treatment, Mim8, are prompting the company to say it will submit the first regulatory approval request toward the end of this year. It could challenge Roche Holding AG’s Hemlibra (emicizumab), a bispecific factor IXa- and factor X-directed antibody for hemophilia A, that was approved in 2017 by the U.S. FDA.
Positive data from Novo Nordisk A/S’s pivotal phase IIIa study of once-weekly and once-monthly doses of its hemophilia treatment, Mim8, are prompting the company to say it will submit the first regulatory approval request toward the end of this year. It could challenge Roche Holding AG’s Hemlibra (emicizumab), a bispecific factor IXa- and factor X-directed antibody for hemophilia A, that was approved in 2017 by the U.S. FDA.
Immatics NV’s IMA-203 “looks like a melanoma drug,” said Cantor Fitzgerald analyst Eric Schmidt after he took a peek at the latest data, prepared as part of an upcoming meeting with the U.S. FDA. The candidate emerged from Immatics’ Actengine platform, set up to formulate a personalized therapy in which a patient’s own T cells are collected, genetically modified and then reinfused. Immatics offered data with IMA-203 as a monotherapy that targets preferentially expressed antigen in melanoma from an ongoing phase I trial testing what’s been established as the recommended phase II dose of 1-10x109 TCR-T cells in 30 heavily pretreated metastatic melanoma patients who were evaluable for efficacy.
Osaka, Japan-based Shionogi & Co. Ltd. said May 13 that ensitrelvir fumaric acid (Xocova), its oral antiviral for COVID-19, showed no statistical difference against placebo in completely resolving 15 common COVID-19-related symptoms in a global phase III Scorpio-HR trial.
As it gets fine-tuned, the Biosecure Act is becoming more than just a topic of conversation in the halls and meeting rooms of the U.S. Capitol. Reps. Brad Wenstrup (R-Ohio) and Raja Krishnamoorthi (D-Ill.) formally introduced a new version of the Biosecure Act in the House May 10 as a defense against China’s national security laws requiring all Chinese firms to share any requested data with the Chinese Communist Party, including biotechnology companies that collect, test and store American genomic data.
Immunotherapy-based cancer vaccines could permanently kill tumors by stimulating immune cells in multiple ways. At the 27th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), researchers presented their advances in this field with different techniques in the scientific symposium “Novel nucleic acid and cell-based vaccines for cancer,” organized by the infectious diseases and vaccines committee.
Buyers challenging patent settlements involving Forest Laboratories LLC’s blood pressure drug, Bystolic (nebivolol), failed to show the deals were illegal pay-for-delay arrangements, the U.S. Court of Appeals for the Second Circuit said in unanimously affirming a lower court’s two-time dismissal of the buyers’ antitrust suit.
The recent cyberattack on Change Healthcare, a part of the Unitedhealth Group, crippled reimbursement claims processing for thousands of providers for several weeks and potentially exposed troves of patient data. Congressional committees are investigating the attack, its scope, and Unitedhealth’s response. Please take a few minutes to fill out this short survey to help BioWorld understand how your company is responding to these threats. You can click through to the questions here.
As South Korea’s Curocell Inc. looks to develop the country’s first homegrown CAR T-cell therapy, CEO Gunsoo Kim highlighted rising and falling trends in the global CAR T development space at Bio Korea 2024.
The BioWorld Infectious Disease Index (BIDI) has continued to decline in the first four months of 2024, finishing April with a year-to-date decrease of 25.12%. BIDI trailed both the Nasdaq Biotechnology Index, which saw a 4.76% downturn by April’s end, and the Dow Jones Industrial Average, which...
In April, the value of biopharma deals climbed to $15.28 billion, increasing 84% from March’s $8.29 billion and also up from February’s $7.76 billion, though there was a decline from January’s $27.9 billion. This amounts to a monthly average of $14.86 billion in deal value for 2024, compared to the...
Homerun success of Novo Nordisk A/S’ semaglutide, which recently became the U.S.’s biggest blockbuster drug, is serving as an “inflection point” for obesity therapeutics and fueling the drive for new and improved therapies, speakers said at Bio Korea 2024 on May 8.
Newco Commit Biologics ApS has arrived on the scene after raising €16 million (US$17.2 million) in a seed round to advance bispecific antibodies that are designed to activate the complement system and direct it to selectively kill cancer cells.
From glaucoma to Stargardt disease, age-related macular degeneration (AMD) to retinitis pigmentosa, or a corneal transplant to Bietti’s crystalline dystrophy, the 27th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) is working to bring some light to patients with age and...
“Prenatal therapies are the next disruptive technologies in health care, which will advance and shape the future of patient care in the 21st century,” said Graça Almeida-Porada, a professor at the Fetal Research and Therapy Center of the Wake Forest Institute for Regenerative Medicine in...
Despite what University of Pennsylvania (Penn) immunotherapy pioneer Carl June referred to as a “cold slap last November” – a launched investigation by the U.S. FDA into a possible link between CAR T-cell immunotherapies and secondary cancers – new unpublished studies by Penn and Stanford...
The use of psychedelics is seeing impressive results in treating psychiatric disorders like treatment-resistant depression and post-traumatic stress disorder, and Mindbio Therapeutics Ltd. is expanding the field to include microdoses of lysergic acid diethylamide (LSD) to treat depression and...
Cancer vaccines specialist Infinitopes Precision Immunomics Ltd. announced the closing of a £12.8 million (US$16.1 million) seed round and outlined plans to start a phase I/IIa study of the lead program in the third quarter of this year.
“A white space opportunity.” That’s how Enlaza Therapeutics Inc. co-founder and CEO Sergio Duron described to BioWorld the company’s efforts to develop the first covalent biologics, an endeavor that has gained the backing of an impressive group of investors in a recently closed $100 million series...
In one of the biggest startups ever, Xaira Therapeutics has launched with more than $1 billion from investors. The financing, according to BioWorld records, is roughly equivalent to Roivant Sciences Inc.’s $1.1 billion raise in August 2017 and Galderma Inc.’s $1 billion private placement in June 2023.
Corner Therapeutics Inc. raised $54 million in a series A financing to create vaccines to protect against cancer and infectious diseases by helping the immune system engineer T cells. The company’s core interest is in advancements in immunotherapy through direct manipulation of T cells, which are...
Intriguing data in pancreatic cancer didn’t do much to help shares of South San Francisco-based Cytomx Therapeutics Inc. (NASDAQ:CTMX), which closed May 9 at $2.04, down $2.15, or 51%, as the company made known initial findings from the ongoing CX-904 phase Ia dose-escalation study, showing a...
Tiumbio Co. Ltd., of Seongnam-si, Gyeonggi-do, reported positive phase IIa top-line data on May 8 for Merigolix, its lead asset to reduce pain in female patients with moderate to severe endometriosis.
Novartis Pharma AG continues to build up its radiopharmaceutical powerhouse and has expanded a peptide discovery collaboration with Peptidream Inc. in a deal worth up to $2.71 billion. Under the multi-program agreement, Kawasaki, Japan-based Peptidream will use its peptide discovery platform system...
Newron Pharmaceuticals SpA added heft to the data supporting evenamide, reporting positive top-line results from a phase II/III placebo-controlled trial of the glutamate inhibitor in patients with chronic schizophrenia who were receiving a second-generation antipsychotic, but having an inadequate...
Citing a high rate of patients leaving the study, Merck & Co. Inc. has discontinued the anti-TIGIT antibody vibostolimab and the anti-PD-1 Keytruda (pembrolizumab) portion of it phase III Keyvibe-10 trial as an adjuvant treatment for those with...
Macrogenics Inc. CEO Scott Koenig said his firm is “on the right pathway” with vobramitamab duocarmazine (vobra duo), previously known as MGC-018, in metastatic castration-resistant prostate cancer. Wall Street proved less than thrilled, and...
Innovent Biologics Inc.’s glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor dual agonist, mazdutide, met the primary endpoint of superiority in a head-to-head phase III trial in Chinese patients with type 2 diabetes compared to Eli...
A boy participating in the phase II Daylight study of Duchenne muscular dystrophy (DMD) “has passed away suddenly,” according to Pfizer Inc. The participant had received fordadistrogene movaparvovec, a mini-dystrophin gene therapy, in early 2023....
Less than a week ago, executives at Lyra Therapeutics Inc. were looking ahead to “imminent” data from its first phase III study in chronic rhinosinusitis (CRS), testing drug-device candidate LYR-210, a drug-device candidate largely expected to...
Not long after Ocular Therapeutix Inc. unveiled positive phase I data in non-proliferative diabetic retinopathy with Axpaxli (axitinib intravitreal implant), Eyepoint Pharmaceuticals Inc. offered less-sunny phase II data from the Pavia trial...
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.