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Home » Newsletters » BioWorld

BioWorld

May 14, 2024

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Illustration of blood vessel that isn't clotting due to hemophilia

With phase IIIa success, Novo preps for Mim8 hemophilia A filing

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. Read More

Immatics nails melanoma phase I; Iovance, Immunocore busy, too

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. Read More
Oral medication

Shionogi’s COVID-19 drug misses endpoint in global phase III

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. Read More

Biosecure Act fine-tuned, new health care tariffs in the offing

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. Read More
Art concept for vaccine for cancer

DNA, mRNA, peptides, cells … everything’s possible in cancer vaccines

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. Read More

Citing Supreme Court, Second Circuit rules against FTC position

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. Read More
cybersecurity-data-lock.png

BioWorld reader feedback needed: Cyberattack impact survey

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. Read More

Appointments and advancements for May 14, 2024

New hires and promotions in the biopharma industry, including: Curadh, Mink, Nanoscope, Nouscom, Sumitomo, Viracta. Read More

Financings for May 14, 2024

Biopharmas raising money in public or private financings, including: Allogene, Alzamend. Read More

In the clinic for May 14, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ascendis, BMS, Bridgebio, Cardurion, Cytokinetics, Delix, Excision, Imunon, Inventiva, Jasper, Merck & Co., Newron, Senti, Valneva. Read More

Other news to note for May 14, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aqilion, Avata, Merrimack, Onkure, Primula, Reneo, Sapient, Veraxa, Walden. Read More

Regulatory actions for May 14, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ajax, Asieris, Biocryst, MC2, Outlook, Regeneron, Sumitomo, Zai. Read More

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