biopharma nl
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In Same Day, UCB Lands Two FDA Drug Approvals in Autoimmune Diseases
FDA approval of UCB’s Bimzelx gives the Belgian drugmaker a contender in the crowded plaque psoriasis therapies market. In the rare disease generalized myasthenia gravis, the agency approved Zilbrysq, a UCB drug with advantages over two blockbuster AstraZeneca drugs addressing the same target.
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Can Psychedelic-Assisted Therapy Be Used for Prevention?
Psychedelic-assisted therapy is currently used to treat severe mental health conditions. But there is evidence it could help with prevention as well, and more research needs to be done on this, said Sherry Rais, CEO and co-founder of Enthea.
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Jorie Healthcare CEO Shares Why Automation is Critical to Revenue Cycle Management
The revenue cycle management business is using AI tools to automate cumbersome tasks to help hospitals operate more efficiently. It’s beginning to attract the attention of major healthcare organizations.
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Roche Deal Aims to Get Molecular Glues to Stick to Elusive Cancer, Neuro Targets
Roche is paying $50 million up front to begin a drug R&D alliance with Monte Rosa Therapeutics, a biotech whose molecular glue technology could address targets previously deemed undruggable. It’s Roche’s second such deal in the past month.
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Novo Nordisk Strikes Deal for Late-Stage Hypertension & Kidney Disease Drug
The KBP Biosciences drug Novo Nordisk is acquiring has reached Phase 3 testing as a potential treatment for uncontrolled hypertension and advanced chronic kidney disease. It’s the latest in a string of business deals aimed at expanding the Novo Nordisk pipeline beyond diabetes.
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What the Radiopharmaceutical Pipeline Means for Patient Care
With increased access to cutting-edge imaging, improved treatment options, greater personalization of treatment, reduced radiation exposure, and potential for future advances, patients can expect to receive more advanced medical care tailored to their specific needs through radiopharmaceuticals.
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Artificial Intelligence, BioPharma, Health Tech
FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech
The FDA’s digital health advisory committee will discuss technologies such as artificial intelligence and machine learning, virtual reality, and digital therapeutics as well as topics like decentralized clinical trials and patient-generated health data. Committee member nominations are due in December.
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Pfizer Expands in Immunology With FDA Approval of New Ulcerative Colitis Drug
Pfizer’s new FDA-approved ulcerative colitis drug Velsipity comes from its $6.7 billion Arena Pharmaceuticals acquisition. The small molecule will compete against blockbuster Bristol Myers Squibb drug Zeposia, which addresses the same target.
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BioNTech Turns to China Again for Cancer Drugs, Paying $70M to Partner on an ADC
BioNTech gains rights to a MediLink Therapeutics antibody drug conjugate that targets tumors expressing the HER3 protein. The deal comes six months after the German company entered the ADC field by acquiring rights to two therapeutic candidates from DualityBio.
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Pharma, Artificial Intelligence, BioPharma
Sanofi Adds Biologics to Its AI Ambitions, Striking Up R&D Alliance With BioMap
Formed by Baidu founder and CEO Robin Li, BioMap uses artificial intelligence technology to glean insight into proteins to guide biologic drug discovery. The startup is the latest company to join a growing list of Sanofi partners as the pharmaceutical giant continues investing in AI-enabled drug discovery.
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Navigating Healthcare’s Data Revolution: Priorities, Opportunities, and Challenges for Health Systems
Arcadia recently partnered with HIMSS Market Insights to survey executives, IT, technology, and clinical leaders. Here’s what we found.
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Bayer’s New $250M Cell & Gene Therapy Site Signals More Investments to Come
Bayer opens its new cell therapy manufacturing facility as it prepares a Parkinson’s disease cell therapy for Phase 2 testing. The new 100,000 square foot facility also has space for manufacturing other cell therapies in the pharma giant’s pipeline.
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How AI Can Fix the Broken Clinical Trial Process
By combining AI with human expertise and oversight, we have the potential to revolutionize the clinical trial process—and most importantly, extend and save lives.
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FDA Rejection Is a Delay, Not a Detour for Alnylam’s Aim to Treat Heart Disorder
Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024.
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Takeda to Pull Lung Cancer Drug from Market After Failed Confirmatory Study
Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond.
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MedCity Influencers, BioPharma
Fostering the Next Generation of Antisense Oligonucleotide Therapies
Antisense oligonucleotides (ASOs) have faced their share of challenges, but a combination of research advances and a market ripe for innovation is setting this drug class up for a resurgence. Antisense oligonucleotide (ASO)—a class of drugs that works by targeting RNA to alter gene expression and control aberrant proteins in ways that traditional drugs can’t.
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Kyowa Kirin Buys Into Gene Therapy With Orchard Therapeutics Acquisition
The Orchard Therapeutics acquisition comes as the biotech’s gene therapy for metachromatic leukodystrophy approaches a March 2024 FDA decision. The ex vivo gene therapy is already commercialized in Europe, marketed as Libmeldy.
Promoted
Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
Promoted
Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
