European Commission
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BeiGene, Novartis Drug Alliance Ends; It’s Their Second Terminated Deal This Year
BeiGene welcomes the return of the immunotherapy’s rights as an opportunity to make it the backbone of its solid tumors strategy. But Novartis cedes an opportunity to gain a competitor to established cancer immunotherapies from Merck and Bristol Myers Squibb.
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Devices & Diagnostics, BioPharma
Europe Imposes Maximum Fine on Illumina for Early Grail Acquisition
Illumina must pay a €432 million fine for closing its Grail acquisition before the European Commission finished its inquiry into the tie-up. The penalty is the maximum amount the regulator can impose on a company for breaching European merger rules.
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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.
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Roche Influenza Antiviral Gets European Commission Approval for Young Kids
Xofluza, a flu antiviral drug developed by Roche and Shionogi, is now approved in Europe for children age 1 and older. The European Commission decision expands the patient population for the drug, which was previously approved for treating adolescents and adults.
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Atara Approval Marks Cell Therapy First; Entrada on Hold, Bluebird Freed & More
The first regulatory approval of an allogeneic cell therapy goes to Atara Biotherapeutics. Other regulatory news highlights from the past week include proposed reforms of the FDA’s accelerated approval process, approval of the first gene therapy for bladder cancer, and a clinical hold for a biotech developing a new class of medicines.
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AstraZeneca & Sanofi Win European Nod for RSV-Preventing Drug for Infants
AstraZeneca already has a respiratory syncytial virus antibody drug on the market for premature babies. But the approval of Beyfortus, which was developed with Sanofi, covers all infants broadly and it protects during the entire RSV season with just a single shot.
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European approval of Novartis cancer drug puts a new STAMP on leukemia
Novartis drug Scemblix is the first in a new class of drugs known as STAMP inhibitors. European Commission approval of the small molecule provides a new treatment option for chronic myeloid leukemia that is resistant to earlier treatments, as well as those cases in which patients cannot tolerate the other therapies for this blood cancer.
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Biohaven migraine drug partnered with Pfizer lands twin European approvals
The European Commission approved Biohaven Pharmaceuticals migraine drug rimegepant. While the regulatory decision marks another milestone for Biohaven, it’s also a win for Pfizer, which holds rights to commercialize the drug outside of the U.S.
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BioMarin stands tall with first approved drug for rare disease that causes dwarfism
The European Commission has approved a BioMarin Pharmaceutical drug that treats achondroplasia, a rare genetic disorder that slows bone growth and is the most common cause of dwarfism. The commission also granted conditional approval to a cancer drug from partners Incyte and MorphoSys.
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Gilead, Galapagos arthritis drug rejected by FDA gets go-ahead from Japanese, European regulators
The European Commission and Japan’s Ministry of Health, Labor and Welfare approved filgotinib, marketed under the name Jyseleca, for rheumatoid arthritis. The drug is partnered in Japan with Eisai. The FDA rejected the drug last month.
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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.
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Moderna to supply up to 160M doses of Covid-19 vaccine to Europe
The biotech company reached a deal with the European Commission to supply an initial 80 million doses, while European Union member states will have the option to purchase 80 million more.
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Propeller gets green light to bundle its digital health tools with inhalers
Propeller Health and Novartis received the green light from European regulators to package their products together. The move is one step of many to make digital therapeutics easier to prescribe.
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Spark, Novartis’s inherited blindness therapy Luxturna wins approval in Europe
The company expects reimbursement decisions by national-level authorities in 2019 and 2020. The UK’s NICE recommended Cancer Drugs Fund coverage for another high-priced Novartis therapy, the CAR-T Kymriah, earlier this month.
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Novartis, Spark make positive step toward gene therapy Luxturna’s European approval
With a positive CHMP decision, the European Commission is expected to rule in two months, but equity research analysts foresee significant headwinds for the gene therapy.
Promoted
Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
Promoted
Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
