European Union regulators ordered Illumina to divest Grail. Illumina is appealing antitrust findings in Europe and the U.S., but the DNA sequencing giant revealed that divesting all or part of Grail is an option even if it wins both legal challenges.
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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
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.
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.
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.
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.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
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.
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.
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.
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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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.
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.
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.
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.