Tests of two Regenxbio gene therapies have been placed under an FDA clinical hold after a patient in one of the studies developed cancer. Our recap of recent regulatory news also includes one clinical hold removed, several complete response letters, and drug approvals in the U.S. and Europe.
Zemcelpro, a cord blood-sourced cell therapy developed by startup ExCellThera, received conditional marketing authorization in Europe as a treatment for blood cancer patients who can’t find a matched donor. It’s the first cell therapy approved in Europe for this group of patients.
In a landscape where complexity has long been the norm, the power of one lies not just in unification, but in intelligence and automation.
BridgeBio Pharma’s approval of Beyonttra comes three months after the drug landed FDA approval for cardiomyopathy caused by transthyretin amyloidosis. Our recap of recent regulatory news also spans approvals in cancer, immunology, vaccines, and more.
The European Union’s highest court sided with Illumina, agreeing that the European Commission had no authority to review the acquisition of liquid biopsy company Grail. The ruling comes after Illumina stopped challenging antitrust litigation, opting to instead spin out Grail as a standalone company.
The PTC Therapeutics drug Translarna failed its confirmatory study in Duchenne muscular dystrophy. Analysts say the European Commission’s decision to not adopt the Committee on Medicinal Products for Human Use’s negative opinion on the drug is unusual, if not unprecedented.
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.
Greenway Health blends smart technology with human expertise to elevate revenue cycle.
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.
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.
In a recent interview, Esperion president and CEO, Sheldon Koenig talks about the reality of statin intolerance and his company’s expansion into new diseases
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.
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.