The beleaguered PI3K-delta inhibitor space took another blow after MEI Pharma Inc. and partner Kyowa Kirin Co. Ltd. said the U.S. FDA won’t greenlight zandelisib without data from a randomized study. The firms had hoped to win accelerated approval in relapsed/refractory follicular lymphoma and marginal zone lymphoma based on a single-arm phase II study called Tidal.
Janssen Pharmaceutical Cos, Inc.’s CAR T-cell therapy, Carvykti (ciltacabtagene autoleucel), looks set for approval in Europe after endorsement by regulators for advanced multiple myeloma. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use recommended Carvykti for adults with relapsed and refractory disease who have received at least three prior therapies and whose cancer has worsened since their last treatment.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arrowhead, Azafaros, Eli Lilly, Fennec, Fluoguide, Innovent, Pfizer, Viiv.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fluoguide, Novartis, Tendonova.
The FDA continues to issue new and revised emergency use authorizations for testing for the COVID-19 pandemic in recent days, including three reissued and four revised EUAs dated March 24.
The lawsuit filed by Illumina Inc., against officials with Guardant Health Inc., revolves around trade secrets allegedly misappropriated by two former Illumina employees, including Helmy Eltoukhy, who helped to found Guardant while still employed at Illumina. Among other things, the complaint states that Eltoukhy had asked another Illumina employee about research that ultimately ended up in the hands of Guardant despite that the document in question was explicitly labeled as confidential and for internal use only.
Building on its partnership with the World Health Organization (WHO) to improve access in Sub-Saharan Africa to vaccines, drugs and medical technologies, the EU committed at least €24.5 million (nearly US$27 million) to fund projects aimed at tackling some of the barriers to that access.
Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA. The pair sought approval of a BLA for sintilimab plus pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small-cell lung cancer (NSCLC) but found near-unanimous opposition from FDA advisers dissatisfied with China-only trial data submitted in support of the application. The medicine is already approved for multiple indications in China, where it’s marketed as Tyvyt.
The U.S. FDA has approved Novartis AG’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly referred to as 177Lu-PSMA-617) for treating adults with metastatic prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. The treatment is the indication’s first FDA-approved targeted radioligand therapy that contains a radioisotope.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Emmaus, Moberg, Morphosys, Novavax, Phanes, Secura, Silence, TC, Xcovery.
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