Galapagos revealed that it is weighing up all options for its only approved product, the JAK inhibitor Jyseleca. Galapagos has disclosed its financials for the first half 2023 which show that Jyseleca (filgotinib), approved in Europe for rheumatoid arthritis and ulcerative colitis, reached €54.3 million in sales, up by 54% on the like, year-earlier period but below consensus estimates. The […]
Taiho Pharmaceutical announced that its partner Servier, has won European regulatory approval for Lonsurf (trifluridine + tipiracil) in combination with bevacizumab for the third-line treatment of metastatic colorectal cancer (mCRC). The European Commission gave its approval to the combination therapy in adult patients with mCRC who have received two prior anticancer treatment regimens, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF […]
Health Canada has authorized the use of maralixibat oral solution (Livmarli) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS), as recently announced by Mirum Pharmaceuticals. Health Canada’s authorization is based on data from the pivotal ICONIC study, which includes 6 years of data from the maralixibat clinical program. The study has provided robust evidence demonstrating statistically […]
The European Commission (EC) approved Jardiance (empagliflozin) for the treatment of adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company have announced. The approval has the potential to advance the standard of care for more than 47 million people in the EU living with CKD and help relieve burden on healthcare systems by reducing the risk […]
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking to expand the indication of Edurant (rilpivirine) to include the treatment of HIV-1 infection in children weighing 10 kg or more. A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support […]
GSK plc announced that the FDA has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H). The supplemental Biologics License Application (sBLA) supporting this […]
Gilead Sciences, Inc. announced that the European Commission (EC) approved Trodelvy (sacituzumab govitecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting. The approval by the European Commission follows the positive opinion of the […]
AbbVie has launched Vyalev (foslevodopa + foscarbidopa), a continuous subcutaneous infusion for Parkinson’s disease, in Japan on July 26. This is the first Parkinson’s drug in the country that can be continuously infused for 24 hours without requiring surgery. In Japan, Vyalev was approved in December 2022 for the improvement of wearing-off symptoms in Parkinson’s inadequately controlled with existing pharmacotherapies […]
The CHMP has recommended granting a marketing authorization for Pfizer’s Abrysvo (bivalent, recombinant), a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is the first RSV vaccine indicated for passive immunization of infants from birth through six months of age following administration of the vaccine to the mother during pregnancy. It is also indicated for […]
Gilead Sciences, Inc. presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including patient-reported outcomes (PRO) from the Phase II/III CAPELLA trial . These latest findings underscore the role of lenacapavir, the first long-acting injectable HIV treatment medication administered twice-yearly, as a person-centric therapy option and its transformative potential impact on the future of coordinated HIV clinical […]
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