September 25, 2023

FDA grants priority review to application for Keytruda + concurrent chemoradiotherapy, as treatment for newly diagnosed high-risk locally advanced cervical cancer – Merck Inc

Merck Inc., known as MSD outside of the United States and Canada, announced the FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment with definitive intent for newly diagnosed […]

admin Health 0 1 min read
September 4, 2023

FDA approves Veklury to treat COVID-19 in people with mild to severe hepatic impairment with no dose adjustment – Gilead Sciences

Gilead Sciences, Inc. announced that the FDA approved a supplemental new drug application (sNDA) for the use of Veklury (remdesivir) with no dose adjustments to treat COVID-19 in people with mild, moderate and severe hepatic impairment. This approval further supports the safety profile of Veklury as the first and only approved antiviral COVID-19 treatment that can be used across all […]

admin Health 0 1 min read
August 31, 2023

Results of phase IV trial (ZOSTER-076) of Shingrix shows efficacy and safety in Herpes Zoster – GSK

GSK announced positive results from the first-ever efficacy trial of Shingrix (Recombinant Zoster Vaccine or RZV) in China. These results come from the post-license phase IV trial (ZOSTER-076), which evaluated the efficacy and safety of RZV in preventing shingles in adults aged 50 and over. The trial included almost 6,000 participants randomised 1:1 to the RZV or placebo group and […]

admin Health 0 1 min read
August 8, 2023

Galapagos to review future of Jyseleca

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 […]

admin Health 0 37 sec read
August 7, 2023

European Commission approves Lonsurf in combination with bevacizumab for the third-line treatment of metastatic colorectal cancer – Servier + Taiho

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 […]

admin Health 0 25 sec read
August 6, 2023

Livmarli receives Health Canada authorization for Alagille syndrome – Mirum Pharmaceuticals

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 […]

admin Health 0 21 sec read
August 5, 2023

Jardiance approved in the EU for the treatment of adults with chronic kidney disease – Boehringer + Eli Lilly

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 […]

admin Health 0 1 min read
August 4, 2023

Janssen submits supplemental new drug application to FDA seeking expanded pediatric indication for HIV-1 therapy Edurant

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 […]

admin Health 0 1 min read
August 3, 2023

Jemperli + chemotherapy approved by the FDA as the first new frontline treatment option in decades for dMMR/MSI-H primary advanced or recurrent endometrial cancer – GSK

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 […]

admin Health 0 1 min read
August 2, 2023

European Commission approves Trodelvy to treat unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer patients who have received endocrine-based therapy – Gilead Sciences

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 […]

admin Health 0 40 sec read

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