AstraZeneca said the company’s Enhertu cancer drug has been shown to significantly help women suffering from a type of breast cancer that leaves them with poor treatment options, opening the door to a much larger potential patient group.
Synairgen’s inhalable therapy failed in late-stage trial testing in patients hospitalized with COVID-19, wiping out over 85% of the British drugmaker’s stock value on February 21 after the blow to the development of the company’s key product.
FDA Action Alert: Immunocore, Reata, CTI, Gilead and Legend/Janssen
Biologics License Application (BLA), Chronic Kidney Disease, Clinical Trials, FDA/Regulatory, Genetic Mutations, Gilead, Kinase Inhibitors, Multi-drug resistant HIV-1 infection, Multiple Myeloma, Myelofibrosis, PDUFA, Priority Review Status, R&D, Uveal MelanomaLegend Biotech has a target action date of February 28 for the company’s BLA for ciltacabtagene autoleucel (cilta-cel) for adults with relapsed and/or refractory multiple myeloma. The BLA was submitted by Legend’s collaboration partner, Janssen Biotech Inc., a Johnson & Johnson company.
BioMarin updated several of the company’s gene therapy programs on February 17 following a September 2021 update, when the drug manufacturer reported the U.S. Food and Drug Administration had placed a clinical hold on the BMN 307 Phearless Phase I/II trial.
Covid-19: A Vision for the “New Normal” and Pfizer’s Paxlovid
CDC, Clinical Trials, Coronavirus Disease (COVID-19) Pandemic, COVID-19 booster shots, COVID-19 shots, COVID-19 Vaccinations, Hospitalized COVID-19 Patients, Immunosuppression, Long COVID, Medicines Patent Pool, New England Journal of Medicine, Omicron BA.2, Paxlovid, R&DEarly in the COVID-19 pandemic, there was a lot of talk about the “new normal,” with most people wanting to get back to the “old normal.” Two-plus years into the pandemic, it’s obvious that COVID-19 is not going away, prompting discussion about what this “new normal” will actually look like.
Regeneron and Sanofi announced that a late-stage trial for the blockbuster anti-inflammatory drug Dupixent for patients with chronic spontaneous urticaria (CSU) was halted due to futility.
Malaysian researchers found that treatment with the anti-parasite drug ivermectin did not prevent patients with COVID-19 from becoming severely ill in a randomized clinical trial published in the JAMA Internal Medicine journal on February 18.
Atara Biotherapeutics, an immunology-focused biopharmaceutical company based in San Francisco, announced a fatal serious adverse event (SAE) with a patient in a clinical trial at Memorial Sloan Kettering Cancer Center.
Moderna Inc. said on February 18 the company is developing three new vaccines based on the same technology used for its COVID-19 shot, including one for viral infection shingles.
A therapy mix including Bayer’s Nubeqa drug was shown to significantly prolong the lives of men suffering from metastatic prostate cancer in a clinical study, prompting the company to boost sales estimates for the product.