SPOTLIGHT -
Novo Nordisk seeks weight-loss indication for Ozempic
Application to the FDA is based on results from a placebo-controlled trial showing a 15% decrease in body weight among those who are obese or overweight.
FDA authorizes new COVID-19 treatment; more vaccine doses on the way
FDA OKs Cosela, first-in-class therapy to protect bone marrow after chemotherapy
FDA clears BMS CAR-T cell therapy, Merck MET inhibitor
One of the new treatments available is a CAR-T cell therapy to treat relapsed or refractory large B-cell lymphoma.
FDA issues new warning on Pfizer’s Xeljanz
Preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the rheumatoid arthritis and ulcerative colitis medicine Xeljanz.
FDA clears Lupkynis, first oral treatment for lupus nephritis
Aurinia’s Lupkynis, used in combination with a background immunosuppressive therapy regimen, is available now.
ViiV Healthcare’s Cabenuva will be available in the U.S. in February
FDA approves first complete long-acting HIV-1 treatment
New Cabometyx-Opdivo combo for renal cell carcinoma treatment
FDA cleared cabozantinib (Cabometyx) for patients with advanced renal cell carcinoma as a first-line treatment in combination with nivolumab (Opdivo).
Top PBMs increase number of formulary exclusions in 2021
CVS Caremark, Express Scripts and OptumRx have increased the number of medications that are excluded from their national formularies.
Biden stimulus plan beefs up COVID-19 vaccinations and testing
His vaccination plans call for creation of 100 federally support community vaccine sites in the first month of his administration.
Diabetes med Farxiga nabs FDA Priority Review for Chronic Kidney Disease
AstraZeneca’s leading diabetes medication could be approved to treat chronic kidney disease for patients with and without type 2 diabetes.
Drugmakers raising prices in 2021 but at lower rate
Many pharmaceutical manufacturers are raising prices this year, but at a lower overall rate than in the past couple of years, according to a new analysis.
FDA clears first generic for treatment for severe hypoglycemia
Amphastar Pharmaceuticals’ generic version will offer stiff competition to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar.
Biosimilar to Rituxan expected to hit market in January
The biosimilar to Rituxan is expected to erode market share of the mainstay cancer drug for Roche.
FDA clears Orgovyx, the first-of-its-kind prostate cancer treatment
Orgovyx, the first oral drug in its class, may help reduce clinic visits for men with prostate cancer. Fewer visits may be important during the COVID-19 pandemic.
FDA fast-tracks novel MAB neuroblastoma treatment
The monoclonal antibody medicine treats neuroblastoma in the bone and bone marrow.
Moderna COVID-19 vaccine approval expected soon
FDA deemed Moderna’s vaccine candidate “highly effective,” so the agency may grant an emergency use authorization later this week.
Pharma maker expects myeloma drug approval after positive results
After positive Phase 3 trial results, Karyopharm Therapeutics expects FDA to clear Xpovio.
FDA okays first combo COVID-19 and flu test
The test is for patients to use at home, with a prescription, to detect both COVID-19 and influenza A and B.
Xofluza, flu drug, snags new indication
FDA official says the approval is important because of the combination of the flu season and the COVID-19 pandemic.
FDA clears Regeneron's COVID-19 monoclonal antibody treatment and a home test
Regeneron's investigational treatment was administered to President Donald Trump in October when he was treated for COVID-19.
Gottlieb optimistic about COVID-19 end after positive Moderna vaccine results
Blockbuster Keytruda earns new breast cancer indication
Merck earned a new indication for pembrolizumab (Keytruda), in combination with chemotherapy, to treat locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC).
Metformin recalls expand
The recall is attributed to higher levels of the carcinogenic ingredient NDMA than are allowed.
Top 5 drugs in the pipeline
Some of the top medications were approved this summer, while others are awaiting FDA approval.
Carcinoma med snags Breakthrough Therapy Designation
The treatment is the first anti-PD-1 antibody from China to receive Breakthrough therapy designation.
U.S. gov’t, Abbot team up to produce millions of rapid COVID-19 tests
The pharma maker will initially produce 150 million of the 5-minute tests.
FDA clears first cell-based gene therapy for lymphoma
The chimeric antigen receptor (CAR) T cell therapy is the first of its kind for mantle cell lymphoma (MCL).
FDA clears novel psoriatic arthritis treatment
The drug is the first treatment approved for active psoriatic arthritis that selectively inhibits interleukin (IL)-23.
Express Scripts accused of overcharging millions of dollars
The PBM overcharged for generic drugs, among other offenses, a new lawsuit claims.