FDA approves Ponvory, once-a-day oral drug for MS
The agency also gave the green light to Zegalogue, an injectable treatment for severe hypoglycemia.
San Fran biotech, GSK seeking EUA for COVID-19 monoclonal antibody treatment
A data monitoring committee stopped a trial early because of evidence of "
profound efficacy," according to a press release issued by Vir Biotechnology and GlaxoSmithKline.
Gilead, Merck partner up on long-acting HIV treatment
Companies are working on a 2-drug regimen of Gilead's lenacapavir and Merck’s islatravir.
FDA okays renal cell carcinoma treatment Fotivda
Merck’s experimental drug shows quick reduction in SARS-CoV-2
The still-experimental oral antiviral drug has been compared to Tamiflu but would be for COVID-19 not the flu.
Roche withdraws bladder cancer indication for blockbuster Tecentriq
The decision by Roche comes shortly after AstraZeneca withdrew the bladder cancer indication for durvalumab (Imfinzi).
HIV therapeutics market to reach $28 billion in 2029
Injectables are driving the growth because they can be taken less frequently and adherence is a problem with oral medications.
Blockbuster heart drug Entresto gets expanded indication
The FDA approved the use of Entresto in a broader group of heart failure patients that includes a large percentage of those with preserved ejection fraction.
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
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