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FDA approves Ponvory, once-a-day oral drug for MS
FDA approves Ponvory, once-a-day oral drug for MS
FDA approves Ponvory, once-a-day oral drug for MS
March 24, 2021
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
San Fran biotech, GSK seeking EUA for COVID-19 monoclonal antibody treatment
San Fran biotech, GSK seeking EUA for COVID-19 monoclonal antibody treatment
March 22, 2021
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
Gilead, Merck partner up on long-acting HIV treatment
Gilead, Merck partner up on long-acting HIV treatment
March 16, 2021
Companies are working on a 2-drug regimen of Gilead's lenacapavir and Merck’s islatravir.
Merck’s experimental drug shows quick reduction in SARS-CoV-2
Merck’s experimental drug shows quick reduction in SARS-CoV-2
Merck’s experimental drug shows quick reduction in SARS-CoV-2
March 9, 2021
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
 Roche withdraws bladder cancer indication for blockbuster Tecentriq
Roche withdraws bladder cancer indication for blockbuster Tecentriq
March 9, 2021
The decision by Roche comes shortly after AstraZeneca withdrew the bladder cancer indication for durvalumab (Imfinzi).
FDA approves sNDAs for Vazalore
FDA approves sNDAs for Vazalore
FDA approves sNDAs for Vazalore
March 3, 2021
Application was submitted for both the 81 and 325 mg doses of the liquid-filled capsule formulation of aspirin.
 HIV therapeutics market to reach $28 billion in 2029
 HIV therapeutics market to reach $28 billion in 2029
HIV therapeutics market to reach $28 billion in 2029
March 1, 2021
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
Blockbuster heart drug Entresto gets expanded indication
Blockbuster heart drug Entresto gets expanded indication
February 24, 2021
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
Novo Nordisk seeks weight-loss indication for Ozempic
Novo Nordisk seeks weight-loss indication for Ozempic
February 22, 2021
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 clears BMS CAR-T cell therapy, Merck MET inhibitor
FDA clears BMS CAR-T cell therapy, Merck MET inhibitor
FDA clears BMS CAR-T cell therapy, Merck MET inhibitor
February 10, 2021
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
FDA issues new warning on Pfizer’s Xeljanz
FDA issues new warning on Pfizer’s Xeljanz
February 9, 2021
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
FDA clears Lupkynis, first oral treatment for lupus nephritis
FDA clears Lupkynis, first oral treatment for lupus nephritis
February 2, 2021
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
ViiV Healthcare’s Cabenuva will be available in the U.S. in February
ViiV Healthcare’s Cabenuva will be available in the U.S. in February
January 27, 2021
FDA approves first complete long-acting HIV-1 treatment
New Cabometyx-Opdivo combo for renal cell carcinoma treatment
New Cabometyx-Opdivo combo for renal cell carcinoma treatment
New Cabometyx-Opdivo combo for renal cell carcinoma treatment
January 27, 2021
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
Top PBMs increase number of formulary exclusions in 2021
Top PBMs increase number of formulary exclusions in 2021
January 19, 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
Biden stimulus plan beefs up COVID-19 vaccinations and testing
Biden stimulus plan beefs up COVID-19 vaccinations and testing
January 18, 2021
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
Diabetes med Farxiga nabs FDA Priority Review for Chronic Kidney Disease
Diabetes med Farxiga nabs FDA Priority Review for Chronic Kidney Disease
January 13, 2021
AstraZeneca’s leading diabetes medication could be approved to treat chronic kidney disease for patients with and without type 2 diabetes.
MacroGenics treatment for HER2-positive breast cancer to be available in March
MacroGenics treatment for HER2-positive breast cancer to be available in March
MacroGenics treatment for HER2-positive breast cancer to be available in March
January 12, 2021
New treatment for metastatic HER2-positive breast cancer is called Margenza.
Drugmakers raising prices in 2021 but at lower rate
Drugmakers raising prices in 2021 but at lower rate
Drugmakers raising prices in 2021 but at lower rate
January 6, 2021
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
FDA clears first generic for treatment for severe hypoglycemia
FDA clears first generic for treatment for severe hypoglycemia
January 4, 2021
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
Biosimilar to Rituxan expected to hit market in January
Biosimilar to Rituxan expected to hit market in January
December 22, 2020
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
FDA clears Orgovyx, the first-of-its-kind prostate cancer treatment
FDA clears Orgovyx, the first-of-its-kind prostate cancer treatment
December 18, 2020
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
FDA fast-tracks novel MAB neuroblastoma treatment
FDA fast-tracks novel MAB neuroblastoma treatment
December 15, 2020
The monoclonal antibody medicine treats neuroblastoma in the bone and bone marrow.
Moderna COVID-19 vaccine approval expected soon
Moderna COVID-19 vaccine approval expected soon
Moderna COVID-19 vaccine approval expected soon
December 15, 2020
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
Pharma maker expects myeloma drug approval after positive results
Pharma maker expects myeloma drug approval after positive results
December 8, 2020
After positive Phase 3 trial results, Karyopharm Therapeutics expects FDA to clear Xpovio.
FDA okays first combo COVID-19 and flu test
FDA okays first combo COVID-19 and flu test
FDA okays first combo COVID-19 and flu test
December 8, 2020
The test is for patients to use at home, with a prescription, to detect both COVID-19 and influenza A and B.
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