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All News - Page 61

Axsome Therapeutics antidepressant drug could become blockbuster
Axsome Therapeutics antidepressant drug could become blockbuster
Axsome Therapeutics antidepressant drug could become blockbuster
April 27, 2021
The major depressive disorder (MDD) market is expected to soar to $7.87 billion by 2029.
BMS’s Opdivo earns indication for gastric cancer
BMS’s Opdivo earns indication for gastric cancer
BMS’s Opdivo earns indication for gastric cancer
April 21, 2021
Opdivo is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.
FDA rescinds EUA for solo use of Lilly's bamlanivimab
FDA rescinds EUA for solo use of Lilly's bamlanivimab
FDA rescinds EUA for solo use of Lilly's bamlanivimab
April 19, 2021
The combination monoclonal antibody treatment of bamlanivimab and etesevimab still OK.
Gilead’s breast cancer treatment snags expanded indication
Gilead’s breast cancer treatment snags expanded indication
Gilead’s breast cancer treatment snags expanded indication
April 14, 2021
The new approval expands the drug's indication to include treatment in adult patients with unresectable locally advanced or metastatic triple-negative breast cancer.
Prozac, antifungal drug inhibit SARS-CoV-2 in new study
Prozac, antifungal drug inhibit SARS-CoV-2 in new study
Prozac, antifungal drug inhibit SARS-CoV-2 in new study
April 13, 2021
Two common antidepressant and antifungal drugs were very effective at inhibiting SARS-CoV-2, the virus that causes COVID-19, according to a new study.
FDA clears Qelbree, first new ADHD drug for children in more than a decade
FDA clears Qelbree, first new ADHD drug for children in more than a decade
FDA clears Qelbree, first new ADHD drug for children in more than a decade
April 7, 2021
The novel nonstimulant medication from Supernus Pharmaceuticals can be sprinkled on food.
FDA okays first CAR-T cell therapy for a specific myeloma
FDA okays first CAR-T cell therapy for a specific myeloma
FDA okays first CAR-T cell therapy for a specific myeloma
March 30, 2021
Bristol Myers Squibb and bluebird bio’s Abecma is the first B-cell maturation antigen (BCMA)-directed CAR-T cell immunotherapy for relapsed or refractory multiple myeloma after 4 or more prior lines of therapy.
A conversation about real-world data with COTA's Viraj Narayanan
A conversation about real-world data with COTA's Viraj Narayanan
A conversation about real-world data with COTA's Viraj Narayanan
March 30, 2021
Precision medicine may mean smaller clinical trials. Collecting real-world data can help supply some of the same information as a control group.
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.
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