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All News - Page 43

Pfizer Recalls Five Lots of Accupril
Pfizer Recalls Five Lots of Accupril
Pfizer Recalls Five Lots of Accupril
April 26, 2022
Higher than normal levels of nitrosamine have been detected. Long-term exposure to high amounts of nitrosamine can lead to cancer.
FDA to Hold Advisory Committee for Xphozah in Kidney Disease
FDA to Hold Advisory Committee for Xphozah in Kidney Disease
FDA to Hold Advisory Committee for Xphozah in Kidney Disease
April 25, 2022
The FDA is seeking input from committee members about the phosphate lowering effect seen in trials for tenapanor, which now has the brand name of Xphozah.
FDA Decisions Expected this Week for Five Products
FDA Decisions Expected this Week for Five Products
FDA Decisions Expected this Week for Five Products
April 25, 2022
The FDA is expected to make decisions on several products later this week, including mavacamten, Qelbree, meloxicam-rizatriptan, surufatinib and toripalimab.
Therapy for Blurry Vision Shows Positive Results
Therapy for Blurry Vision Shows Positive Results
Therapy for Blurry Vision Shows Positive Results
April 25, 2022
Phase 3 trials show CSF-1, a low-dose pilocarpine, met clinical endpoints for improving presbyopia, or age-related blurry vision.
WHO Issues New Recommendations on Paxlovid, Remdesivir for COVID-19
WHO Issues New Recommendations on Paxlovid, Remdesivir for COVID-19
WHO Issues New Recommendations on Paxlovid, Remdesivir for COVID-19
April 22, 2022
The World Health Organization now recommends Paxlovid and Veklury for non-severe COVID-19 at high risk of hospitalization but still advises against use in mild disease with low risk of hospitalization.
Biogen Withdraws European Application of Aduhelm
Biogen Withdraws European Application of Aduhelm
Biogen Withdraws European Application of Aduhelm
April 22, 2022
The EMA’s Committee for Medicinal Products for Human Use indicated that the data provided is not sufficient for marketing authorization.
FDA Accepts Resubmitted BLA for Cosmetic Therapy
FDA Accepts Resubmitted BLA for Cosmetic Therapy
FDA Accepts Resubmitted BLA for Cosmetic Therapy
April 22, 2022
The new PDUFA date for is Sept. 8, 2022, for daxibotulinumtoxinA, Revance’s therapy to treat frown lines.
Breckenridge Gets FDA Approval of One Generic and Launches Two Others
Breckenridge Gets FDA Approval of One Generic and Launches Two Others
Breckenridge Gets FDA Approval of One Generic and Launches Two Others
April 21, 2022
The FDA has approved miglustat for Gaucher disease. Breckenridge launches pencillamine for Wilson’s disease and lacosamide for seizure disorder.
IQVIA: Medication Use Reached Record Levels Last Year
IQVIA: Medication Use Reached Record Levels Last Year
IQVIA: Medication Use Reached Record Levels Last Year
April 21, 2022
An estimated additional 81 million prescriptions were abandoned at the pharmacy because of high out-of-pocket costs for patients.
Survey: Patient Impact of Utilization Management Not Understood
Survey: Patient Impact of Utilization Management Not Understood
Survey: Patient Impact of Utilization Management Not Understood
April 21, 2022
Carole Florman, policy fellow at CancerCare, talks about how utilization management can have unintended consequences for patients.
FDA Issues CRL for Teva’s Schizophrenia Drug
FDA Issues CRL for Teva’s Schizophrenia Drug
FDA Issues CRL for Teva’s Schizophrenia Drug
April 20, 2022
Teva Pharmaceutical and MedinCell, the drug’s developers, didn’t provide a reason for the complete response letter.
Cancer, Scleroderma Treatments Granted Orphan Drug Designation
Cancer, Scleroderma Treatments Granted Orphan Drug Designation
Cancer, Scleroderma Treatments Granted Orphan Drug Designation
April 19, 2022
The FDA has granted orphan drug designation to a potential first-in-class therapy for scleroderma and a PD-1 inhibitor for small cell lung cancer.
The FDA Accepts NDA for Novel Therapy for CKD-Related Anemia
The FDA Accepts NDA for Novel Therapy for CKD-Related Anemia
The FDA Accepts NDA for Novel Therapy for CKD-Related Anemia
April 19, 2022
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 1, 2023, for daprodustat.
FDA Accepts sBLA of Enhertu to Treat Metastatic Lung Cancer
FDA Accepts sBLA of Enhertu to Treat Metastatic Lung Cancer
FDA Accepts sBLA of Enhertu to Treat Metastatic Lung Cancer
April 19, 2022
The PDUFA date for Enhertu in the lung cancer indication is in the third quarter of 2022.
Can Psychedelics Treat Mental Health Conditions?
Can Psychedelics Treat Mental Health Conditions?
Can Psychedelics Treat Mental Health Conditions?
April 18, 2022
Dr. Caroline Carney of Magellan Healthcare discusses the psychedelics in the pipeline for treating mental health conditions.
Prime Removes Four Products from Medicare Formularies
Prime Removes Four Products from Medicare Formularies
Prime Removes Four Products from Medicare Formularies
April 18, 2022
A Parkinson’s therapy, a treatment for seizures, a drug used in the treatment of heart failure, and a therapy for a rare disease have been removed from Prime’s Medicare formularies.
Pfizer Updates Warnings Section of Zosyn
Pfizer Updates Warnings Section of Zosyn
Pfizer Updates Warnings Section of Zosyn
April 18, 2022
Zosyn’s label was updated to warn about the risk of a severe immune response called hemophagocytic lymphohistiocytosis.
Generics Recently Launched in the United States
Generics Recently Launched in the United States
Generics Recently Launched in the United States
April 16, 2022
Generic launches include equivalents of Combigan, Abraxane, Cytotec, Solu-Medrol, and Tobradex.
FDA Issues EUA for First COVID-19 Breath Test
FDA Issues EUA for First COVID-19 Breath Test
FDA Issues EUA for First COVID-19 Breath Test
April 15, 2022
The InspectIR Systems Breathalyzer test can provide results in three minutes.
A PBM with More Stable Drug Pricing
A PBM with More Stable Drug Pricing
A PBM with More Stable Drug Pricing
April 15, 2022
Capital Rx uses the NADAC model, which was developed by CMS for Medicare and Medicaid drug pricing.
NCCN Adds Vonjo to Guidelines for Myeloproliferative Neoplasms
NCCN Adds Vonjo to Guidelines for Myeloproliferative Neoplasms
NCCN Adds Vonjo to Guidelines for Myeloproliferative Neoplasms
April 14, 2022
Vonjo is the first therapy that specifically addresses the needs of patients with cytopenic myelofibrosis, a bone marrow cancer.
FDA Okays Third Biosimilar of Avastin
FDA Okays Third Biosimilar of Avastin
FDA Okays Third Biosimilar of Avastin
April 14, 2022
Amneal's Alymsys is approved to treat several cancers.
The FDA Extends Review of REGEN-COV
The FDA Extends Review of REGEN-COV
The FDA Extends Review of REGEN-COV
April 14, 2022
The FDA needs to review additional data from a trial that assessed REGEN-COV for the prevention of COVID-19. The new PDUFA date is July 13, 2022.
ViiV Healthcare Updates Warning Label for Triumeq
ViiV Healthcare Updates Warning Label for Triumeq
ViiV Healthcare Updates Warning Label for Triumeq
April 13, 2022
The label of Triumeq now includes additional information about use in patients who have both HIV and hepatitis B.
Mylan Recalls One Batch of Insulin Glargine
Mylan Recalls One Batch of Insulin Glargine
Mylan Recalls One Batch of Insulin Glargine
April 13, 2022
Some vials have been found to be missing a label.
OIG: Biosimilars Can Save Money for Medicare and Beneficiaries
OIG: Biosimilars Can Save Money for Medicare and Beneficiaries
OIG: Biosimilars Can Save Money for Medicare and Beneficiaries
April 12, 2022
Increased use of biosimilars could reduce Medicare Part D spending by 18% and beneficiaries’ out-of-pocket costs by 12%.
FDA Clears First Elcys Generic
FDA Clears First Elcys Generic
FDA Clears First Elcys Generic
April 12, 2022
The generic cysteine could be available after a ruling in a patent dispute, which is expected in the third quarter of 2022.
Aeglea Submits BLA for Pegzilarginase for Rare Metabolic Disease
Aeglea Submits BLA for Pegzilarginase for Rare Metabolic Disease
Aeglea Submits BLA for Pegzilarginase for Rare Metabolic Disease
April 12, 2022
If approved, pegzilarginase would be the first treatment for ARG1 deficiency, a rare progressive disease.
Study: Increased Cost Sharing Can Lead to Medication Non-Adherence
Study: Increased Cost Sharing Can Lead to Medication Non-Adherence
Study: Increased Cost Sharing Can Lead to Medication Non-Adherence
April 11, 2022
A literature review found an association between increased cost-sharing and lower patient adherence, which in turn could be associated with increased hospitalizations.
FDA Accepts Resubmitted BLA for Rolontis
FDA Accepts Resubmitted BLA for Rolontis
FDA Accepts Resubmitted BLA for Rolontis
April 11, 2022
The FDA had previously issued a CRL due to manufacturing issues for the therapy, which is seeking an indication for preventing infections after chemotherapy for breast cancer. The agency has set a new PDUFA date of September 9, 2022.
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