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All News - Page 51

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.
CMS Finalizes Narrow Aduhelm Medicare Coverage
CMS Finalizes Narrow Aduhelm Medicare Coverage
CMS Finalizes Narrow Aduhelm Medicare Coverage
April 8, 2022
CMS’s final decision is that monoclonal antibodies to treat Alzheimer’s disease may only be covered in a randomized controlled trial conducted under an investigational new drug application.
Jazz Pharmaceuticals Updates Safety Label for Cancer Treatment Zepzelca
Jazz Pharmaceuticals Updates Safety Label for Cancer Treatment Zepzelca
Jazz Pharmaceuticals Updates Safety Label for Cancer Treatment Zepzelca
April 8, 2022
Two new subsections have been added to the warning and precautious section of Zepzelca’s label to address serious adverse events that were identified during post-market monitoring.
A Partner in Hospice Care
A Partner in Hospice Care
A Partner in Hospice Care
April 7, 2022
Drew Mihalyo of Delta Care Rx discusses the company’s pass-through pharmacy pricing model.
Budget Impact Analysis Shows Zegalogue Could Cut Costs for Severe Hypoglycemia
Budget Impact Analysis Shows Zegalogue Could Cut Costs for Severe Hypoglycemia
Budget Impact Analysis Shows Zegalogue Could Cut Costs for Severe Hypoglycemia
April 7, 2022
Treatment with Zegalogue for severe hypoglycemia has the potential to save costs and reduce emergency department visits and hospitalizations.
FDA Approves Novel Therapy for Schizophrenia and Bipolar
FDA Approves Novel Therapy for Schizophrenia and Bipolar
FDA Approves Novel Therapy for Schizophrenia and Bipolar
April 7, 2022
Igalmi is the first and only film that dissolves under the tongue that treats adults with agitation associated with schizophrenia or bipolar. BioXcel expects to launch the therapy in the second quarter of 2022.
Health Plan Saved by Switching from Cosentyx to Taltz
Health Plan Saved by Switching from Cosentyx to Taltz
Health Plan Saved by Switching from Cosentyx to Taltz
April 6, 2022
A proof-of-concept study showed that patients can be successfully switched from Cosentyx to Taltz with similar outcomes and lower costs.
FDA Grants Accelerated Approval for Vijoice to Treat Rare Disorder
FDA Grants Accelerated Approval for Vijoice to Treat Rare Disorder
FDA Grants Accelerated Approval for Vijoice to Treat Rare Disorder
April 6, 2022
Novartis’ Vijoice is the first approved treatment for PIK3CA-related overgrowth spectrum, a group of rare disorders.
PBM as a Health Care Company
PBM as a Health Care Company
PBM as a Health Care Company
April 6, 2022
Karthik Ganesh, CEO of EmpiRx Health, discusses how its technology and clinical focus provide strategies for patient management that results in lower costs for clients.
CVS Caremark Updates 2022 Formulary
CVS Caremark Updates 2022 Formulary
CVS Caremark Updates 2022 Formulary
April 5, 2022
The PBM has removed 20 products and added a half dozen new therapies, including several generics. The changes are effective April 1, 2022.
Study: High Costs Prevent Medicare Beneficiaries from Filling Specialty Meds
Study: High Costs Prevent Medicare Beneficiaries from Filling Specialty Meds
Study: High Costs Prevent Medicare Beneficiaries from Filling Specialty Meds
April 5, 2022
Medicare beneficiaries without subsidies were 35% to 50% less likely to fill their prescriptions for drugs used to treat cancers, immune system disorders, and high cholesterol.
Telix Launches Imaging Agent Illuccix
Telix Launches Imaging Agent Illuccix
Telix Launches Imaging Agent Illuccix
April 5, 2022
Illuccix is approved to detect prostate cancer when using PET scan. It is available through Cardinal Health, PharmaLogic, and United Pharmacy Partners.
FDA Grants Breakthrough Therapy Designation to Treat Rare Disease vEDS
FDA Grants Breakthrough Therapy Designation to Treat Rare Disease vEDS
FDA Grants Breakthrough Therapy Designation to Treat Rare Disease vEDS
April 4, 2022
A phase 3 trial is expected to begin by the end of the second quarter.
FDA Extends PDUFA Date for Vutrisiran
FDA Extends PDUFA Date for Vutrisiran
FDA Extends PDUFA Date for Vutrisiran
April 4, 2022
The agency has extended the review period to address pending inspection classification at third-party secondary packaging and labeling facility. The new PDUFA date is July 14, 2022.
FDA Accepts sBLA for Actemra for Hospitalized COVID-19 Patients
FDA Accepts sBLA for Actemra for Hospitalized COVID-19 Patients
FDA Accepts sBLA for Actemra for Hospitalized COVID-19 Patients
April 4, 2022
Genentech also announced progress in meeting the supply challenges associated with Actemra, which is currently available under an emergency use authorization.
Accord BioPharma Launches Camcevi for Advanced Prostate Cancer
Accord BioPharma Launches Camcevi for Advanced Prostate Cancer
Accord BioPharma Launches Camcevi for Advanced Prostate Cancer
April 2, 2022
Camcevi is the first ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required.
FDA Extends Review of Vaxneuvance for Infants and Children
FDA Extends Review of Vaxneuvance for Infants and Children
FDA Extends Review of Vaxneuvance for Infants and Children
April 1, 2022
The FDA has asked Merck to provide to additional data from studies. The new PDUFA date is July 1, 2022.
FDA Advisory Committee Votes Down ALS Drug
FDA Advisory Committee Votes Down ALS Drug
FDA Advisory Committee Votes Down ALS Drug
April 1, 2022
The FDA’s final decision on AMX0035 is expected by June 29, 2022
FDA Issues CRL for Vadadustat for Anemia
FDA Issues CRL for Vadadustat for Anemia
FDA Issues CRL for Vadadustat for Anemia
March 31, 2022
The FDA cited safety concerns related to vadadustat, which is under review for the treatment of anemia due to chronic kidney disease.
AMCP 2022: Patients with Rare Liver Disease Need Treatment Adherence Support
AMCP 2022: Patients with Rare Liver Disease Need Treatment Adherence Support
AMCP 2022: Patients with Rare Liver Disease Need Treatment Adherence Support
March 31, 2022
AllianceRx Walgreens Prime study has found that patients taking Ocaliva may not be adherent to their treatment regimen for rare liver disease.
AMCP 2022: Payers Skeptical of Patient Input in Formulary Process
AMCP 2022: Payers Skeptical of Patient Input in Formulary Process
AMCP 2022: Payers Skeptical of Patient Input in Formulary Process
March 31, 2022
A disconnect exists between payers and patients with rare diseases about including patient input in the formulary process for orphan drugs.
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