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FDA Approves Amvuttra for Neuropathy Associated with Rare Disease
FDA Approves Amvuttra for Neuropathy Associated with Rare Disease
FDA Approves Amvuttra for Neuropathy Associated with Rare Disease
June 14, 2022
Amvuttra is expected to launch in July, and the developer, Alnylam, plans to make this available through value-based agreements.
FDA Approves Olumiant to Treat Patients with Alopecia
FDA Approves Olumiant to Treat Patients with Alopecia
FDA Approves Olumiant to Treat Patients with Alopecia
June 14, 2022
Olumiant is the first systemic therapy available to treat alopecia.
FDA Extends PDUFA Date for sNDA of Brukinsa
FDA Extends PDUFA Date for sNDA of Brukinsa
FDA Extends PDUFA Date for sNDA of Brukinsa
June 13, 2022
The FDA needs time to review additional clinical data submitted by BeiGene for the leukemia/lymphoma indication. The new date is Jan. 20, 2023.
Mallinckrodt Resubmits Application for Terlipressin
Mallinckrodt Resubmits Application for Terlipressin
Mallinckrodt Resubmits Application for Terlipressin
June 13, 2022
In February 2022, the FDA had issued a complete response letter in order to inspect a new third-party packaging and labeling facility.
FDA Accepts Keytruda Application for Earlier NSCLC After Surgery
FDA Accepts Keytruda Application for Earlier NSCLC After Surgery
FDA Accepts Keytruda Application for Earlier NSCLC After Surgery
June 13, 2022
The FDA has set a PDUFA date of Jan. 29, 2023, but Merck indicated additional data may be provided to regulators that extends this date.
FDA Advisory Committee Supports Approval of Gene Therapy for Blood Disease
FDA Advisory Committee Supports Approval of Gene Therapy for Blood Disease
FDA Advisory Committee Supports Approval of Gene Therapy for Blood Disease
June 11, 2022
If approved, beti-cel will be the first potentially curative gene therapy for people with beta-thalassemia who require regular red blood cell transfusions. The PDUFA date is Aug. 19, 2022.
FDA Advisory Committee Endorses Gene Therapy for Neurogenerative Disease
FDA Advisory Committee Endorses Gene Therapy for Neurogenerative Disease
FDA Advisory Committee Endorses Gene Therapy for Neurogenerative Disease
June 10, 2022
If approved, elivaldogene autotemcel will be the first gene therapy to address the underlying genetic cause of cerebral adrenoleukodystrophy, a rare disease that affects young boys.
Hemophilia A Treatment Earns Breakthrough Therapy Designation
Hemophilia A Treatment Earns Breakthrough Therapy Designation
Hemophilia A Treatment Earns Breakthrough Therapy Designation
June 10, 2022
Efanesoctocog alfa is a new class of factor VIII therapy with once-weekly prophylactic dosing. The application for approval expected to be filed mid year.
Nephron Recalls More Than 2 Million Doses of Epinephrine, Other Injections
Nephron Recalls More Than 2 Million Doses of Epinephrine, Other Injections
Nephron Recalls More Than 2 Million Doses of Epinephrine, Other Injections
June 9, 2022
The recalls were made because the medications failed sterility testing.
Studies: Adherence to CF, UC/Crohn’s Meds Lowered Hospitalizations, Costs
Studies: Adherence to CF, UC/Crohn’s Meds Lowered Hospitalizations, Costs
Studies: Adherence to CF, UC/Crohn’s Meds Lowered Hospitalizations, Costs
June 9, 2022
Two studies conducted by AllianceRx Walgreens Prime call attention to the importance of adherence for reducing risk of negative health outcomes and financial costs.
FDA Committee Recommends EUA for Novavax’s COVID-19 Vaccine
FDA Committee Recommends EUA for Novavax’s COVID-19 Vaccine
FDA Committee Recommends EUA for Novavax’s COVID-19 Vaccine
June 9, 2022
Novavax’s COVID-19 vaccine demonstrated 90.4% efficacy with a low number of serious and severe adverse events, including myocarditis.
Study Finds Express Scripts’ Exclusions Based on Contracts
Study Finds Express Scripts’ Exclusions Based on Contracts
Study Finds Express Scripts’ Exclusions Based on Contracts
June 8, 2022
In some cases, the exclusions favored brand medicines that were more expensive than the excluded generics.
Study Finds New Drugs are Increasingly Launched with Higher Prices
Study Finds New Drugs are Increasingly Launched with Higher Prices
Study Finds New Drugs are Increasingly Launched with Higher Prices
June 8, 2022
This trend in prescription drug pricing outpaces growth in prices for other healthcare services.
FTC Launches Investigation of PBMs
FTC Launches Investigation of PBMs
FTC Launches Investigation of PBMs
June 8, 2022
The commission will review PBM business practices, including the impact of rebates on formulary design, the costs of prescription drugs to patients, and methods to determine pharmacy reimbursement.
FDA Approves Dupixent for Young Children with Atopic Dermatitis
FDA Approves Dupixent for Young Children with Atopic Dermatitis
FDA Approves Dupixent for Young Children with Atopic Dermatitis
June 8, 2022
Dupixent is the first biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy through adulthood.
Halozyme Launches the Testosterone Replacement Tlando
Halozyme Launches the Testosterone Replacement Tlando
Halozyme Launches the Testosterone Replacement Tlando
June 7, 2022
Approved in March, Tlando is an oral testosterone that doesn’t require dose titration.
Report Updates Number of Rare Diseases
Report Updates Number of Rare Diseases
Report Updates Number of Rare Diseases
June 7, 2022
A more accurate number of rare diseases is more than 10,000, and just 500 of these disorders have treatment options available for patients, according to RARE-X.
PBM Exclusions Increasing, Finds New Analysis
PBM Exclusions Increasing, Finds New Analysis
PBM Exclusions Increasing, Finds New Analysis
June 7, 2022
Xcenda’s review of the three largest PBMs—CVS Caremark, Express Scripts, and OptumRx—finds they are excluding medicines in classes where generics are not available or for serious conditions, such as oncology and autoimmune disorders.
Myovant Selects Onco360 as Specialty Pharmacy for Orgovyx
Myovant Selects Onco360 as Specialty Pharmacy for Orgovyx
Myovant Selects Onco360 as Specialty Pharmacy for Orgovyx
June 6, 2022
The FDA approved Orgovyx in December 2021 to treat patients with advanced prostate cancer.
FDA Approves the Biosimilar Riabni for Rheumatoid Arthritis
FDA Approves the Biosimilar Riabni for Rheumatoid Arthritis
FDA Approves the Biosimilar Riabni for Rheumatoid Arthritis
June 6, 2022
Riabni is now approved to treat all available Rituxan indications.
Survey: ICER Assessments Impact Payer Decision-Making
Survey: ICER Assessments Impact Payer Decision-Making
Survey: ICER Assessments Impact Payer Decision-Making
June 6, 2022
An Xcenda survey of payers found that cost-effectiveness analyses from the Institute for Clinical and Economic Review (ICER) are used in price negotiations and to implement prior authorizations.
BMS Withdraws sBLA for Reblozyl for Rare Blood Disorder
BMS Withdraws sBLA for Reblozyl for Rare Blood Disorder
BMS Withdraws sBLA for Reblozyl for Rare Blood Disorder
June 5, 2022
Reblozyl was being reviewed to treat anemia in adults with non-transfusion dependent beta thalassemia, an inherited blood disorder. BMS indicated it couldn’t appropriately address FDA’s questions about risk-benefit.
New Generic Launches
New Generic Launches
New Generic Launches
June 4, 2022
New launches this week include: new strength of Alimta, a generic of Esbriet, a generic of Toradol, and a generic of Florinef.
FDA Extends Review of ALS Therapy
FDA Extends Review of ALS Therapy
FDA Extends Review of ALS Therapy
June 3, 2022
The FDA has extended review time to allow for review of additional analyses of data from the company’s clinical studies. The new PDUFA date is Sept. 29, 2022.
BMS Updates Vidaza Label After Pediatric Indication Approval
BMS Updates Vidaza Label After Pediatric Indication Approval
BMS Updates Vidaza Label After Pediatric Indication Approval
June 3, 2022
The label now includes a new section about the risk of substituting an oral azacitidine product, Onureg, for the injection therapy.
FDA Issues Refusal to File Letter for Pegzilarginase
FDA Issues Refusal to File Letter for Pegzilarginase
FDA Issues Refusal to File Letter for Pegzilarginase
June 3, 2022
The FDA is asking for additional data to support effectiveness of pegzilarginase to treat a rare metabolic disease. If approved, pegzilarginase would be the first treatment for ARG1 deficiency.
IQVIA Finds New Cancer Clinical Trials are Increasing
IQVIA Finds New Cancer Clinical Trials are Increasing
IQVIA Finds New Cancer Clinical Trials are Increasing
June 2, 2022
More than 5,700 trials worldwide are investigating PD-1/PD-L1 inhibitors, and new trials of these therapies were of combination regimens.
Biogen/Samsung Bioepis Launch the Biosimilar Byooviz
Biogen/Samsung Bioepis Launch the Biosimilar Byooviz
Biogen/Samsung Bioepis Launch the Biosimilar Byooviz
June 2, 2022
Byooviz, the first FDA approved ophthalmology biosimilar for macular degeneration, will be priced 40% lower than the reference product. It will be commercially available on July 1, 2022.
FDA Puts Hold on Trial for Cialis OTC
FDA Puts Hold on Trial for Cialis OTC
FDA Puts Hold on Trial for Cialis OTC
June 2, 2022
The regulatory agency indicated there is an issue surrounding the protocol design.
FDA Accepts Dupixent Application for Treating Skin Lesions
FDA Accepts Dupixent Application for Treating Skin Lesions
FDA Accepts Dupixent Application for Treating Skin Lesions
June 1, 2022
If approved, Dupixent would be the first and only medicine in the United States specifically indicated to treat prurigo nodularis, or persistent itch with thick skin lesions. The PDUFA target action date for the FDA decision is Sept. 30, 2022.
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