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Advisory Committee Votes Against Approving Anemia Drug
Advisory Committee Votes Against Approving Anemia Drug
Advisory Committee Votes Against Approving Anemia Drug
July 15, 2021
Committee members raised safety concerns about FibroGen/AstraZeneca’s oral therapy roxadustat.
Study: Janssen’s Delay of Generics for Zytiga Achieved $2.05 Billion in Additional Sales
Study: Janssen’s Delay of Generics for Zytiga Achieved $2.05 Billion in Additional Sales
Study: Janssen’s Delay of Generics for Zytiga Achieved $2.05 Billion in Additional Sales
July 15, 2021
After generic entry, Zytiga’s market share fell to about 14% and monthly net sales across the entire market fell 85%.
Aduhelm’s Impact on Medicaid Programs Could be High
Aduhelm’s Impact on Medicaid Programs Could be High
Aduhelm’s Impact on Medicaid Programs Could be High
July 15, 2021
New analysis suggests that even with rebates, the new Alzheimer’s therapy could have implications for Medicaid drug spending.
CMS Provides Temporary Code for New Multiple Myeloma Therapy
CMS Provides Temporary Code for New Multiple Myeloma Therapy
CMS Provides Temporary Code for New Multiple Myeloma Therapy
July 14, 2021
A permanent code is expected in the third quarter of 2021.
Movantik Chosen as Preferred Brand for Some Blue Cross Plans
Movantik Chosen as Preferred Brand for Some Blue Cross Plans
Movantik Chosen as Preferred Brand for Some Blue Cross Plans
July 13, 2021
The therapy for opioid-induced constipation has no restrictions on an unidentified national formulary that serves these Blues plans.
Janssen Snags New Multiple Myeloma Indication for Darzalex Faspro
Janssen Snags New Multiple Myeloma Indication for Darzalex Faspro
Janssen Snags New Multiple Myeloma Indication for Darzalex Faspro
July 13, 2021
The new indication provides a subcutaneous option for multiple myeloma that can be administrated in minutes, rather than hours.
Jardiance Lowers Hospitalization Risk in Some Patients
Jardiance Lowers Hospitalization Risk in Some Patients
Jardiance Lowers Hospitalization Risk in Some Patients
July 12, 2021
Jardiance lowered risk of hospitalization from acute kidney injury but increased risk of hospitalized from diabetic ketoacidosis compared with a DPP4 inhibitor in one interim analysis.
Some Blues Plans Won’t Cover New Alzheimer’s Therapy Aduhelm
Some Blues Plans Won’t Cover New Alzheimer’s Therapy Aduhelm
Some Blues Plans Won’t Cover New Alzheimer’s Therapy Aduhelm
July 12, 2021
Commercial insurers are beginning to provide coverage information on Biogen’s controversial therapy.
New Executive Order Aims to Lower Drug Prices
New Executive Order Aims to Lower Drug Prices
New Executive Order Aims to Lower Drug Prices
July 9, 2021
This is part of a larger effort by President Joe Biden to promote competition in the American economy.
Breckenridge Pharmaceutical Launches Generic of Ambien CR
Breckenridge Pharmaceutical Launches Generic of Ambien CR
Breckenridge Pharmaceutical Launches Generic of Ambien CR
July 9, 2021
This is the eighth generic version of the drug to treat insomnia.
PANTHERx Chosen as Pharmacy Provider for Exservan to treat ALS
PANTHERx Chosen as Pharmacy Provider for Exservan to treat ALS
PANTHERx Chosen as Pharmacy Provider for Exservan to treat ALS
July 9, 2021
Orally dissolving film formulation of riluzole is now available for patients who have difficulty swallowing.
Jardiance First to Reduce Risk of Death in Heart Failure Patients
Jardiance First to Reduce Risk of Death in Heart Failure Patients
Jardiance First to Reduce Risk of Death in Heart Failure Patients
July 8, 2021
New data show efficacy in all forms of heart failure regardless of ejection fraction.
FDA Approves Updated Label for Controversial Alzheimer’s Therapy
FDA Approves Updated Label for Controversial Alzheimer’s Therapy
FDA Approves Updated Label for Controversial Alzheimer’s Therapy
July 8, 2021
The prescribing information for Aduhelm now specifies its use in patients with a mild form of the disease.
Amgen Submits Application for Asthma Biologic
Amgen Submits Application for Asthma Biologic
Amgen Submits Application for Asthma Biologic
July 8, 2021
The agency also granted tezepelumab priority review with a PDUFA date sometime in the first quarter of 2022.
Skin Infection Treatment Now Available
Skin Infection Treatment Now Available
Skin Infection Treatment Now Available
July 7, 2021
The single-dose antibiotic with a one-hour infusion is approved to treat MRSA and other skin infections.
Novartis Resubmits Application for Inclisiran
Novartis Resubmits Application for Inclisiran
Novartis Resubmits Application for Inclisiran
July 7, 2021
The company is transferring manufacturing of the final product to its own site in Austria.
The FDA Issues Complete Response Letter for Teplizumab
The FDA Issues Complete Response Letter for Teplizumab
The FDA Issues Complete Response Letter for Teplizumab
July 6, 2021
Despite an advisory committee recommendation for approval, the FDA did not approve what would have been the first disease-modifying therapy for type 1 diabetes.
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Keytruda Approved for Cutaneous Squamous Cell Carcinoma
Keytruda Approved for Cutaneous Squamous Cell Carcinoma
July 6, 2021
This approval comes days after Merck announced it would withdraw indication for third-line gastric cancer.
Local Anesthetic Zynrelef is Now Available
Local Anesthetic Zynrelef is Now Available
Local Anesthetic Zynrelef is Now Available
July 6, 2021
New, extended-release therapy for post-operative pain reduces the need for opioid pain relief.
Acerus Grabs Additional Formulary Status for Testosterone Brand
Acerus Grabs Additional Formulary Status for Testosterone Brand
Acerus Grabs Additional Formulary Status for Testosterone Brand
July 2, 2021
Coverage now includes 85% of commercial lives.
Acacia Pharma Expects to Meet Formulary Goals
Acacia Pharma Expects to Meet Formulary Goals
Acacia Pharma Expects to Meet Formulary Goals
July 2, 2021
Formulary adoption is a key step in achieving sales pull through starting in 2022, company officials said.
The FDA Approves Rylaze for Leukemia and Lymphoma
The FDA Approves Rylaze for Leukemia and Lymphoma
The FDA Approves Rylaze for Leukemia and Lymphoma
July 1, 2021
The therapy, a recombinant version, was developed to address supply and manufacturing issues.
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