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All News - Page 59

Counterfeit Versions of Biktarvy and Descovy Found in Pharmacies
Counterfeit Versions of Biktarvy and Descovy Found in Pharmacies
Counterfeit Versions of Biktarvy and Descovy Found in Pharmacies
August 9, 2021
The bottles have a counterfeit foil seal or label and contain an incorrect number of tablets.
Formulary Watch: Drug Shortages, August 8, 2021
Formulary Watch: Drug Shortages, August 8, 2021
Formulary Watch: Drug Shortages, August 8, 2021
August 8, 2021
Current drug shortages based on FDA data, prepared by Formulary Watch.
KVK Tech Recalls Two Lots of Atovaquone
KVK Tech Recalls Two Lots of Atovaquone
KVK Tech Recalls Two Lots of Atovaquone
August 6, 2021
The therapy for HIV-related pneumonia was exposed to cold weather during shipment.
Regeneron’s COVID-19 Cocktail Snags Expanded EUA Indication
Regeneron’s COVID-19 Cocktail Snags Expanded EUA Indication
Regeneron’s COVID-19 Cocktail Snags Expanded EUA Indication
August 6, 2021
The therapy can now be used for post-exposure prevention in people at high risk for progression to severe disease.
Exelixis Submits Cabometyx for Thyroid Cancer
Exelixis Submits Cabometyx for Thyroid Cancer
Exelixis Submits Cabometyx for Thyroid Cancer
August 5, 2021
The PDUFA date has been set for December 4, 2021; FDA has designated this as a Priority Review.
FDA Grants Keytruda Priority Review for Melanoma
FDA Grants Keytruda Priority Review for Melanoma
FDA Grants Keytruda Priority Review for Melanoma
August 5, 2021
The PDUFA date for this indication is December 4, 2021.
ParaPRO’s Antiparasitic Natroba is Now Available
ParaPRO’s Antiparasitic Natroba is Now Available
ParaPRO’s Antiparasitic Natroba is Now Available
August 4, 2021
A single application targets the infection without entering the circulatory system.
FDA Grants Tecentriq Priority Review for NSCLC
FDA Grants Tecentriq Priority Review for NSCLC
FDA Grants Tecentriq Priority Review for NSCLC
August 4, 2021
The FDA is expected to make a decision on this indication by December 1, 2021.
BMS Pulls Lymphoma Indication for Istodax
BMS Pulls Lymphoma Indication for Istodax
BMS Pulls Lymphoma Indication for Istodax
August 3, 2021
The therapy had received accelerated approval in 2011 but a phase 3 confirmatory trial found it did not meet the end point of progression-free survival.
Texas Medicaid Changes Formulary Status of Endari
Texas Medicaid Changes Formulary Status of Endari
Texas Medicaid Changes Formulary Status of Endari
August 2, 2021
The sickle cell disease therapy will now be on the Preferred Drug List.
FDA Approves AstraZeneca Lupus Drug
FDA Approves AstraZeneca Lupus Drug
FDA Approves AstraZeneca Lupus Drug
August 2, 2021
This is the first new approval for lupus in a decade.
FDA Grants Breakthrough Therapy Designation for Narcolepsy Drug
FDA Grants Breakthrough Therapy Designation for Narcolepsy Drug
FDA Grants Breakthrough Therapy Designation for Narcolepsy Drug
August 2, 2021
The agent targets excessive daytime sleepiness.
FDA Updates Clozapine REMS Program
FDA Updates Clozapine REMS Program
FDA Updates Clozapine REMS Program
August 2, 2021
Pharmacies will need to obtain pre-dispense authorization for clozapine.
Piqray’s Safety Label is Updated
Piqray’s Safety Label is Updated
Piqray’s Safety Label is Updated
July 30, 2021
Some fatal cases of ketoacidosis have occurred, and high-risk patients should be monitored when starting treatment.
Ardelyx Receives Complete Response Letter for Kidney Disease Therapy
Ardelyx Receives Complete Response Letter for Kidney Disease Therapy
Ardelyx Receives Complete Response Letter for Kidney Disease Therapy
July 29, 2021
The FDA is requesting an additional study to demonstrate tenapanor lowers serum phosphorus.
Specialty Pharmacies Grapple with Assessing Costs and Value of Oncology Therapies
Specialty Pharmacies Grapple with Assessing Costs and Value of Oncology Therapies
Specialty Pharmacies Grapple with Assessing Costs and Value of Oncology Therapies
July 29, 2021
Drugs that provide only incremental benefit may not be included on clinical pathways.
FDA Approves First Interchangeable Biosimilar Insulin
FDA Approves First Interchangeable Biosimilar Insulin
FDA Approves First Interchangeable Biosimilar Insulin
July 29, 2021
The approval allows for substitution at the pharmacy counter for Lantus, its reference product.
FDA Safety Alert: Pepaxto is Associated with Increased Risk of Death
FDA Safety Alert: Pepaxto is Associated with Increased Risk of Death
FDA Safety Alert: Pepaxto is Associated with Increased Risk of Death
July 28, 2021
The agency has stopped enrollment in all ongoing trials.
Analysis Finds Farxiga a Cost-effective Addition for Some Patients with Heart Failure
Analysis Finds Farxiga a Cost-effective Addition for Some Patients with Heart Failure
Analysis Finds Farxiga a Cost-effective Addition for Some Patients with Heart Failure
July 28, 2021
The findings were similar in people with or without diabetes.
Study: Branded Direct Oral Anticoagulants Raised Medicare Part D Spending
Study: Branded Direct Oral Anticoagulants Raised Medicare Part D Spending
Study: Branded Direct Oral Anticoagulants Raised Medicare Part D Spending
July 27, 2021
Competition among branded products did not substantially curb annual spending increases.
ICER: Soliris and Efgartigimod Not Cost-effective
ICER: Soliris and Efgartigimod Not Cost-effective
ICER: Soliris and Efgartigimod Not Cost-effective
July 26, 2021
A substantial discount would be needed to meet cost-effectiveness thresholds.
Incyte Receives Complete Response Letter for Oncology Therapy
Incyte Receives Complete Response Letter for Oncology Therapy
Incyte Receives Complete Response Letter for Oncology Therapy
July 26, 2021
The FDA would like to see additional data on clinical benefit for patients with anal cancer.
Study: Blood Pressure Meds Work Equally, But One Has Fewer Side Effects
Study: Blood Pressure Meds Work Equally, But One Has Fewer Side Effects
Study: Blood Pressure Meds Work Equally, But One Has Fewer Side Effects
July 26, 2021
Angiotensin receptor blockers may be less likely to cause side effects than ACE inhibitors.
Formulary Watch: Drug Shortages, July 25, 2021
Formulary Watch: Drug Shortages, July 25, 2021
Formulary Watch: Drug Shortages, July 25, 2021
July 25, 2021
Current drug shortages based on FDA data, prepared by Formulary Watch.
Merck Vaccine and Other FDA Updates
Merck Vaccine and Other FDA Updates
Merck Vaccine and Other FDA Updates
July 25, 2021
Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.
Medicare Part D Plans are Slower to Cover First Generics
Medicare Part D Plans are Slower to Cover First Generics
Medicare Part D Plans are Slower to Cover First Generics
July 23, 2021
When Medicare D plans do provide coverage for first generics, they are often placed on non-generic tiers.
NCCN Adds Jazz’s ALL Therapy Rylaze to Practice Guidelines
NCCN Adds Jazz’s ALL Therapy Rylaze to Practice Guidelines
NCCN Adds Jazz’s ALL Therapy Rylaze to Practice Guidelines
July 23, 2021
The June 30 approval meets an unmet need in this cancer.
AllianceRx Walgreens Prime Home Delivery Earns Reaccreditation
AllianceRx Walgreens Prime Home Delivery Earns Reaccreditation
AllianceRx Walgreens Prime Home Delivery Earns Reaccreditation
July 22, 2021
The accreditation is effective through July 2024.
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Onco360 Chosen as Pharmacy Provider for Rezurock
Onco360 Chosen as Pharmacy Provider for Rezurock
July 22, 2021
The FDA had approved Kadmon's therapy for graft-versus-host disease July 16.
Jazz Pharmaceuticals Launches ALL Therapy Rylaze
Jazz Pharmaceuticals Launches ALL Therapy Rylaze
Jazz Pharmaceuticals Launches ALL Therapy Rylaze
July 21, 2021
The therapy is approved for both adults and children.
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