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All News - Page 63

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FDA Approves Lyumjev for Use with Insulin Pump
FDA Approves Lyumjev for Use with Insulin Pump
August 16, 2021
Trials result show that Lyumjev compares favorably to Humalog.
Image courtesy of Vector Stock
Study: Utilization Management Efforts Add Billions to Health Care Costs
Study: Utilization Management Efforts Add Billions to Health Care Costs
August 16, 2021
All stakeholders together incur about $93.3 billion in costs for implementing, contesting, and navigating drug utilization management.
Drug Shortages Update
Drug Shortages Update
Drug Shortages Update
August 15, 2021
FDA Approves Generic of Chantix, Pfizer's Smoking Cessation Drug
FDA Approves Generic of Chantix, Pfizer's Smoking Cessation Drug
FDA Approves Generic of Chantix, Pfizer's Smoking Cessation Drug
August 13, 2021
This is the first approval of generic version of Chantix, and it comes just weeks after a recall of the brand-name drug.
Veltassa product shot
Study: Veltassa Lowers Overall Health Care Costs
Study: Veltassa Lowers Overall Health Care Costs
August 12, 2021
The potassium-lowering agent was associated with a 20% relative reduction in costs related to outpatient, inpatient, and emergency department visits.
Express Scripts Releases List of 2022 Formulary Exclusions
Express Scripts Releases List of 2022 Formulary Exclusions
August 12, 2021
Four products on the preferred list this year will be excluded next year.
Veterans Administration Declines Coverage for Aduhelm
Veterans Administration Declines Coverage for Aduhelm
Veterans Administration Declines Coverage for Aduhelm
August 12, 2021
The VA recommends against offering this agent to patients with Alzheimer’s dementia, mild or otherwise.
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GoodRx, Boehringer Ingelheim Partner on Savings Program for Top Meds
GoodRx, Boehringer Ingelheim Partner on Savings Program for Top Meds
August 11, 2021
The program and proposed integrations could produce $15 million in savings annually.
FDA Issues CRL for FibroGen’s Roxadustat
FDA Issues CRL for FibroGen’s Roxadustat
FDA Issues CRL for FibroGen’s Roxadustat
August 11, 2021
The decision follows an advisory committee recommendation not to approve because of safety issues.
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NSCLC Drug Trial Stopped Early After Strong Survival Results
NSCLC Drug Trial Stopped Early After Strong Survival Results
August 10, 2021
Libtayo also reduced the risk of death by 29% compared with chemotherapy alone.
FDA Accepts NDA for Dermavant’s Tapinarof
FDA Accepts NDA for Dermavant’s Tapinarof
FDA Accepts NDA for Dermavant’s Tapinarof
August 10, 2021
A decision on the plaque psoriasis therapy is expected in the second quarter of 2022.
Second Specialty Pharmacy Chosen to Dispense Rezurock
Second Specialty Pharmacy Chosen to Dispense Rezurock
Second Specialty Pharmacy Chosen to Dispense Rezurock
August 9, 2021
The graft-versus-host disease therapy has also been added to NCCN Guidelines.
Psoriasis Drug Skyrizi is Now Available as a Single Injection
Psoriasis Drug Skyrizi is Now Available as a Single Injection
Psoriasis Drug Skyrizi is Now Available as a Single Injection
August 9, 2021
Previously patients administered as two, 75-mg shots. Now they can inject a single 150-mg dose.
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.
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