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All News - Page 30

FDA Approves Libtayo for Second Indication in Advanced Lung Cancer
FDA Approves Libtayo for Second Indication in Advanced Lung Cancer
FDA Approves Libtayo for Second Indication in Advanced Lung Cancer
November 9, 2022
The new indication expands the patient population eligible for a Libtayo-based regimen to include combination treatment with chemotherapy irrespective of PD-L1 expression levels.
Battery Issues Affect Omnipod Dash Personal Diabetes Managers
Battery Issues Affect Omnipod Dash Personal Diabetes Managers
Battery Issues Affect Omnipod Dash Personal Diabetes Managers
November 8, 2022
Omnipod DASH PDMs are at increased risk of malfunction if overcharged beyond the maximum battery voltage.
FDA Calls Attention to Serious Skin Reactions of Amoxicillin
FDA Calls Attention to Serious Skin Reactions of Amoxicillin
FDA Calls Attention to Serious Skin Reactions of Amoxicillin
November 8, 2022
The regulatory agency has added the risk of rare skin infections to the warnings and precautions section of the labeling for amoxicillin products.
FDA: Bebtelovimab Does Not Neutralize New Omicron Subvariants
FDA: Bebtelovimab Does Not Neutralize New Omicron Subvariants
FDA: Bebtelovimab Does Not Neutralize New Omicron Subvariants
November 7, 2022
Bebtelovimab is used to treat COVID-19, but omicron subvariants BQ.1 and BQ.1.1 may be resistant, the FDA said.
Florida Blue Selects Amazon Pharmacy as Home Delivery Provider
Florida Blue Selects Amazon Pharmacy as Home Delivery Provider
Florida Blue Selects Amazon Pharmacy as Home Delivery Provider
November 7, 2022
Subscribers will be able to compare medications through Amazon and pay either their insurance copay price or the price from Prime Therapeutics’ MedsYourWay discount card.
Real-world Data Show Gardasil Protects Against Cervical, Non-Cervical Diseases
Real-world Data Show Gardasil Protects Against Cervical, Non-Cervical Diseases
Real-world Data Show Gardasil Protects Against Cervical, Non-Cervical Diseases
November 7, 2022
The greatest reductions were seen in girls who were vaccinated when they were adolescents, with up to 73% reduction in cervical pre-cancerous lesions.
FDA Approves Melanoma Drug to Treat Blood Cancers
FDA Approves Melanoma Drug to Treat Blood Cancers
FDA Approves Melanoma Drug to Treat Blood Cancers
November 4, 2022
Cotellic, an oral inhibitor of MEK1 and MEK2, was approved to treat patients with histiocytic neoplasms based on a phase 2 trial conducted solely at Memorial Sloan Kettering Cancer Center.
Pharmacist Prescribing Improves Access, GoodRx Report Finds
Pharmacist Prescribing Improves Access, GoodRx Report Finds
Pharmacist Prescribing Improves Access, GoodRx Report Finds
November 4, 2022
Expanding pharmacist prescriber authority for HIV PrEP medications significantly increased PrEP use.
Employers are Concerned about Specialty Drug Costs
Employers are Concerned about Specialty Drug Costs
Employers are Concerned about Specialty Drug Costs
November 3, 2022
Wendy Barnes and Mark Campbell of RxBenefits discuss the company’s survey, which finds employers are curious about solutions to manage both specialty drug spend and the potential volatility that comes with employees who may be diagnosed with cancer and other high-dollar conditions.
Prime Therapeutics Drops Two Drugs from Medicare Formularies
Prime Therapeutics Drops Two Drugs from Medicare Formularies
Prime Therapeutics Drops Two Drugs from Medicare Formularies
November 3, 2022
The changes were made because generics are now available; the change impacts specific client formularies.
Amoxicillin in Shortage Due to Increased Demand
Amoxicillin in Shortage Due to Increased Demand
Amoxicillin in Shortage Due to Increased Demand
November 3, 2022
Several suppliers of the widely-used antibiotic have limited or no availability of some formulations.
FDA Approves Hepatitis B Therapy for Adolescents
FDA Approves Hepatitis B Therapy for Adolescents
FDA Approves Hepatitis B Therapy for Adolescents
November 2, 2022
This approval expands the use of Vemlidy to children 12 years of age and older. Vemlidy is already available for adults living with this chronic liver disease.
Accelerated Approval and the Tension Between Safety and Access
Accelerated Approval and the Tension Between Safety and Access
Accelerated Approval and the Tension Between Safety and Access
November 2, 2022
Mikkael A. Sekeres, M.D., University of Miami Health System, discusses his latest book Drugs and the FDA and the use of accelerated approvals based on surrogate endpoints.
FDA Grants Priority Review for Adult RSV Vaccine
FDA Grants Priority Review for Adult RSV Vaccine
FDA Grants Priority Review for Adult RSV Vaccine
November 2, 2022
If approved, GSK’s vaccine could be the first available to help protect adults over the age of 60. The Prescription Drug User Fee Act date is May 3, 2023.
Study: PBMs’ Reimbursement Puts Pharmacies at Risk
Study: PBMs’ Reimbursement Puts Pharmacies at Risk
Study: PBMs’ Reimbursement Puts Pharmacies at Risk
November 1, 2022
A study of Oregon pharmacies finds there is significant disparities in reimbursement between the pharmacies, particularly in already disadvantaged communities.
CytoDyn Withdraws BLA for HIV Therapy
CytoDyn Withdraws BLA for HIV Therapy
CytoDyn Withdraws BLA for HIV Therapy
November 1, 2022
The withdrawal is related to the quality of the data collection and monitoring of the pivotal clinical trials by the clinical research organization.
FDA Again Extends Review for Pompe Disease Therapy
FDA Again Extends Review for Pompe Disease Therapy
FDA Again Extends Review for Pompe Disease Therapy
October 31, 2022
The FDA cited COVID-19-related travel restrictions that have impacted the agency’s inspection of a manufacturing site in China.
Paxlovid Has Hospitalization, Mortality Benefits Among the Vaccinated
Paxlovid Has Hospitalization, Mortality Benefits Among the Vaccinated
Paxlovid Has Hospitalization, Mortality Benefits Among the Vaccinated
October 31, 2022
Findings by researchers at Epic, the electronic health record company, show that the benefits extend to people ages 50-64.
Genmab Submits Applications for Bispecific Therapy for Large B-cell Lymphoma
Genmab Submits Applications for Bispecific Therapy for Large B-cell Lymphoma
Genmab Submits Applications for Bispecific Therapy for Large B-cell Lymphoma
October 29, 2022
Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells
Glass in a Vial Leads to Recall of One Lot of Octreotide
Glass in a Vial Leads to Recall of One Lot of Octreotide
Glass in a Vial Leads to Recall of One Lot of Octreotide
October 28, 2022
Administration of a solution containing glass could lead to irritation or swelling, vasculitis/phlebitis, allergic reactions, and pulmonary embolism.
Impurities Lead to Recall of Two Lots of Quinapril/Hydrochlorothiazide
Impurities Lead to Recall of Two Lots of Quinapril/Hydrochlorothiazide
Impurities Lead to Recall of Two Lots of Quinapril/Hydrochlorothiazide
October 28, 2022
The recall was triggered by the presence of nitrosamine above the proposed limit.
Centene Selects Express Scripts to Administer Pharmacy Benefits
Centene Selects Express Scripts to Administer Pharmacy Benefits
Centene Selects Express Scripts to Administer Pharmacy Benefits
October 28, 2022
Express Scripts will manage pharmacy benefits for about 20 million Centene members.
Digital Health Assistant Company Offers Generics for $25 Monthly Subscription
Digital Health Assistant Company Offers Generics for $25 Monthly Subscription
Digital Health Assistant Company Offers Generics for $25 Monthly Subscription
October 27, 2022
Renee Dua, M.D., chief strategy officer at Renee, discusses the digital health assistant and its subscription-based services for generic drugs.
FDA Postpones Advisory Committee Meeting for OTC Birth Control
FDA Postpones Advisory Committee Meeting for OTC Birth Control
FDA Postpones Advisory Committee Meeting for OTC Birth Control
October 27, 2022
If approved, Perrigo’s Opill could be the first-ever nonprescription birth control pill.
Updated: FDA Approves First Bispecific Antibody for Multiple Myeloma
Updated: FDA Approves First Bispecific Antibody for Multiple Myeloma
Updated: FDA Approves First Bispecific Antibody for Multiple Myeloma
October 27, 2022
Tecvayli targets BCMA and CD3 to activate the body’s immune system. It was approved for heavily pretreated patients with relapsed or refractory multiple myeloma.
FDA Grants Priority Review for Novel C. Difficile Therapeutic
FDA Grants Priority Review for Novel C. Difficile Therapeutic
FDA Grants Priority Review for Novel C. Difficile Therapeutic
October 26, 2022
If approved, SER-109 would be the first oral microbiome therapeutic available. The Prescription Drug User Fee Act action date is April 26, 2023.
PSG Survey: Payer Satisfaction with PBMs Declines
PSG Survey: Payer Satisfaction with PBMs Declines
PSG Survey: Payer Satisfaction with PBMs Declines
October 25, 2022
One of the drivers of a lowered payer satisfaction is the public perception of PBMs, said Morgan Lee, Ph.D., of PSG.
FDA Grants Priority Review for Acute Myeloid Leukemia Drug
FDA Grants Priority Review for Acute Myeloid Leukemia Drug
FDA Grants Priority Review for Acute Myeloid Leukemia Drug
October 25, 2022
Quizartinib, which is under review to treat adult patients with newly diagnosed acute myeloid leukemia who are FLT3-ITD positive, has a Prescription Drug User Fee Act date (PDUFA) of April 24, 2023.
FDA Clears Novel Liver Cancer Combo Treatment
FDA Clears Novel Liver Cancer Combo Treatment
FDA Clears Novel Liver Cancer Combo Treatment
October 24, 2022
Regulators have approved Imjudo, a monoclonal antibody that targets the activity CTLA-4, to be used in combination with Imfinzi, a PD-L1 inhibitor.
FDA Accepts NDA for Novaliq’s New Dry Eye Therapy
FDA Accepts NDA for Novaliq’s New Dry Eye Therapy
FDA Accepts NDA for Novaliq’s New Dry Eye Therapy
October 24, 2022
Novaliq’s CyclASol uses the EyeSol technology that allows for improved bioavailability and better efficacy. The PDUFA target action date set by the FDA is June 8, 2023.
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