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FDA Approves First Drug that Delays Diabetes
FDA Approves First Drug that Delays Diabetes
FDA Approves First Drug that Delays Diabetes
November 18, 2022
Tzield addresses the underlying cause of the disease, where the immune system destroys the insulin producing cells in the pancreas. It will be available by the end of the year with a wholesale acquisition cost of $13,850 per vial.
OptumRx to Cover Amgen’s Biosimilar of Humira
OptumRx to Cover Amgen’s Biosimilar of Humira
OptumRx to Cover Amgen’s Biosimilar of Humira
November 17, 2022
OptumRx will offer Amjevita and two other biosimilars alongside Humira. OptumRx is the first PBM to make public its plans for the seven Humira biosimilars that could be introduced in 2023.
Express Scripts Adds Zoryve to National Formulary
Express Scripts Adds Zoryve to National Formulary
Express Scripts Adds Zoryve to National Formulary
November 17, 2022
Launched in August, Zoryve is a once-daily, steroid-free cream and is the first topical PDE4 inhibitor approved to treat plaque psoriasis in patients 12 years of age or older.
FDA Advisory Committee Supports Xphozah in CKD
FDA Advisory Committee Supports Xphozah in CKD
FDA Advisory Committee Supports Xphozah in CKD
November 17, 2022
If approved, Xphozah will be the first phosphate absorption inhibitor for adults with chronic kidney disease who are on dialysis. An FDA decision is expected within 30 days.
Generic Drug Roundup
Generic Drug Roundup
Generic Drug Roundup
November 16, 2022
Sun Pharma will market SPARC’s phenobarbital, which is under FDA review to treat neonatal seizures. In addition, several new generics have been approved, including a generic of Novartis’ Gilenya for multiple sclerosis and AbbVie’s Lupron for prostate cancer.
FDA Proposes Prescription-to-OTC Naloxone
FDA Proposes Prescription-to-OTC Naloxone
FDA Proposes Prescription-to-OTC Naloxone
November 16, 2022
The agency is encouraging sponsors to submit applications for low-dose, nonprescription naloxone products.
GSK Limits Use of Zejula for Some Cancer Patients
GSK Limits Use of Zejula for Some Cancer Patients
GSK Limits Use of Zejula for Some Cancer Patients
November 15, 2022
After review of phase 3 data, GSK will limit the use of Zejula in the second line to those with inherited BRCA mutations.
OptumRx Makes Utilization Management Changes for 2023
OptumRx Makes Utilization Management Changes for 2023
OptumRx Makes Utilization Management Changes for 2023
November 15, 2022
OptumRx now requires prior authorization for 16 products, including 11 that are used to treat patients with diabetes.
FDA Grants Accelerated Approval of Novel Ovarian Cancer Therapy
FDA Grants Accelerated Approval of Novel Ovarian Cancer Therapy
FDA Grants Accelerated Approval of Novel Ovarian Cancer Therapy
November 15, 2022
Elahere is a first-in-class antibody-drug conjugate targeted against folate receptor alpha, a protein on the surface of ovarian cancer cells.
Omnipod 5 Charging Ports are Subject to Overheating
Omnipod 5 Charging Ports are Subject to Overheating
Omnipod 5 Charging Ports are Subject to Overheating
November 14, 2022
This is second issue related to Omnipod. Last week, the company announced that it had received 50 complaints related to the batteries of Omnipod DASH Personal Diabetes Manager.
FDA Approves Liletta IUD to Prevent Pregnancy for 8 Years
FDA Approves Liletta IUD to Prevent Pregnancy for 8 Years
FDA Approves Liletta IUD to Prevent Pregnancy for 8 Years
November 14, 2022
The approval extends the use of Liletta for an additional two years. It is the only hormonal IUD approved for continuous use up to eight years.
FDA Accepts NDA for Generalized Myasthenia Gravis Therapy
FDA Accepts NDA for Generalized Myasthenia Gravis Therapy
FDA Accepts NDA for Generalized Myasthenia Gravis Therapy
November 14, 2022
Zilucoplan is a targeted therapy that inhibits key components in the underlying disease pathology. The anticipated PDUFA date is in the fourth quarter of 2023.
Protalix, Chiesi Resubmit BLA to Treat Fabry Disease
Protalix, Chiesi Resubmit BLA to Treat Fabry Disease
Protalix, Chiesi Resubmit BLA to Treat Fabry Disease
November 14, 2022
PRX-102 is an enzyme replacement therapy for Fabry disease, a rare genetic disorder.
FDA Clears Imfinzi/Imjudo Combination for Lung Cancer
FDA Clears Imfinzi/Imjudo Combination for Lung Cancer
FDA Clears Imfinzi/Imjudo Combination for Lung Cancer
November 11, 2022
Imjudo is a monoclonal antibody that targets the activity CTLA-4 that was approved to be used in combination with Imfinzi, a PD-L1 inhibitor, for patients with non-small cell lung cancer.
FDA Accepts NDA for Novel Parkinson’s Disease Therapy
FDA Accepts NDA for Novel Parkinson’s Disease Therapy
FDA Accepts NDA for Novel Parkinson’s Disease Therapy
November 11, 2022
IPX203 is an oral formulation of carbidopa/levodopa extended-release capsules that, if approved, could provide patients with better symptom control. The FDA assigned a Prescription Drug User Fee Act date of June 30, 2023.
FDA Approves Adcetris for Younger Patients with Hodgkin Lymphoma
FDA Approves Adcetris for Younger Patients with Hodgkin Lymphoma
FDA Approves Adcetris for Younger Patients with Hodgkin Lymphoma
November 11, 2022
In a trial of patients two years and older, Adcetris plus standard of care chemotherapy led to a 59% reduction in risk of disease progression or relapse, second malignancy or death
How Long Should a PBM Implementation Take?
How Long Should a PBM Implementation Take?
How Long Should a PBM Implementation Take?
November 10, 2022
A 10-day implementation has given the team at Abarca Health the opportunity to challenge how they manage implementations in general.
Hospital Demand for Amoxicillin Increases While Shortage Continues
Hospital Demand for Amoxicillin Increases While Shortage Continues
Hospital Demand for Amoxicillin Increases While Shortage Continues
November 10, 2022
Vizient saw a 43% surge in demand for all amoxicillin products in the acute care setting from September to October, but fill rates have dropped 25%.
FDA Accepts NDA of Aphexda for Use in Stem Cell Mobilization
FDA Accepts NDA of Aphexda for Use in Stem Cell Mobilization
FDA Accepts NDA of Aphexda for Use in Stem Cell Mobilization
November 10, 2022
If approved, Aphexdra would be used along with G-CSF treatment for autologous transplantation in patients with multiple myeloma. The Prescription Drug User Fee Act target action date is Sept. 9, 2023.
FDA Issues EUA for Kineret for Hospitalized COVID-19 Patients
FDA Issues EUA for Kineret for Hospitalized COVID-19 Patients
FDA Issues EUA for Kineret for Hospitalized COVID-19 Patients
November 9, 2022
Kineret has been granted an EUA for hospitalized adults with pneumonia who require supplemental oxygen.
Transcarent and Prescryptive Health Partner for Integrated Pharmacy
Transcarent and Prescryptive Health Partner for Integrated Pharmacy
Transcarent and Prescryptive Health Partner for Integrated Pharmacy
November 9, 2022
Snezana Mahon, Pharm.D., Transcarent’s chief operating officer, discusses the company’s efforts to provide a seamless and interconnected pharmacy ecosystem.
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.
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