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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.
FDA Accepts Supplemental Application for Camzyos
FDA Accepts Supplemental Application for Camzyos
FDA Accepts Supplemental Application for Camzyos
October 21, 2022
The FDA has assigned a PDUFA goal date of June 16, 2023, for an expanded indication to reduce the need for septal reduction therapy (SRT), which is a procedure to treat hypertrophic cardiomyopathy.
FDA Grants Six Months Pediatric Exclusivity for Eylea
FDA Grants Six Months Pediatric Exclusivity for Eylea
FDA Grants Six Months Pediatric Exclusivity for Eylea
October 21, 2022
Eylea is being reviewed as a treatment for retinopathy in premature infants.
Mark Cuban’s Pharmacy and Vivio Team up to Manage Specialty Drugs
Mark Cuban’s Pharmacy and Vivio Team up to Manage Specialty Drugs
Mark Cuban’s Pharmacy and Vivio Team up to Manage Specialty Drugs
October 20, 2022
The arrangement allows Vivio customers to stop overpaying for drugs, the company said.
Drugs and Older Age: An Increasingly Deadly Combination
Drugs and Older Age: An Increasingly Deadly Combination
Drugs and Older Age: An Increasingly Deadly Combination
October 20, 2022
Two reports show that drug-related deaths are skyrocketing among people 65 years and older.
Novavax COVID-19 Vaccine Booster Gets FDA EUA
Novavax COVID-19 Vaccine Booster Gets FDA EUA
Novavax COVID-19 Vaccine Booster Gets FDA EUA
October 19, 2022
Novavax’ protein-based vaccine is engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
Up, Up and Not Going Away: Cancer Drug Prices
Up, Up and Not Going Away: Cancer Drug Prices
Up, Up and Not Going Away: Cancer Drug Prices
October 19, 2022
Escalating costs are hitting patients hard. CMS price negotiation and the $2,000 cap on Part D out-of-pocket expenses should benefit many patients with Medicare coverage.
Cigna Removes Brands in Favor of Generics for 2023
Cigna Removes Brands in Favor of Generics for 2023
Cigna Removes Brands in Favor of Generics for 2023
October 18, 2022
Most of the brands that have been removed fall into the categories of hormonal therapies, pain and inflammatory conditions or skin conditions or high blood pressure/heart medications.
OptumRx’s Top Pipeline Drugs to Watch This Fall
OptumRx’s Top Pipeline Drugs to Watch This Fall
OptumRx’s Top Pipeline Drugs to Watch This Fall
October 18, 2022
Arash Sadeghi, Pharm.D., discusses three drugs in development, which treat a rare kidney disease, hemophilia B, and an advanced form of age-related macular degeneration.
FDA Extends Review Time for Biogen’s ALS Therapy
FDA Extends Review Time for Biogen’s ALS Therapy
FDA Extends Review Time for Biogen’s ALS Therapy
October 17, 2022
If approved, tofersen will be the first treatment that targets a genetic cause of ALS. The updated PDUFA date is April 25, 2023.
AMA Analysis: Lack of Competition Among PBMs in Local Markets
AMA Analysis: Lack of Competition Among PBMs in Local Markets
AMA Analysis: Lack of Competition Among PBMs in Local Markets
October 17, 2022
The lack of competition and the vertical integration of PBMs and insurers can have a negative impact on patients’ access to and cost of prescription drugs, AMA said.
Trikafta Effective But Costly, Says Prime Therapeutics
Trikafta Effective But Costly, Says Prime Therapeutics
Trikafta Effective But Costly, Says Prime Therapeutics
October 17, 2022
A real-world study by the PBM shows major benefits from the new cystic fibrosis drug when it comes to hospitalizations and pulmonary exacerbations. But total cost of care of patients tripled because the drug is expensive.
Report: PBMs Provide Uneven Coverage of Biosimilars
Report: PBMs Provide Uneven Coverage of Biosimilars
Report: PBMs Provide Uneven Coverage of Biosimilars
October 14, 2022
The Amgen Biosimilars Trend Report found that competition is lowering prices of biosimilars but the largest PBMs are inconsistent in their management of these products.
Vial Breakage Leads to Recall of 49 Lots of Sodium Bicarbonate
Vial Breakage Leads to Recall of 49 Lots of Sodium Bicarbonate
Vial Breakage Leads to Recall of 49 Lots of Sodium Bicarbonate
October 14, 2022
Exela has received five reports of flying glass injuring skin, eye and/or other parts. The recall includes both Exela and Civica brands.
FDA Announces Adderall Shortage
FDA Announces Adderall Shortage
FDA Announces Adderall Shortage
October 13, 2022
Until supply is restored, the FDA suggests the use of alternatives such as the extended-release version of amphetamine mixed salts.
Regence Health Plans Save by Switching to Infliximab Biosimilars
Regence Health Plans Save by Switching to Infliximab Biosimilars
Regence Health Plans Save by Switching to Infliximab Biosimilars
October 13, 2022
Regence implemented a preferred infliximab biosimilar strategy and was able to achieve more than 90% adoption.
FDA Accepts BLA for Hemophilia A Gene Therapy
FDA Accepts BLA for Hemophilia A Gene Therapy
FDA Accepts BLA for Hemophilia A Gene Therapy
October 13, 2022
If approved, valoctocogene roxaparvovec would be the first gene therapy in the U.S. for the treatment of severe hemophilia A. A PDUFA action date has been set for March 31, 2023.
FDA Authorizes Updated COVID-19 Boosters for Younger Children
FDA Authorizes Updated COVID-19 Boosters for Younger Children
FDA Authorizes Updated COVID-19 Boosters for Younger Children
October 12, 2022
The bivalent booster vaccines add the omicron variant BA.4 and BA.5 to the original SARS-CoV-2 along with a component of omicron BA.1.
CVS Caremark Removes, Adds Products to Formulary
CVS Caremark Removes, Adds Products to Formulary
CVS Caremark Removes, Adds Products to Formulary
October 12, 2022
In total, CVS Caremark has removed 26 products and added 31 products effective Jan. 1, 2023.
FDA Accepts sBLA for Eylea for Retinopathy in Premature Infants
FDA Accepts sBLA for Eylea for Retinopathy in Premature Infants
FDA Accepts sBLA for Eylea for Retinopathy in Premature Infants
October 12, 2022
The FDA has assigned a target action date of Feb. 11, 2023.
Nonprofit Company Begins Application Process for OTC Naloxone
Nonprofit Company Begins Application Process for OTC Naloxone
Nonprofit Company Begins Application Process for OTC Naloxone
October 11, 2022
The submission is expected to be complete by the end of the year, and if approved, could be available in early 2024.
FDA Issues CRL for Parkinson’s Therapy
FDA Issues CRL for Parkinson’s Therapy
FDA Issues CRL for Parkinson’s Therapy
October 11, 2022
The FDA is asking for additional analysis related to the infusion device used with SPN-830, which contains apomorphine to treat patients with Parkinson’s disease.
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