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All News - Page 37

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.
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.
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