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FDA Advisory Committee Supports COVID-19 Boosters for Some People
FDA Advisory Committee Supports COVID-19 Boosters for Some People
FDA Advisory Committee Supports COVID-19 Boosters for Some People
September 18, 2021
The vaccines advisory committee voted late on Friday, September 17, 2021, to provide emergency authorization of Pfizer’s COVID-19 vaccine as a booster for those over the age of 65, as well as for those at high risk of developing severe disease.
Pfizer Recalls All Lots of Smoking Cessation Drug Chantix
Pfizer Recalls All Lots of Smoking Cessation Drug Chantix
Pfizer Recalls All Lots of Smoking Cessation Drug Chantix
September 17, 2021
To date, Pfizer has not received reports of adverse events related to this recall, but is making the move as a precaution.
FDA Expands EUA for Lilly’s COVID-19 Monoclonal Antibody
FDA Expands EUA for Lilly’s COVID-19 Monoclonal Antibody
FDA Expands EUA for Lilly’s COVID-19 Monoclonal Antibody
September 16, 2021
The combination of bamlanivimab/etesevimab can now be given to both treat and prevent COVID-19 infection after exposure.
Amber Specialty, Hy-Vee to Dispense Regeneron Monoclonal Antibody for COVID-19
Amber Specialty, Hy-Vee to Dispense Regeneron Monoclonal Antibody for COVID-19
Amber Specialty, Hy-Vee to Dispense Regeneron Monoclonal Antibody for COVID-19
September 16, 2021
Regeneron also announced an expanded contract with the U.S. government for the purchase of additional doses of REGEN-COV.
FDA Approves Exkivity, a Novel Oral Therapy for Lung Cancer
FDA Approves Exkivity, a Novel Oral Therapy for Lung Cancer
FDA Approves Exkivity, a Novel Oral Therapy for Lung Cancer
September 16, 2021
Takeda Oncology’s Exkivity treats non-small lung cancer in patients with EGFR exon 20 insertion mutations. This is the second approval for this mutation and the first oral therapy.
Investigational Oral Migraine Treatment Closer to Full FDA Approval
Investigational Oral Migraine Treatment Closer to Full FDA Approval
Investigational Oral Migraine Treatment Closer to Full FDA Approval
September 15, 2021
The FDA has set a Prescription Drug User Fee Act target action date of April 30, 2022.
Prime Therapeutics Removes Two Therapies from Medicare D Formulary
Prime Therapeutics Removes Two Therapies from Medicare D Formulary
Prime Therapeutics Removes Two Therapies from Medicare D Formulary
September 14, 2021
Alinia and Sutent have been removed from the drug lists because of the introduction of generic therapies.
FDA Recalls Three Lots of Ruzurgi
FDA Recalls Three Lots of Ruzurgi
FDA Recalls Three Lots of Ruzurgi
September 14, 2021
The affected lots of this rare disease therapy have been contaminated with yeast, mold, and bacteria, which could lead to life-threatening infections.
Jardiance Snags Breakthrough Therapy for Heart Failure with Preserved Injection Fraction
Jardiance Snags Breakthrough Therapy for Heart Failure with Preserved Injection Fraction
Jardiance Snags Breakthrough Therapy for Heart Failure with Preserved Injection Fraction
September 13, 2021
Jardiance demonstrated a 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure.
OptumRx Reveals Top Drugs in the Pipeline
OptumRx Reveals Top Drugs in the Pipeline
OptumRx Reveals Top Drugs in the Pipeline
September 10, 2021
Officials with OptumRx predict four new therapies that are expected to an impact on patients and on the market.
Point32Health Selects OptumRx for PBM Services
Point32Health Selects OptumRx for PBM Services
Point32Health Selects OptumRx for PBM Services
September 10, 2021
Point32Health is the name of the not-for-profit health care organization formed by the merger of Harvard Pilgrim Health Care and Tufts Health Plan.
Study: Anoro Increases Adherence and Lowers Costs in COPD
Study: Anoro Increases Adherence and Lowers Costs in COPD
Study: Anoro Increases Adherence and Lowers Costs in COPD
September 9, 2021
Investigators found patients with COPD taking Anoro Ellipta had low overall on-treatment exacerbation rates, which can reduce medical costs due to increased adherence to therapy.
Study: Black, Latinos More Likely to Stop HIV-Prevention Therapy
Study: Black, Latinos More Likely to Stop HIV-Prevention Therapy
Study: Black, Latinos More Likely to Stop HIV-Prevention Therapy
September 8, 2021
Investigators find there is strong adherence soon after patients fill prescriptions but less consistent use after initial treatment.
ICER: Hereditary Angioedema Therapies Less Cost-Effective than Earlier Estimates
ICER: Hereditary Angioedema Therapies Less Cost-Effective than Earlier Estimates
ICER: Hereditary Angioedema Therapies Less Cost-Effective than Earlier Estimates
September 7, 2021
ICER’s updated analysis uses observational, real-world data for three therapies — Takhzyro, Haegarda, and Cinryze.
FDA Clears Novel Nasal Spray for Migraine
FDA Clears Novel Nasal Spray for Migraine
FDA Clears Novel Nasal Spray for Migraine
September 7, 2021
The therapy, to be launched in October, is delivered quickly to the bloodstream by targeting the upper nasal space.
Flumist logo
AstraZeneca’s Flumist for Annual Flu is now Available
AstraZeneca’s Flumist for Annual Flu is now Available
September 6, 2021
The CDC and the FDA have updated their recommendations for the 2021-2022 flu season.
FDA’s New Warning Includes Xeljanz and other JAK Inhibitors
FDA’s New Warning Includes Xeljanz and other JAK Inhibitors
FDA’s New Warning Includes Xeljanz and other JAK Inhibitors
September 3, 2021
The FDA’s review of the JAK inhibitor class concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with these arthritis and ulcerative colitis medicines.
Hospital Pharmacists Concerned About Actemra Shortage
Hospital Pharmacists Concerned About Actemra Shortage
Hospital Pharmacists Concerned About Actemra Shortage
September 2, 2021
Pharmacists are referring patients elsewhere or are shifting patients who were using the IV form to the subcutaneous injection. The NIH has also recommended using Kevzara as an alternative where there are shortages of Actemra.
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