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Pfizer Begins Trial of mRNA-based Flu Vaccine
Pfizer Begins Trial of mRNA-based Flu Vaccine
Pfizer Begins Trial of mRNA-based Flu Vaccine
September 28, 2021
The flu program is the first in programs leveraging BioNTech’s mRNA technology for vaccines for other respiratory viruses, oncology, and genetic diseases.
Lilly Lowers List Price of Insulin Lispro
Lilly Lowers List Price of Insulin Lispro
Lilly Lowers List Price of Insulin Lispro
September 28, 2021
Effective Jan. 1 2022, the move brings the price to 2008 levels.
Study: Insurers Pay More for Cancer Therapies Administered in Hospital Setting
Study: Insurers Pay More for Cancer Therapies Administered in Hospital Setting
Study: Insurers Pay More for Cancer Therapies Administered in Hospital Setting
September 24, 2021
Shifting cancer patients to the physician setting for administration of cancer therapies could save insurers $1.28 billion.
Merck Shares Significant Keytruda Breast Cancer Results
Merck Shares Significant Keytruda Breast Cancer Results
Merck Shares Significant Keytruda Breast Cancer Results
September 23, 2021
Keytruda plus chemotherapy reduces the risk of death by 27% in patients with triple-negative breast cancer.
FDA Issues EUA for Booster of Pfizer’s COVID-19 Vaccine
FDA Issues EUA for Booster of Pfizer’s COVID-19 Vaccine
FDA Issues EUA for Booster of Pfizer’s COVID-19 Vaccine
September 23, 2021
People over the age 65 and those at high risk of severe COVID-19, including health care workers and those with occupational exposure, are eligible for the booster.
FDA Approves First Biosimilar to Treat Macular Degeneration
FDA Approves First Biosimilar to Treat Macular Degeneration
FDA Approves First Biosimilar to Treat Macular Degeneration
September 20, 2021
Biogen/Samsung Bioepis’ Byooviz is a biosimilar of Genentech’s Lucentis.
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.
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