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Pfizer-BioNTech to Apply for FDA EUA for Their COVID-19 Vaccine in Children Ages 6 Months Through 4 Years of Age
Pfizer-BioNTech to Apply for FDA EUA for Their COVID-19 Vaccine in Children Ages 6 Months Through 4 Years of Age
Pfizer-BioNTech to Apply for FDA EUA for Their COVID-19 Vaccine in Children Ages 6 Months Through 4 Years of Age
February 2, 2022
Pfizer and BioNTech initiated an application yesterday (Feb. 1) for emergency use authorization (EUA) of their COVID-19 vaccine for children ages 6 months through 4 years.
Immunocore Snags Approval of First T Cell Receptor Cancer Therapy
Immunocore Snags Approval of First T Cell Receptor Cancer Therapy
Immunocore Snags Approval of First T Cell Receptor Cancer Therapy
January 31, 2022
The new therapy treats patients with unresectable or metastatic uveal melanoma.
health care cost
NSCLC Drugs Raised Prices Despite Evidence of Price Competition
NSCLC Drugs Raised Prices Despite Evidence of Price Competition
January 29, 2022
Price increases on promising non–small cell lung cancer drugs despite evidence price competition raise concerns about affordability.
Regeneron, Sanofi Pull FDA Application for Libtayo
Regeneron, Sanofi Pull FDA Application for Libtayo
Regeneron, Sanofi Pull FDA Application for Libtayo
January 28, 2022
Regeneron Pharmaceuticals and Sanofi said they are voluntarily withdrawing their supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer.
FDA Approves Quviviq, New DORA for Treatment of Insomnia in Adults
FDA Approves Quviviq, New DORA for Treatment of Insomnia in Adults
FDA Approves Quviviq, New DORA for Treatment of Insomnia in Adults
January 27, 2022
The dual orexin receptor antagonist (DORA) from a Swiss drugmaker will be available in May 2022.
Gilead Discovers Millions Worth of Counterfeit HIV-1 Meds Distributed
Gilead Discovers Millions Worth of Counterfeit HIV-1 Meds Distributed
Gilead Discovers Millions Worth of Counterfeit HIV-1 Meds Distributed
January 26, 2022
More than $250 million worth of counterfeit and illegally resold versions of Gilead Sciences’ HIV medications Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) and Descovy (emtricitabine and tenofovir alafenamide) were distributed to pharmacies and patients.
Mark Cuban Cost Plus Drug Company Launches Online Pharmacy, PBM
Mark Cuban Cost Plus Drug Company Launches Online Pharmacy, PBM
Mark Cuban Cost Plus Drug Company Launches Online Pharmacy, PBM
January 21, 2022
The company joins the wide array of online pharmacy services, such as Amazon Pharmacy, that have popped up in recent years. Cuban has also launched a namesake PBM.
Xarelto Becomes the First DOAC FDA-Approved for Use in Pediatric Patients After Fontan Procedure
Xarelto Becomes the First DOAC FDA-Approved for Use in Pediatric Patients After Fontan Procedure
Xarelto Becomes the First DOAC FDA-Approved for Use in Pediatric Patients After Fontan Procedure
January 20, 2022
The Janssen drug is the only DOAC available in an oral suspension, which facilitates pediatric weight-based dosing.
US Drug Prices, Healthcare Spending Soars
US Drug Prices, Healthcare Spending Soars
US Drug Prices, Healthcare Spending Soars
January 19, 2022
United States healthcare spending rose 9.7% in 2020, while medication spending is increasing by more than 18%.
FDA Clears Two JAK 1 Inhibitors for Atopic Dermatitis
FDA Clears Two JAK 1 Inhibitors for Atopic Dermatitis
FDA Clears Two JAK 1 Inhibitors for Atopic Dermatitis
January 17, 2022
The FDA okayed two Janus kinase 1 (JAK1) JAK inhibitors January 14 the for atopic dermatitis: Cibinqo and Rinvoq.
Researchers: Ancillary Services Would Comprise 20% of Medicare Spending on Aduhelm
Researchers: Ancillary Services Would Comprise 20% of Medicare Spending on Aduhelm
Researchers: Ancillary Services Would Comprise 20% of Medicare Spending on Aduhelm
January 15, 2022
In a research letter published in JAMA Health Forum, researchers say most of the cost figures for Aduhelm have left out the additional MRI scans and other services that will be required because the drug is associated with the development of amyloid-related imaging abnormalities (ARIAs).
In First 2022 Recall, Metformin Pulled Back Because of Carcinogenic NDMA
In First 2022 Recall, Metformin Pulled Back Because of Carcinogenic NDMA
In First 2022 Recall, Metformin Pulled Back Because of Carcinogenic NDMA
January 14, 2022
Problems with N-nitrosodimethylamine (NDMA)-contaminated metformin were identified by the FDA in 2020. Viona Pharmaceuticals announced in earlier this month that it was recalling 23 lots of the popular diabetes medication.
Dupixent Has Company. The FDA Has Approved Another Biologic for the Treatment of Atopic Dermatitis.
Dupixent Has Company. The FDA Has Approved Another Biologic for the Treatment of Atopic Dermatitis.
Dupixent Has Company. The FDA Has Approved Another Biologic for the Treatment of Atopic Dermatitis.
January 13, 2022
Leo Pharma's Adbry (tralokinumab-ldrm) is the second, FDA-approved biologic for atopic dermatitis. Dupixent (dupilumab) was the first.
Analyst: CMS Decision Will “Significantly Limit" Biogen’s Aduhelm
Analyst: CMS Decision Will “Significantly Limit" Biogen’s Aduhelm
Analyst: CMS Decision Will “Significantly Limit" Biogen’s Aduhelm
January 13, 2022
CMS has proposed covering the anti-amyloid treatment only if the person taking it is enrolled in a clinical trial.
Analyst Report: These 7 Treatments Destined To Be Blockbusters Within 5 Years
Analyst Report: These 7 Treatments Destined To Be Blockbusters Within 5 Years
Analyst Report: These 7 Treatments Destined To Be Blockbusters Within 5 Years
January 10, 2022
Lecanemab and donanemab, monoclonal antibodies for Alzheimer’s, are on the list of drugs in late-stage development that Clarivate analysts will have annual sales of a $1 billion or more in the next five years.
FDA Approves First-in-Class Therapy to Lower LDL Cholesterol
FDA Approves First-in-Class Therapy to Lower LDL Cholesterol
FDA Approves First-in-Class Therapy to Lower LDL Cholesterol
January 6, 2022
Leqvio (inclisiran) is the first small interfering RNA therapy approved to lower LDL cholesterol in certain adults at risk for life-threatening cardiovascular events.
Walmart, Sam’s Club to Distribute COVID-19 Antivirals
Walmart, Sam’s Club to Distribute COVID-19 Antivirals
Walmart, Sam’s Club to Distribute COVID-19 Antivirals
January 5, 2022
But Paxlovid and molnupiravir will be available only at certain Walmart and Sam’s Club locations.
FDA Expands Pfizer Vaccine Booster EUA to Include 12-15 Year Olds
FDA Expands Pfizer Vaccine Booster EUA to Include 12-15 Year Olds
FDA Expands Pfizer Vaccine Booster EUA to Include 12-15 Year Olds
January 3, 2022
A review of real-world data from Israel didn't show any increase risk of myocardities or pericarditis.
ICER To Assess Aduhelm, Other Monoclonal Antibody Treatments for Alzheimer's  in 2022
ICER To Assess Aduhelm, Other Monoclonal Antibody Treatments for Alzheimer's  in 2022
ICER To Assess Aduhelm, Other Monoclonal Antibody Treatments for Alzheimer's in 2022
January 2, 2022
ICER's analysis is slated to include two as-yet unapproved monoclonal antibody treatments, donanemab and lecanemab, as well as Aduhelm (aducanumab).
Analyst: Uptake of Amgen and AstraZeneca’s Tezspire Could Be Limited in the Early Going
Analyst: Uptake of Amgen and AstraZeneca’s Tezspire Could Be Limited in the Early Going
Analyst: Uptake of Amgen and AstraZeneca’s Tezspire Could Be Limited in the Early Going
December 31, 2021
The FDA has approved Amgen and AstraZeneca’s Tezspire (tezepelumab-akko) for severe asthma. But the drug may have limited uptake in the near term, according to one analyst.
Best Read Articles on Safety Issues and Recalls in 2021
Best Read Articles on Safety Issues and Recalls in 2021
Best Read Articles on Safety Issues and Recalls in 2021
December 30, 2021
News about counterfeit versions of Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) and Descovy (emtricitabine, tenofovir alafemamide) and the pause in the REMS program for clozapine were among the best read articles of 2021.
Best Read Articles on Formularies and Formulary Changes in 2021
Best Read Articles on Formularies and Formulary Changes in 2021
Best Read Articles on Formularies and Formulary Changes in 2021
December 29, 2021
Our best read stories about formularies include news about 2022 formularies from CVS Caremark and Express Scripts.
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