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FDA Approves Updated Label for Controversial Alzheimer’s Therapy
FDA Approves Updated Label for Controversial Alzheimer’s Therapy
FDA Approves Updated Label for Controversial Alzheimer’s Therapy
July 8, 2021
The prescribing information for Aduhelm now specifies its use in patients with a mild form of the disease.
Amgen Submits Application for Asthma Biologic
Amgen Submits Application for Asthma Biologic
Amgen Submits Application for Asthma Biologic
July 8, 2021
The agency also granted tezepelumab priority review with a PDUFA date sometime in the first quarter of 2022.
Skin Infection Treatment Now Available
Skin Infection Treatment Now Available
Skin Infection Treatment Now Available
July 7, 2021
The single-dose antibiotic with a one-hour infusion is approved to treat MRSA and other skin infections.
Novartis Resubmits Application for Inclisiran
Novartis Resubmits Application for Inclisiran
Novartis Resubmits Application for Inclisiran
July 7, 2021
The company is transferring manufacturing of the final product to its own site in Austria.
The FDA Issues Complete Response Letter for Teplizumab
The FDA Issues Complete Response Letter for Teplizumab
The FDA Issues Complete Response Letter for Teplizumab
July 6, 2021
Despite an advisory committee recommendation for approval, the FDA did not approve what would have been the first disease-modifying therapy for type 1 diabetes.
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Keytruda Approved for Cutaneous Squamous Cell Carcinoma
Keytruda Approved for Cutaneous Squamous Cell Carcinoma
July 6, 2021
This approval comes days after Merck announced it would withdraw indication for third-line gastric cancer.
Local Anesthetic Zynrelef is Now Available
Local Anesthetic Zynrelef is Now Available
Local Anesthetic Zynrelef is Now Available
July 6, 2021
New, extended-release therapy for post-operative pain reduces the need for opioid pain relief.
Acerus Grabs Additional Formulary Status for Testosterone Brand
Acerus Grabs Additional Formulary Status for Testosterone Brand
Acerus Grabs Additional Formulary Status for Testosterone Brand
July 2, 2021
Coverage now includes 85% of commercial lives.
Acacia Pharma Expects to Meet Formulary Goals
Acacia Pharma Expects to Meet Formulary Goals
Acacia Pharma Expects to Meet Formulary Goals
July 2, 2021
Formulary adoption is a key step in achieving sales pull through starting in 2022, company officials said.
The FDA Approves Rylaze for Leukemia and Lymphoma
The FDA Approves Rylaze for Leukemia and Lymphoma
The FDA Approves Rylaze for Leukemia and Lymphoma
July 1, 2021
The therapy, a recombinant version, was developed to address supply and manufacturing issues.
Cigna Moves Remicade Biosimilars to Preferred Formulary Status
Cigna Moves Remicade Biosimilars to Preferred Formulary Status
Cigna Moves Remicade Biosimilars to Preferred Formulary Status
July 1, 2021
Patients are being offered $500 to make the switch.
Biosimilar Insulin Glargine Led to Downward Trend in Pricing
Biosimilar Insulin Glargine Led to Downward Trend in Pricing
Biosimilar Insulin Glargine Led to Downward Trend in Pricing
June 30, 2021
A recent study finds that the approval of a biosimilar was associated with a change in the trajectory of net prices.
Gilead Submits NDA for HIV Therapy Lenacapavir
Gilead Submits NDA for HIV Therapy Lenacapavir
Gilead Submits NDA for HIV Therapy Lenacapavir
June 30, 2021
Data from a phase 2/3 study will be presented in July.
FDA Approves Safety Updates to Synjardy Label
FDA Approves Safety Updates to Synjardy Label
FDA Approves Safety Updates to Synjardy Label
June 29, 2021
The label for the type 2 diabetes treatment has been updated to include the risk of ketoacidosis and damage to the kidney.
Immunotherapy Multikine Shows Benefit in Patients with Head and Neck Cancer
Immunotherapy Multikine Shows Benefit in Patients with Head and Neck Cancer
Immunotherapy Multikine Shows Benefit in Patients with Head and Neck Cancer
June 29, 2021
But there is no benefit for patients receiving chemotherapy.
Yescarta Meets Endpoints in Second-line DLBCL; Supplemental BLA Planned
Yescarta Meets Endpoints in Second-line DLBCL; Supplemental BLA Planned
Yescarta Meets Endpoints in Second-line DLBCL; Supplemental BLA Planned
June 28, 2021
Kite plans to submit a supplemental BLA based on these findings.
Rheumatoid Arthritis Drug Actemra Receives EUA for COVID-19
Rheumatoid Arthritis Drug Actemra Receives EUA for COVID-19
Rheumatoid Arthritis Drug Actemra Receives EUA for COVID-19
June 28, 2021
The authorization is based on four studies that evaluated Actemra in more than 5,500 hospitalized patients.
Study: Medicare Drug Spending Lacks Understanding of Cost-effectiveness
Study: Medicare Drug Spending Lacks Understanding of Cost-effectiveness
Study: Medicare Drug Spending Lacks Understanding of Cost-effectiveness
June 25, 2021
Implementation of value-based approaches requires measurement of value, authors said.
Bayer Introduces Updated Packaging for Stivarga
Bayer Introduces Updated Packaging for Stivarga
Bayer Introduces Updated Packaging for Stivarga
June 24, 2021
The anticancer therapy is now available in 21-count bottles to help accommodate dispensing.
LIU Pharmacy and Agilum Partner to Advance Evidence-Based Care
LIU Pharmacy and Agilum Partner to Advance Evidence-Based Care
LIU Pharmacy and Agilum Partner to Advance Evidence-Based Care
June 24, 2021
The two organizations have created a fellowship program to help improve patient outcomes and reduce costs.
FDA Oks First Oral Blood Thinner for Children
FDA Oks First Oral Blood Thinner for Children
FDA Oks First Oral Blood Thinner for Children
June 23, 2021
The longstanding medicine for adults is now approved to treat children 3 months to less than 12 years old with venous thromboembolism.
Janssen Submits NDA for Use of Xarelto in Children
Janssen Submits NDA for Use of Xarelto in Children
Janssen Submits NDA for Use of Xarelto in Children
June 23, 2021
The therapy would be used to help prevent and treat blood clots in pediatric patients.
Study Shows Treatment of IBD Differs in Older vs. Younger Patients
Study Shows Treatment of IBD Differs in Older vs. Younger Patients
Study Shows Treatment of IBD Differs in Older vs. Younger Patients
June 22, 2021
Understanding medication utilization patterns is important for future evaluations of clinical outcomes, investigators say.
Prostate Cancer Drug Nabs Breakthrough Therapy Designation
Prostate Cancer Drug Nabs Breakthrough Therapy Designation
Prostate Cancer Drug Nabs Breakthrough Therapy Designation
June 22, 2021
Novartis’ investigational targeted radioligand therapy extends survival in patients with advanced metastatic prostate cancer.
Certain Blood Pressure Meds Improve Memory
Certain Blood Pressure Meds Improve Memory
Certain Blood Pressure Meds Improve Memory
June 21, 2021
Adults taking medications that cross the blood-brain barrier had better memory recall.
CMS Changes Coverage for CGM Devices
CMS Changes Coverage for CGM Devices
CMS Changes Coverage for CGM Devices
June 21, 2021
A longstanding four times per day testing requirement will cease, and patients using inhaled insulin now qualify for continuous glucose monitoring.
Consumers Across the Political Spectrum Want Lower Drug Prices, Poll Finds
Consumers Across the Political Spectrum Want Lower Drug Prices, Poll Finds
Consumers Across the Political Spectrum Want Lower Drug Prices, Poll Finds
June 18, 2021
Regardless of political affiliation, the public supports congressional action to allow the federal government to negotiate prices.
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