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Study: High Costs Prevent Medicare Beneficiaries from Filling Specialty Meds
Study: High Costs Prevent Medicare Beneficiaries from Filling Specialty Meds
Study: High Costs Prevent Medicare Beneficiaries from Filling Specialty Meds
April 5, 2022
Medicare beneficiaries without subsidies were 35% to 50% less likely to fill their prescriptions for drugs used to treat cancers, immune system disorders, and high cholesterol.
FDA Grants Breakthrough Therapy Designation to Treat Rare Disease vEDS
FDA Grants Breakthrough Therapy Designation to Treat Rare Disease vEDS
FDA Grants Breakthrough Therapy Designation to Treat Rare Disease vEDS
April 4, 2022
A phase 3 trial is expected to begin by the end of the second quarter.
FDA Extends PDUFA Date for Vutrisiran
FDA Extends PDUFA Date for Vutrisiran
FDA Extends PDUFA Date for Vutrisiran
April 4, 2022
The agency has extended the review period to address pending inspection classification at third-party secondary packaging and labeling facility. The new PDUFA date is July 14, 2022.
FDA Accepts sBLA for Actemra for Hospitalized COVID-19 Patients
FDA Accepts sBLA for Actemra for Hospitalized COVID-19 Patients
FDA Accepts sBLA for Actemra for Hospitalized COVID-19 Patients
April 4, 2022
Genentech also announced progress in meeting the supply challenges associated with Actemra, which is currently available under an emergency use authorization.
FDA Advisory Committee Votes Down ALS Drug
FDA Advisory Committee Votes Down ALS Drug
FDA Advisory Committee Votes Down ALS Drug
April 1, 2022
The FDA’s final decision on AMX0035 is expected by June 29, 2022
AMCP 2022: Patients with Rare Liver Disease Need Treatment Adherence Support
AMCP 2022: Patients with Rare Liver Disease Need Treatment Adherence Support
AMCP 2022: Patients with Rare Liver Disease Need Treatment Adherence Support
March 31, 2022
AllianceRx Walgreens Prime study has found that patients taking Ocaliva may not be adherent to their treatment regimen for rare liver disease.
 AMCP 2022: Payers Skeptical of Patient Input in Formulary Process
 AMCP 2022: Payers Skeptical of Patient Input in Formulary Process
AMCP 2022: Payers Skeptical of Patient Input in Formulary Process
March 31, 2022
A disconnect exists between payers and patients with rare diseases about including patient input in the formulary process for orphan drugs.
FDA Seeks Funding for Pandemics, Cancer Drugs, and Generic Drug Approvals
FDA Seeks Funding for Pandemics, Cancer Drugs, and Generic Drug Approvals
FDA Seeks Funding for Pandemics, Cancer Drugs, and Generic Drug Approvals
March 30, 2022
The FDA is asking for nearly a 34% increase over the agency's fiscal year 2022 funding level.
FDA Approves Oral Testosterone Replacement Tlando
FDA Approves Oral Testosterone Replacement Tlando
FDA Approves Oral Testosterone Replacement Tlando
March 30, 2022
Antares Pharma plans to launch Tlando, which doesn’t require dose titration, in the second quarter of 2022.
FDA Authorizes Second COVID-19 Vaccine Booster
FDA Authorizes Second COVID-19 Vaccine Booster
FDA Authorizes Second COVID-19 Vaccine Booster
March 29, 2022
The FDA determined that the benefits of the second booster dose outweighed the risks after reviewing data from Pfizer, BioNTech, and Moderna.
Survey: Patients Face Insurance Barriers to Medication Access
Survey: Patients Face Insurance Barriers to Medication Access
Survey: Patients Face Insurance Barriers to Medication Access
March 29, 2022
Prior authorization and step therapy can impact compliance and outcomes, according to a survey by the Pharmaceutical Research and Manufacturers of America.
ViiV Healthcare Updates the Label for HIV-1 Med Cabenuva
ViiV Healthcare Updates the Label for HIV-1 Med Cabenuva
ViiV Healthcare Updates the Label for HIV-1 Med Cabenuva
March 28, 2022
The FDA has okayed allowing patients to start treatment with the injection instead of having a lead in with the oral version.
New Campaign Highlights Generic Drug Markups
New Campaign Highlights Generic Drug Markups
New Campaign Highlights Generic Drug Markups
March 25, 2022
Some generics have as much of a 10,000-times increase from the manufacturers weighted average manufacturers price to what a patient could pay at the pharmacy if they chose to pay the cash price.
FDA Issues CRL for Lilly’s Sintilimab for First-Line NSCLC
FDA Issues CRL for Lilly’s Sintilimab for First-Line NSCLC
FDA Issues CRL for Lilly’s Sintilimab for First-Line NSCLC
March 24, 2022
The FDA has asked for an additional clinical trial with overall survival as the endpoint.
CMS Establishes New Code for Digital Behavioral Therapies
CMS Establishes New Code for Digital Behavioral Therapies
CMS Establishes New Code for Digital Behavioral Therapies
March 24, 2022
The new code will be effective April 1, 2022.
Janssen to Study Tremfya in People of Color
Janssen to Study Tremfya in People of Color
Janssen to Study Tremfya in People of Color
March 23, 2022
The study aims to generate data related to Tremfya in people of color who have plaque psoriasis.
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