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New FDA Proposal Would Make Adding OTC Approval to Prescription Drugs Easier
New FDA Proposal Would Make Adding OTC Approval to Prescription Drugs Easier
New FDA Proposal Would Make Adding OTC Approval to Prescription Drugs Easier
June 29, 2022
The FDA is accepting comments on the proposed rule through Oct. 26, 2022.
Sanofi Lowers Insulin Price
Sanofi Lowers Insulin Price
Sanofi Lowers Insulin Price
June 29, 2022
Sanofi has lowered the out-of-pocket cost for those without insurance of its insulins to $35 for a 30-day supply through the company’s savings program.
Gilead Resubmits NDA of Long-Acting Lenacapavir for HIV
Gilead Resubmits NDA of Long-Acting Lenacapavir for HIV
Gilead Resubmits NDA of Long-Acting Lenacapavir for HIV
June 28, 2022
If approved, lenacapavir would be the first HIV-1 treatment administered twice-yearly.
Biogen Terminates Aduhelm Clinical Trial
Biogen Terminates Aduhelm Clinical Trial
Biogen Terminates Aduhelm Clinical Trial
June 27, 2022
The trial was an observational study aimed at collecting real-world data on the Alzheimer’s treatment.
FDA Updates Safety Labels of Buprenorphine Products
FDA Updates Safety Labels of Buprenorphine Products
FDA Updates Safety Labels of Buprenorphine Products
June 27, 2022
Labels now warn that buprenorphine products that dissolve in the mouth can cause dental problems. Buprenorphine is used to treat opioid use disorder and pain.
Survey: Patient Satisfaction is a Barrier to Utilization Management of Drug Plans
Survey: Patient Satisfaction is a Barrier to Utilization Management of Drug Plans
Survey: Patient Satisfaction is a Barrier to Utilization Management of Drug Plans
June 24, 2022
Benefits leaders surveyed in PSG’s Trends in Drug Benefit Design Report say the importance of the member experience has increased since the start of the pandemic.
COVID-19 had an Impact on Drug Supply
COVID-19 had an Impact on Drug Supply
COVID-19 had an Impact on Drug Supply
June 22, 2022
Increased demand for certain medications used to treat hospitalized patients with COVID-19 had a significant impact on medication supply last year.
Purdue Launches Opioid Reversal Nalmefene
Purdue Launches Opioid Reversal Nalmefene
Purdue Launches Opioid Reversal Nalmefene
June 22, 2022
The company will take no profit, which is part of the company’s bankruptcy filing and settlement with states.
Study: The Cost-effectiveness of Polivy Depends on Outcomes
Study: The Cost-effectiveness of Polivy Depends on Outcomes
Study: The Cost-effectiveness of Polivy Depends on Outcomes
June 20, 2022
A study in the journal Blood has found that the cost-effectiveness of the Polivy treatment regimen used to treat patients with diffuse large B-cell lymphoma would decrease if the five-year progression-free survival decreased.
FDA Advisory Committee Votes Down Nuplazid in Alzheimer’s Psychosis
FDA Advisory Committee Votes Down Nuplazid in Alzheimer’s Psychosis
FDA Advisory Committee Votes Down Nuplazid in Alzheimer’s Psychosis
June 18, 2022
Committee members said the data from the two trials submitted didn’t support efficacy of Nuplazid in Alzheimer’s patients. The PDUFA target date is Aug. 4, 2022.
Walgreens Launches Clinical Trial Patient Recruitment Service
Walgreens Launches Clinical Trial Patient Recruitment Service
Walgreens Launches Clinical Trial Patient Recruitment Service
June 18, 2022
Walgreen’s patient insights and technology capabilities, along with partner healthcare companies, will aim to engage broader and more diverse communities for participation in clinical trials.
FDA Expands EUA for Moderna, Pfizer-BioNTech COVID-19 Vaccines to Children 6 Months and Up
FDA Expands EUA for Moderna, Pfizer-BioNTech COVID-19 Vaccines to Children 6 Months and Up
FDA Expands EUA for Moderna, Pfizer-BioNTech COVID-19 Vaccines to Children 6 Months and Up
June 17, 2022
On June 15, 2022, the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted in favor of both vaccines.
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