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All News - Page 46

FDA Approves Breyanzi for Additional Indication in Large B-Cell Lymphoma
FDA Approves Breyanzi for Additional Indication in Large B-Cell Lymphoma
FDA Approves Breyanzi for Additional Indication in Large B-Cell Lymphoma
June 26, 2022
Breyanzi is now available as a second-line treatment for this aggressive blood cancer.
New Generic Approvals
New Generic Approvals
New Generic Approvals
June 25, 2022
Generics of Viibryd, Tranxane and Timoptic have recently been approved and launched.
FDA Updates Safety Label of Byetta
FDA Updates Safety Label of Byetta
FDA Updates Safety Label of Byetta
June 24, 2022
Byetta is used to control blood sugar in patients with diabetes. A new warning includes the risk of gallstones and gallbladder inflammation.
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.
Menarini Submits NDA Elacestrant for Advanced Breast Cancer
Menarini Submits NDA Elacestrant for Advanced Breast Cancer
Menarini Submits NDA Elacestrant for Advanced Breast Cancer
June 23, 2022
Elacestrant is oral therapy that targets estrogen receptor 1, a key resistance mechanism in advanced breast cancer.
FDA Approves Drug Combination for Tumor Agnostic Indication
FDA Approves Drug Combination for Tumor Agnostic Indication
FDA Approves Drug Combination for Tumor Agnostic Indication
June 23, 2022
The FDA approved the combination of Tafinlar and Mekinist for solid tumors with a BRAF V600E mutation. This is the first therapy to be approved that is tumor agnostic for patients with this mutation.
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.
FDA Announces Advisory Committee Meeting for Xphozah
FDA Announces Advisory Committee Meeting for Xphozah
FDA Announces Advisory Committee Meeting for Xphozah
June 22, 2022
The Cardiovascular and Renal Drugs Advisory Committee meets Nov. 16, 2022, to discuss Xphozah for patients with kidney disease.
AbbVie Submits Supplemental NDA for Qulipta for Chronic Migraine
AbbVie Submits Supplemental NDA for Qulipta for Chronic Migraine
AbbVie Submits Supplemental NDA for Qulipta for Chronic Migraine
June 21, 2022
If approved, Qulipta would be the first oral calcitonin gene-related peptide receptor antagonist with a broad preventive treatment of both chronic and episodic migraine.
CMS Issues J-Code for Xipere to Treat Macular Edema
CMS Issues J-Code for Xipere to Treat Macular Edema
CMS Issues J-Code for Xipere to Treat Macular Edema
June 21, 2022
Xipere became commercially available in March 2022. It is the first therapy for patients with macular edema that provides a targeted delivery to the retina.
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.
Clovis Oncology Pulls Rubraca Indication in Late-Stage Ovarian Cancer
Clovis Oncology Pulls Rubraca Indication in Late-Stage Ovarian Cancer
Clovis Oncology Pulls Rubraca Indication in Late-Stage Ovarian Cancer
June 20, 2022
Trial results showed overall survival was shorter compared with chemotherapy. The move doesn’t affect other indications.
Sierra Oncology Submits NDA For Momelotinib
Sierra Oncology Submits NDA For Momelotinib
Sierra Oncology Submits NDA For Momelotinib
June 19, 2022
Sierra Oncology is seeking approval of momelotinib as a treatment for patients with myelofibrosis, a bone marrow cancer.
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.
FDA Approves Skyrizi for Patients with Crohn’s Disease
FDA Approves Skyrizi for Patients with Crohn’s Disease
FDA Approves Skyrizi for Patients with Crohn’s Disease
June 17, 2022
This is the third approval for Skyrizi, which also treats psoriatic arthritis and plaque psoriasis.
FDA Approves Imcivree for Obesity Associated with the Rare Disease
FDA Approves Imcivree for Obesity Associated with the Rare Disease
FDA Approves Imcivree for Obesity Associated with the Rare Disease
June 17, 2022
The FDA also issued a complete response letter for Imcivree for use in patients with Alstrom syndrome, another genetic rare disease that can cause obesity.
FTC to Consider Some Drug Rebates as Bribes
FTC to Consider Some Drug Rebates as Bribes
FTC to Consider Some Drug Rebates as Bribes
June 17, 2022
The Federal Trade Commission said that paying or accepting rebates or fees in exchange for excluding lower cost drugs on formularies could be considered commercial bribery.
Study: Higher Out-of-Pocket Costs Lead to Nonadherence
Study: Higher Out-of-Pocket Costs Lead to Nonadherence
Study: Higher Out-of-Pocket Costs Lead to Nonadherence
June 16, 2022
A literature review by AmerisourceBergen's Xcenda identifies a link between high cost sharing and patient nonadherence to medication regimens.
FDA Committee Recommends Expanding COVID-19 Vaccines to Infants, Children
FDA Committee Recommends Expanding COVID-19 Vaccines to Infants, Children
FDA Committee Recommends Expanding COVID-19 Vaccines to Infants, Children
June 16, 2022
The committee recommended Moderna’s and Pfizer’s COVID-19 vaccines were recommended for children 6 months to five years, as well as Moderna’s vaccine for children ages 7 to 16.
Crenezumab Fails to Show Benefit for Alzheimer’s Disease
Crenezumab Fails to Show Benefit for Alzheimer’s Disease
Crenezumab Fails to Show Benefit for Alzheimer’s Disease
June 16, 2022
Genentech’s anti-amyloid crenezumab did not slow or prevent cognitive decline in people with early-onset Alzheimer’s disease.
A High-Touch Approach to Utilization Management
A High-Touch Approach to Utilization Management
A High-Touch Approach to Utilization Management
June 15, 2022
Joe Murad, president and CEO of the pharmacy benefit manager WithMe Health, talks about how consumer-driven healthcare requires access, transparency, and easier navigation.
Study: Manufacturers Device Hop to Extend Patent Protection
Study: Manufacturers Device Hop to Extend Patent Protection
Study: Manufacturers Device Hop to Extend Patent Protection
June 15, 2022
Researchers writing in Health Affairs have found that new patents for updated devices have delayed generic competition in asthma and COPD treatments.
Study: FDA Approves Oncology Drugs Faster than EMA
Study: FDA Approves Oncology Drugs Faster than EMA
Study: FDA Approves Oncology Drugs Faster than EMA
June 15, 2022
But investigators found that U.S. approvals often come before publication of results.
Prime Therapeutics Removes Three Drugs from Medicare Formularies
Prime Therapeutics Removes Three Drugs from Medicare Formularies
Prime Therapeutics Removes Three Drugs from Medicare Formularies
June 14, 2022
A generic is available for one, and Centers for Medicare & Medicaid Services has removed two others from Medicare Part D coverage.
FDA Approves Amvuttra for Neuropathy Associated with Rare Disease
FDA Approves Amvuttra for Neuropathy Associated with Rare Disease
FDA Approves Amvuttra for Neuropathy Associated with Rare Disease
June 14, 2022
Amvuttra is expected to launch in July, and the developer, Alnylam, plans to make this available through value-based agreements.
FDA Approves Olumiant to Treat Patients with Alopecia
FDA Approves Olumiant to Treat Patients with Alopecia
FDA Approves Olumiant to Treat Patients with Alopecia
June 14, 2022
Olumiant is the first systemic therapy available to treat alopecia.
FDA Extends PDUFA Date for sNDA of Brukinsa
FDA Extends PDUFA Date for sNDA of Brukinsa
FDA Extends PDUFA Date for sNDA of Brukinsa
June 13, 2022
The FDA needs time to review additional clinical data submitted by BeiGene for the leukemia/lymphoma indication. The new date is Jan. 20, 2023.
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