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Study: COPD Patients with High Deductibles More Likely to Abandon Prescriptions
Study: COPD Patients with High Deductibles More Likely to Abandon Prescriptions
Study: COPD Patients with High Deductibles More Likely to Abandon Prescriptions
June 1, 2022
In high-deductible plans, patients had the highest out-of-pockets costs and abandoned and discontinued therapy at greater rates than other benefit designs.
FDA Approves Evrysdi in Pre-symptomatic Newborns with SMA
FDA Approves Evrysdi in Pre-symptomatic Newborns with SMA
FDA Approves Evrysdi in Pre-symptomatic Newborns with SMA
May 31, 2022
Evrysdi is now approved to treat spinal muscular atrophy in children and adults of all ages.
FDA Approves Two Opdivo Regimens for Metastatic Esophageal Cancer
FDA Approves Two Opdivo Regimens for Metastatic Esophageal Cancer
FDA Approves Two Opdivo Regimens for Metastatic Esophageal Cancer
May 31, 2022
Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers.
Bipartisan Bill Aims to Require Transparency Among PBMs
Bipartisan Bill Aims to Require Transparency Among PBMs
Bipartisan Bill Aims to Require Transparency Among PBMs
May 31, 2022
The bill would allow the Federal Trade Commission to impose penalties on PBMs of up to $1 million for unfair and deceptive practices.
FDA Approves Kymriah for Adults with Follicular Lymphoma
FDA Approves Kymriah for Adults with Follicular Lymphoma
FDA Approves Kymriah for Adults with Follicular Lymphoma
May 30, 2022
Kymriah is now approved in three indications and is the only CAR-T cell therapy approved in both adult and pediatric settings.
New Global Coalition Aims to Improve Access to Cancer Medicines
New Global Coalition Aims to Improve Access to Cancer Medicines
New Global Coalition Aims to Improve Access to Cancer Medicines
May 28, 2022
The Access to Oncology Medicines Coalition brings together pharma companies and other organizations to help countries develop the capacity and access to essential cancer medicines.
FDA Approves Amneal’s Biosimilar of Neulasta
FDA Approves Amneal’s Biosimilar of Neulasta
FDA Approves Amneal’s Biosimilar of Neulasta
May 27, 2022
This is the fifth biosimilar of Neulasta and the third biosimilar from Amneal to receive FDA approval.
FDA Accepts NDA for Omaveloxolone for Friedreich’s Ataxia
FDA Accepts NDA for Omaveloxolone for Friedreich’s Ataxia
FDA Accepts NDA for Omaveloxolone for Friedreich’s Ataxia
May 27, 2022
The FDA has assigned a Prescription Drug User Fee Act target action date of Nov. 30, 2022. Regulators indicated they plan to hold an advisory committee meeting to discuss the application.
FDA Approves Tibsovo Combination for Older Patients with Leukemia
FDA Approves Tibsovo Combination for Older Patients with Leukemia
FDA Approves Tibsovo Combination for Older Patients with Leukemia
May 26, 2022
Tibsovo is the first therapy targeting cancer metabolism for patients with newly diagnosed IDH1-mutated acute myeloid leukemia.
FDA Issues Second CRL for Poxvirus Treatment
FDA Issues Second CRL for Poxvirus Treatment
FDA Issues Second CRL for Poxvirus Treatment
May 26, 2022
Deficiencies at the contract manufacturing company are, for the second time, holding up approval of VP-102 to treat molluscum contagiosum, a mild skin infection.
FDA Accepts BLA for Hemophilia B Gene Therapy
FDA Accepts BLA for Hemophilia B Gene Therapy
FDA Accepts BLA for Hemophilia B Gene Therapy
May 25, 2022
If approved, etranacogene dezaparvovec would be the first gene therapy for patients with hemophilia B. An FDA decision is expected in November 2022.
Shining Light on the Barriers Payers Place on Medications
Shining Light on the Barriers Payers Place on Medications
Shining Light on the Barriers Payers Place on Medications
May 25, 2022
Molly Beinfeld, senior research lead, evidence synthesis at the Institute for Clinical and Economic Review, talks about the organization’s research assessing payer coverage policies of prescription drugs.
Teva Recalls One Lot of Anagrelide
Teva Recalls One Lot of Anagrelide
Teva Recalls One Lot of Anagrelide
May 25, 2022
The impacted lot failed a dissolution test, meaning it was taking longer to dissolve once ingested. This can result in less anagrelide available in the body, possibly leading to clotting or bleeding events such as a heart attack or stroke.
FDA Approves First Non-Steroid Cream for Psoriasis
FDA Approves First Non-Steroid Cream for Psoriasis
FDA Approves First Non-Steroid Cream for Psoriasis
May 24, 2022
Vtama is approved to treat adults with mild, moderate, and severe psoriasis. It is expected to be available in the first week of June 2022.
FDA Approves New Formulation of Tyvaso
FDA Approves New Formulation of Tyvaso
FDA Approves New Formulation of Tyvaso
May 24, 2022
Tyvaso DPI is a dry inhalation powder and new inhalation device to treat patients with pulmonary arterial hypertension, a life-threatening disease. It is expected to be available in June 2022.
COVID-19’s Impact on Teenagers’ Mental Health
COVID-19’s Impact on Teenagers’ Mental Health
COVID-19’s Impact on Teenagers’ Mental Health
May 24, 2022
Doug Nemecek, M.D., chief medical officer, behavioral health at Evernorth, talks about the mental health issues teenagers are facing.
Prime Therapeutics’ Biosimilar Program Cut Expenses by 26%
Prime Therapeutics’ Biosimilar Program Cut Expenses by 26%
Prime Therapeutics’ Biosimilar Program Cut Expenses by 26%
May 23, 2022
Launched last year, Prime’s MedDrive is an integrated drug management solution that leverages biosimilars to help reduce drug spend.
FDA Accepts NDA for Nasal Migraine Treatment
FDA Accepts NDA for Nasal Migraine Treatment
FDA Accepts NDA for Nasal Migraine Treatment
May 23, 2022
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for the first quarter of 2023 for zavegepant, a nasal spray for the acute treatment of patients with migraine.
FDA Accepts BLA for Mirvetuximab Soravtansine for Ovarian Cancer
FDA Accepts BLA for Mirvetuximab Soravtansine for Ovarian Cancer
FDA Accepts BLA for Mirvetuximab Soravtansine for Ovarian Cancer
May 23, 2022
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Nov. 28, 2022.
FDA Approves Dupixent for Eosinophilic Esophagitis
FDA Approves Dupixent for Eosinophilic Esophagitis
FDA Approves Dupixent for Eosinophilic Esophagitis
May 20, 2022
Dupixent is the first medicine specifically to treat eosinophilic esophagitis, an inflammatory condition that causes the esophagus to narrow and makes it difficult to eat.
AbbVie Submits NDA for Parkinson’s Disease
AbbVie Submits NDA for Parkinson’s Disease
AbbVie Submits NDA for Parkinson’s Disease
May 20, 2022
ABBV-951 is a combination of foscarbidopa and foslevodopa, prodrugs of carbidopa and levodopa, that is designed to provide 24-hour, continuous subcutaneous delivery.
Study: Medicare Part D Enrollees’ Spending for Insulin Increased
Study: Medicare Part D Enrollees’ Spending for Insulin Increased
Study: Medicare Part D Enrollees’ Spending for Insulin Increased
May 20, 2022
If insulin copays were capped at $35, Part D enrollees would save 29% on average, according to new analysis from Kaiser Family Foundation.
Prime Removes Two Drugs from Medicare Formularies
Prime Removes Two Drugs from Medicare Formularies
Prime Removes Two Drugs from Medicare Formularies
May 19, 2022
Generics are now available for the two drugs: Vimpat and Combigan.
FDA Modifies Dsuvia REMS Program
FDA Modifies Dsuvia REMS Program
FDA Modifies Dsuvia REMS Program
May 19, 2022
The FDA has changed how often AcelRx Pharmaceuticals is required to audit healthcare settings that administer Dsuvia, which is a synthetic opioid.
FDA Issues CRL for Bimekizumab for Psoriasis
FDA Issues CRL for Bimekizumab for Psoriasis
FDA Issues CRL for Bimekizumab for Psoriasis
May 18, 2022
Bimekizumab, now called Bimzelx, is a monoclonal antibody being reviewed as treatment for adults with moderate-to-severe plaque psoriasis.
Aetna Adds Recently Approved Drugs to Precertification List
Aetna Adds Recently Approved Drugs to Precertification List
Aetna Adds Recently Approved Drugs to Precertification List
May 18, 2022
Aetna has made available four specialty drugs that were approved early in 2022 through prior authorization. These include a biosimilar, a CAR-T immunotherapy, and therapies for macular degeneration and a rare auto-immune disease.
Analysis Finds 2020 Drug Approvals Based on Smaller, Less Rigorous Trials
Analysis Finds 2020 Drug Approvals Based on Smaller, Less Rigorous Trials
Analysis Finds 2020 Drug Approvals Based on Smaller, Less Rigorous Trials
May 18, 2022
While regulatory flexibility is important for drugs for rare diseases, investigators are concerned the trend toward surrogate endpoints decreases confidence that new drugs can improve patient outcomes.
FDA Expands EUA for Pfizer/BioNTech COVID-19 Booster to Children 5 to 11 Years
FDA Expands EUA for Pfizer/BioNTech COVID-19 Booster to Children 5 to 11 Years
FDA Expands EUA for Pfizer/BioNTech COVID-19 Booster to Children 5 to 11 Years
May 17, 2022
The booster is given at least five months after completion of a primary series.
FDA Clears First At-Home Combo COVID-19, RSV and Flu Test
FDA Clears First At-Home Combo COVID-19, RSV and Flu Test
FDA Clears First At-Home Combo COVID-19, RSV and Flu Test
May 17, 2022
The FDA emergency use authorization allows the nonprescription test to use at-home sample collection with testing performed in a laboratory.
FDA Declines EUA for Fluvoxamine for COVID-19
FDA Declines EUA for Fluvoxamine for COVID-19
FDA Declines EUA for Fluvoxamine for COVID-19
May 17, 2022
FDA regulators said the data to support the EUA, which was submitted by a physician, is not sufficient to support the use of the antidepressant fluvoxamine for the treatment of patients with COVID-19.
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