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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.
Demand for Real-World Evidence of Medications is Growing
Demand for Real-World Evidence of Medications is Growing
Demand for Real-World Evidence of Medications is Growing
May 16, 2022
The role of health economic and real-world evidence has become, and will continue to be, an important aspect of healthcare decision-making.
FDA Okays Lilly’s Novel Diabetes Drug
FDA Okays Lilly’s Novel Diabetes Drug
FDA Okays Lilly’s Novel Diabetes Drug
May 16, 2022
Mounjaro is a first-in-class medicine that activates both the GLP-1 and GIP receptors, which leads to improved blood sugar control.
Janssen Updates Warnings Section of Imbruvica Label
Janssen Updates Warnings Section of Imbruvica Label
Janssen Updates Warnings Section of Imbruvica Label
May 16, 2022
The label for Imbruvica now includes information about the possibility of cardiac failure, which has occurred in 1% of patients. Imbruvica is used to treat B-cell blood cancers.
FDA Updates Warning Labels on Parkinson’s Therapies
FDA Updates Warning Labels on Parkinson’s Therapies
FDA Updates Warning Labels on Parkinson’s Therapies
May 13, 2022
Apokyn and Kynmobi contain apomorphine hydrochloride, which can cause hemolytic anemia that requires hospitalization. The products both treat the loss of muscle movement control caused by Parkinson’s disease.
Sandoz Launches First Generic of Esbriet
Sandoz Launches First Generic of Esbriet
Sandoz Launches First Generic of Esbriet
May 13, 2022
Pirfenidone is used to treat patients with idiopathic pulmonary fibrosis, a progressive rare disease that make it difficult to breathe.
FDA Approves Oral Form of ALS Therapy
FDA Approves Oral Form of ALS Therapy
FDA Approves Oral Form of ALS Therapy
May 13, 2022
Radicava ORS has the same dosing regimen as the IV form of the ALS therapy, with a treatment cycle followed drug-free periods.
FDA Launches New Rare Disease Program
FDA Launches New Rare Disease Program
FDA Launches New Rare Disease Program
May 12, 2022
The goal of the new program is to help increase the development new treatments for patients with rare diseases.
FDA Extends Review Time for Pompe Disease Therapy
FDA Extends Review Time for Pompe Disease Therapy
FDA Extends Review Time for Pompe Disease Therapy
May 11, 2022
The FDA needs more time to assess information submitted by the company.
FDA Approves Olumiant for New COVID-19 Indication
FDA Approves Olumiant for New COVID-19 Indication
FDA Approves Olumiant for New COVID-19 Indication
May 11, 2022
Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval.
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