Industry News

CDC Unanimously Recommends J&J, Moderna COVID-19 Vaccine Booster

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CDC recently recommended Johnson & Johnson and Moderna’s COVID-19 vaccine booster shots for all eligible individuals who receive any FDA authorized vaccine.  The organization...

FDA Approves Interchangeable Biosimilar for Inflammatory Diseases

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FDA recently approved Boehringer Ingelheim’s Cyltezo as the first interchangeable biosimilar product to treat certain inflammatory diseases. Specifically, the agency approved the drug for...

FDA Approves First Treatment for Rare Disease Congenital Athymia

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FDA recently approved Rethymic to treat pediatric patients with rare disease congenital athymia.  Congenital athymia is a rare immune disorder in which a child is born without a thymus. The...

FDA Recommends Booster Dose of Moderna’s COVID-19 Vaccine

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FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recently recommended a booster dose of Moderna’s COVID-19 vaccine, mRNA-1273, at the 50 microgram...

FDA Recommends Authorization For J&J’s COVID-19 Vaccine Booster

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FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recently recommended emergency use authorization for a booster dose of Johnson & Johnson’s COVID-19 vaccine. VRBPAC...

Roche Receives Breakthrough Therapy for Alzheimer’s Disease

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FDA recently granted Roche’s anti-amyloid beta antibody, gantenerumab, breakthrough therapy designation to treat individuals living with Alzheimer’s disease.  The agency based its...

Moderna to Build State-of-the-Art mRNA Facility in Africa

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Moderna recently announced that it will build a state-of-the-art mRNA facility in Africa to produce up to 500 million doses of vaccines annually at the 50 microgram dose level. The company will invest...

FDA Grants Designation For Daiichi Sankyo’s Breast Cancer Treatment

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FDA recently granted Daiichi Sankyo’s Enhertu breakthrough therapy designation in the US to treat adult patients with unresectable or metastatic HER2-positive breast cancer.  Enhertu is an...

ViiV Healthcare Submits FDA Application for HIV Regimen

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ViiV Healthcare recently announced it made a regulatory submission to FDA for approval of a new dispersible tablet regimen for children living with HIV. The tablet formulation, Triumeq, includes...

FDA Approves Kite’s CAR T-Cell Therapy For Leukemia

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FDA recently approved Kite’s chimeric antigen receptor (CAR) T-cell therapy, Tecartus, to treat adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia...

FDA Approves Amgen’s Repatha for Autosomal Dominant Disease

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FDA recently approved Amgen’s Repatha to treat pediatric patients ten and older with autosomal dominant disease, heterozygous familial hypercholesterolemia (HeFH), to reduce low-density...

Eli Lilly and Company to Drop Insulin Costs 40% in the US

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Eli Lilly and Company recently announced it will lower the list price of Insulin Lispro Injection in the US by another 40 percent. Effective January 1, 2022, the new list price will be $82.41 for...

Resilience to Manufacture mRNA for Moderna’s COVID-19 Vaccine

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National Resilience recently entered into a multi-year agreement with Moderna to manufacture drug substance mRNA for its COVID-19 vaccine.  Resilience is a manufacturing and technology company...

FDA Approves Johnson & Johnson’s Schizophrenia Injectable

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FDA recently approved Johnson & Johnson’s long-acting atypical antipsychotic, Invega Hafyera, the first and only twice yearly injectable to treat schizophrenia in adults.  Providers...

Novartis Boosts Access to Cholesterol-Lowering RNA Therapy

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Novartis and NHS England recently reached a commercial agreement to enable broad access to Novartis’ RNA therapy, Leqvio, which helps lower LDL cholesterol (LDL-C) in eligible patients with...

AMA, APhA, ASHP Call for Immediate End to Ivermectin for COVID-19

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The AMA, American Pharmacists Association (APhA), and American Society of Health-System Pharmacists (ASHP) have called for an “immediate end” to the prescribing, dispensing, and use of...

FDA Approves Vivistim System for Chronic Ischemic Stroke

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FDA recently approved the MicroTransponder Vivistim Paired VNS System (Vivistim System) to treat moderate to severe upper extremity motor deficits associated with chronic ischemic...

New CEO to Take Over for Gorsky at Johnson & Johnson

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Johnson & Johnson will have a new CEO in 2022. Current chairman and CEO Alex Gorsky is transitioning to the role of executive chairman and will be replaced as CEO by Joaquin Duato, according to a...

UPMC Expands Access to Monoclonal COVID-19 Antibody Treatments

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The University of Pittsburgh Medical Center (UPMC) recently announced expanded access to its potential COVID-19 antibody treatments in outpatient and inpatient settings for eligible...

NCQA Program Supports Best Practices in Specialty Pharmacy

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NCQA recently launched Specialty Pharmacy Accreditation, a service to help discern quality leaders and support value-based contracting in specialty pharmacy.  Specialty Pharmacy Accreditation...