Inhaled Alpha-1 Proteinase Inhibitor Safe, Well-Tolerated and Effective in Raising Sputum Levels in Patients with Cystic Fibrosis
Inhalation of aerosolized alpha-1 proteinase inhibitor (A1PI) permits delivery of drug to the site of active airway disease while limiting systemic exposure, and has been shown to reduce neutrophil elastase burden and inflammation in respiratory secretions of alpha-1 antitrypsin-deficient patients.
FDA Approves Adynovate to Treat Hemophilia A
The U.S. Food and Drug Administration has approved Baxalta’s Adynovate for use in hemophilia A patients aged 12 years and older.
FDA Approves Boosted Flu Vaccine for Older Adults
The U.S. Food and Drug Administration has approved Fluad (Seqirus), an influenza vaccine that contains the adjuvant MF59.
FDA Approves NUWIQ to Treat Hemophilia A
The U.S. Food and Drug Administration ha approved Octapharma’s NUWIQ, antihemophilic factor (recombinant), an intravenous therapy for adults and children living with hemophilia A.
FDA Approves Belbuca Buccal Film for Chronic Pain
The U.S. Food and Drug Administration has approved Belbuca (buprenorphine) buccal film for patients with severe chronic pain.
CMS Announces Biosimilars Reimbursement Rule
The Centers for Medicare and Medicaid Services issued final rules detailing how it will pay for services provided to Medicare beneficiaries in 2016.
FDA Approves First Combination Immunotherapy for Melanoma
The U.S. Food and Drug Administration (FDA) approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of advanced melanoma.
FDA Approves First-in-Class Treatment of Melanoma
Hailed as a major advancement in the fight against skin cancer, the U.S. Food and Drug Administration (FDA) has approved a new immune-based therapy for treating metastatic melanoma.
