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Drug Update: January 2017 Issue 1

Industry News 21st Century Cures Act Signed into Law In mid-December, Congress passed and the President signed into law the 21st Century Cures Act. The nearly 1,000 page legislation provides funding for a variety of initiatives including efforts to aid in the fight against the opioid epidemic with $1 billion in grants over 2 years being […]

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Drug Update: December 2016 Issue 2

New Drug Launch Follow-On Product to Lantus® Launched: Basaglar® Last December, the U.S. Food and Drug Administration (FDA) approved the first “follow-on” insulin glargine product, Basaglar® (insulin glargine injection). However, due to patent ligitation, Basaglar was not released to the U.S. market until December 15, 2016. Basaglar is a copycat of Sanofi-Aventis’ long-acting insulin product Lantus® (insulin […]

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Drug Update: December 2016 Issue 1

New Drug Approvals FDA Approves Two New Combination Products for Type 2 Diabetes Last month, the U.S. Food and Drug Administration (FDA) approved two new combination fixed dose diabetes medications each containing a glucagon-like peptide 1 (GLP-1) receptor agonist and a long-acting insulin: Xultophy® (insulin degludec/liraglutide) and Soliqua® (insulin glargine/lixisenatide). Both medications are indicated as an adjunct […]

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Drug Update: November 2016 Issue 2

New Drug Launch: Inflectra Expected to Become Available in Late November The second biosimilar approved in the United States, Inflectra® (infliximab-dyyb), is expected to become commercially available in late November 2016. Inflectra is a biosimilar to reference product Remicade® (infliximab) and is approved for most of the reference product’s indications. Pfizer is responsible for marketing of the biosimilar […]

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Drug Update: November 2016 Issue 1

New Drug Approval: FDA Grants Accelerated Approval to New Cancer Drug Last month, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Lartruvo® (olaratumab) to treat adults with certain types of soft tissue sarcoma (STS). Lartruvo is approved for use in combination with doxorubicin for patients with STS who cannot be cured with […]

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Drug Update: October 2016 Issue 2

Specialty Update FDA Reviewing New Biologic for Rheumatoid Arthritis: Sarilumab The U.S. Food and Drug Administration (FDA) is currently in the process of reviewing a biologics license application (BLA) for a new monoclonal antibody, sarilumab. The new biologic is being reviewed for the treatment of adults with active, moderate-to-severe rheumatoid arthritis (RA) who have had […]

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Drug Update: October 2016 Issue 1

New Drug Approvals FDA Approves New Immune Globulin: Cuvitru® Last month, the U.S. Food and Drug Administration (FDA) approved Cuvitru®, a subcutaneous immune globulin solution indicated as replacement therapy for primary humoral immunodeficiency in adults and pediatric patients two years of age and older. Cuvitru 200 mg/mL (20%) solution is infused subcutaneously at regular intervals […]

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Drug Update: September 2016 Issue 2

Specialty Update FDA Delays Review of New Clostridium Difficile Drug In January of this year, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for a new monoclonal antibody for the prevention of recurrent Clostridium difficile (C. difficile) infections. The BLA for the investigational antitoxin, bezlotoxumab, was granted Priority Review and […]