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Halozyme Therapeutics, Inc. today announced the completion of its root cause investigation regarding HYLENEX manufacturing and has identified a corrective action plan and regulatory strategy to reintroduce HYLENEX to the market. Halozyme and Baxter are finalizing the materials for a meeting with the U.S. Food and Drug Administration to seek concurrence with the reintroduction strategy.
Mylan Inc. today announced that its subsidiary Bioniche Pharma received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fludarabine Phosphate Injection USP, 25 mg/mL, packaged in 50 mg/2 mL Single-dose Vials. The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Teva Parenteral's Fludarabine Phosphate Injection USP, 25 mg/mL, a chemotherapy medication for B-cell chronic lymphocytic leukemia (CLL).
As stay-at-home orders are being lifted in some states and extended in others, uncertainty continues to surround the COVID-19 pandemic.
Using artificial cell-like particles, Yale biomedical engineers have devised a rapid and efficient way to produce a 45-fold enhancement of T cell activation and expansion, an immune response important for a patient's ability to fight cancer and infectious diseases, according to an advance on line report in Molecular Therapy.
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