Mylan Confirms First-to-File Patent Challenge Relating to Zytiga
News Aug 18, 2015
This product is the generic version of Zytiga®, which is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.
Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon final FDA approval. The plaintiffs have filed a lawsuit against Mylan in the United States District Court for the District of New Jersey.
For the 12 months ending June 30, 2015, Zytiga had U.S. sales of approximately $1.08 billion, according to IMS Health.
Currently, Mylan has 268 ANDAs pending FDA approval representing $101.3 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $33.4 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.
H7N9 Influenza Vaccine Clinical Trials CommenceNews
Two new clinical trials testing an experimental vaccine to prevent influenza caused by an H7N9 influenza virus are now enrolling volunteers at sites across the United States. The Phase 2 studies will test different dosages of the inactivated influenza vaccine candidate as well as different vaccination schedules. The studies also will evaluate whether an adjuvant boosts the immune responses of people receiving the vaccine.
Alternative to Antibiotics: Antibody Approach for Treating Multidrug-Resistant Bacterial InfectionsNews
Researchers are developing a promising alternative to antibiotic treatment for infections caused by Klebsiella pneumoniae bacteria resistant to carbapenem antibiotics. The approach uses antibodies to target the K. pneumoniae protective capsule polysaccharide.READ MORE
Combination Drug Trial Launched to Eradicate B-Cell MalignanciesNews
Researchers at University of California San Diego School of Medicine, in collaboration with local biotechnology company Oncternal Therapeutics, have launched a phase Ib/II clinical trial to evaluate the combined effectiveness of a standard of care drug with a novel monoclonal antibody that target B-cell malignancies, which include leukemias and lymphomas.READ MORE
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