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Mylan N.V.and Biocon Ltd.  announced that the U.S. Food and Drug Administration (FDA) has approved Mylan´s Ogivri^TM (trastuzumab­dkst), a biosimilar to Herceptin® (trastuzumab), co-developed with Biocon. OgivriTM has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).

Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Prolia® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP). The sBLA, which was submitted on July 28, 2017, is based on a Phase 3 study evaluating Prolia compared with risedronate in patients receiving glucocorticoid treatment. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2018.

Zosano Pharma Corp a clinical stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to subjects using its proprietary Adhesive Dermally-Applied Microarray (“ADAM”) technology, announced that Cephalalgia had published the Company’s positive results from our pivotal, multi-center, double blind, placebo controlled, trial demonstrating efficacy and safety of M207, our formulation of zolmitriptan using our ADAM technology.

Antares Pharma, Inc. announced that, the Company received a letter from the U.S. Food and Drug Administration (FDA) stating that, as part of their ongoing review of the Company’s New Drug Application (NDA) for XYOSTED™ (testosterone enanthate) injection, they have identified deficiencies that preclude the continuation of the discussion of labeling and postmarketing requirements/commitments at this time.

Fibrocell Science, Inc a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today reported interim results in its Phase 1/2 clinical trial of FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).

BioCryst Pharmaceuticals, Inc a biotechnology company focused on the development and commercialization of treatments for rare and infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for RAPIVAB (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor, extending its availability for the treatment of acute uncomplicated influenza to pediatric patients 2 years and older who have been symptomatic for no more than two days. The pediatric approval was based on the interim analysis of an ongoing pediatric clinical study. Those results will be presented at the upcoming ID Week 2017 meeting in San Diego.

Myriad Genetics, Inc a leader in molecular diagnostics and personalized medicine, announced that two important studies will be featured in podium presentations at the 36th annual conference of the National Society of Genetic Counselors (NSGC) in Columbus, OH.

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MacroGenics, Inc. a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, today announced the presentation of clinical data from its Phase 1 study of flotetuzumab in an oral session at the European Society for Medical Oncology Annual Congress, ESMO 2017, in Madrid, Spain. Norbert Vey, M.D., Team Leader Translational Medicine – Hematology at Institut Paoli-Calmettes, Marseille, France, presented "Interim Results from a Phase 1 First-in-Human study of flotetuzumab, a CD123 x CD3 bispecific DART molecule, in AML/MDS."

MacroGenics, Inc a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, today announced the advancement of two of its proprietary bispecific DART product candidates. This progress includes: a first patient has been dosed with MGD013, a DART molecule that recognizes PD-1 and LAG-3; and the submission of an Investigational New Drug (IND) application with the FDA for MGD014, a DART molecule that targets HIV-infected cells and CD3. MacroGenics retains worldwide rights to both of these product candidates.

Bioverativ Inc a global biotechnology company focused on the discovery, development and commercialisation of innovative therapies for haemophilia and other rare blood disorders, and Bicycle Therapeutics Ltd., a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) product platform, today announced a research collaboration focused on the discovery, development and commercialisation of innovative therapies for haemophilia and sickle cell disease.