USFDA

PTC Therapeutics, Inc. announced that it received yesterday evening a Refuse to File letter from the United States Food and Drug Administration (FDA) regarding PTC's New Drug Application (NDA) for Translarna™ (ataluren), an oral, first-in-class, protein restoration therapy for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.

formulation approved dose, tolerability and immunologic efficacy, investigational new formulation Astellas Pharma Inc. and Medivation, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) that they have submitted for XTANDI® (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase 2 TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication. Enzalutamide is approved by the FDA for the treatment of patients with mCRPC.

Vericel Corporation , a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, announced that the U.S. Food and Drug Administration has approved the Company's Humanitarian Device Exemption (HDE) supplement for Epicel® (cultured epidermal autografts) to revise the labeled indications of use to specifically include pediatric patients and to add pediatric labeling.  The revised product label also specifies that the probable benefit of Epicel, mainly related to survival, was demonstrated in two Epicel clinical experience databases and a randomized, controlled, independent physician-sponsored study comparing outcomes in patients with severe burns treated with Epicel and standard care compared to standard care alone.

Aeolus Pharmaceutical inc.  announced that it has received notice that the U.S. Food & Drug Administration ("FDA") has removed the clinical hold on the Company's Investigational New Drug application for AEOL 10150 ("10150") as a treatment for the lung and delayed effects of acute radiation exposure ("Lung-ARS"). The lifting of the clinical hold allows the Company to initiate its planned human safety study in healthy normal volunteers.

Bellicum Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for BPX-501, the Company’s lead product candidate.

Nivalis Therapeutics, Inc. announced the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation for the Company’s lead investigational drug, N91115, a novel stabilizer of the cystic fibrosis transmembrane conductance regulator (CFTR) protein.

Mylan announced that its abbreviated new drug application (ANDA) for fluticasone propionate 100, 250, 500 mcg and salmeterol 50 mcg inhalation powder has been accepted for filing by the U.S. Food and Drug Administration (FDA).

Novartis announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to PKC412 (midostaurin). PKC412 (midostaurin) is an investigational treatment for adults with newly-diagnosed AML who are FLT3 mutation-positive, as detected by an FDA-approved test, and who are eligible to receive standard induction and consolidation chemotherapy.

Spectrum announced that the U.S. Food and Drug Administration (the "FDA") has accepted the EOquin® (apaziquone for intravesical instillation) New Drug Application (NDA) for review.

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