Industry News

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.

Amgen and UCB announced top-line results from the Phase 3 placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis (FRAME). These data showed FRAME met the co-primary endpoints by reducing the incidence of new vertebral fracture through months 12 and 24 in postmenopausal women with osteoporosis treated with romosozumab. The study also met the secondary endpoint of reducing the incidence of clinical fractures (composite of vertebral and non-vertebral fractures) in postmenopausal women with osteoporosis through 12 months. However, the secondary endpoint of reducing the incidence of non-vertebral fractures through months 12 and 24 was not met.

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.

Zydus Cadila has received approval from the USFDA to market Doxycycline Capsules USP, 50 mg, 75 mg, and 100 mg.  The drug falls in the anti-bacterials segment.

AstraZeneca announced that the European Commission (EC) has granted marketing authorisation for ZurampicTM (lesinurad) 200mg in combination with a xanthine oxidase inhibitor (XOI) for the adjunctive treatment of hyperuricemia in adult gout patients (with or without tophi) who have not achieved target serum uric acid (sUA) levels with an adequate dose of an XOI alone.

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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