Industry News

- Read more about Amgen and UCB announce positive top-line results from the Phase 3 study of Romosozumab
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.
- Read more about FDA Grants Orphan Drug Designation to Bellicum’s BPX-501
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.
- Read more about Nivalis Therapeutics announces FDA Fast Track Designation for N91115
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.
- Read more about Zydus Cadila received approval to market Doxycycline
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.
- Read more about Astrazeneca Zurampic (lesinurad) approved in the European Union
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.
- Read more about Mylan's ANDA for generic Advair Diskus® accepted for filing by FDA
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).
- Read more about Novartis drug PKC412 (midostaurin) receives Breakthrough Therapy designation from the 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.
- Read more about Spectrum Pharmaceuticals announces FDA's acceptance of NDA filing for EOquin
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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- Read more about Impax receives FDA approval for Generic Version of Adderall XR® capsules, CII
Impax Laboratories, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (mixed salts of a single-entity amphetamine product) extended-release capsules, CII, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg.
- Read more about Portola Pharmaceuticals announces BLA for Andexanet Alfa accepted for review by FDA
Portola Pharmaceuticals announced that the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for andexanet alfa for filing under a priority review. Portola submitted the BLA in December 2015 under an Accelerated Approval pathway. The FDA is expected to take action on the application by the Prescription Drug User Fee Act (PDUFA) action date of August 17, 2016.