Regulatory

Novus Therapeutics Receives FDA Guidance at Type C Meeting for OP-02 in the Treatment and Prevention of Otitis Media

June 19, 2018

IRVINE, Calif.–(BUSINESS WIRE)–Novus Therapeutics, Inc. (NASDAQ: NVUS), a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat (ENT), announced receipt of final meeting minutes from the U.S. Food and Drug Administration (FDA) following a Type C meeting held at the Company’s request to discuss its OP-02 development […]

Celltrion Completes Resubmission to FDA for Proposed Trastuzumab Biosimilar

June 18, 2018

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion (KRX:068270) has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P6, a proposed mAb biosimilar to Herceptin® (trastuzumab). Celltrion submitted its abbreviated Biologics License Applications (aBLAs) for CT-P10 and CT-P6 to the FDA in April and May of last year, respectively. However, […]

ImmunoGen Announces FDA Fast Track Designation for Mirvetuximab Soravtansine in Patients with Platinum-Resistant Ovarian Cancer

June 18, 2018

WALTHAM, Mass.–(BUSINESS WIRE)–ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead program, mirvetuximab soravtansine. The designation is for the treatment of patients with medium to high folate […]

Solid Biosciences Announces FDA Removes Clinical Hold on SGT-001

June 18, 2018

CAMBRIDGE, Mass., June 18, 2018 (GLOBE NEWSWIRE) — Solid Biosciences Inc. (NASDAQ:SLDB) today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on IGNITE DMD, the Company’s Phase I/II clinical trial for its investigational microdystrophin gene transfer, SGT-001, for the treatment of Duchenne muscular dystrophy (DMD). In its letter, the […]

Ziopharm Oncology Reports on Status of Investigational New Drug Application for Phase 1 Trial to Evaluate CD19-targeted CAR T Therapy

June 18, 2018

BOSTON, June 18, 2018 (GLOBE NEWSWIRE) — Ziopharm Oncology, Inc. (Nasdaq:ZIOP) today announced the U.S. Food and Drug Administration (FDA) placed on clinical hold a Phase 1 trial to evaluate CD19-specific CAR-T therapies manufactured under point-of-care and requested additional information in support of the investigational new drug (IND) application for the trial. Ziopharm, Precigen, Inc., […]

ImmunoGen Announces FDA Fast Track Designation for Mirvetuximab Soravtansine in Patients with Platinum-Resistant Ovarian Cancer

June 18, 2018

WALTHAM, Mass.–(BUSINESS WIRE)–Jun. 18, 2018– ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead program, mirvetuximab soravtansine. The designation is for the treatment of patients with medium […]

ContraVir Pharmaceuticals Announces the Approval of the IND and Initiation of the Clinical Development Program of CRV431 in the United States

June 14, 2018

EDISON, N.J., June 14, 2018 (GLOBE NEWSWIRE) — ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical company focused on the development and commercialization of therapeutic drugs for the treatment of hepatitis B virus (HBV), announced today, the initiation of the clinical development program of CRV431, pursuant to the acceptance of the Investigational New Drug (IND) application by […]

FDA Knocks Back Mylan’s Advair Generic For Second Time

June 14, 2018

The FDA has rejected Mylan’s generic version of GlaxoSmithKline’s Advair for the second time following its knockback last year, citing “minor deficiencies” in its efficacy as reason for the decision.   The inhaled lung therapy was originally accepted for review in 2016, but has faced an uphill struggle since then to secure marketing authorization. Mylan […]

vTv Alzheimer’s Drug Fails Again But Company Sees Hope in Additional Development

June 14, 2018

More disappointing news for North Carolina-based vTv Therapeutics has sent shareholders running. The company reported the second part of its Phase III Alzheimer’s disease study failed to meet co-primary efficacy endpoints. This was the second failure for the company’s late-stage Alzheimer’s drug azeliragon. Although the company was disappointed in April when he first part of […]

FDA Finds Deficiencies In Mylan’s Generic Advair; Shares Fall

June 14, 2018

(Reuters) – Mylan NV said on Wednesday that U.S. health regulators were unable to approve its generic version of GlaxoSmithKline’s blockbuster inhaled lung drug Advair for the second time, as they found “minor deficiencies” in the treatment. Shares of Mylan fell 4.5 percent to $39.80 after the bell. Mylan did not provide details on the […]

Sunovion Announces FDA Acceptance of New Drug Application for Apomorphine Sublingual Film (APL-130277)

June 13, 2018

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease (PD). The expected action date by the FDA under the Prescription Drug User Fee […]

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