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Process & Production

Aldeyra Therapeutics submits FDA IND filing for noninfectious anterior uveitis Aldeyra Therapeutics, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, announced that an Investigational New Drug application (IND) to conduct Phase 2 clinical testing of NS2 for the treatment of noninfectious anterior uveitis, was submitted to the United States Food and Drug Administration (FDA) on December 16, 2014.
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Bayer files BLA for BAY 81-8973 to treat Hemophilia A in adults and children By PBR Staff Writer
Bayer HealthCare has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking approval for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, to treat hemophilia A in children and adults.
Production & Manufacturing > Process & Production > News HedgePath gets FDA nod to begin proposed cancer drug development By PBR Staff Writer
HedgePath Pharmaceuticals has received clearance from the US Food and Drug Administration (FDA) for the first investigational new drug (IND) application to start development of its proposed cancer treatment.
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CSL Behring seeks FDA approval for rIX-FP to treat hemophilia B patients
By PBR Staff Writer
CSL Behring has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP).
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Jazz begins rolling NDA submission for defibrotide to treat severe hepatic VOD
By PBR Staff Writer
Ireland-based Jazz Pharmaceuticals has started rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for defibrotide to treat severe hepatic veno-occlusive disease (VOD) in patients undergoing hematopoietic stem-cell transplantation (HSCT) therapy.
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Wilshire confirms first-to-file patent challenge relating to LASTACAFT
Wilshire Pharmaceuticals, confirmed that it has been sued by Allergan and Vistakon Pharmaceuticals in connection with Wilshire's filing of an Abbreviated New Drug Application with the US Food and Drug Administration for Alcaftadine (alcaftadine ophthalmic solution) 0.25%.
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FDA grants orphan drug status for ARCA's rNAPc2 as potential treatment for Ebola
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation to ARCA biopharma's drug candidate rNAPc2 as a potential treatment of viral hemorrhagic fever post-exposure to Ebola virus.
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MultiCell Technologies files new antibody-drug conjugate patent application
MultiCell Technologies, has filed a U.S. patent application covering the design and therapeutic use of novel, next-generation antibody drug conjugates (ADCs) which provide for the simultaneous targeted delivery of multiple drugs from a single antibody.
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Mast announces plans for development of Vepoloxamer in heart failure
Mast Therapeutics, a clinical-stage biopharmaceutical company, provided details of its plan to develop vepoloxamer (MST-188), its lead product candidate, in heart failure.
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Can-Fite to begin development program of next generation drug CF602
Can-Fite BioPharma a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, reported that it will initiate a pre-clinical development program of its next generation drug CF602 for the indication of sexual dysfunction.
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Acura receives additional US patent for abuse deterrent drug formulations
Acura Pharmaceuticals, a specialty pharmaceutical company innovating abuse deterrent drugs, today announced that the company has been issued US Patent No. 8,901,113 by the United States Patent and Trademark Office.
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FDA clears Advaxis IND application to initiate Phase I/II combination prostate cancer trial
By PBR Staff Writer
The US Food and Drug Administration (FDA) has cleared Advaxis' investigational new drug (IND) application to conduct a Phase I/II clinical trial of its Lm-LLO immunotherapy ADXS-PSA (ADXS31-142) to treat patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC).
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Sunovion seeks FDA approval for Aptiom as monotherapy treatment for partial-onset seizures
By PBR Staff Writer
US-based Sunovion Pharmaceuticals has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) seeking approval for the use of Aptiom (eslicarbazepine acetate) as monotherapy treatment of partial-onset seizures.
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