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Process & Production

Synageva begins rolling submission of BLA to FDA for sebelipase alfa to treat LAL Deficiency By PBR Staff Writer
Synageva BioPharma has started rolling submission of a biologics license application (BLA) to the US Food and Drug Administration (FDA) for sebelipase alfa to treat patients with lysosomal acid lipase deficiency (LAL Deficiency).
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FDA to review Eisai's sNDA for antiepileptic drug perampanel to treat PGTC seizures By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for review Eisai's supplemental new drug application (sNDA) for its in-house-discovered AMPA receptor antagonist perampanel to treat primary generalized tonic-clonic (PGTC) seizures.
Production & Manufacturing > Process & Production > News Matinas submits IND for MAT9001 to treat severe hypertriglyceridemia By PBR Staff Writer
US-based biopharmaceutical firm Matinas BioPharma Holdings has submitted an investigational new drug application (IND) for its lead drug candidate, MAT9001, to the US Food and Drug Administration (FDA) for the treatment of severe hypertriglyceridemia (TG>500mg/dL).
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Amgen files Lawsuit against Sanofi and Regeneron for patent infringement
By PBR Staff Writer
Amgen announced that it filed a lawsuit in the United States (US) District Court of Delaware against Sanofi, Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals for patent infringement of US Patent Numbers 8,563,698, 8,829,165, and 8,859,741.
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OctreoPharm's OPS202 receives FDA orphan drug status for neuroendocrine tumors
By PBR Staff Writer
German radiopharmaceutical firm OctreoPharm Sciences has received orphan drug designation from the US food and Drug Administration (FDA) for its new radiotracer OPS202, based on a next generation antagonistic somatostatin analog for the management of neuroendocrine tumors (NET).
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FDA approves Navidea’s lymphoseek for lymphatic mapping in solid tumors
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Navidea Biopharmaceuticals' supplemental new drug application (sNDA) for the expanded use of Lymphoseek injection for lymphatic mapping in solid tumors and adding Sentinel Lymph Node detection for breast cancer and melanoma to the approved indications.
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Prima announces immutep's IMP321 patent application receives Australian notice of allowance
Prima BioMed is pleased to announce that Immutep has received a Notice of Allowance from the Australian Patent Office for Patent Application AU 2008306576 "Use of recombinant LAG-3 or the derivatives thereof for eliciting monocyte immune response".
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Mariel Therapeutics announces issuance of two US patents for use BMP-7 in OA and CKD
Mariel Therapeutics, a clinical stage therapeutic company focusing on Bone Morphogenetic Protein-7 and its application in Osteoarthritis (OA) and Chronic Kidney Disease (CKD), has announced that the US Patent and Trademark Office (USPTO) has issued two new patents related to BMP-7 in OA and CKD.
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FDA grants priority review to Pfizer's breast cancer drug palbociclib
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review for Pfizer's palbociclib, which is intended to treat postmenopausal women with advanced breast cancer.
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Prosensa begins NDA submission to FDA for DMD drug drisapersen
By PBR Staff Writer
Dutch biotechnology firm Prosensa Holding has started the submission process for a new drug application (NDA) regulatory filing to the US Food and Drug Administration (FDA) for its lead exon-skipping drug candidate, drisapersen, to treat Duchenne muscular dystrophy (DMD).
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Cipla Medpro, Teva Pharmaceuticals partner to market products in South Africa
By PBR Staff Writer
India-based drug maker Cipla’s Medpro Pharmaceutica has collaborated with Israel's Teva Pharmaceuticals to provide South Africans with access to a broader range of affordable medicines.
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Regen files IND application for dCellVax with FDA to treat breast cancer
By PBR Staff Writer
Regen BioPharma has filed an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to begin a clinical trial evaluating safety and therapeutic effects of its immunotherapeutic product, dCellVax, to treat patients with metastatic breast cancer.
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Aciex announces issuance of separate US patents covering two leading product candidates
Aciex Therapeutics has announced that the US Patent and Trademark Office (USPTO) has issued a US Patent (No. 8,829,005) covering AC-170 Cetirizine Ophthalmic Compositions and a US Patent (No. 8,765,725) covering AC-155 Fluticasone Propionate Nano-crystalline Compositions.
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