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Process & Production

Biostar files PRC patent application for oleanolic acid injection for hepatitis B and liver cancer Biostar Pharmaceuticals (BSPM), a PRC-based manufacturer and marketer of pharmaceutical and health supplement products in China for a variety of diseases and conditions, has announced that it has filed PRC national invention and creation patent for the pharmaceutical and preparation method of its new developed product, Oleanolic Acid Injection, which designed to treat Hepatitis B and liver cancer.
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Navidea's Lymphoseek cancer drug gets FDA orphan drug status By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for Navidea Biopharmaceuticals' Lymphoseek (technetium Tc 99m tilmanocept) Injection for use in sentinel lymph node detection in patients with cancer of the head and neck.
Production & Manufacturing > Process & Production > News Synthetic Biologics gets FDA orphan drug status for SYN-005 to treat whooping cough By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation to Synthetic Biologics' SYN-005 monoclonal antibody (mAb) combination to treat Pertussis (whooping cough), a highly contagious disease.
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Manuel Zahn to Attend GMP-BERATER Tage 2014
Manuel Zahn, founder and managing director of 3R Pharma Consulting will attend the GMP-BERATER Tage 2014. The meeting will see a small group of GMP experts meet and discuss new GMP regulations and will share their experiences at Schloss Reinach, near Freiburg, Germany, 8-9 October 2014.
Production & Manufacturing > Process & Production > Press Releases
Synthetic Biologics gets FDA orphan drug status for SYN-005 to treat whooping cough
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation to Synthetic Biologics' SYN-005 monoclonal antibody (mAb) combination to treat Pertussis (whooping cough), a highly contagious disease.
Production & Manufacturing > Process & Production > News
Lakewood-Amedex gets notice of allowance from USPTO for new patent covering nanoRNA gene-silencing technology
Lakewood-Amedex, a leading developer of novel anti-infective pharmaceuticals, announced today that the United States Patent and Trademark Office has issued a 'Notice of Allowance' for patent application 11/673,486 entitled 'Oligonucleotide-Containing Pharmacological Compositions And Their Uses'.
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Molecular Templates' IND application for MT-3724 gets FDA clearance
By PBR Staff Writer
Biopharmaceutical firm Molecular Templates has received approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to start clinical studies for MT-3724 as monotherapy to treat refractory non-Hodgkin’s lymphoma (NHL).
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Breckenridge announces paragraph IV ANDA litigation with Novartis for generic version of Zortress
Breckenridge Pharmaceutical, Inc. has announced that it has filed an ANDA with a Paragraph IV certification for Everolimus oral tablets, 0.25 mg, 0.5 mg, and 0.75 mg, a generic version of Zortress by Novartis.
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FDA accepts filing of Astellas' NDA for isavuconazole to treat fungal infections
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for filing Astellas' new drug application (NDA) for isavuconazole to treat invasive aspergillosis and invasive mucormycosis, also known as zygomycosis.
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Takeda submits NDA for Leuplin to treat hormone-dependent diseases in Japan
By PBR Staff Writer
Takeda Pharmaceutical Company has submitted a new drug application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) for Leuplin six-month depot, to treat hormone-dependent diseases such as prostate cancer and premenopausal breast cancer.
Production & Manufacturing > Process & Production > News
Alitair secures US composition of matter patent for benzonatate polacrilex
By PBR Staff Writer
Alitair Pharmaceuticals has received a second patent from the US Patent and Trademark Office (USPTO) for its ion exchange resin formulation of benzonatate, benzonatate polacrilex.
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DelMar receives notice of allowance for second US patent for VAL-083
DelMar Pharmaceuticals (DelMar) has announced that the US Patent and Trademark Office (USPTO) has issued a notice of allowance for patent application number 13/933,751, covering improved methods for synthesizing VAL-083, DelMar's lead drug candidate, which is currently in a Phase I/II clinical trial in the United States for the treatment of refractory glioblastoma multiforme (GBM).
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Orexigen expands NB32 intellectual property portfolio with new US patent
Orexigen Therapeutics has announced that the US Patent and Trademark Office (PTO) has issued a patent related to NB32, the company's investigational medication being evaluated for weight loss.
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