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Process & Production

Catalyst starts process to offer Firdapse at no cost to LEMS patients in US By PBR Staff Writer
US-based Catalyst Pharmaceutical Partners has initiated the process necessary to establish an expanded access program (EAP) to make available its investigational potassium channel inhibitor, Firdapse in the US, to patients diagnosed with Lambert-Eaton Myasthenic Syndrome (LEMS) through their neuromuscular disease specialists.
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VistaGen receives notice of allowance for US patent expanding stem cell technology platform VistaGen Therapeutics has announced that the US Patent and Trademark Office has issued a notice of allowance for US Patent Application 12/836,275, entitled ‘Cell populations enriched for endoderm cells’.
Production & Manufacturing > Process & Production > News Abbvie submits NDA to FDA for hepatitis C drug By PBR Staff Writer
US-based biopharmaceutical firm AbbVie has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for its investigational, all-oral, interferon-free regimen to treat adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.
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ProLynx gets US patent covering controlled drug release from dendrimer conjugates
By PBR Staff Writer
US-based biotechnology firm ProLynx has announced that the US Patent and Trademark Office has issued Patent 8,703,907 covering controlled release of drugs from dendrimer conjugates over prolonged periods.
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Regenerx gets notice of allowance for US patent for treatment of stroke using Tß4
By PBR Staff Writer
US-based RegeneRx Biopharmaceuticals has received a Notice of Allowance for a second US patent for treating central nervous system injuries and disorders using Thymosin beta 4 (Tβ4) to regenerate damaged tissue.
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Enzymotec announces final decision issued by USPTO rejecting all claims in Neptune's patent
Enzymotec has announced that on 18 April 2014 the US Patent and Trademark Office (USPTO) issued a final decision in the inter partes reexamination of Neptune Technologies & Bioressources 8,030,348 patent rejecting all of the claims.
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Foamix announces issuance of five additional US patents
Foamix, a clinical-stage, specialty pharmaceutical company, has announced that the US Patent and Trademark Office (USPTO) has issued five new patents covering its technologies.
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Coldstream Laboratories completes successful FDA inspection
Coldstream Laboratories, a provider of sterile drug product development and manufacturing services, has announced the completion of a successful inspection by the Food and Drug Administration (FDA).
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Depomed announces settlements with two Gralise ANDA filers
US-based specialty pharmaceutical company Depomed has announced it has entered into settlement agreements with two of the three defendants involved in the company's ongoing patent infringement litigation against filers of Abbreviated New Drug Applications (ANDAs) seeking approval to market generic versions of its Gralise (gabapentin) 300mg and 600mg tablets.
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Advaxis announces notice of allowance for two patent applications in Japan
Advaxis, a biotechnology company, has announced that the Japan Patent Office issued to the company two notices of allowance for two patent applications (P-72863-JP, P-7924) with claims for each patent application related to the company's proprietary cancer immunotherapy platform technology.
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Federal judge enforces settlement agreement between Mylan and Endo Pharmaceuticals regarding generic Frova
Mylan has confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and the company settling patent litigation in connection with Mylan's filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for Frovatriptan Succinate Tablets, 2.5mg.
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Fate gets US patent for class of small molecule modulators of Rho-associated kinase
By PBR Staff Writer
US-based biopharmaceutical firm Fate Therapeutics has announced that the US Patent and Trademark Office (PTO) has issued Patent No. 8,691,573 entitled 'Stem Cell Cultures.'
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USPTO grants additional patent to BrainStorm for autologous stem cell technology
By PBR Staff Writer
The US Patent and Trademark Office (USPTO) has granted an additional patent to BrainStorm Cell Therapeutics, a developer of adult stem cell technologies for neurodegenerative diseases, for its autologous stem cell technology.
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