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Process & Production

FDA accepts to review Adamis' NDA for Epinephrine pre-filled syringe By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for review Adamis Pharmaceuticals' new drug application (NDA) for the product, Epinephrine Injection, USP, 1:1000 (0.3mg Pre-filled single dose syringe) (PFS), for the emergency treatment of allergic reactions (Type I) including anaphylaxis.
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FDA clears Fate Therapeutics' IND for PROHEMA in inherited metabolic disorders By PBR Staff Writer
The US Food and Drug Administration (FDA) has cleared US-based biopharmaceutical firm Fate Therapeutics' investigational new drug application (IND) for the clinical development of PROHEMA in pediatric patients undergoing hematopoietic stem cell (HSC) transplantation for the treatment of inherited metabolic disorders (IMDs).
Production & Manufacturing > Process & Production > News Ryogen awarded two patents directed to polynucleotide sequences Ryogen, an R&D company focusing on polynucleotide sequences implicated in human diseases, was awarded two new patents this month, bringing the total number of its issued U.S. Patents to 32.
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MacroGenics' IND for colorectal cancer drug candidate MGD007 gets FDA clearance
By PBR Staff Writer
US-based biopharmaceutical firm MacroGenics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) to proceed with the Phase I human clinical trial for this drug candidate 'MGD007'.
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Kinex announces allowance of IND application for KX2-391 ointment by USFDA
Kinex Pharmaceuticals has announced the receipt of an allowance by the US FDA for the Company's KX2-391 Ointment for the commencement of a Phase I clinical study in actinic keratosis. This is the Company's third IND to be allowed by the US FDA in the past 12 months.
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Lightlake Therapeutics files IND application for Naloxone opioid overdose nasal spray
By PBR Staff Writer
UK-based biopharmaceutical firm Lightlake Therapeutics has filed an investigational new drug application (IND) for its naloxone-based opioid overdose reversal nasal spray.
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OPKO granted patent from US Patent & Trademark Office for RAYALDEE
OPKO Health, a multinational biopharmaceutical and diagnostics company, has announced that the United States Patent and Trademark Office granted OPKO a patent covering RAYALDEE, the company’s product to treat secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
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FDA approves Avanir's Phase II trial of MDD candidate AVP-786
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Avanir Pharmaceuticals' investigational new drug (IND) application for a Phase II trial evaluating the safety and efficacy of its next generation compound AVP-786.
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ViaCyte files IND with FDA for new cell replacement therapy for type 1 diabetes
ViaCyte a privately held regenerative medicine company developing a cell replacement therapy for the treatment of diabetes, announced that it has filed an Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes.
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FDA accepts to review POZEN's NDA refiling for PA8140/PA32540 tablets
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted to review, the resubmission of US-based pharmaceutical firm POZEN's new drug application (NDA) for PA8140/PA32540 tablets.
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FDA grants priority review for Medivir's sNDA for Olysio-sofosbuvir combination
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted a Priority Review designation to Swedish pharmaceutical firm Medivir's supplemental New Drug Application (sNDA) for the use of once-daily Olysio (simeprevir) in combination with sofosbuvir for 12 weeks treatment of adult patients with genotype 1 chronic hepatitis C.
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Otsuka, Lundbeck file NDA for brexpiprazole to treat schizophrenia and MDD
By PBR Staff Writer
Japan-based Otsuka Pharmaceutical and Danish pharmaceutical firm Lundbeck have submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for brexpiprazole to treat schizophrenia as well as an adjunctive treatment of major depressive disorder (MDD).
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FDA accepts to review Teva's NDA for Albuterol MDPI
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted to review Teva Pharmaceuticals' new drug application (NDA) for albuterol multi-dose dry-powder inhaler (MDPI), an investigational breath-actuated dry-powder inhaler to treat or prevent bronchospasm in patients 12 years of age and older with reversible obstructive airway disease.
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