Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club
Production & Manufacturing
Process & Production
Return to: PBR Home | Production & Manufacturing | Process & Production

Process & Production

Relypsa submits NDA for FDA clearance of hyperkalemia treatment Patiromer FOS By PBR Staff Writer
Biopharmaceutical firm Relypsa has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking clearance to market Patiromer for Oral Suspension (Patiromer FOS) to treat hyperkalemia.
Production & Manufacturing > Process & Production > News
USPTO grants Epizyme with notices of allowance for patent applications covering PRMT5 inhibitors Epizyme, a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, has announced that the US Patent and Trademark Office has granted Notices of Allowance for US Patent Applications, Nos. 14/136,551 and 14/136,738, both entitled “PRMT5 Inhibitors and Uses Thereof.”
Production & Manufacturing > Process & Production > News FDA clears Tonix's IND for TNX-201 to treat episodic tension-type headache By PBR Staff Writer
The US Food and Drug Administration (FDA) has cleared Tonix Pharmaceuticals' investigational new drug (IND) application to evaluate TNX-201, a single isomer of isometheptene (IMH), to treat episodic tension-type headache.
Production & Manufacturing > Process & Production > News
See more Process & Production news

Latest Process & Production News and Insight

View all Process & Production news or find news targeted to your interests
TWi Biotechnology's AC-201 secures FDA orphan drug status for epidermolysis bullosa
By PBR Staff Writer
TWi Biotechnology has received the Orphan Drug designation from the US food and Drug Administration (FDA) for AC-201, a first-in-class, small molecule, to treat epidermolysis bullosa (EB).
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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".
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
View all Process & Production news or find news targeted to your interests

Buy the latest industry research online today!
Shire Plc : Pharmaceuticals & Healthcare - Company Profile, SWOT & Financial Report 03 October 2013 This report is a crucial resource for industry executives and anyone looking to access key information about "Shire Plc" The report utilizes a wide range of primary and secondary sources, which are analyzed and presented in a consistent and easily accessible format. ICD Research strictly follows a standardized research methodology to ensure high levels of data quality and these characteristics guarantee a unique report. Buy online from $250