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FDA approves Eagle's malignant hyperthermia treatment Ryanodex
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Eagle Pharmaceuticals' Ryanodex (dantrolene sodium) for injectable suspension to treat malignant hyperthermia (MH), along with the appropriate supportive measures.
Drug Research > Drug Delivery > News
BioSyent signs licensing deal for new urgent care drug product
By PBR Staff Writer
BioSyent Pharma has signed an exclusive licensing and distribution agreement with an existing European partner for a new product that will be marketed by its Hospital Products Division.
Contract Research & Services > Contract Services > News
Neurotrope, Mount Sinai to develop Bryostatin-1 for NPC treatment
By PBR Staff Writer
Neurotrope Bioscience has entered into a license agreement with Icahn School of Medicine at Mount Sinai to use its information and data package for the development of Bryostatin-1 to treat Niemann-Pick Type C Disease (NPC).
Drug Research > Drug Discovery & Development > News
Biogen Idec's multiple sclerosis drug Plegridy gets European approval
By PBR Staff Writer
US-based biotechnology firm Biogen Idec (BIIB) has received marketing authorization from the European Commission (EC) for Plegridy (peginterferon beta-1a) to treat adults with relapsing-remitting multiple sclerosis (RRMS).
Drug Research > Drug Delivery > News
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.
Production & Manufacturing > Process & Production > News
Welichem enters into termination agreement with Celestial and BWTP
Welichem Biotech has entered into a termination agreement with Shenzhen Celestial Pharmaceuticals (Celestial) and Beijing Wenfeng Tianji Pharmaceuticals (BWTP) to terminate the asset purchase agreement dated March 26, 2013 among the parties, pursuant to which the Company agreed to purchase the exclusive development and commercialization rights to the novel anti-inflammatory agent, WBI-1001, in China , Taiwan , Macao and Hong Kong.
Production & Manufacturing > Manufacturing > News
Biosceptre reports positive Phase I results for BIL-010t to treat Basal Cell Carcinoma
Biosceptre, the oncology company developing antibody products that target the nf-P2X7 receptor, has reported positive results from its Phase I trial to assess the safety and tolerability of BIL-010t (formerly known as BSCT (Anti-nf-P2X7) 10% Ointment), a topically administered, highly purified sheep antibody therapy, to treat Basal Cell Carcinoma (BCC).
Contract Research & Services > Clinical Trials > News
Essentialis gets foundation for Prader-Willi Research Grant to help advance DCCR for Prader-Willi syndrome
Essentialis has announced the receipt of a grant from the Foundation for Prader-Willi Research (FPWR) to support clinical study PC025, which is designed to evaluate the safety and efficacy of diazoxide choline controlled release tablets (DCCR) in obese Prader-Willi syndrome patients.
Contract Research & Services > Contract Research > News
Sinovac receives Beijing CDC tender to supply seasonal flu vaccine Anflu
Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it has been selected by the Beijing Centers for Disease Control and Prevention to be a supplier of the seasonal influenza vaccine to the citizens of Beijing for 2014.
Contract Research & Services > Contract Services > News
Mezzion Pharma begins clinical development program to evaluate Udenafil in adolescents with single ventricle heart defects
Mezzion Pharma has initiated a clinical program to evaluate the use of udenafil to treat adolescents who have undergone the Fontan surgical palliation for single ventricle heart defects.
Drug Research > Drug Discovery & Development > News
ArmaGen, Shire to develop AGT-182 for treatment of hunter syndrome
ArmaGen, a privately held biotechnology company, has announced that it has entered into a worldwide licensing and collaboration agreement with Shire plc to develop AGT-182, an investigational enzyme replacement therapy (ERT) for potential treatment of both the central nervous system (CNS) and somatic (body-related) manifestations of Hunter syndrome.
Drug Research > Drug Discovery & Development > News
Bristol-Myers enters into immuno-oncology collaboration with Ono Pharmaceutical
By PBR Staff Writer
Bristol-Myers Squibb (BMS) and Ono Pharmaceutical have entered into a strategic agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens for cancer patients in Japan, South Korea and Taiwan.
Drug Research > Drug Discovery & Development > News
Puma Biotechnology revises Neratinib licensing deal with Pfizer
By PBR Staff Writer
US-based biopharmaceutical firm Puma Biotechnology has revised its licensing agreement with Pfizer for Puma's investigational drug PB272 (neratinib).
Contract Research & Services > Contract Services > News
Antares starts dosing in Phase III QuickShot trial evaluating testosterone-deficient adult males
By PBR Staff Writer
US-based Antares Pharma has dosed first patient in a Phase III trial designed to evaluate the efficacy and safety of QuickShot Testosterone (QS T) administered subcutaneously once each week to testosterone-deficient adult males.
Contract Research & Services > Clinical Trials > News
Iroko Pharmaceuticals, CALOX partner to commercialize Zorvolex in Latin America
By PBR Staff Writer
US-based Iroko Pharmaceuticals has signed a licensing agreement with CALOX DE COSTA RICA for exclusive rights to market and sell Zorvolex (diclofenac) capsules in specified countries in Latin America.
Contract Research & Services > Contract Services > News

PBR Supplier Recommendations

Pharmaphenix - International Pharmaceutical Consulting Company
Pharmaphenix, established in 2008, is an international pharmaceutical consulting company that specializes in all aspects of the business development chain. We work with a broad range of biotechnology companies, start-up ventures, investors and pharmaceutical companies, and our main focus is on the rapidly emerging markets of Latin America, MENA and Asia. Our deep corporate experience gives us a global reach, with a contact base that includes key players in our focus markets.... Suppliers
Woodley Equipment Company – International Supply of Medical and Laboratory Equipment for Clinical Trials
Woodley Equipment Company is a specialist global supplier of medical equipment to the clinical trials industry, with unrivalled levels of customer service and an extensive range of laboratory and medical equipment for rental and purchase.... Automation > Laboratory Instrumentation > Suppliers
Custom Powder Systems©: The Art of Engineering in Dry Material Containment, Blending and Beyond
The light bulb, the telegraph, the aeroplane: like our heroes, we reject the notion that something cannot be done just because no one has done it before.... Production & Manufacturing > Manufacturing > Suppliers
IDT - Biopharmaceutical Development & Contract Manufacturing Services
IDT Biologika GmbH is an innovative, privately-held company with more than 90 years of experience in researching, developing, manufacturing and marketing of biologics. IDT operates one of Europe’s premiere integrated biological and pharmaceutical development and manufacturing facilities.... Production & Manufacturing > Manufacturing > Suppliers
TSS - Temperature Sensitive Solutions
TSS is a leading provider of products and services for cold chain management, with focus on temperature monitoring. TSS has since its establishment in 1992, provided cold chain solutions to the pharmaceutical industry. The product portfolio contains the Cold Chain Information System (web based temperature monitoring system), CoolKeeper refrigerants and ProBox shipping containers.... Contract Research & Services > Clinical Trials > Suppliers
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PBR White Paper Recommendations

IDT Biologika - A Strategic Partner for Your Sterile Liquid Dosage Forms By IDT Biologika
In the highly specialized world of sterile liquid dosage forms, IDT Biologika is a contract manufacturing organization with the experience, the capability and the commitment to excellence to offer you a strategic advantage in your commercialization process. Our expertise drives our activities into higher-value pharmaceutical and biotechnology applications.... Production & Manufacturing > Manufacturing > White Papers Freeze Drying - Large-Scale Production for Biologics By IDT Biologika
IDT's new world-class multi-purpose high-speed filling and large-scale freeze-drying plant for human vaccines (liquid and lyophilized) is equipped to handle and respond to the complex quality and safety demands of current and future live vaccines and immunotherapeutic medicines.... Production & Manufacturing > Manufacturing > White Papers IDT Biopharmaceutical Contract Manufacturing By IDT Biologika
IDT's special expertise and capabilities include: development and aseptic filling services for parenterals in syringes, vials and ampoules; proven expertise in processing of biopharmaceutical and chemical substances; leading competence in freeze drying of narcotics; and integrated bio and pharma manufacturing site with comprehensive quality control services.... Production & Manufacturing > Manufacturing > White Papers IDT Human Vaccines Contract Manufacturing By IDT Biologika
IDT produces a wide variety of vaccines for clinical testing and is also developing new technologies for many innovative and future orientated human vaccines, for instance against tuberculosis, AIDS and malaria. Over 20 different vaccines for clinical trials in humans have been handled by IDT to date.... Production & Manufacturing > Manufacturing > White Papers Vaccines - Creating Value, Protecting Lives By IDT Biologika
IDT is a knowledgeable partner and an expert in the field of biologics contract manufacturing. IDT is focused on four business segments: animal health, vaccines, pharmaceuticals and quality control. We are a vital link in the development chain of new vaccines. Our core competency is in the contract production of viral and bacterial vaccines. We offer a comprehensive portfolio of services and solutions, from development up to large-scale production.... Production & Manufacturing > Manufacturing > White Papers See more
1-15 of 49384 results