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EISAI seeks approval to expand antiepilepsy agent Fycompa as adjunctive cure of primary generalised tonic-clonic seizures
By PBR Staff Writer
Eisai announced today that it has submitted applications to regulatory authorities in the U.S. and Europe (the FDA and EMA respectively) for the indication expansion of its in-house developed antiepileptic drug Fycompa as an adjunctive treatment of primary generalized tonic-clonic seizures (PGTC).
Regulatory Affairs > News
Glenmark starts IND-enabling studies of new bispecific antibody
By PBR Staff Writer
Glenmark Pharmaceuticals has started the investigational new drug (IND)-enabling studies of a new bispecific antibody.
Drug Research > Drug Discovery & Development > News
Lannett agrees to purchase two generic pharmaceutical products
By PBR Staff Writer
Lannett has signed an agreement to acquire abbreviated new drug applications (ANDAs) for two generic pharmaceutical products.
Contract Research & Services > Contract Services > News
Mitsubishi Tanabe Pharma, Astrazeneca partner on diabetic nephropathy research
By PBR Staff Writer
Japan-based Mitsubishi Thnabe Pharma (MTPC) has collaborated with AstraZeneca to carry out research on diabetic nephropathy.
Drug Research > Drug Discovery & Development > News
UK launches emergency research to help battle Ebola outburst
By PBR Staff Writer
The UK Department for International Development (DIFD) and the Wellcome Trust health research charity have offered experts £6.5m to find ways to save the lives of citizens hit with the Ebola virus.
Contract Research & Services > Contract Research > News
FDA authorizes Kronus ZnT8Ab Elisa Assay for marketing
By PBR Staff Writer
The US Food and Drug Administration (FDA) has authorized the marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that helps in determination of Type 1 Diabetes.
Regulatory Affairs > News
Regeneus, Cryosite to jointly manufacture human stem cell products
By PBR Staff Writer
Regeneus has signed an agreement with Cryosite to collaborate on the development and manufacture of new stem cell products for human applications.
Production & Manufacturing > Manufacturing > News
MorphoSys, Emergent BioSolutions to co-develop and commercialize ES414
By PBR Staff Writer
MorphoSys AG and Emergent BioSolutions Inc. announced an agreement for the joint development and commercialization of ES414.
FDA approves GSK’s Arnuity Ellipta to treat asthma in US
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline’s (GSK) fluticasone furoate inhalation powder, to be sold as Arnuity Ellipta, as a daily-once corticosteroid for treatment of asthma in patients aged above twelve years in the US.
Drug Research > Drug Discovery & Development > News
Pernix Therapeutics acquires US rights For Treximet
By PBR Staff Writer
Pozen, a pharmaceutical company committed to transforming medicine that transforms lives, announced that the acquisition of all of GlaxoSmithKline’s (GSK) rights to Treximet® (sumatriptan / naproxen sodium) have been acquired by Pernix Therapeutics Holdings, Inc. (Pernix).
Contract Research & Services > Contract Services > News
TB Alliance to receive drug candidate compounds from Novartis
By PBR Staff Writer
Novartis has signed an exclusive worldwide licensing agreement with the Global Alliance for TB Drug Development (TB Alliance) for compounds to fight tuberculosis (TB) that have been discovered at the Novartis Institutes for Tropical Diseases (NITD).
Contract Research & Services > Contract Services > News
Mylan launches generic version of Precedex injection
By PBR Staff Writer
Mylan has launched its new dexmedetomidine hydrochoride injection, 100 mcg (base)/mL after receiving the final approval from the US Food and Drug Administration (FDA) for the product’s Abbreviated New Drug Application (ANDA).
Drug Research > Drug Delivery > News
FDA approves Lilly and Boehringer’s Basaglar insulin glargine injection
By PBR Staff Writer
The US Food and Drug Administration (FDA) has offered tentative approval for Basaglar insulin glargine injection, which is jointly developed by Eli Lilly and Boehringer Ingelheim, signifying its compliance with all the regulatory needs for approval.
Drug Research > Drug Delivery > News
US DoJ clears AstraZeneca’s clinical trial
By PBR Staff Writer
The United States Department of Justice (US DoJ) has concluded its probe into PLATO clinical trial for AstraZeneca's Brilinta (ticagrelor), with no further action required.
Regulatory Affairs > News

PBR Supplier Recommendations

Sanofi CEPiA - Suppliers of APIs, Custom Synthesis and Pharmaceutical Contract Manufacturing
CEPiA (Commercial & External Partnership, Industrial Affairs) is an organization fully dedicated to third-party activities within the industrial affairs of Sanofi. ... Production & Manufacturing > Fine & Speciality Chemicals > Suppliers
INFOTEHNA Group - Pharmaceutical Software Solutions
INFOTEHNA Group is a leading provider of software solutions for the life sciences industries. We develop and deliver integral enterprise content, process management and regulatory compliance.... Automation > IT & Software > Suppliers
Vertellus Specialties UK Ltd – Supplier of Biocompatible Materials
Vertellus Biomaterials, a business unit of Vertellus Specialties UK Ltd, is the exclusive supplier of a range of clinically proven biocompatible materials known collectively as PC Technology™. ... Suppliers
Pharmathen - Integrated Pharma Solutions
Pharmathen was founded in 1969 as a private pharmaceutical company. The company focuses on developing and marketing health care products, and has a particularly strong position in generics. Pharmathen is located in Athens, Greece, and is one of the fastest growing pharmaceutical companies in Europe. It has a global reach – 75% of its turnover is generated from exports. ... Suppliers
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, so far, has been on the rapidly emerging markets of Latin America, MENA and Asia; however, we recently intensified our activities in Europe and North America. Our deep corporate experience gives us a global reach, with a contact base that includes key players in our focus markets.... Suppliers
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PBR White Paper Recommendations

Free White Paper - Quality Inspection By Pharmacontrol Electronic
This free white paper aims to familiarize you with the key aspects of optical inspection systems, along with the process improvement opportunities they provide.

  • Brand protection and product safety
  • The benefits of machine vision inspection
  • Rating criteria for vision inspection solutions
  • Committed to quality
  • Product quality and the quality of printed information
  • Essential technologies and PC-based systems
  • Smart camera solutions and sensors
  • Requirements for complete systems
  • Maximizing costs and minimizing downtime
  • Further information
Packaging > White Papers Free White Paper - Aggregation By Pharmacontrol Electronic
Aggregation - integrated solutions for the traceability of products:

  • Marking, verifying, safeguarding - From cardboard boxes to shipping containers
  • Safety first - Safety requires rules and expertise
  • Tracking - Codes and markings are what tips the scales
  • Solutions - Maximum safety in the pharmaceutical packaging process
  • Performance - The expert partner for Track & Trace systems and aggregation solutions
  • Outlook - The world of Track & Trace is evolving
Packaging > White Papers Free White Paper - Serialization of Pharmaceuticals By Pharmacontrol Electronic
METTLER TOLEDO PCE has developed a guide that provides companies, in accordance with current or emerging serialization legislation, with crucial information on making an implementation decision by:

  • Summarizing the minimum requirements of a serialization solution
  • Outlining the complexity involved when implementing a serialization solution
  • Detailed questions that must be addressed when choosing a production line equipment supplier
Packaging > White Papers IDT Biologika - Pharmaceuticals 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 The Value of Product Identity By Systech International
The shift towards item-level traceability coupled with the development of intelligent consumer interfaces and smart phone technology offers manufacturers the opportunity to drive competitive differentiation from the personification of their products. This paper examines the process of creating Product Identity and the enterprisewide returns that can be derived from it. ... Production & Manufacturing > Manufacturing > White Papers See more
1-15 of 49474 results