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EMA committee recommends AstraZeneca's ovarian cancer drug Lynparza
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending AstraZeneca's marketing authorization of ovarian cancer drug Lynparza (olaparib) as monotherapy.
Regulatory Affairs > News
Cytori gets FDA nod to resume enrolment in ATHENA cardiovascular trial
By PBR Staff Writer
Cytori Therapeutics has received notification from the US Food and Drug Administration (FDA) that the company has provided additional information sufficient to support continuation of enrollment in its ATHENA cardiovascular trials.
Contract Research & Services > Clinical Trials > News
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
NICE recommends Bayer's rivaroxaban as option for secondary prevention in ACS
By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has issued its Appraisal Consultation Document (ACD) recommending Bayer HealthCare's Xarelto (rivaroxaban) 2.5mg twice daily as an option for secondary prevention in acute coronary syndrome (ACS).
Regulatory Affairs > News
Islet and BHV report two Phase IIb clinical trials of remogliflozin etabonate to treat type 2 diabetes
Islet Sciences has announced the publication of two peer-reviewed articles highlighting clinical results from completed 12-week Phase 2b studies of remogliflozin etabonate, a selective sodium glucose transporter 2 (SGLT2) inhibitor currently being developed by Brighthaven Ventures for type 2 diabetes and nonalcoholic steatohepatitis (NASH).
Contract Research & Services > Clinical Trials > News
Vaxart accelerates Ebola tablet vaccine development
Vaxart, a privately held company developing vaccines that are administered by tablet rather than by injection, has announced that the company is accelerating its Ebola tablet vaccine program.
Drug Research > Drug Discovery & Development > 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
Medivation licenses anti-PD-1 immune modulatory monoclonal antibody from CureTech
Medivation, and CureTech, announced Medivation has licensed exclusive worldwide rights to CureTech's late-stage clinical molecule pidilizumab (CT-011), an immune modulatory anti-PD-1 monoclonal antibody.
Contract Research & Services > Contract Services > News
Roche to invest $3.2bn in Basel site development
By PBR Staff Writer
Swiss health-care firm Roche is planning to invest CHF3bn ($3.2bn) over the next ten years on development work at its Basel site, including CHF1.7bn ($1.8bn) on the construction of a new research and development (R&D) centre.
Contract Research & Services > Contract Research > News
Zymeworks, Lilly extend deal for new bi-specific immunotherapies on Azymetric platform
By PBR Staff Writer
Zymeworks and Eli Lilly and Company have extended their existing licensing and collaboration agreement for development of an undisclosed number of new bi-specific antibody therapeutics using Zymeworks’ Azymetric platform.
Automation > IT & Software > News
Novartis reports positive results from two Phase III trials of secukinumab in ankylosing spondylitis
By PBR Staff Writer
Novartis has reported positive results from its Phase III trials MEASURE 1 and MEASURE 2 of its investigational medicine AIN457 (secukinumab) in patients with ankylosing spondylitis (AS).
Contract Research & Services > Clinical Trials > News
Global Biosimilar Development
| By PRA Health Sciences
Many different terms are used in different parts of the world to describe “biosimilar products.” It is important to understand and differentiate true biosimilars from others because of the potential concern for patient safety and efficacy, and the misconceptions that can arise from misleading published reports.
Contract Research & Services > Contract Research > White Papers
Boehringer starts Phase III colorectal cancer trial of nintedanib
By PBR Staff Writer
Germany-based Boehringer Ingelheim has initiated patient enrollment in a new global Phase III trial called LUME-COLON 1 of nintedanib to treat advanced colorectal cancer (CRC).
Contract Research & Services > Clinical Trials > News
EMA grants orphan status for GW Pharmaceuticals' Epidiolex to treat Dravet syndrome
By PBR Staff Writer
The European Medicines Agency (EMA) has granted orphan designation to GW Pharmaceuticals' investigational product Epidiolex (cannabidiol or CBD) to treat Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy.
Regulatory Affairs > 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

PBR Supplier Recommendations

Mexichem Fluor - Pure Quality
Mexichem Fluor is the world leader in medical propellants and we have many years of experience operating to the highest current Good Manufacturing Practice (cGMP) standards. Our detailed understanding of the needs, standards and regulatory requirements of the pharmaceutical sector, coupled with our expertise in fluorine chemistry, makes us unique in our industry.... Production & Manufacturing > Fine & Speciality Chemicals > Suppliers
3R PHARMA CONSULTING - Reducing Regulatory Risk
3R PHARMA CONSULTING provides cost-effective, timely solutions to registration filings and challenges in pharmaceutical development strategies across Europe, the US and the rest of world. ... Regulatory Affairs > Suppliers
FeF Chemicals - Insulin Human and Benzalkonium Chloride Products
FeF Chemicals is a Novo Nordisk company that specialises in the supply of ingredients for the biopharmaceutical and pharmaceutical industries, such as insulin human for cell culture media and cGMP manufactured quaternary ammonium compounds (usually referred to as quats) such as benzalkonium chloride, cetrimide and cetrimonium bromide.... Production & Manufacturing > Manufacturing > Suppliers
Fujifilm Diosynth Biotechnologies - Biopharmaceutical Process Development and Manufacturing Services
We are one of the world’s leading suppliers of contract process development and manufacturing services for the biopharmaceutical industry. Created in April 2011, Fujifilm Diosynth Biotechnologies has more than 900 employees, operating from two sites in Billingham, UK, and the Research Triangle Park in North Carolina, US.... Production & Manufacturing > Manufacturing > Suppliers
IDDI - eClinical and Biostatistical Services for Phase I to IV Clinical Trials
Established for more than 23 years, International Drug Development Institute (IDDI), has grown thanks to its niche positioning as a major service provider in the trial design and collection, analysis and reporting of clinical research data. IDDI combines expert methodology in biostatistics with innovative integrated technology (eClinical suite of made-to-measure secure web systems: IWRS and web coding integrated to EDC) to optimise the design and conduct of clinical trials. ... Suppliers
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PBR White Paper Recommendations

Global Biosimilar Development By PRA Health Sciences
Many different terms are used in different parts of the world to describe “biosimilar products.” It is important to understand and differentiate true biosimilars from others because of the potential concern for patient safety and efficacy, and the misconceptions that can arise from misleading published reports.... Contract Research & Services > Contract Research > White Papers Global Capabilities in Central Nervous System Research By PRA Health Sciences
PRA Health Sciences’ (PRA) Early Development Services (EDS) group has a long-standing track record of early clinical development work in various CNS indications through our global clinical facilities.... Contract Research & Services > Contract Research > White Papers Cystic Fibrosis: Pulmonary Aspects of the Disease By Cromsource
Cystic fibrosis (CF) is a genetic disease which is usually caused by the absence, dysfunction or reduced number of the multifunctional CF transmembrane regulator (CFTR) protein... Recently new therapy approaches such as ivacaftor have emerged which target the cause of the condition itself. This white paper focusses only on the current treatment of pulmonary complications of CF.... Contract Research & Services > Contract Research > White Papers Studying Low-Affinity Fragments of Ligands by ITC By Malvern Instruments
Molecular recognition is a fundamental prerequisite to all biological processes from enzymatic catalysis to signal transduction. The modern pharmaceutical industry is built upon the concept of selective intervention in such systems (1). Furthermore, similar concepts are being implemented, through supramolecular chemistry, to develop novel smart materials, components for nanotechnology and molecular electronics (2). If we are to harness the full potential of molecular recognition, it is essential that we understand the subtle interplay between structure and thermodynamics in complex formation.... White Papers Pharmaceutical Excipient Characterisation By Malvern Instruments
The aim of formulation development is to design a product and its manufacturing process to consistently deliver the intended Quality Target Product Profile (QTPP). This involves determining the Critical Quality Attributes (CQAs) for the Active Pharmaceutical Ingredient (API) and excipients that define the performance of the product. These are generally identified through an assessment of the extent to which the variation in a specific attribute, for example particle size, can impact the drug product’s quality and performance.... White Papers See more
1-15 of 50114 results