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PhoenixBio invests in KMT Hepatech
KMT Hepatech has reached an agreement to join efforts with PhoenixBio. Together the companies will advance the use of the cDNA-uPA/SCID mouse model with highly humanized liver to support researchers across a range of drug development fields.
Drug Research > Drug Discovery & Development > News
European Commission approves Tremfya to treat moderate to severe plaque psoriasis
Janssen-Cilag International announced that the European Commission (EC) has approved Tremfya (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Regulatory Affairs > News
Cancer Research UK to use Astra Zeneca’s AZD1775 in head and neck cancer trial
By PBR Staff Writer
UK researchers are all set to launch an early-stage trial to evaluate an experimental drug from Astra Zeneca’s for improving the treatment of head and neck cancer.
Contract Research & Services > Clinical Trials > News
Cytokinetics’ ALS treatment tirasemtiv fails to meet primary endpoint in phase 3 study
Cytokinetics has announced that international phase 3 clinical trial of tirasemtiv in patients with amyotrophic lateral sclerosis (ALS) has did not meet the primary endpoint.
Contract Research & Services > Clinical Trials > News
Midatech secures manufacturing certification from Spanish regulatory authority
Midatech Pharma has received manufacturing certification from Spanish regulatory authority AEMPS.
Production & Manufacturing > Manufacturing > News
Research finds gastric acid suppressant lansoprazole could target tuberculosis
By PBR Staff Writer
A new research in the UK suggests that a cheap and commonly used drug to treat heartburn, gastritis and ulcers has the potential to target Mycobacterium tuberculosis, the bacteria that causes tuberculosis (TB).
Drug Research > Drug Discovery & Development > News
FDA approves ViiV Healthcare’s two-drug regimen to treat HIV-1 infection
By PBR Staff Writer
Specialist HIV firm ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its two-drug regimen (2DR) Juluca to treat certain adults with human immunodeficiency virus type 1 (HIV-1).
Fresenius Kabi to extend pharmaceutical manufacturing in North Carolina
The State of North Carolina and Fresenius Kabi have announced plans to expand the company's presence in Wilson, North Carolina.
Production & Manufacturing > Manufacturing > News
Janssen seeks EMA approval for Darzalex for newly diagnosed multiple myeloma
Janssen-Cilag International has submitted a Type II variation application to the European Medicines Agency (EMA), for its immunotherapy Darzalex (daratumumab).
Production & Manufacturing > Process & Production > News
UK regulator accuses Concordia of overcharging NHS for thyroid drug
By PBR Staff Writer
The UK Competition and Markets Authority (CMA) has accused Canadian pharma company Concordia International of abusing its dominant position by increasing the price of a thyroid drug by about 6,000%.
Regulatory Affairs > News

PBR Supplier Recommendations

MSP Kofel – Analytical Accessories and Software Specialists
MSP Kofel provides analytical scientists with software and databases for interpretation, confirmation and archival of spectra, chromatographic data, structures and chemical compound information.... Suppliers
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
Biovian - cGMP Contract Manufacturing of Biopharmaceuticals
Biovian is a dynamic and effective new generation one-stop-shop CMO in cGMP contract manufacturing of biopharmaceuticals. Biovian's services cover the full range from antigen isolation, expression, vector construction, cell line cultivation, cGMP protein purification to product fill and finish.... Suppliers
Greater Copenhagen
Greater Copenhagen is a metropolitan region that covers eastern Denmark and Skåne in southern Sweden.... Suppliers
Outsourcing in Clinical Trials Pacific Northwest
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PBR White Paper Recommendations

Do you have a robust and compliant CAPA System? By NSF International
Pharma biotech companies around the globe are struggling to juggle numerous priorities and challenges. One of their biggest struggles is to effectively manage CAPAs.... White Papers How to write to Regulatory Agencies when things go wrong By NSF International
Your essential guidance on what to do next after you receive a less than positive regulator's audit report. ... White Papers SHL Group: Auto Injectors - From Planning to Launch By SHL Group
Preparing for the overall development process.... Regulatory Affairs > White Papers Greater Copenhagen HealthTech Brief By Greater Copenhagen
Evolving technology and the global demand for innovative health care solutions make Greater Copenhagen the perfect location for two converging industries: life science and tech. This is your chance to get a free business brief about our HealthTech industry. In the report, you will find all the information you need about setting up a HealthTech business in Greater Copenhagen.... White Papers Cellular Technology Limited: A multicolor Natural Killer cell-mediated cytotoxicity detection By CTL Laboratories
A multicolor Natural Killer cell-mediated cytotoxicity detection using fluorescence and direct cell imaging.... Contract Research & Services > Clinical Trials > White Papers See more
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