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1-15 of 51997 results
Neos resubmits ADHD drug application for FDA review
By PBR Staff Writer
Neos Therapeutics has resubmitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its amphetamine XR orally disintegrating tablet (XR-ODT) product candidate, NT‐0202, to treat attention deficit hyperactivity disorder (ADHD).
Production & Manufacturing > Process & Production > News
Ferrer completes second Phase III trial of impetigo treatment ozenoxacin
By PBR Staff Writer
Canada-based Cipher Pharmaceuticals' partner Ferrer International has completed the second Phase III clinical trial for ozenoxacin, a topical treatment for adult and paediatric patients with impetigo, a highly contagious bacterial skin infection.
Drug Research > Drug Discovery & Development > News
Juno IND application given FDA nod for leukemia drug candidate JCAR015
By PBR Staff Writer
The US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application of biopharmaceutical firm Juno Therapeutics for its product candidate JCAR015 to treat adults with relapsed/refractory acute lymphoblastic leukemia (r/r ALL).
Production & Manufacturing > Process & Production > News
Pediatric cancer treatment based on Nanosmart platform obtains FDA's orphan drug status
By PBR Staff Writer
US-based NanoSmart Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for a second drug product that uses the company's drug delivery platform.
Automation > IT & Software > News
AbbVie's Humira gets European approval to treat hidradenitis suppurativa
By PBR Staff Writer
US-based biopharmaceutical firm AbbVie has received approval from the European Commission (EC) to market Humira (adalimumab) for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS treatment.
Production & Manufacturing > Process & Production > News
Ligand licenses Captisol to Sanofi for development of MET kinase inhibitor
By PBR Staff Writer
Ligand Pharmaceuticals (LGND) has licensed chemically modified cyclodextrin Captisol to Sanofi for use in the development and commercialization of SAR-125844, a potent MET kinase inhibitor.
Automation > IT & Software > News
Eisai and Halozyme to evaluate combination drug for treatment of metastatic breast cancer
Eisai and Halozyme Therapeutics have agreed to evaluate the combination of their drugs, Halaven (eribulin) and PEGPH20 (PEGylated recombinant human hyaluronidase), respectively, in the treatment of first line HER2-negative metastatic breast cancer.
Drug Research > Drug Discovery & Development > News
Malvern Instruments Establishes new Biopharmaceutical Applications Laboratory in the Heart of San Diego's Biotech Community
Malvern Instruments has established a new biopharmaceutical applications laboratory in the heart of San Diego’s biotechnology cluster. The new laboratory will enable customers and Malvern applications specialists alike to experience and use Malvern’s range of specialist biophysical characterization systems in a working biopharmaceutical environment.
Press Releases
Medivir begins Phase I trial of AL-704 to treat hepatitis C
By PBR Staff Writer
Swedish research based pharmaceutical firm Medivir has started a Phase I clinical trial of the nucleotide polymerase inhibitor AL-704 for treatment of patients with hepatitis C.
Contract Research & Services > Clinical Trials > News
KaloBios' IND application for KB003 gets FDA clearance to treat patients with CMML
By PBR Staff Writer
KaloBios Pharmaceuticals has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for KB003, an anti-GM-CSF monoclonal antibody (mAb), to treat patients with chronic myelomonocytic leukemia (CMML).
Production & Manufacturing > Process & Production > News
Flexion completes patient enrollment in FX006 Phase III trial for osteoarthritis of the knee
By PBR Staff Writer
US-based pharmaceutical firm Flexion Therapeutics has completed enrollment of 486 patients in the Phase III clinical trial of its lead compound FX006 about three months earlier than anticipated.
Drug Research > Drug Discovery & Development > News
Kyowa Hakko Kirin, Bristol-Myers enter into immuno-oncology clinical collaboration
By PBR Staff Writer
Kyowa Hakko Kirin and Bristol-Myers Squibb have entered into a clinical trial collaboration agreement to conduct a Phase I/II combination trial with mogamulizumab, an anti-CCR4 antibody and Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor to treat advanced or metastatic solid tumors.
Drug Research > Drug Discovery & Development > News
Sanofi's first Lixilan Phase III trial meets primary endpoint
Sanofi announced that the LixiLan-O Phase III clinical trial met its primary objective in patients with type 2 diabetes treated with metformin.
Drug Research > Drug Discovery & Development > News
Lightlake partner Adapt Pharma submits NDA to FDA for Narcan nasal spray
Lightlake Therapeutics announced that Adapt Pharma Limited (Adapt), Lightlake's partner for treating opioid overdose with intranasal naloxone, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Narcan (naloxone) Nasal Spray, an investigational drug intended to treat opioid overdose.
Production & Manufacturing > Process & Production > News
CSSi LifeSciences, PRC Clinical partner to provide extended clinical trial services
CSSi LifeSciences formalized a strategic partnership agreement with PRC Clinical, a Silicon Valley-based CRO specializing in Clinical Trial Management. CSSi LifeSciences is specialized in strategic, marketing, and regulatory consulting, FDA advisory services, and patient recruitment services.
Contract Research & Services > Contract Research > News

PBR Supplier Recommendations

Axol - Succeed with Axol Your Human Cell Culture Specialists
Axol specializes in human cell culture, including extensive expertise in cellular reprogramming and lineage-specific differentiation of iPS cells. We have a passion for great science, delivering postdoctoral level support and providing innovative future products to help our customers advance faster in their research. Whether you would like ready-made cells from our portfolio of cell types and disease backgrounds, or need a customized project tailored to your research, we are here for you. ... Suppliers
PANalytical - Key Analytical Techniques and Products
PANalytical offers a wide range of key analytical techniques and products that are used in the pharmaceutical industry for research, development and quality control purposes. These rapid non-destructive analytical techniques such as near-infrared spectroscopy (NIR), X-ray diffraction (XRD) and X-ray fluorescence spectrometry (XRF) can be used for a large variety of (bio-)pharmaceutical applications including drug discovery, pre-formulation, formulation, stability testing and final product quality control. ... Automation > Laboratory Instrumentation > Suppliers
APCER Life Sciences – Together for better health
APCER Life Sciences is committed to improving health in partnership with its clients. We bring together safety, medical, regulatory, and technology resources to ensure that patients receive the safest, most effective therapies possible.... Suppliers
Copernicus - Specialists in the Development and Manufacture of Drug Delivery Systems
Copernicus specialise in the development and manufacture of drug delivery systems. We offer a complex range of activities needed for the introduction of a competitive drug delivery device: from the product concept, through design to manufacture and registration. ... Suppliers
Dow Pharma Solutions
Dow 's innovative DESIGNED PARTICLE MORPHOLOGY (DPM) brings pharmaceutical companies new differentiated IP-protected products and improved manufacturing capability. Through significant improved flow, METHOCEL™ DC2 enabled by Dow's patented DPM Technology helps you enjoy the benefits of dry powder processing techniques while improving tablet quality and delivering the controlled release performance expected from the proven family of METHOCEL™ excipients.... Suppliers
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PBR White Paper Recommendations

Truly Parallel - Microbiology By Eppendorf
DASGIP® Bioreactor Systems for Microbiology.... White Papers Truly Parallel - Cell Culture By Eppendorf
DASGIP® Bioreactor Systems for Cell Culture Applications.... White Papers Product Brochure: Most Compact By Eppendorf
DASbox® Mini Bioreactor System for Cell Culture and Microbiology.... White Papers Product Brochure: The Smarter Solution By Eppendorf
BioFlo® 320 bioprocess control station.... White Papers Translatability Assessment of the e-Health Impact Questionnaire By RWS Group
A study by researchers at the University of Oxford which demonstrates the importance of including a translatability assessment during the development of a questionnaire.... White Papers See more
1-15 of 51997 results