Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices | Videos
Pharmaceutical Business Review
Return to: PBR Home
Search Refinements
Search Results:
1-15 of 51422 results
Growing Potential: mAb Production With Fibra-Cel
| By Eppendorf
The market for monoclonal antibodies continues to grow steadily, but there are still bottlenecks in the development of new products, including long development times mostly due to R&D. Advanced bioprocess equipment that meets the specific demands of mAb-producing hybridoma can accelerate design and production, and reduce overall development costs along the way.
White Papers
DoE Bioprocess Development
| By Eppendorf
Eppendorf DASware is the effective route to design of experiments (DoE) in early-stage bioprocess development. Claudia M Huether-Franken and Sebastian Kleebank explain how the design software applies DoE to DASGIP parallel bioreactor systems.
White Papers
Taking the Strain
| By Eppendorf
Today, the rapidly expanding demand for vaccine products for viral diseases such as rabies has necessitated the development of more sophisticated production techniques based around cell culture systems. This article reviews vaccine production strategies, with a focus on rabies, looking specifically at the use of the Vero cell line - used worldwide and approved by the US Food and Drug Administration - as well as media technology and the bioreactor options available.
White Papers
Highland Therapeutics gets three US patents and one notice of allowance
Highland Therapeutics, a pharmaceutical company, announced that the US Patent and Trademark Office (USPTO) has issued three patents and one Notice of Allowance (NOA) for the Company’s lead products.
Automation > IT & Software > News
Ampio reports positive study results on Optina to treat Diabetic Macular Edema
Ampio Pharmaceuticals, announced positive results of the OptimEyes trial for DME. The OptimEyes trial was a multiple site, randomized, placebo controlled, parallel, double masked study to evaluate the safety and efficacy of two doses of oral Optina (adjusted to body mass index-BMI) in adult patients with Diabetic Macular Edema (DME).
Contract Research & Services > Clinical Trials > News
Tribute acquires US rights to Fibricor and commercial expansion into US Market
Tribute Pharmaceuticals Canada a specialty pharmaceutical company with a primary focus on the acquisition, licensing, development and promotion of healthcare products in Canada and the US, is pleased to announce that its wholly owned subsidiary, Tribute Pharmaceuticals International, a Barbados corporation, has acquired the US rights to Fibricor and its related authorized generic from a wholly owned step-down subsidiary of Sun Pharmaceutical Industries Ltd.
Contract Research & Services > Contract Services > News
FDA accepts Tris Pharma's NDA for Dyanavel XR to treat ADHD
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for review Tris Pharma's new drug application (NDA) for Dyanavel XR (amphetamine) CII, an Extended-Release Oral Suspension, for the treatment of attention deficit hyperactivity disorder (ADHD).
Automation > IT & Software > News
Kite Pharma begins dosing in Phase I/II trial of KTE-C19 to treat refractory aggressive NHL
By PBR Staff Writer
US-based Kite Pharma has started dosing in its Phase I/II clinical trial of KTE-C19, an anti-CD19 chimeric antigen receptor (CAR) T-Cell therapy, in patients with refractory aggressive Non-Hodgkin's Lymphoma (NHL) has been treated.
Contract Research & Services > Clinical Trials > News
Aura Biosciences gets FDA orphan disease designation for AU-011 to treat uveal melanoma
By PBR Staff Writer
US-based biotech firm Aura Biosciences received orphan disease designation from the US Food and Drug Administration (FDA) for its drug AU-011 for the treatment of Uveal Melanoma, also referred to as Ocular Melanoma (OM).
Production & Manufacturing > Process & Production > News
Strides Arcolab to buy Aspen's generic drugs business in Australia for $300m
By PBR Staff Writer
India-based Strides Arcolab's two subsidiaries have signed definitive agreements with certain wholly-owned subsidiaries of Aspen Pharmacare to acquire their generic pharmaceutical business in Australia, along with certain branded pharmaceutical assets for about A$380m ($300m).
Production & Manufacturing > Manufacturing > News
Wockhardt gets FDA QIDP status for new pneumonia drug WCK 4873
By PBR Staff Writer
Indian drug-maker Wockhardt has received Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA) for one of its product, WCK 4873, for the treatment of pneumonia.
Production & Manufacturing > Process & Production > News
Baxter BioScience submits MAA in Europe for IGSC 20% to treat primary immunodeficiency
By PBR Staff Writer
Baxter BioScience has submitted a marketing authorization application (MAA) to 17 competent authorities in Europe following the decentralized procedure (DCP) for approval of its investigational 20% concentration subcutaneous immune globulin (IGSC) treatment for primary immunodeficiencies (PI).
Production & Manufacturing > Process & Production > News
Boehringer, Eureka Therapeutics to develop new antibodies for cancer treatment
By PBR Staff Writer
German pharmaceutical firm Boehringer Ingelheim has entered into a research agreement with US-based Eureka Therapeutics to discover new therapeutic antibodies in oncology.
Contract Research & Services > Contract Research > News
Novare enters into research agreement with Lawson Health Research Institute
Novare Pharmaceuticals, which is developing therapeutic products that modulate the Receptor for Hyaluronan-Mediated Motility (RHAMM), is pleased to announce a research and licensing agreement with Lawson Health Research Institute that includes the creation of an incubator focused on potential treatments for major diseases, including arthritis, breast cancer, and lung fibrosis.
Contract Research & Services > Contract Research > News
Vical completes enrollment in Phase II trial of investigational CMV vaccine
Vical Incorporated announced the completion of enrollment in a Phase II trial of its therapeutic cytomegalovirus (CMV) vaccine in solid organ transplant recipients.
Drug Research > Drug Delivery > News

PBR Supplier Recommendations

Butterworth Laboratories Ltd – Experts in Pharmaceutical Analysis
Butterworth is a UK based contract laboratory providing pharmaceutical analysis in accordance with cGMP to the global pharmaceutical industry. We specialise in Quality Control, Method Development & Validation and Stability Storage & Testing. Our focus and expertise centre on raw materials but we also have experience of finished products and medical devices.... Suppliers
Rentschler - High-Performance Biopharmaceutical Development and Manufacturing
Identifying the most appropriate contract manufacturer who can best fulfil what you need for your lead pharmaceutical candidate is a real challenge. With over 40 years’ experience, Rentschler is one of the industry leaders for contract development and manufacturing.... Suppliers
Accutest Research Laboratories - Contract Research Organization
Accutest - a leading global independent and internationally accredited Contract Research Organization (CRO), offering services to customers around the world. Since its inception in 1998, the company has built an unmatched platform to provide end-to-end services to pharmaceutical and biotechnology companies globally. Accutest is the market leader amongst independent CROs, with the highest quality standards, quick turnaround time and global regulatory accreditations/approvals. ... Suppliers
SHL Healthcare - Developer and Manufacturer for Equipment Solutions
SHL Healthcare develops and manufactures equipment solutions for home, hospital and long-term care use with a focus on patient comfort and functionality. Our broad range of products include medical slings, rehabilitation beds, pressure mattress systems, lifting equipment, medical soft goods and a variety of related accessories. ... Suppliers
SHL Technologies - Contract Development and Manufacturing
SHL Technologies is a Contract Development and Manufacturing Organisation (CDMO) that provides OEM and ODM services for various industrial sectors from electronics to healthcare and medical.... Suppliers
See more

PBR White Paper Recommendations

Growing Potential: mAb Production With Fibra-Cel By Eppendorf
The market for monoclonal antibodies continues to grow steadily, but there are still bottlenecks in the development of new products, including long development times mostly due to R&D. Advanced bioprocess equipment that meets the specific demands of mAb-producing hybridoma can accelerate design and production, and reduce overall development costs along the way.... White Papers DoE Bioprocess Development By Eppendorf
Eppendorf DASware is the effective route to design of experiments (DoE) in early-stage bioprocess development. Claudia M Huether-Franken and Sebastian Kleebank explain how the design software applies DoE to DASGIP parallel bioreactor systems.... White Papers Taking the Strain By Eppendorf
Today, the rapidly expanding demand for vaccine products for viral diseases such as rabies has necessitated the development of more sophisticated production techniques based around cell culture systems. This article reviews vaccine production strategies, with a focus on rabies, looking specifically at the use of the Vero cell line - used worldwide and approved by the US Food and Drug Administration - as well as media technology and the bioreactor options available.... White Papers Amino Acid Analysis in Pharmaceuticals By Butterworth Laboratories Ltd
The European Pharmacopeia (Ph Eur) is moving away from the historical Thin Layer Chromatography technique (TLC) for the determination of Ninhydrin-positive substances, to more specific and sensitive methods utilising Liquid Chromatography (LC) or Amino Acid Analysers. This paper will explore the history of the test, the benefits of the change and considerations for validation of the LC approach to analysis.... White Papers Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Transport, Storage and Analysis. By Butterworth Laboratories Ltd
Residual solvents are organic volatile chemicals used or produced in the manufacture of active pharmaceutical ingredients (API), excipients or drug products, which remain in the material at the end of the manufacturing process. Their control is important in limiting exposure and guidelines exist to maintain patient safety, not just to satisfy competent authorities. It is a requirement that all pharmaceutical substances comply with ICH limits even if not required by individual monographs or if no compendial monograph exists.... White Papers See more
1-15 of 51422 results