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1-15 of 54950 results
FDA extends review period by three months for rheumatoid arthritis candidate baricitinib
By PBR Staff Writer
The US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date by three months for investigational rheumatoid arthritis treatment, Baricitinib.
Production & Manufacturing > Process & Production > News
Sunovion’s dasotraline improves ADHD symptoms in children in phase 2/3 study
By PBR Staff Writer
Sunovion Pharmaceuticals’ novel drug candidate dasotraline has demonstrated significantly improved attention deficit hyperactivity disorder (ADHD) symptoms in children compared to placebo in a phase 2/3 study.
Contract Research & Services > Clinical Trials > News
Heron submits CINVANTI NDA to FDA for CINV prevention
Heron Therapeutics has submitted its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for CINVANTI (HTX-019), a polysorbate 80-free, intravenous formulation of aprepitant for the prevention of Chemotherapy-Induced Nausea and Vomiting (CINV).
Production & Manufacturing > Process & Production > News
Clinical-stage biopharmaceutical firm OncoImmune raises $15m funding
OncoImmune, a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel immunotherapies for cancer, inflammation and autoimmune diseases, has secured $15m in Series A round of fundraising led by 3E Bioventures Capital.
Drug Research > Drug Discovery & Development > News
FDA grants QIDP status for RedHill's RHB-104 to treat nontuberculous mycobacteria infections
By PBR Staff Writer
RedHill Biopharma has secured the Qualified Infectious Disease Product (QIDP) fast-track designation from the US Food and Drug Administration (FDA) for its candidate RHB-104 to treat nontuberculous mycobacteria (NTM) infections.
Production & Manufacturing > Process & Production > News
Novartis to commence phase 2 trial with bimagrumab in obese patients with type 2 diabetes
MorphoSys said its partner Novartis will conduct a phase 2 clinical trial of the HuCAL antibody bimagrumab in obese patients having type 2 diabetes.
Contract Research & Services > Clinical Trials > News
US appeals court upholds Eli Lilly's patent on Alimta cancer drug
By PBR Staff Writer
Eli Lilly and Company has received a favorable court ruling in the US regarding the vitamin regimen patent for its cancer drug Alimta.
Production & Manufacturing > Manufacturing > News
Merck expands oncology portfolio with four Vertex cancer programs
By PBR Staff Writer
Merck has agreed to license four oncology research and development (R&D) programs from Vertex Pharmaceuticals.
Drug Research > Drug Discovery & Development > News
Visterra doses first patient in phase 2a trial of influenza A candidate VIS410
Visterra has dosed the first patient in the VIS410 Phase 2a clinical trial to study the monoclonal antibody for the treatment of hospitalized patients with influenza A, irrespective of the viral strain.
Contract Research & Services > Clinical Trials > News
Gilead gets European approval for hepatitis B drug Vemlidy
Gilead Sciences has received marketing authorization from the European Commission for Vemlidy (tenofovir alafenamide, TAF) 25 mg, a once-daily tablet for chronic hepatitis B virus (HBV) infection treatment in adults and adolescents (aged 12 years and older with body weight at least 35 kg).
Regulatory Affairs > News
FDA grants orphan drug status for Sangamo’s SB-318 genome editing treatment for MPS I
Sangamo Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its genome editing product candidate, SB-318, to treat Mucopolysaccharidosis Type I (MPS I).
Regulatory Affairs > News
FDA to review Biocon and Mylan's biosimilar drug for breast cancer
By PBR Staff Writer
Netherlands-incorporated generics firm Mylan and Indian biopharmaceutical company Biocon are a step closer to secure approval for a biosimilar version of Roche’s cancer drug trastuzumab in the US.
Production & Manufacturing > Process & Production > News
Johnson Matthey Launches New Online Catalyst Store
West Deptford, N.J. – 11 January 2017, Johnson Matthey (LSE: JMAT), a leading provider of pharmaceutical services, active pharmaceutical ingredients (APIs) and catalyst technologies, is pleased to announce the launch of its new online catalyst store
Production & Manufacturing > Fine & Speciality Chemicals > Press Releases

PBR Supplier Recommendations

NSF Health Sciences Pharma Biotech
NSF partners with you to provide world-class regulatory and compliance consulting, auditing and training on a global basis.... 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
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
Life Chemicals - Specialists in Development, Production and Sales of Novel Screen Compounds
Life Chemicals Inc, established in 2004, specialises in development, production and sales of novel screening compounds for HTS, targeted screening libraries and core building blocks for drug discovery projects.... Production & Manufacturing > Fine & Speciality Chemicals > Suppliers
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PBR White Paper Recommendations

Synergy of Complementary Nanomaterial Characterization Techniques: NTA+DLS By Malvern Instruments
Dynamic Light Scattering (DLS) is a mature and proven technology for nanomaterial characterization. Nanoparticle Tracking Analysis (NTA) is a more recent addition to the spectrum of particle characterization techniques and has many similarities to DLS, leading to some confusion as to their relative capabilities. The broad range of measurement capabilities for each technique is complementary in nature, providing a wealth of valuable information. The differences between the two techniques allow the data from one technology to validate and support the other. ... White Papers Using the Zetasizer Nano to Optimize Formulation Stability By Malvern Instruments
Formulation development is a critical activity for many industries, from pharmaceuticals, to paints and coatings. Indeed, it is estimated that in the UK alone, sales of formulated products amount to some £180 billion per year1. This means that getting formulation ‘right’ is an important goal, with considerable value attached to it. Stability is a crucial attribute for many products with a direct impact on performance, shelf-life, kerb appeal and ultimately, worth. A systematic approach to understanding and developing stability can therefore be extremely helpful in improving the likelihood of success in long-term stability trials and accelerating formulation. The Zetasizer range from Malvern is the world’s most widely used system for nanoparticle, colloid and protein size and zeta potential measurements. In this whitepaper, we examine how these capabilities can be exploited to develop stable dispersions.... White Papers Key Considerations when Purchasing an Advanced GPC/SEC System By Malvern Instruments
Investing in a new GPC/SEC system is a big decision with many factors to consider. This white paper lists the key items that you should think about when buying a new system and discusses the reasons for their importance. Finally, it discusses what Malvern has to offer in this area.... White Papers Biovian's Contract Manufacturing of Biopharmaceuticals By Biovian
Biovian is a one-stop-shop in GMP contract manufacturing of biopharmaceuticals covering services from early development to finished vial.... White Papers Going with the Flow: Malvern Instruments' Basic Introduction to Rheology By Malvern Instruments
Rheology concerns itself with materials that have aspects of both solids and liquids, and researches the flow and deformation of matter. Malvern Instruments explores this study, and reveals its fundamental in relation to force, deformation and time.... White Papers See more
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