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Tonix announces successful end-of-phase 2 meeting with FDA for TNX-102 SL in PTSD
Tonix Pharmaceuticals, which is developing next-generation medicines for fibromyalgia and post-traumatic stress disorder (PTSD), has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) from an End-of-Phase 2/Pre-Phase 3 meeting.
Production & Manufacturing > Process & Production > News
Amgen unveils positive results from phase 3 study of Prolia in patients receiving glucocorticoid therapy
Amgen announced positive top-line results from the primary analysis conducted in a Phase 3 randomized, double-blind, double-dummy, active-controlled study evaluating the safety and efficacy of Prolia (denosumab) compared with risedronate in patients receiving glucocorticoid treatment.
Contract Research & Services > Clinical Trials > News
CTI BioPharma reports mixed results for pacritinib in advanced myelofibrosis
By PBR Staff Writer
CTI BioPharma announced that a phase 3 clinical trial of pacritinib for high-risk patients with advanced myelofibrosis met one of the co-primary endpoints.
Contract Research & Services > Clinical Trials > News
BioInvent extends manufacturing services contract with global pharmaceutical client
BioInvent International has signed an extended contract for manufacturing services with one of its current customers, a major global pharmaceutical client.
Production & Manufacturing > Manufacturing > News
TaiGen out-licenses Taigexyn to Productos Cientificos for Latin American market
TaiGen Biotechnology Company has signed an exclusive licensing agreement with Mexican pharmaceutical firm Productos Científicos (PC) to develop and commercialize Taigexyn (nemonoxacin) in Latin America.
Contract Research & Services > Contract Services > News
BirchBioMed completes anti-scarring drug clinical trial
BirchBioMed announced that a unique and ground-breaking topical treatment developed by University of British Columbia (UBC) researchers to prevent scarring has completed a Health Canada approved Phase I trial.
Contract Research & Services > Clinical Trials > News
Impax recalls one lot of Lamotrigine Orally Disintegrating Tablet 200 mg
Impax Laboratories has issued a voluntary nationwide retail level recall on August 19, 2016 for one lot of Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg.
Drug Research > Drug Delivery > News
Mallinckrodt’s DMD drug receives FDA fast track designation
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Mallinckrodt’s request for a fast track designation of its new Duchenne muscular dystrophy (DMD) drug, Synacthen Depot.
Production & Manufacturing > Process & Production > News
NeuroDerm starts phase III trial of NDO612L in Parkinson's disease
By PBR Staff Writer
Clinical stage pharmaceutical firm NeuroDerm has started a phase III clinical trial, evaluating NDO612L for the treatment of Parkinson's disease (PD).
Contract Research & Services > Clinical Trials > News
European Medical Agency to review Mylan and Biocon’s anti cancer biosimilar
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted for review Mylan's marketing authorization application (MAA) for a proposed biosimilar Trastuzumab to treat several HER2-positive breast and gastric cancers.
Production & Manufacturing > Process & Production > News
Highland Therapeutics' subsidiary starts phase 2 Trial for HLD100 in pediatric ADHD patients
Highland Therapeutics' subsidiary, Ironshore Pharmaceuticals & Development, has initiated enrollment in a Phase 2 study of HLD100, which is currently under development as a new amphetamine-based treatment option for patients with Attention Deficit/Hyperactivity Disorder (ADHD).
Contract Research & Services > Clinical Trials > News
BioLineRx and I-Bridge Capital establish drug development JV in China
BioLineRx has established a joint venture (JV) with I-Bridge Capital, a Chinese venture capital fund focused on developing innovative therapies in China.
Drug Research > Drug Discovery & Development > News
FDA issues complete response letter for Amgen's NDA for Parsabiv
The US Food and Drug Administration (FDA) has issued a Complete Response Letter for Amgen's New Drug Application (NDA) for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Production & Manufacturing > Process & Production > News
F-star, Denali Therapeutics partner to develop multispecific antibody platform
By PBR Staff Writer
UK-based biopharmaceutical firm F-star has signed a collaborative agreement with the US start-up Denali Therapeutics to develop a multispecific antibody platform for delivering therapeutics across the blood-brain barrier into the central nervous system (CNS).
Drug Research > Drug Discovery & Development > News
AstraZeneca to sell part of antibiotics business to Pfizer in $1.6bn deal
By PBR Staff Writer
AstraZeneca has agreed to sell part of its antibiotics business to Pfizer in a deal worth about $1.6bn.
Production & Manufacturing > Manufacturing > News

PBR Supplier Recommendations

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
Hybrigenics Services - Protein Interactions Expert
Who else knows your protein better than you? Who else knows proteins interactions better than us?... Contract Research & Services > Contract Research > Suppliers
SchuF Valves- Innovative, custom valve solutions for the pharmaceutical industry
The SchuF group, inventor of the bottom outlet valve, manufactures custom, flush-mounted valves that eliminate dead space in the reactor outlet nozzle. The main features and benefits of SchuF valves include the following;... Suppliers
Bruker Optics - Fourier Transform Infrared, Near Infrared and Raman Spectrometers
Bruker Optics is the leading manufacturer and worldwide supplier of fourier transform Infrared (FTIR), near infrared and raman spectrometers for a number of industries and applications, such as pharmaceutical and life sciences.... Automation > Laboratory Instrumentation > Suppliers
LABORATORIOS INIBSA - Pharmaceutical Contract Manufacturing Company
LABORATORIOS INIBSA is a pharmaceutical contract manufacturing company. We have more than 60 years' experience and belong to the INIBSA GROUP. INIBISA supplies products and services to Biotools, Inibsa Dental and Inibsa Hospital, as well as other pharmaceutical companies through our contract manufacturing division. From our facilities in Lliçà de Vall, 20km from Barcelona LABORATORIOS INIBSA currently supplies more than 50 countries worldwide.... Production & Manufacturing > Manufacturing > Suppliers
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PBR White Paper Recommendations

Reliable, Long-range Wireless Sensors for Environmental Monitoring By Vaisala pbr
The Vaisala viewLinc Monitoring System tracks environmental conditions wirelessly using Vaisala’s VaiNet wireless devices based on LoRa™* technology. By using a chirp spread spectrum (CSS)* wireless protocol, VaiNet provides robust communication that is extremely reliable over long distances and under harsh, complex and obstructed conditions.... Contract Research & Services > Clinical Trials > White Papers Five Ways That the Mastersizer 3000 Saves you Money By Malvern Instruments
To earn its place in today’s busy analytical laboratories, an instrument must meet certain practical criteria, and stand-up to rigorous economic evaluation. For labs that need particle sizing, laser diffraction systems are typically the technology of choice; delivering accurate and reliable information for the broadest range of sample types. Here, we look at how the Mastersizer 3000, the market leading laboratory particle size analyzer from Malvern Instruments, can save you time, money and resources, and ultimately deliver a healthy return on investment.... White Papers Time to Spec up? Top Five Reasons to Replace a Viscometer with a Rheomete By Malvern Instruments
Is your viscometer approaching the end of its life? Are you starting to feel that your trial and error, ‘rheology-light’ approach to formulation is becoming dated? Or are there longstanding product performance issues that you’re failing to gain traction with, where you suspect rheology may hold the answer?... White Papers Biophysical Characterization of Epigenetic Protein Interactions By Malvern Instruments
Epigenetics is the study of heritable changes in gene expression caused by nongenetic mechanisms, without alterations in gene structure or DNA sequence. The epigenetic state of a cell evolves during the cellular differentiation and development of an organism, and epigenetic changes are linked to cellular reprogramming. Because epigenetic mechanisms may also be responsible for the integration of environmental responses at he cellular level, they potentially play an important role in the development of som diseases.... White Papers Overcoming and Quantifying 'Wall Slip' in Measurements from a Rotational Rheometer By Malvern Instruments
When making shear rheological measurements on structured liquids, in particular suspensions, emulsions or foams there is a high probability that the measurement may be affected by a phenomenon known as 'wall slip'. Wall slip generally results from a localdepletion of the dispersed phase near the geometry walls, effectively forming a lubrication layer at the surface. As a consequence bulk rheological properties are no longer being accurately measured leading to an underestimation of the true viscosity. A similar effect can be observed when measuring solid like materials where there is insufficient friction between the sample and the wall to support the applied stress.... White Papers See more
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