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CDC confirms first Ebola case in US
By PBR Staff Writer
The US Centers for Disease Control and Prevention (CDC) has confirmed the first case of Ebola in Dallas, Texas, US.
Production & Manufacturing > Manufacturing > News
Glialogix, Fast Forward partner to support development of new multiple sclerosis treatments
By PBR Staff Writer
US-based biopharma firm Glialogix has entered into a Sponsored Research Agreement with Fast Forward, a nonprofit organization established by the National Multiple Sclerosis (MS) Society to accelerate the development of treatments for multiple sclerosis (MS).
Contract Research & Services > Contract Research > News
FDA approves XTANDI to treat metastatic castration-resistant prostate cancer
By PBR Staff Writer
Diplomat has announced that the US Food and Drug Administration (FDA) has approved XTANDI to treat metastatic castration-resistant prostate cancer (CRPC).
Regulatory Affairs > News
CSL Behring expands manufacturing facility in Kankakee, US
CSL Behring announced that it is set to commence operations in its newly expanded facility now that the US Food & Drug Administration (FDA) has granted approval.
Production & Manufacturing > Manufacturing > News
Cellular Biomedicine completes acquisition of Agreen Biotech
Cellular Biomedicine Group (CBMG), a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, has announced it has completed the previously announced acquisition of privately held Agreen Biotech and its founder's US patent.
Automation > IT & Software > News
USPTO issues can-fite patent for CF102 to treat liver regeneration and function after surgery
Can-Fite BioPharma, a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer and inflammatory diseases, has announced the US Patent and Trademark Office has issued a patent to the Company which covers its drug candidate, CF102, in the treatment of liver regeneration and function following liver surgery.
Production & Manufacturing > Process & Production > News
KemPharm gets patent from USPTO for new prodrug of hydromorphone
KemPharm, a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary new molecular entity (NME) prodrugs, has announced that the United States Patent and Trademark Office (USPTO) issued US Patent No. 8,816,083 to KemPharm for its patent application entitled, "Benzoic Acid, Benzoic Acid Derivatives and Heteroaryl Carboxylic Acid Conjugates of Hydromorphone, Prodrugs, Methods of Making and Use Thereof."
Production & Manufacturing > Process & Production > News
KAI secures CDC contract to support annual influenza vaccine serology testing
KAI Research (KAI), a wholly owned subsidiary of Altarum Institute, announced today that the Centers for Disease Control and Prevention (CDC) awarded it a contract to evaluate samples of pediatric, adult, and elderly individuals’ serum levels after flu vaccination to determine whether antibodies induced by the current vaccine effectively inhibit circulating influenza viruses.
Drug Research > Drug Delivery > News
Johnson & Johnson to buy Alios BioPharma for $1.75bn
By PBR Staff Writer
Johnson & Johnson (J&J) has agreed to acquire US-based biopharmaceutical firm Alios BioPharma for about $1.75bn.
Production & Manufacturing > Manufacturing > News
SHL to Introduce Product Case Studies at the 2014 PDA Conference
Taking an advanced injection device from concept to reality requires careful planning, key design and manufacturing competencies and a thorough understanding of end-user needs. While challenges are often encountered when it comes to product development, it is the ability to overcome them in a timely manner and in a way that further improves the device project that is even more valuable.
Regulatory Affairs > Press Releases
Inergetics launches Surgex Warrior Sports Nutrition
By PBR Staff Writer
Inergetics, a US-based developer of nutritional supplements, has launched Surgex Warrior Sports Nutrition, the preferred nutritional supplements of Army Sports.
Production & Manufacturing > OTC > News
Boehringer invests €100m to increase Respimat production in Dortmund
By PBR Staff Writer
German research-driven pharmaceutical firm Boehringer Ingelheim is investing more than €100m at its Dortmund site to increase the production capacity of Respimat inhaler to 44 million units per year.
Production & Manufacturing > Manufacturing > News
Attending CPhI 2014?. There's Still Time to Book a Meeting with us.
Johnson Matthey Catalysis and Chiral Technologies is exhibiting at CPhI 2014 at stand 6F29.
Production & Manufacturing > Fine & Speciality Chemicals > Press Releases
EMA validates the marketing authorization for lung cancer drug nivolumab
By PBR Staff Writer
The European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) for Bristol-Myers Squibb' nivolumab to treat non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
TherapeuticsMD starts Phase III trial of TX-004HR to treat VVA
By PBR Staff Writer
TherapeuticsMD, a US-based women’s healthcare firm, has started patient enrollment in its Phase III clinical trial of TX-004HR (VagiCap) to treat painful intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
Automation > IT & Software > News

PBR Supplier Recommendations

Fujifilm Diosynth Biotechnologies - Biopharmaceutical Process Development and Manufacturing Services
We are one of the world’s leading suppliers of contract process development and manufacturing services for the biopharmaceutical industry. Created in April 2011, Fujifilm Diosynth Biotechnologies has more than 900 employees, operating from two sites in Billingham, UK, and the Research Triangle Park in North Carolina, US.... Production & Manufacturing > Manufacturing > Suppliers
IDDI - eClinical and Biostatistical Services for Phase I to IV Clinical Trials
Established for more than 23 years, International Drug Development Institute (IDDI), has grown thanks to its niche positioning as a major service provider in the trial design and collection, analysis and reporting of clinical research data. IDDI combines expert methodology in biostatistics with innovative integrated technology (eClinical suite of made-to-measure secure web systems: IWRS and web coding integrated to EDC) to optimise the design and conduct of clinical trials. ... Suppliers
Polipharma Industries - Pharmaceutical Product Manufacturer
Polipharma Industries is a GMP-certified drug manufacturer established in 2003, whose core business is the manufacturing of pharmaceutical products. We provide activities and services such as: research & development, out-licensing, contract manufacturing, contract development, batch release, analytical services and clinical trials.... Suppliers
VALOS - Statistical Programming, Biostatistics and Real-World Evidence Solutions for Phase I-IV and Retrospective Studies
If you need to outsource a part of your clinical trial or drug development project, VALOS is the partner you can count on. VALOS values developing long-lasting partnerships with its clients.... Suppliers
Atlant Clinical - Professional and Competent International CRO
Founded in 2007, Atlant Clinical had a vision of becoming the most professional and reputable CRO in Russia, Eastern Europe, the Baltics, and the CIS. Now, Atlant Clinical has established itself as one of the best professional service providers on the market. Atlant Clinical has successfully completed numerous clinical research Phase I-IV trials for leading companies such as AstraZeneca, Sanofi and many others. ... Suppliers
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PBR White Paper Recommendations

The use of ITC for Obtaining Enzyme Kinetic Constants By Malvern Instruments
Enzymes are proteins that function as biological catalysts and they play a crucial role in nearly all processes that take place in living organisms. Therefore studies of these molecules and the reactions they catalyze have been a core activity for biochemists for at least the past fifty years.... White Papers Understanding the Conformational Stability of Protein Therapeutics using Raman Spectroscopy By Malvern Instruments
The combination of Dynamic Light Scattering (DLS) with Raman Spectroscopy provides the ability to extract a wealth of chemical, structural, and physical information about biotherapeutic proteins under formulation conditions.... White Papers Using Laser Diffraction Particle Size Data to Optimise the Performance of Sprays By Malvern Instruments
Many industries share the need to closely control the characteristics of sprays, albeit for very different reasons, and one of the most critical parameters is the particle size of the droplets within the spray plume.... White Papers Developing a Bioformulation Stability Profile By Malvern Instruments
When used in combination, light scattering and microcapillary viscometry can be used to develop a stability profile to screen biotherapeutic candidates, with light scattering providing a suite of dilute solution properties and microcapillary viscometry providing analysis of viscosity even at high sample concentration. ... White Papers Real-Time Particle Sizing for Granulation Control By Malvern Instruments
This paper considers various granulation processes and the use of real-time particle size measurement in their optimisation, focusing on two different sizing methods: laser diffraction and the spatial filter technique (SFT).... White Papers See more
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