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Extending Soft Gelatin Capsule Benefits to Novel Fixed Dose Combinations: Unigel
Fixed dose combinations are desirable for several reasons such as different release profiles and guaranteeing patients´ compliance by reducing the daily intake of a drug product(s).
Drug Research > Drug Discovery & Development > Press Releases
Scientist finds way to improve antibiotics to treat staph infections
By PBR Staff Writer
A scientist from the Saint Louis University in the US has discovered new information about how antibiotics like azithromycin can stop staph infections including the reason why staph sometimes becomes resistant to drugs.
News
EMA recommends sale suspension of medicines based on GVK Bio’s ‘flawed’ clinical data
By PBR Staff Writer
The European Medicines Agency has recommended suspension of sale of around 700 medicines whose authorization was given based on clinical trial conducted by Hyderabad, India based GVK Biosciences.
Production & Manufacturing > Manufacturing > News
Alexza begins Phase IIa trial of AZ-002 to treat epilepsy patients
By PBR Staff Writer
US-based Alexza Pharmaceuticals has started a Phase IIa trial of AZ-002 (Staccato alprazolam), which is being developed for the management of epilepsy in patients with acute repetitive seizures (ARS).
Contract Research & Services > Clinical Trials > News
ImmuPharma, Simbec-Orion collaborate to execute Phase III Lupuzor trial for Lupus
By PBR Staff Writer
ImmuPharma and Simbec-Orion have entered into a collaboration agreement to execute ImmuPharma's Phase III clinical trial of its lead compound Lupuzor to treat Lupus, a chronic, potentially life-threatening autoimmune disease.
Contract Research & Services > Clinical Trials > News
CytRx reports overall survival results from phase IIb trial of aldoxorubicin
CytRx, a biopharmaceutical research and development company specializing in oncology, announced encouraging overall survival (OS) results, the secondary endpoint, from its completed multicenter, randomized, open-label global Phase 2b clinical trial investigating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in subjects with metastatic, locally advanced or unresectable soft tissue sarcomas (STS).
Drug Research > Drug Discovery & Development > News
TiGenix gets European patent relating to adipose-derived stem cell composition
TiGenix, an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platform of allogeneic expanded adipose-derived stem cells in inflammatory and autoimmune diseases, announced that the European Patent Office (EPO) has issued European Patent EP2292736 relating to an adipose-derived stem cell composition.
Production & Manufacturing > Process & Production > News
WCCT global enters into clinical research partnerhip with DynPort Vaccine Company
WCCT Global, a full service contract research organization was announced to be a strategic partner with Dynport Vaccine Company along with two other CROs for supporting clinical trials to evaluate Anti-Infective Drugs with the NIAID.
Contract Research & Services > Contract Research > News
Syncona, UCLB form cancer immunotherapy firm Autolus
Syncona and UCL Business, the wholly-owned technology transfer company of University College London, announce the creation of Autolus Limited, a biopharmaceutical company focused on the development and commercialisation of next-generation engineered T-cell therapies for haematological and solid tumours.
Automation > IT & Software > News
Pfizer's Prevenar 13 gets CHMP positive opinion for prevention of vaccine-type pneumococcal pneumonia in adults
Pfizer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that the indication for Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) be expanded to include the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults 18 years and older.
Drug Research > Drug Delivery > News
Aprea's ovarian cancer drug candidate APR-246 gets European orphan drug status
By PBR Staff Writer
Swedish biotech company Aprea has secured orphan drug designation from the European Medicines Agency (EMA) for its anti-cancer agent APR-246 to treat ovarian cancer.
Production & Manufacturing > Process & Production > News
FDA clears Advaxis' IND application to conduct Phase I trial of ADXS-HER2
By PBR Staff Writer
The US Food and Drug Administration (FDA) has cleared Advaxis' investigational new drug (IND) application to conduct a Phase I clinical trial of ADXS-HER2 (ADXS31-164) to treat patients with metastatic HER2 expressing solid tumors.
Contract Research & Services > Clinical Trials > News
NovaMedica gets Russian rights for three gastrointestinal products from Omega Pharma
By PBR Staff Writer
NovaMedica and Belgian pharmaceutical firm Omega Pharma have signed a partnership agreement to promote, distribute and sell a line of OTC gastrointestinal products under Benegast brand in Russia.
Production & Manufacturing > OTC > News
FDA committee recommends approval of Astellas' Cresemba
By PBR Staff Writer
The US Food and Drug Administration’s (FDA) Anti-infective Drugs Advisory Committee voted unanimously to recommend approval of Astellas' investigational once-daily intravenous and oral broad-spectrum Cresemba (isavuconazonium) to treat invasive aspergillosis and mucormycosis.
Drug Research > Drug Delivery > News

PBR Supplier Recommendations

MEGGLE – Experts in Excipients: The Whole World of Lactose
MEGGLE Excipients & Technology is a global leader in the manufacture of lactose for the pharmaceutical industry. Supporting supply chain security with manufacturing facilities in Europe and North America, MEGGLE offers a broad product portfolio of lactose excipients, co-processed technologies and excipient contract manufacturing.... Production & Manufacturing > Fine & Speciality Chemicals > Suppliers
Apps & Digital Resources Vie for Top Honour at eyeforpharma Barcelona Awards
Two thirds of the finalists for the 'Most Valuable Patient Initiative' in the 2015 eyeforpharma Barcelona Awards have used interactive digital resources or mobile applications to engage with the patient; a tell-tale sign of the dominance of patient engagement as a focus for pharma right now. The list of finalists, announced today, includes Abbvie, AstraZeneca, Bayer, Janssen Healthcare Innovation and Novartis all vying for the ultimate accolade in pharma; to be crowned 'most valuable' to their patients.... Suppliers
Vetter Pharma International - High-Quality Aseptically Pre-Filled Injection Systems
From preclinical development through commercial supply.... Drug Research > Drug Delivery > Suppliers
leon-nanodrugs - Nanotechnology for Drug Formulations
leon-nanodrugs is an expert drug development company located in Munich Germany. Our core business is the reformulation of poor soluble oral and parenteral pharmaceutical active pharmaceutical ingredients (APIs) based on our proprietary nano-precipitation technology platform (MJR-technology), is under patent protection until 2030. ... Drug Research > Drug Delivery > Suppliers
Eppendorf - We Know Bioprocessing
Eppendorf is a leading life science company that develops and sells instruments, consumables, and services for liquid-, sample-, and cell handling in laboratories worldwide. Its product range includes pipettes and automated pipetting systems, dispensers, centrifuges, mixers, spectrometers, and DNA amplification equipment as well as ultra-low temperature freezers, fermentors, bioreactors, CO² incubators, shakers, and cell manipulation systems. Consumables such as pipette tips, test tubes, microtiter plates, and disposable bioreactors complement the range of highest-quality premium products.... Suppliers
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PBR White Paper Recommendations

Evaluation of the BioFlo® 320 Process Capabilities By Eppendorf
This poster characterizes the capabilities of the BioFlo320 in terms of key process parameters including oxygen transfer rate (OTR), volumetric mass transfer coecient (kLa), tip speed, mixing time, and water consumption. These data enable quantitative analyses of bioprocess engineering parameters, thus allowing potential users to gain insight into the system’s cell culture and fermentation capabilities.... White Papers The Smarter Solution By Eppendorf
BioFlo® 320 bioprocess control station.... White Papers Temperature Monitoring Solution - CCIS By TSS
CCIS provides centralised control over global operations performance and is tailored to suit each user level. No matter your corporate role, CCIS helps you tackle the challenges you face, both today and tomorrow.... Contract Research & Services > Clinical Trials > White Papers Global Temperature Monitoring Solutions: For the Life Science Industry By TSS
TSS’ cloud solutions enable life science companies to take informed decisions, to ultimately ensure global patient safety. ... Contract Research & Services > Clinical Trials > White Papers On-Site Manufacturing in Early Clinical Drug Development (in Europe) By PRA Health Sciences
Written by Suzanne Jansen MSC, Pharmacist and Arjen Akkerman, MSc Senior Manager.... Contract Research & Services > Contract Research > White Papers See more
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