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FDA grants QIDP status for Wockhardt anti-infective drug discovery program Wockhardt Limited has announced a major boost to the New Drug Discovery program in Anti-Infective research when two of its drugs, WCK 771 and WCK 2349, received the coveted Qualified Infectious Disease Product (QIDP) status from U.S. Food & Drug Administration (FDA).
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Janssen expands EXPLORER research program to evaluate XARELTO Janssen Research & Development (Janssen) and its development partner, Bayer HealthCare, have announced the expansion of the EXPLORER global cardiovascular research program for XARELTO (rivaroxaban) to include additional high-risk patient populations.
Contract Research & Services > Contract Research > News Biothera gets NIH funding to further develop fungal vaccine By PBR Staff Writer
US-based biotechnology firm Biothera has received a small business innovation research grant from the National Institutes of Health (NIH) to continue development of a fungal vaccine that may protect against infection from many different fungal species.
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Clinical Research in France
| By Cromsource
In France, the process for submission and approval by the Ethics Committee and the Competent Authority is well defined. However, the requirements of other stakeholders must also be met before your study can start. And since the publication of the “Sunshine Act” decree in May 2013, the process for contracting with the investigational sites became more complex.Here, Martine Roggemans shares her knowledge of clinical research in France, describing both the landscape for clinical research and introducing the regulatory processes involved.
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Clinical Research in Poland
| By Cromsource
Poland is a country in East-Central Europe with a population of about 38 million people. After the Polish accession to the European Union in May 2004, the legal and administrative framework to implement the EU Directive on Clinical Trials was enacted, just as in all other member states.

Joining the EU has significantly contributed to a change in the perception of Poland as a suitable place to conduct clinical trials. Sponsors include Poland because they benefit from a regulatory environment which is standardized and predictable, whilst maintaining the advantage of lower cost and higher subject recruitment potential.

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Biothera gets NIH funding to further develop fungal vaccine
By PBR Staff Writer
US-based biotechnology firm Biothera has received a small business innovation research grant from the National Institutes of Health (NIH) to continue development of a fungal vaccine that may protect against infection from many different fungal species.
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Synexus acquires research centre in South Africa
Synexus has expanded its global presence with the acquisition of a specialist clinical trial site close to Cape Town’s international airport.
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NEOMED secures $12m from Canadian government
NEOMED, a not-for-profit organization whose mission is to create a bridge between academic research and the pharmaceutical industry, will receive $12 million in funding from the Government of Canada to help academic researchers turn their early discoveries into future medicines.
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Roche's Spring Bioscience introduces PD-L1 IHC antibody for immunotherapy research
By PBR Staff Writer
Roche's Spring Bioscience has launched its PD-L1 (SP142) rabbit monoclonal immunohistochemistry (IHC) antibody.
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FDA grants orphan drug status for Insys’ CBD to treat glioblastoma multiforme
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Insys Therapeutics' pharmaceutical cannabidiol (CBD) to treat glioblastoma multiforme (GBM).
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BreedIT, Seach form KanaboSeed to develop new medical cannabis varieties
BreedIT Corp through its Israeli subsidiary, BreedIT Ltd., the exclusive worldwide license holder and distributor of highly sophisticated agro-breeding solutions software for plant breeders and researchers, is pleased to announce the formation of KanaboSeed Ltd., a joint venture with Seach Ltd, a leading Israeli medical Cannabis breeder.
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UK launches emergency research to help battle Ebola outburst
By PBR Staff Writer
The UK Department for International Development (DIFD) and the Wellcome Trust health research charity have offered experts £6.5m to find ways to save the lives of citizens hit with the Ebola virus.
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Softigel - Manufacturers of Softgel Pharmaceutical Products
Softigel develops and manufactures softgel (soft gelatin) capsules, advanced drug delivery technologies, nutritional supplements, as well as veterinary, cosmetic and pharmaceutical products. Softgels are an effective delivery system for oral drugs, especially those with low solubility and/or permeability (BCS classes II, III and IV). We are Procaps' stategic business division for contract manufacturing services.
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