2017

Report: 74% of medicines in development could be first-in-class treatments

Thursday, July 20, 2017

Seventy-four percent of medicines in clinical development around the world are potentially first-in-class medicines, meaning they use a completely new approach to fighting a disease, according to a new report by The Analysis Group, commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA). The Biopharmaceutical Pipeline: Innovative Therapies in Clinical Development report examines the global state of the drug development pipeline and provides insights into new approaches biopharmaceutical researchers are pursuing.

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UK Biobank partners with the EGA

Thursday, July 20, 2017

Genomic data from the 500,000 people participating in the UK Biobank initiative will be distributed via the European Genome–phenome Archive (EGA), a resource developed jointly by the European Bioinformatics Institute (EMBL-EBI) and the Centre for Genomic Regulation (CRG). UK Biobank provides extremely detailed, high-quality datasets on individuals. It is an unprecedented collection that offers endless possibility and substantial efficiency savings for biomedical research and understanding the causes of disease.

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GB Sciences, Worldwide Clinical Trials partner on cannabis-based therapy trials

Thursday, July 20, 2017

GB Sciences has signed a Consulting Services Agreement with Worldwide Clinical Trials to evaluate the company’s intellectual property portfolio and to assist with pre-IND planning for its proprietary cannabis-based formulations. These pre-IND consulting services will be performed by the chief medical and scientific officer (CMSO) of Worldwide, Michael F. Murphy, M.D., Ph.D., as the representative of an extended Worldwide team. Dr. Murphy has participated in the IND application process for multiple small molecules and biologics with 19 therapeutic targets, across five divisions of the FDA. Dr. Murphy was also the Clinical Research and Excellence (CARE) Lifetime Achievement Award recipient for 2017. The award is presented annually to an extraordinary individual with exceptional contributions and a consistent history of service to the clinical research industry throughout their career.

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South Korean pharma rapidly becoming manufacturing export hub

Thursday, July 20, 2017

CPhI Korea returns to Seoul COEX Convention and Exhibition Centre for its fourth edition from 22nd-24th August 2017. The show will co-locate with ICSE, P-MEC, BioPh and Health Ingredients Korea. Reflecting the global interest in the South Korean pharma market, CPhI Korea 2017 will see a 13% rise in the number of exhibitors, in addition to a more than doubling of overseas buyers since 2015.

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Median Technologies awarded Futur40 Prize by Forbes France

Wednesday, July 19, 2017

Median Technologies, the Imaging Phenomics Company, announced that on it was awarded the Futur40 Prize by Forbes France, in association with PME finance – Europe Entrepreneurs, the French Finance Association Paris Europlace and the Federation of Individual Investors and the Finance Clubs (F2iC – Fédération des Investisseurs Individuels et des Clubs d’investissement).

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FDA Accepts Otonomy’s Otiprio sNDA filing for acute otitis externa

Wednesday, July 19, 2017

Otonomy, a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, announced that its Supplemental New Drug Application (sNDA) for the approval of OTIPRIO as a treatment of acute otitis externa (AOE) has been accepted for filing by the FDA and been assigned a Prescription Drug User Fee Act (PDUFA) action date of March 2, 2018. The acceptance of the sNDA indicates that the application is sufficiently complete to permit a substantive review by the FDA.

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TrialScope expands languages in trial results portal

Tuesday, July 18, 2017

TrialScope, a global leader in patient-centric clinical trial transparency and compliance solutions, announced that the Trial Results Summaries Portal now supports trial summaries in English and seven additional languages: Chinese, French, German, Japanese, Polish, Russian and Spanish.

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Sangamo receives FDA Fast Track for SB-318a SB-913

Monday, July 17, 2017

Sangamo Therapeutics announced that the FDA has granted Fast Track designation to SB-318 and SB-913, the company’s clinical stage in vivo genome editing product candidates for the treatment of Mucopolysaccharidosis Type I (MPS I) and MPS II, respectively. The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics to treat serious conditions and fill an unmet medical need. Once a drug receives Fast Track designation, early and frequent communication with the FDA is encouraged throughout the development and review process. The frequency of communication is designed to ensure that questions and issues are resolved quickly, potentially leading to earlier drug approval and access by patients.

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