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Preview: Market Wire - Pharmaceuticals and Biotech: Trials

Marketwired - Trials



Marketwired - Trials



Last Build Date: Tue, 21 Feb 2017 02:48:14 EST

Copyright: Copyright: (C) Marketwired
 



Vernalis PLC: Unaudited Interim Results for the six months ended 31 December 2016

Tue, 21 Feb 2017 02:00:00 EST

WINNERSH, UNITED KINGDOM--(Marketwired - Feb 21, 2017) - Vernalis PLC (LSE: VER)




ORYZON to present ORY-2001 new preclinical data of therapeutic activity at ACTRIMS-2017 in Orlando, Fl. USA

Mon, 20 Feb 2017 09:29:47 EST

The company will present a poster on February 24th 2017




AssistRx and Surescripts Collaborate to Eliminate Manual Processes for Specialty Medications

Mon, 20 Feb 2017 08:00:00 EST

Electronic processing of specialty medications will help improve efficiency and time savings to pharmacies and providers




Hutchison China Meditech Limited: Start of Phase II Savolitinib PSC trial in China

Mon, 20 Feb 2017 02:09:43 EST

HONG KONG, CHINA--(Marketwired - Feb 20, 2017) - Hutchison China Meditech Limited (NASDAQ: HCM) (AIM: HCM)




Model N to Present CPQ and Tendering Strategies at the 4th Annual Medical Device Commercial Leaders Forum

Mon, 20 Feb 2017 02:00:00 EST

Join Model N to learn industry trends and best practices for optimal global pricing and tendering in the Medical Device industry




Taconic Biosciences gera modelo de camundongo de síndrome de Vici

Fri, 17 Feb 2017 17:36:45 EST

CRISPR acelera a disponibilidade da ferramenta vital para pesquisas




Taconic Biosciences genera modelo de ratón del síndrome de Vici

Fri, 17 Feb 2017 17:22:57 EST

CRISPR acelera disponibilidad de herramienta de investigación vital




Aldeyra Therapeutics, Inc. Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters' Option to Purchase Additional Shares

Fri, 17 Feb 2017 16:01:00 EST

LEXINGTON, MA--(Marketwired - Feb 17, 2017) -  Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company focused on the development of products to treat diseases related to aldehydes, today announced the closing of its previously announced underwritten public offering. Aldeyra sold 2,555,555 shares of its common stock, including 333,333 shares sold in connection with the exercise in full by the underwriters of their option to purchase additional shares. The net proceeds of the offering, including the full exercise of the option, were approximately $10.5 million, after deducting the underwriting discounts and commissions and the other estimated offering expenses payable by Aldeyra.




Axiom Real-Time Metrics exhibiting Fusion eClinical Suite at Outsourcing in Clinical Trials -- West Coast in Burlingame, California

Fri, 17 Feb 2017 15:10:02 EST

TORONTO, ON--(Marketwired - February 17, 2017) - Axiom Real-Time Metrics, the premier provider of eClinical software solutions and services to small to mid-sized life sciences organizations, will be exhibiting at the Outsourcing in Clinical Trials event on the West Coast taking place in Burlingame, California on February 22-23, 2017. Axiom invites attendees to join them for gourmet coffee and a conversation at Booth 36.




Taconic Biosciences Generates Vici Syndrome Mouse Model

Fri, 17 Feb 2017 12:03:21 EST

CRISPR Accelerates Availability of Vital Research Tool




Vitamin B3 prevents glaucoma, JAX researchers find

Thu, 16 Feb 2017 14:17:18 EST

BAR HARBOR, ME--(Marketwired - February 16, 2017) - In mice genetically predisposed to glaucoma, vitamin B3 added to drinking water is effective at preventing the disease, a research team led by Jackson Laboratory Professor and Howard Hughes Medical Investigator Simon W.M. John reports in the journal Science.




The Alliance for Regenerative Medicine Publishes Position on Hospital Exemption of Advanced Therapy Medicinal Products in Europe

Thu, 16 Feb 2017 09:17:02 EST

BRUSSELS, BELGIUM and WASHINGTON, DC--(Marketwired - Feb 16, 2017) - The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader regenerative medicine and advanced therapies sector, today announced it has published its position on Hospital Exemption (HE) in response to vastly different interpretations and implementations across the European Union of Article 3(7) of Directive 2001/83/EC within article 28 (2) of the Advanced Therapy Medicinal Products (ATMP) Regulation.




Prolacta Bioscience(R) Initiates Clinical Trial to Evaluate the Effect of a Specially Fortified Exclusive Human Milk Diet to Improve Growth in Infants Born with Single Ventricle Congenital Heart Defect

Thu, 16 Feb 2017 09:05:00 EST

DUARTE, CA--(Marketwired - Feb 16, 2017) - Prolacta Bioscience®, the pioneer in human milk-based neonatal nutritional products, announced today that the first patient has been enrolled in a clinical study to evaluate the effect of a specially fortified exclusive human milk diet (EHMD)1 to improve growth in infants who have undergone surgery for a serious heart defect known as single ventricle cardiac physiology. Prolacta developed a first-of-its-kind, human milk-based fortifier to address the post-surgical nutrition needs of this fragile infant population. 




Model N Announces Howard Dean and Tom Coburn as Keynote Speakers at Rainmaker 2017

Thu, 16 Feb 2017 09:00:00 EST

Join industry leaders for a thought provoking debate on the future of Healthcare and global businesses at Model N's 13th annual Revenue Management Conference




Vitality Biopharma to Present at SeeThruEquity 3rd Annual Innovations Investor Conference in Miami

Thu, 16 Feb 2017 08:55:00 EST

LOS ANGELES, CA--(Marketwired - Feb 16, 2017) - Vitality Biopharma, Inc. (OTCQB: VBIO) ("Vitality Biopharma," "Vitality," or the "Company") a corporation dedicated to the development of cannabinoid prodrug pharmaceuticals, and to unlocking the power of cannabinoids for the treatment of serious neurological and inflammatory disorders, is pleased to advise there will be a corporate presentation at the SeeThruEquity 3rd Annual Innovations Investor Conference to be held on Wednesday, February 22nd at the W Hotel, in South Beach, Miami.




Top US Medical Device Companies Look to 501(k) Clearance to Support Class 2 Devices and PMAs for Class 3 Products

Thu, 16 Feb 2017 07:16:00 EST

RESEARCH TRIANGLE PARK, NC--(Marketwired - February 16, 2017) - Sixty five percent of surveyed medical device companies report using a 501(k) clearance pathway for Class 2 devices, and 50% trend towards pre-market approvals (PMAs) for regulatory submissions of Class 3 drugs, according to a study by business intelligence firm Cutting Edge Information.




Medigus Receives Approval for Commencement of the First Multi-Center MUSE Clinical Study from CFDA in China

Thu, 16 Feb 2017 07:00:00 EST

OMER, ISRAEL--(Marketwired - Feb 16, 2017) - Medigus Ltd. (NASDAQ: MDGS) (TASE: MDGS), a medical device company developing minimally invasive endosurgical tools and a leader in direct visualization technology, today announced that the China Food and Drug Administration, or CFDA, has approved the commencement of the first multi-center MUSET Clinical Study in China.




Dynavax to Present at the 2017 RBC Capital Markets Global Healthcare Conference

Thu, 16 Feb 2017 06:00:00 EST

BERKELEY, CA--(Marketwired - February 16, 2017) - Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that Michael Ostrach, Dynavax's senior vice president and chief financial officer, will present at the 2017 RBC Capital Markets Global Healthcare Conference next week in New York, NY. The presentation will be webcast live and will occur on Wednesday, February 22, 2017 at 8:30 a.m. ET.




CipherCloud Wins Nine 2017 Info Security Products Guide (ISPG) Global Excellence Awards at RSA 2017

Thu, 16 Feb 2017 06:00:00 EST

CipherCloud's multi-cloud security platform, mobile app and customer service gain industry recognition




Ogilvy Healthworld takes home Silver at the 2016 PM Society Awards

Wed, 15 Feb 2017 12:06:04 EST

PARSIPPANY, NJ--(Marketwired - Feb 15, 2017) - Ogilvy CommonHealth Worldwide (www.ogilvychww.com), the health behavior change specialists of Ogilvy & Mather (www.ogilvy.com), and a WPP company (NASDAQ: WPPGY) (www.wpp.com), today announced its London-based Ogilvy Healthworld agency was awarded a Silver recognition at the PM Society Awards on Friday, February 3rd at the Grosvenor House Hotel in London, UK.




Multi-Pronged Product Distribution Agreements Announced by Premier Biomedical Pain Management Solutions for Their Superior Pain Relief Products

Wed, 15 Feb 2017 11:11:32 EST

EL PASO, TX--(Marketwired - Feb 15, 2017) - Premier Biomedical, Inc. (OTCQB: BIEI) announced today their joint venture, Premier Biomedical Pain Management Solutions, LLC (PBPMS), has signed distribution agreement contracts with multi-state pharmacies to sell and distribute PBPMS pain relief products. These outlets augment PBPMS's existing internet sales through their website, www.painreliefmeds.com, and other direct outlets announced in earlier press releases. Initially, the distribution contracts cover pain relief patches and roll-ons, but will expand as planned new products are introduced later this calendar year.




Asterand Bioscience and MolecularMD announce a partnership to accelerate targeted therapeutic biomarker validation, optimization, development and commercialization

Wed, 15 Feb 2017 10:00:00 EST

Partnership facilitates therapeutic biomarker and target validation, assay development and clinical trial management for companion diagnostics and drug development




Pegasystems Launches Industry's First Robotic Automation Capabilities to Reduce Time and Costs of Managing Onboarding and KYC

Wed, 15 Feb 2017 09:00:00 EST

Pega Robotic Automation now fully unified with Pega CLM and Pega KYC applications




InMed Pharma CEO Discusses Company's Cannabinoid Biosynthesis -- CFN Media

Wed, 15 Feb 2017 09:00:00 EST

SEATTLE, WA--(Marketwired - Feb 15, 2017) - CFN Media Group ("CannabisFN"), the leading creative agency and digital media network dedicated to legal cannabis, today announced the publication of an article and video CEO interview covering InMed Pharmaceuticals Inc.'s (OTCQB: IMLFF) (CSE: IN) groundbreaking cannabinoid biosynthesis technology.




Nutra Pharma and Nyloxin Featured on NBC News-Miami

Wed, 15 Feb 2017 08:30:00 EST

Nutra Pharma's over the counter (OTC) products, Nyloxin(R) and Pet Pain-Away(TM), were featured on the NBC News Miami affiliate last night




Planning Phase 4 Studies: When (and Where) to Involve Medical Affairs Teams

Wed, 15 Feb 2017 08:08:00 EST

RESEARCH TRIANGLE PARK, NC--(Marketwired - February 15, 2017) - Global pharmaceutical businesses are the most likely to involve multiple functions in postmarketing, or Phase 4, study planning. A recent study of pharmaceutical companies found that among surveyed global teams, 100% reported involving medical affairs, compliance and legal functions in their Phase 4 strategy-building activities. Additionally, 88% of surveyed global teams involve market access, and 75% involve both marketing and regulatory functions in Phase 4 study plans.




Aevi Genomic Medicine Announces 2017 Investor Day

Wed, 15 Feb 2017 08:00:00 EST

PHILADELPHIA, PA--(Marketwired - Feb 15, 2017) - Aevi Genomic Medicine, Inc. (NASDAQ: GNMX) (the Company) announced that it will host an Investor Day with senior management and key opinion leaders to discuss AEVI-001 and opportunities in the ADHD market. The event will be held at the NASDAQ Market Site in New York City on Wednesday, February 22, 2017 with breakfast beginning at 8:30 a.m. Eastern Time and speaker presentations beginning at 9:00 a.m. Eastern Time.




From Market Compliance to Business Supply: The Necessity for Serialization, New Webinar Hosted by Xtalks

Wed, 15 Feb 2017 07:30:00 EST

TORONTO, ON--(Marketwired - February 15, 2017) - Mario R. Scigliano, Serialization and Automation Manager at CordenPharma Latina S.p.A will address the necessity of serialization from market compliance to business supply, covering all aspects from line choice and regulation approach to management of data and related products. The live event will take place on Wednesday, March 8th, 2017 at 4pm CET (10am EST).




Amedica Granted 180-Day Extension by NASDAQ to Regain Compliance with Minimum Bid Price Rule

Wed, 15 Feb 2017 07:20:00 EST

SALT LAKE CITY, UT--(Marketwired - Feb 15, 2017) - Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, announced today that on February 14, 2017, it received notification from the NASDAQ Stock Market indicating that the Company will have an additional 180-day grace period, until August 14, 2017, to regain compliance with NASDAQ's $1.00 minimum bid requirement. The notification indicated that the Company did not regain compliance during the initial 180-day grace period provided under the rule. In accordance with NASDAQ Marketplace Rule 5810(c)(3)(A), the Company is eligible for the additional grace period because it meets the initial listing requirements for the NASDAQ Capital Market except for the bid price and provided written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary.




Trillium Therapeutics to Present New Data from TTI-621 Phase 1 Trial

Wed, 15 Feb 2017 07:00:00 EST

Increased drug exposure and acceptable platelet counts achieved with repeat dosing




Amunix announces broad alliance with Genentech using XTEN(R) technology

Wed, 15 Feb 2017 07:00:00 EST

MOUNTAIN VIEW, CA--(Marketwired - February 15, 2017) - Amunix Operating Inc. (Amunix), a biopharmaceutical company focused on the discovery and development of novel biologics, announced today that it has entered into a research and development collaboration with Genentech, a member of the Roche Group. The agreement will focus on the discovery and development of therapeutics utilizing Amunix's proprietary XTEN® technology against multiple targets selected by Genentech.




Renowned Homeland Security Experts Take The Stage At Milipol Asia-Pacific 2017 Conference

Tue, 14 Feb 2017 22:30:00 EST

SINGAPORE--(Marketwired - Feb 14, 2017) - The highly acclaimed Milipol Asia-Pacific Conference, returns this year from 4 to 6 April 2017 at the Sands Expo and Convention Centre, with a world class line-up of international speakers who will be sharing their latest insights on the homeland security environment. Themed "Emerging Threats -- The Case for Collaborative Public Safety", the three-day conference will expound on how governments and private organisations can build an effective internal and cross-border collaborative approach in tackling emerging threats to homeland security. 




The Alliance for Regenerative Medicine Releases Statement in Response to National Academies Report on Human Genome Editing

Tue, 14 Feb 2017 15:22:32 EST

WASHINGTON, DC--(Marketwired - Feb 14, 2017) - The National Academies of Sciences, Engineering and Medicine today issued a report that examines the scientific, clinical, ethical, legal and social implications of human genome editing. The Alliance for Regenerative Medicine (ARM) believes that genomic medicines, including genome editing, hold great promise for the treatment of a multitude of hereditary and acquired diseases where there is presently no effective treatment available.




Invivoscribe anuncia Acuerdo de Colaboración a largo plazo con Illumina y planea lanzamiento de kits de ensayo IVD basados en NGS

Tue, 14 Feb 2017 11:01:56 EST

SAN JOSÉ, CA--(Marketwired - Feb 14, 2017) - Invivoscribe(R) Technologies Inc., una compañía internacional con décadas de experiencia ofreciendo soluciones de pruebas de clonalidad y biomarcador para los campos de oncología y diagnóstico molecular personalizado (R) y medicina molecular personalizada (R), anuncia hoy su acuerdo de colaboración a largo plazo con Illumina(R) Inc., para el desarrollo y comercialización de ensayos de diagnóstico in vitro (IVD) para la plataforma de secuenciación de próxima generación (NGS) MiSeqDx(R). Este acuerdo permite a Invivoscribe traer ensayos de IVD a través de la FDA, conjuntamente con el software de bioinformática asociado, para venta y distribución en Estados Unidos.




ProcessUnity Updates Risk and Compliance Management Platform with Winter 2017 Release

Tue, 14 Feb 2017 10:01:00 EST

Newest Version of Cloud-based Suite Expands Reporting and Dashboard Capabilities; Increases Configuration Options




Aldeyra Therapeutics, Inc. Prices Public Offering of Common Stock

Tue, 14 Feb 2017 09:39:45 EST

LEXINGTON, MA--(Marketwired - Feb 14, 2017) - Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company focused on the development of products to treat diseases related to aldehydes, today announced the pricing of an underwritten public offering of 2,222,222 shares of its common stock at a price to the public of $4.50 per share. In connection with the offering, Aldeyra granted the underwriters a 30-day option to purchase 333,333 additional shares of common stock. All of the shares in the offering are being sold by Aldeyra. This offering is expected to close on or about February 17, 2017 subject to customary closing conditions.




Marina Biotech Announces Key Additions to its Executive Management Team

Tue, 14 Feb 2017 09:20:00 EST

CITY OF INDUSTRY, CA--(Marketwired - Feb 14, 2017) - Marina Biotech, Inc. (OTCQB: MRNA), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for disease intersections of arthritis, hypertension and cancer, today announced the appointment of Larn Hwang, Ph.D. as Chief Scientific Officer and Mihir Munsif as Chief Operating Officer.




Invivoscribe Announces Long-Term Collaboration Agreement with Illumina and Plans Release of NGS-based IVD Assay Kits

Tue, 14 Feb 2017 09:00:00 EST

SAN DIEGO, CA--(Marketwired - Feb 14, 2017) - Invivoscribe® Technologies Inc., an international company with decades of experience providing clonality and biomarker test solutions for the fields of oncology, personalized molecular diagnostics® and personalized molecular medicine®, announces today its long-term collaboration agreement with Illumina® Inc., to develop and commercialize in vitro diagnostic (IVD) assays for the next-generation sequencing (NGS) MiSeqDx® platform. This agreement allows Invivoscribe to bring IVD assays through the FDA, together with the associated bioinformatics software, for sale and distribution in the US.




StoneCalibre Portfolio Company Anatrace Acquires Modern Reagents and Screens Provider Molecular Dimensions

Tue, 14 Feb 2017 09:00:00 EST

LOS ANGELES, CA--(Marketwired - February 14, 2017) - StoneCalibre is pleased to announce that its portfolio company, Anatrace, has completed the acquisition of Molecular Dimensions Ltd. ("Molecular Dimensions" or the "Company"), a Cambridge, UK based leading supplier of modern screens, reagents, other consumables and instrumentation for structural biology research.




Invivoscribe anuncia assinatura de Contrato de Colaboração de Longo Prazo com a Illumina e planeja o lançamento dos Kits de ensaio de IVD de NGS

Tue, 14 Feb 2017 09:00:00 EST

SAN DIEGO, CA--(Marketwired - Feb 14, 2017) - A Invivoscribe(R) Technologies Inc., uma empresa global com mais de 20 anos de experiência com fornecimento de soluções para testes de clonalidade e biomarcador para os campos de oncologia e diagnósticos moleculares personalizados (personalized molecular diagnostics(R)) e de medicina molecular personalizada (personalized molecular medicine(R)), anunciou hoje que fechou um contrato de colaboração de longo prazo com a Illumina(R) Inc., para o desenvolvimento e comercialização de ensaios de diagnóstico in vitro (in vitro diagnostic - IVD) para a plataforma MiSeqDx(R) de sequenciamento da próxima geração (next-generation sequencing - NGS). Este contrato permite que a Invivoscribe leve o ensaio de IVD por meio do FDA, juntamente com o software de bioinformática para venda e distribuição nos EUA.




StoneCalibre-Portfolio-Unternehmen Anatrace erwirbt Molecular Dimensions, einen Anbieter von modernen Reagenzien und Testverfahren

Tue, 14 Feb 2017 09:00:00 EST

LOS ANGELES, KALIFORNIEN--(Marketwired - 14. Februar 2017) - StoneCalibre freut sich bekanntzugeben, dass sein Portfolio-Unternehmen Anatrace die Übernahme des Unternehmens Molecular Dimensions Ltd. ("Molecular Dimensions" oder das "Unternehmen") abgeschlossen hat. Dieses Unternehmen hat seinen Sitz in Cambridge im Vereinigten Königreich und ist ein führender Anbieter von modernen Testverfahren, Reagenzien, Verbrauchsmaterialien und Instrumenten für die strukturbiologische Forschung.




Tetra Discusses Clinical Program in New Interview with CFN Media

Tue, 14 Feb 2017 09:00:00 EST

SEATTLE, WA--(Marketwired - Feb 14, 2017) - CFN Media Group ("CannabisFN"), the leading creative agency and digital media network dedicated to legal cannabis, announces publication of an exclusive interview and article discussing the progress made by Tetra Bio-Pharma Inc. (OTC PINK: GRPOF) (CNSX: TBP) in its clinical trial program. The interview is with Dr. Guy Chamberland, Tetra's Chief Science Officer.




Propanc Successfully Completes Low Dose Group for GLP-Compliant 28-Day Repeat-Dose Toxicity Study

Tue, 14 Feb 2017 08:30:00 EST

In-Life Phase for Middle and High Dose Groups Set to Commence Immediately




NuGene International Appoints John Ohanesian as Chief Strategic Advisor, Hair

Tue, 14 Feb 2017 08:00:00 EST

Ohanesian Led Bosley, Inc.'s Growth to Worldwide Hair Restoration Leadership




Study Finds Variations in Percentage of Clinical Development Teams Involved in Adaptive Design Clinical Trials

Tue, 14 Feb 2017 07:48:00 EST

RESEARCH TRIANGLE PARK, NC--(Marketwired - February 14, 2017) - Although adaptive design clinical trials are a trending practice for developing new drugs, pharmaceutical companies still pursue plenty of non-adaptive trials. In fact, 76% of clinical development teams at surveyed drug manufacturers in a recent study plan and execute adaptive studies, while a higher percentage of these teams -- 82% -- plan and execute traditional, non-adaptive clinical trials.




Desiccant Dehumidification for Energy Efficient Drying of Gelatine and HPMC Capsules, New Webinar Hosted by Xtalks

Tue, 14 Feb 2017 07:30:00 EST

TORONTO, ON--(Marketwired - February 14, 2017) - During manufacturing of gelatine and HPMC capsules, efficient and carefully controlled drying is essential for ensuring product quality and consistence. Users of Munters' desiccant dehumidification have reported faster and more consistent drying times for freshly produced capsules thus allowing higher production volume and lower rates of non-compliant product, which in turn reduces production costs and fault finding efforts. These dehumidification solutions have the additional benefits of being energy efficient, hygienic and easy to maintain.




Adgero Biopharmaceuticals Holdings, Inc. Expands Executive Management Team with Appointment of Jane M. Maida as Chief Financial Officer

Tue, 14 Feb 2017 07:00:00 EST

PRINCETON, NJ--(Marketwired - February 14, 2017) - Adgero Biopharmaceuticals Holdings, Inc. ("Adgero" or the "Company"), a privately-held biopharmaceutical company leveraging its late stage photodynamic therapy ("PDT") platform for the treatment of serious oncology indications, announced today that it has appointed Jane M. Maida as Chief Financial Officer and Vice President of Finance.