Clinical trials

Aradigm Announces Detailed Third Party Evaluation Results for Apulmiq (FDA)/Linhaliq (EMA)

Retrieved on: 
Wednesday, January 16, 2019

Aradigm Corporation (OTCQB: ARDM) ("Aradigm" or the "Company") today announced specific, detailed results of an independent third party evaluation (TPE) of the Phase 3 clinical trial results for Apulmiq.

Key Points: 
  • Aradigm Corporation (OTCQB: ARDM) ("Aradigm" or the "Company") today announced specific, detailed results of an independent third party evaluation (TPE) of the Phase 3 clinical trial results for Apulmiq.
  • The TPE results also verify the already reported non-significant primary and secondary PE endpoint results of ORBIT-3.
  • A meeting has been scheduled with the FDA to discuss these TPE verified Phase 3 trial results.
  • Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation.

Anokion Expands Leadership Team with Appointment of Simon Cooper, MBBS, as Chief Medical Officer

Retrieved on: 
Wednesday, January 16, 2019

Anokion (Anokion or the Company), a leading immune tolerance company advancing novel, antigen-specific treatments for autoimmune disease, today announced that Simon Cooper, MBBS., has been appointed to the newly created position of chief medical officer.

Key Points: 
  • Anokion (Anokion or the Company), a leading immune tolerance company advancing novel, antigen-specific treatments for autoimmune disease, today announced that Simon Cooper, MBBS., has been appointed to the newly created position of chief medical officer.
  • Dr. Cooper will join the executive leadership team and will report directly to Anokion President and CEO John Hohneker, M.D.
  • We are delighted to have Simon join the leadership team at a time when the company is preparing to initiate its first clinical study this year, said Dr. Hohneker.
  • Simon is an accomplished drug development executive with an extensive and successful track record of leading product candidates through development, approval and commercial launch.

Scientist.com Hosts Webinar Exploring Global Strategies for Sourcing of Real World Evidence (RWE) and Health Economics and Outcomes Research (HEOR)

Retrieved on: 
Wednesday, January 16, 2019

I am excited to serve on such a distinguished panel focusing on the practical uses of real world data, said Patti Peeples, RPh, PhD, CEO and Founder, HealthEconomics.com, and Principal Researcher, HE Institute.

Key Points: 
  • I am excited to serve on such a distinguished panel focusing on the practical uses of real world data, said Patti Peeples, RPh, PhD, CEO and Founder, HealthEconomics.com, and Principal Researcher, HE Institute.
  • Many research organizations are looking to maximize this data to optimize market access while informing value-focused healthcare decisions and reducing research costs.
  • The panelists will cover topics surrounding the uses of RWE such as sourcing opportunities and challenges, how it relates to HEOR and varying strategies and regulations when sourcing these types of services.
  • Go here for more information or to register for the complimentary webinar, HEOR & RWE: Global Sourcing Strategies and Best Practices.

Massive Bio Announces SYNERGY-AI Trial-in-Progress Poster Presentation at Upcoming ASCO Gastrointestinal Cancers Symposium 2019, and Opens a New Patient Contact and Clinical Research Center to Enable Rapid Access to Clinical Trials

Retrieved on: 
Wednesday, January 16, 2019

will be presented by Selin Kurnaz, PhD., a lead investigator, at the ASCO-Gastrointestinal Cancers Symposium on January 19, 2019 in San Francisco, California, USA.

Key Points: 
  • will be presented by Selin Kurnaz, PhD., a lead investigator, at the ASCO-Gastrointestinal Cancers Symposium on January 19, 2019 in San Francisco, California, USA.
  • Massive Bio has also expanded its Patient Contact and Clinical Research Center and opened a second location in Newtown, Pennsylvania, in addition to its main headquarters in New York City.
  • This center is staffed with a team of oncology nurse navigators, patient advocates and research coordinators and focuses on Massive Bios growing portfolio of clinical trials and patient support services.
  • Massive Bio provides virtual tumor board, clinical trial services (patient identification, pre-screening, site selection) and real-world evidence services.

Five Prime Announces Restructuring to Focus on Clinical Development and Later-Stage Research Priorities

Retrieved on: 
Tuesday, January 15, 2019

We remain committed to successfully executing our clinical trials and advancing our later-stage research programs with the same intensity and quality for which Five Prime is known.

Key Points: 
  • We remain committed to successfully executing our clinical trials and advancing our later-stage research programs with the same intensity and quality for which Five Prime is known.
  • The company is eliminating 41 current positions, representing approximately 20% of its current headcount, and will take a disciplined approach to replacing and adding headcount.
  • Five Prime Therapeutics, Inc.discovers and develops innovative therapeutics to improve the lives of patients with serious diseases.
  • Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development.

Illumina to Announce Fourth Quarter and Fiscal Year 2018 Financial Results on Tuesday, January 29, 2019

Retrieved on: 
Tuesday, January 15, 2019

Illumina, Inc. (NASDAQ:ILMN) today announced that it will issue results for fourth quarter and fiscal year 2018 following the close of market on Tuesday, January 29, 2019.

Key Points: 
  • Illumina, Inc. (NASDAQ:ILMN) today announced that it will issue results for fourth quarter and fiscal year 2018 following the close of market on Tuesday, January 29, 2019.
  • The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, January 29, 2019.
  • Interested parties may access the live teleconference through the Investor Relations section of Illuminas website under the company tab at www.illumina.com .
  • Alternatively, individuals can access the call by dialing 1 (800) 708-4539, or 1 (847) 619-6396 outside North America, both with passcode 47970793.

Herbalife Nutrition Hosts 6th Annual Nutrition Industry Scientific Summit

Retrieved on: 
Tuesday, January 15, 2019

Herbalife Nutrition(NYSE: HLF), a premier global nutrition company whose purpose is to make the world healthier and happier, today hosted the 6th annual nutrition industry scientific summit, in Torrance, California.

Key Points: 
  • Herbalife Nutrition(NYSE: HLF), a premier global nutrition company whose purpose is to make the world healthier and happier, today hosted the 6th annual nutrition industry scientific summit, in Torrance, California.
  • "Our continued investment in technology, research and manufacturing quality, further strengthens our position as a nutrition industry leader and helps set industry standards, said Dr. John Agwunobi, Co-President and Chief Health and Nutrition Officer, Herbalife Nutrition.
  • Additionally, Herbalife Nutrition announced that Dr. Lus paper has been accepted for publishing in the peer reviewed Journal of AOAC International.
  • Through its corporate social responsibility efforts, Herbalife Nutrition supports the Herbalife Nutrition Foundation (HNF) and its Casa Herbalife programs to help bring good nutrition to children in need.

Company Profile for VenatoRx Pharmaceuticals, Inc.

Retrieved on: 
Tuesday, January 15, 2019

VenatoRx Pharmaceuticals is a world leader in antibacterial and antiviral drug research and development.

Key Points: 
  • VenatoRx Pharmaceuticals is a world leader in antibacterial and antiviral drug research and development.
  • VenatoRxs lead product, VNRX-5133, is an injectable beta-lactamase inhibitor (BLI) that features uniquely potent and selective activity against both serine- and metallo-beta-lactamases.
  • VenatoRx is currently developing VNRX-5133 in a fixed combination with the fourth generation cephalosporin, cefepime.
  • engineerable with serine- and metallo-beta-lactamases, and suspected polymicrobial infections caused by both gram-negative and gram-positive pathogens.

PharmaCyte Biotech Announces Encapsulation of Live Cells for Clinical Trial in Pancreatic Cancer

Retrieved on: 
Tuesday, January 15, 2019

Once the capsules are completely full of live cells, they will be placed into syringes and frozen.

Key Points: 
  • Once the capsules are completely full of live cells, they will be placed into syringes and frozen.
  • Austrianova will then commence testing the capsules in the frozen syringes to finalize PharmaCytes clinical trial material.
  • PharmaCyte Biotech is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as Cell-in-a-Box.
  • The cell lines being studied are human liver cells, stem cells and beta islet cells.

Niche Biometric CRO Launches Dedicated Pharmacovigilance Business

Retrieved on: 
Tuesday, January 15, 2019

Quanticate, a leading global data-focused clinical research organisation (CRO) has launched QVigilance to provide dedicated pharmacovigilance (PV) and risk management services.

Key Points: 
  • Quanticate, a leading global data-focused clinical research organisation (CRO) has launched QVigilance to provide dedicated pharmacovigilance (PV) and risk management services.
  • David Hukin, Managing Director of QVigilance said: " Quanticate is an experienced niche biometric CRO supporting a wide range of customers and we are always working to further our expertise and service offering.
  • Hukin added: "It is a natural progression for Quanticate to expand its capabilities through the launch a company dedicated to delivering PV services.
  • Our team is adept in supporting customers transitioning from clinical trials to post-marketing and establishing a compliant pharmacovigilance system to support our customers' products.