Medical research

PRA Health Sciences pioneers connecting clinical trial patients with their real-world data with Synoma

Thursday, May 13, 2021 - 9:02pm

b'RALEIGH, N.C., May 13, 2021 (GLOBE NEWSWIRE) -- PRA Health Sciences, Inc. (NASDAQ: PRAH) announced today an innovative tokenization solution using Synoma\xc2\xae, PRA\xe2\x80\x99s proprietary technology that allows for the generation of enhanced evidence for drug development.

Key Points: 
  • b'RALEIGH, N.C., May 13, 2021 (GLOBE NEWSWIRE) -- PRA Health Sciences, Inc. (NASDAQ: PRAH) announced today an innovative tokenization solution using Synoma\xc2\xae, PRA\xe2\x80\x99s proprietary technology that allows for the generation of enhanced evidence for drug development.
  • PRA\xe2\x80\x99s solution makes it possible to connect clinical trial data and secondary data sets with privacy at the forefront.
  • The missing link, however, is the ability to connect clinical trial data to the insights from real-world data \xe2\x80\x93 enabling researchers to understand what is happening outside and after a study in a way that protects privacy,\xe2\x80\x9d said Kent Thoelke, Executive Vice President and Chief Scientific Officer, PRA Health Sciences.
  • Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide.

CTT Named 'Best Clinical Trial Site' by World Vaccine Congress

Thursday, May 13, 2021 - 10:00pm

b'SAN ANTONIO, May 13, 2021 /PRNewswire-PRWeb/ -- Clinical Trials of Texas, Inc. (CTT) was named "Best Clinical Site" at the 14th annual Vaccine Industry Excellence (ViE) Awards during the 2021 World Vaccine Congress.\n"CTT is so honored to be recognized for its vaccine work alongside some of the most prestigious names in the pharmaceutical industry," said President/CEO Kay Scroggins, RN.\nCTT has conducted more than 40 vaccine trials including COVID-19, Influenza, Pneumonia, RSV and Meningitis.

Key Points: 
  • b'SAN ANTONIO, May 13, 2021 /PRNewswire-PRWeb/ -- Clinical Trials of Texas, Inc. (CTT) was named "Best Clinical Site" at the 14th annual Vaccine Industry Excellence (ViE) Awards during the 2021 World Vaccine Congress.\n"CTT is so honored to be recognized for its vaccine work alongside some of the most prestigious names in the pharmaceutical industry," said President/CEO Kay Scroggins, RN.\nCTT has conducted more than 40 vaccine trials including COVID-19, Influenza, Pneumonia, RSV and Meningitis.
  • In 2020, CTT was recognized as a top Latino COVID-19 vaccine enroller in an investigational vaccine study.
  • Minority participation in COVID-19 vaccine trials topped 50%, due to ongoing community outreach efforts.
  • CTT conducts studies across Phases I-IV, working with more than 13 investigators across multiple therapeutic areas such as vaccines, metabolic disorders, women\'s health, mental/behavioral health and devices.\n'

Virgo Investment Group Announces CROs Clinipace and dMed Merge to Accelerate Growth

Thursday, May 13, 2021 - 4:29pm

We were able to evolve the team, the culture, the business processes in both sales and clinical trial delivery, and the technology backbone of the company.

Key Points: 
  • We were able to evolve the team, the culture, the business processes in both sales and clinical trial delivery, and the technology backbone of the company.
  • "\nClinipace has almost 25 years of broad clinical experience, extensive regulatory expertise, and core therapeutic specialties in oncology, nephrology, rare disease, gastroenterology, and women\'s health.
  • Clinipace delivers a level of collaboration and flexibility not possible in a traditional CRO environment, with an emphasis on personalized services and solutions, regulatory expertise, and therapeutic leadership.
  • dMed\'s U.S. presence includes Target Health, a full-service technology driven CRO with expertise in digital capabilities and regulatory affairs.\nView original content to download multimedia: http://www.prnewswire.com/news-releases/virgo-investment-group-announces...\n'

Pure Green Pharmaceuticals Reports Unexpected Results of a Randomized, Placebo Controlled Clinical Trial with Sublingual CBD in Patients with Painful Diabetic Peripheral Neuropathy

Thursday, May 13, 2021 - 1:38pm

Interestingly, the results of this placebo-controlled trial mirrored those of Pure Green Pharmaceuticals\' open-label pDPN trial where both studies revealed a significant drop in pain scores by approximately 50%.

Key Points: 
  • Interestingly, the results of this placebo-controlled trial mirrored those of Pure Green Pharmaceuticals\' open-label pDPN trial where both studies revealed a significant drop in pain scores by approximately 50%.
  • There were no adverse events in either clinical trial to patients on treatment medication.
  • The damage to the nerves results in debilitating pain that adversely impacts both quality of life and healthcare costs.
  • This innovative treatment modality delivers the medication in minutes, with enhanced efficacy through increased bioavailability.\nContact: Jim Smith, Pure Green Pharmaceuticals (650) 454-0811; 309799@email4pr.com\n'

DGAP-News: CureVac : Second-Generation COVID-19 Vaccine Candidate, CV2CoV, Demonstrates High Immunogenicity Against Virus Variants in Preclinical Study

Thursday, May 13, 2021 - 1:06pm

In addition, the serum of vaccinated animals showed significant cross-neutralization against variants first discovered in Denmark (B.1.1.298), the UK (B.1.1.7) and South Africa (B.1.351).

Key Points: 
  • In addition, the serum of vaccinated animals showed significant cross-neutralization against variants first discovered in Denmark (B.1.1.298), the UK (B.1.1.7) and South Africa (B.1.351).
  • "Spurred by the emergence of virus variants that have the potential to affect the efficacy of currently approved first-generation mRNA COVID-19 vaccines, CureVac and GSK aim to jointly develop second-generation vaccine candidates that offer improved immune responses and target emerging variants.
  • Combined with lower doses, these second-generation vaccines could enable also broad protection against selected strains in a multivalent vaccine format.
  • In December 2020, CureVac initiated a pivotal Phase 2b/3, the HERALD study, with a 12\xc2\xb5g dose of CVnCoV.

Evaxion Biotech Announces Q1 2021 Financial Results and Provides Business Update

Thursday, May 13, 2021 - 12:30pm

Our two lead product candidates, EVX-01 and EVX-02, are on track for results from Phase 1/2a trials late in Q2 and we continue to develop our RAVEN AI platform for vaccine design and development for viral infections.

Key Points: 
  • Our two lead product candidates, EVX-01 and EVX-02, are on track for results from Phase 1/2a trials late in Q2 and we continue to develop our RAVEN AI platform for vaccine design and development for viral infections.
  • The increase of $1.4 million was primarily related to increased spending, net of grant income, for ongoing development on our platform, pre-clinical product candidates, and clinical trials.
  • In addition, employee-related costs increased due to higher headcount.\nGeneral and Administrative expenses were $1.3 million for the quarter ended March 31, 2021, compared to $0.8 million for the same period in 2020.
  • In addition, Evaxion is advancing a portfolio of vaccines to prevent bacterial and viral infections currently in preclinical development.\n'

Merck Announces Phase 3 KEYNOTE-522 Trial Met Dual Primary Endpoint of Event-Free Survival (EFS) in Patients With High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC)

Thursday, May 13, 2021 - 11:45am

KEYNOTE-522 met its dual primary endpoint of event-free survival (EFS) for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC).

Key Points: 
  • KEYNOTE-522 met its dual primary endpoint of event-free survival (EFS) for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC).
  • As previously communicated, KEYNOTE-522 met its other dual primary endpoint of pathological complete response (pCR).
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
  • At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment.

Community Partners Announce First Vaccination Site for Underserved Youth

Thursday, May 13, 2021 - 11:00am

b'PHOENIX, May 13, 2021 /PRNewswire-PRWeb/ -- The Equality Health Foundation , the HeroZona Foundation and other community partners are excited to announce the launch of the first vaccine site in Arizona for underserved youth ages 12 to 15 at the C.O.

Key Points: 
  • b'PHOENIX, May 13, 2021 /PRNewswire-PRWeb/ -- The Equality Health Foundation , the HeroZona Foundation and other community partners are excited to announce the launch of the first vaccine site in Arizona for underserved youth ages 12 to 15 at the C.O.
  • "We\'ve operated several successful vaccination events and can now give parents and gaurdians in at-risk communities the chance to protect their kids as well.
  • This wouldn\'t be possible without Equality Health Foundation, HeroZona and the other partners committed to keeping our people safe.
  • The third event was held on April 10 at South Mountain Community College, which is now a permanent COVID-19 vaccination site.

CenterWatch Announces GCP Questions, FDA Answers, 2021 Edition

Thursday, May 13, 2021 - 5:00am

What are the penalties for not complying with ClinicalTrials.gov reporting procedures?

Key Points: 
  • What are the penalties for not complying with ClinicalTrials.gov reporting procedures?
  • How should ongoing training efforts be documented?\nIt can only help to learn from questions others have already asked.\nThrough this compilation of more than 100 questions and responses, GCP Questions, FDA Answers provides answers to questions about the many guidelines from the FDA, including those related to adverse events, investigator responsibilities, electronic medical records and data privacy protection.
  • But one can better understand the many changes that have occurred with this book.
  • Learn from the many responses other professionals have received and ensure you are prepared to keep the trial on track.\nGet answers and ensure trial success with GCP Questions, FDA Answers, 2021 Edition.\n'

COVID-19 Vaccine Age Eligibilty Expands at All Rite Aid Locations

Wednesday, May 12, 2021 - 11:41pm

Those ages 12 through 17 are only authorized to be vaccinated with the Pfizer vaccine, per CDC guidance.\nAdditionally, Rite Aid is enabling schools and organizations in its footprint to inquire about vaccine clinics directly with the company by visiting www.riteaid.com/covid-19/community-clinics .

Key Points: 
  • Those ages 12 through 17 are only authorized to be vaccinated with the Pfizer vaccine, per CDC guidance.\nAdditionally, Rite Aid is enabling schools and organizations in its footprint to inquire about vaccine clinics directly with the company by visiting www.riteaid.com/covid-19/community-clinics .
  • The clinic inquiry tool provides a seamless and efficient way to organize on-site vaccine clinics, helping to bring the vaccine directly into communities and reach people at schools, community centers, churches, and workplaces.
  • Whether it\xe2\x80\x99s COVID-19 testing or vaccine clinics, we\xe2\x80\x99re eager to help our communities thrive.\xe2\x80\x9d\nFor more information about Rite Aid\xe2\x80\x99s COVID-19 vaccine efforts, please visit www.RiteAid.com/covid-19 .\nRite Aid Corporation is on the front lines of delivering healthcare services and retail products to Americans 365 days a year.
  • We provide an array of whole being health products and services for the entire family through over 2,500 retail pharmacy locations across 17 states.