Clinical trial

MERIT Expands into Skincare with Great Skin™

Retrieved on: 
Thursday, September 22, 2022
Clinical trial, CEO, Skin, Skin care, Time, Oil, Sephora, SKU, Industry, Cosmetics

NEW YORK, Sept. 22, 2022 /PRNewswire/ -- MERIT, the minimalist beauty brand known for creating intentional luxury products that are safe for body, skin, and planet, is taking their first step into skincare with Great Skin™ Instant Glow Serum. In under two years, MERIT has become a leader in the oversaturated makeup space by challenging the established beauty playbook. Now, they're bringing the same level of intentionality and excellence to skin. 

Key Points: 
  • NEW YORK, Sept. 22, 2022 /PRNewswire/ -- MERIT, the minimalist beauty brand known for creating intentional luxury products that are safe for body, skin, and planet, is taking their first step into skincare with Great Skin Instant Glow Serum.
  • MERIT's Great Skin Instant Glow Serum is a lightweight, bi-phase formula that instantly hydrates and plumps skin for a smooth, glass-like appearance, while also leaving skin calmer, brighter and more even over time.
  • MERIT has a well-earned reputation for developing products that won't trigger reactions and improve the look and feel of skin, making Great Skin a natural evolution in its uncompromising commitment to safe and effective products.
  • To ensure its entrance into skincare was truly differentiated, MERIT perfected Great Skin over nearly 5 years and tweaked the formula 52 times.

Checkpoint Therapeutics to Participate in Two Upcoming Investor Conferences

Retrieved on: 
Thursday, September 22, 2022
Securities Exchange Act of 1934, Investor, COVID-19, Dana–Farber Cancer Institute, Risk, Biologics license application, Chemistry, Drug Quality and Security Act, U.S. Securities and Exchange Commission, Fortress Biotech, News, Acquisition, Private Securities Litigation Reform Act, Securities Act of 1933, Patient, Clinical trial, Regulation, CSCC, Annual report, Data, NASDAQ, Research, Conference, BLA, Marketing, Patent, EGFR, Baozou Big News Events, Pharmaceutical industry

Checkpoint will also participate in one-on-one meetings during the conference.

Key Points: 
  • Checkpoint will also participate in one-on-one meetings during the conference.
  • Checkpoint Therapeutics, Inc. (Checkpoint) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers.
  • Following positive topline and interim results in metastatic and locally advanced cSCC, respectively, Checkpoint intends to submit a Biologics License Application for both these indications, targeted for year-end.
  • Checkpoint is headquartered in Waltham, MA and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO).

Optimi Health, ATMA Journey Centers To Proceed With Phase I Natural Psilocybin and MDMA Clinical Trial Application to Health Canada

Retrieved on: 
Thursday, September 22, 2022
Temperature, FRA, Safety, Blood pressure, FDA, Food, ATMA, Psilocybin, CTA, Company, Growth, MDMA, BioCompute Object, Partnership, Industry, Harder, FOR, Patient, Clinical trial, Attention, Multidisciplinary Association for Psychedelic Studies, Breakthrough therapy, Health Canada, CSE, Letter, Heart rate, Leadership, ECG, Substance abuse, GLOBE, Phobia, Food and Drug Administration Amendments Act of 2007, PTSD, Social anxiety, Pharmaceutical industry

Optimi CEO, Bill Ciprick, says the goal of the clinical trial is to acquire data, including blood pressure, temperature, heart rate, and ECG readings, for Optimis proprietary formulation using natural EU-GMP psilocybin and MDMA.

Key Points: 
  • Optimi CEO, Bill Ciprick, says the goal of the clinical trial is to acquire data, including blood pressure, temperature, heart rate, and ECG readings, for Optimis proprietary formulation using natural EU-GMP psilocybin and MDMA.
  • Coming off the success of ATMAs recently completed Phase I psilocybin trial and a No Objection Letter to conduct its N-500 Phase II psilocybin clinical trial on frontline healthcare professionals, were excited to officially begin the process, he added.
  • ATMA is currently the only Canadian organization that has received approval from Health Canada to conduct a Phase I safety trial with psilocybin in healthy therapists, which it completed last month.
  • Optimis plan for commercialization involves the Company being an active leader in meeting therapist demand for natural EU-GMP psilocybin and MDMA.

MEI Pharma Announces Changes to Board of Directors

Retrieved on: 
Thursday, September 22, 2022
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Safety, Doctor of Philosophy, COVID-19, Risk, Sale, FDA, Food, LLC, Â, Nature, LinkedIn, Company, Private Securities Litigation Reform Act, COO, Industry, Patient, Clinical trial, Regulation of tobacco by the U.S. Food and Drug Administration, History, Cancer, Needham, MEI, Regulation, Leadership, Massachusetts Institute of Technology, Drug development, Needham & Company, Retirement, Marketing, Thermo Fisher Scientific, Failure, Disclosure, Pharmaceutical industry

Charles V. Baltic III, J.D., who has served on the board since 2011, has been elected to replace Dr. White as chair of the board.

Key Points: 
  • Charles V. Baltic III, J.D., who has served on the board since 2011, has been elected to replace Dr. White as chair of the board.
  • On behalf of the board and management, I would like to thank Christine for her unwavering dedication and strategic guidance during her 12-year tenure on the board of directors, said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma.
  • We look forward to working with Charles in his new capacity as board chair to leverage his history and familiarity with MEI.
  • MEI Pharma, Inc. (Nasdaq: MEIP) is a late-stage pharmaceutical company focused on developing potential new therapies for cancer.

Celsius Therapeutics Names Scientific Advisers

Retrieved on: 
Thursday, September 22, 2022
Oncology, Health, Genetics, Other Health, General Health, Pharmaceutical, Biotechnology, Computer science, Autoimmunity, Netherlands Cancer Institute, Leonard M. Miller School of Medicine, Doctor of Philosophy, Autoimmune disease, Department, FRS, Weizmann Institute of Science, Third Rock Ventures, ECCO, Twitter, Machine learning, Immunology, Inflammatory bowel disease, University of California, Berkeley, European, Nutrition, LinkedIn, Terra Venture Partners, Computational biology, Yale School of Medicine, Therapy, Patient, Clinical trial, Cleveland Clinic, Cancer, CEO, Transcriptome, Ulcerative colitis, Biology, Associate professor, Howard Hughes Medical Institute, Harvard Medical School, B cell, RNA, Research, Biotechnology, IBD, University, Health informatics, Electrical engineering, Pharmaceutical industry, Vaccine, Celsius, Microbiology, Medicine

Celsius Therapeutics, a biotechnology company pioneering new precision medicines for patients with cancer and autoimmune disease by harnessing the power of single-cell RNA sequencing and human biology at scale, today announced the appointments of six scientific advisers.

Key Points: 
  • Celsius Therapeutics, a biotechnology company pioneering new precision medicines for patients with cancer and autoimmune disease by harnessing the power of single-cell RNA sequencing and human biology at scale, today announced the appointments of six scientific advisers.
  • As Celsius prepares to advance our first programs into the clinic, we are entering a transitional point in our evolution, said Tariq Kassum, M.D., President and CEO of Celsius.
  • Director, Crohns and Colitis Center, Professor of Medicine, and Professor of Microbiology and Immunology, University of Miami Miller School of Medicine.
  • Celsius Therapeutics is a biotechnology company developing novel precision medicines in autoimmune disease and cancer by harnessing the power of single cell RNA sequencing and human biology at scale.

Team Arnav Foundation Partners with OS Therapies Supporting the Phase IIb Trial of OST-HER2 (Listeria monocytogenes) in Recurred, Resected Osteosarcoma

Retrieved on: 
Thursday, September 22, 2022
OS, Listeria monocytogenes, Memory, OST, Immunotherapy, Sarcoma, FDA, Partnership, AYA, Foundation, Patient, Clinical trial, RDD, Cancer, CEO, Adolescence, LM, Metastasis, Toxic leukoencephalopathy, Founder, Research, BTD, Awareness, EMA, Recurrence, Listeria, Pharmaceutical industry, Dhruv, Osteosarcoma

"We are honored to have Team Arnav join our battle against Osteosarcoma, along with six other foundations and numerous investors.

Key Points: 
  • "We are honored to have Team Arnav join our battle against Osteosarcoma, along with six other foundations and numerous investors.
  • OS Therapies has two platform technologies being developed for therapies to treat and cure Osteosarcoma (OS) and other solid tumors including ovarian, esophageal, endometrial and lung cancers.
  • AOST-2121 is a Phase IIB clinical trial intended to prevent metastasis and improve Overall Survival (OS) in Osteosarcoma.
  • OST hopes to seek a Break-Through Designation (BTD) based on data from this Phase IIb clinical trial.

New Global Survey Reveals Shift in Clinical Trial Priorities; Payment Efficiencies Emerge as Leading Concern for Sponsors, CROs and Sites

Retrieved on: 
Thursday, September 22, 2022
Time, Movement, Organization, Degenerative disease, Industry, Cros, Patient, Clinical trial, Automation, CEO, United Kingdom, Technology, CRO, Solution, Connex, Infection, Pharmaceutical industry, Fine chemical

KING OF PRUSSIA, Pa., Sept. 22, 2022 /PRNewswire/ -- Greenphire, the global leader in financial lifecycle management for clinical trials, today announced results from its 2022 annual market trends survey which examined top challenges and opportunities for sponsors, CROs, and sites across the globe. While survey respondents represented a variety of therapeutic areas, including cardiovascular, medical device, rare diseases, infectious diseases and oncology, responses across the board revealed payments as a central concern for all stakeholders.

Key Points: 
  • Comparing data from Greenphire's 2020 and 2021 market trends surveys indicate there is a clear shift in focus for the research industry.
  • In fact, the survey showed the most important activity sponsors and CROs can do to enhance relationships with sites is to streamline site payments and invoicing.
  • Greenphire will also be hosting a webinar discussing the survey results on Thursday, September 22, 2022, from 12:00-1:00 PM EDT.
  • Greenphire's best-in-class solutions optimize clinical trial performance by streamlining payment and logistical workflows from sponsors and CROs to sites and patients.

Vir Biotechnology Announces First Patient Dosed in the Phase 2 SOLSTICE Trial Evaluating VIR-2218 and VIR-3434 for the Treatment of Chronic Hepatitis D Virus Infection

Retrieved on: 
Thursday, September 22, 2022
Adult, Half-life, Safety, COVID-19, Sirna, Risk, Virus, Blood, ALT, U.S. Securities and Exchange Commission, HBsAg, Week, Coinfection, Viremia, Liver cancer, Private Securities Litigation Reform Act, Hepatitis B, HBV, Forward-looking statement, Alanine transaminase, Patient, Clinical trial, Drug development, Disease, Hepatitis B virus, Technology, HIV, Therapeutic index, Viral hepatitis, RNA, Research, GLOBE, Hepatocyte, HDV, Superinfection, Mortality, Immune system, Monoclonality, Infection, Death, Hepatocellular carcinoma, Vaccine, Pharmaceutical industry

SAN FRANCISCO, Sept. 22, 2022 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first patient has been dosed in the Phase 2 SOLSTICE clinical trial evaluating VIR-2218 and VIR-3434 as monotherapy and in combination for the treatment of people living with chronic hepatitis D virus (HDV), which occurs as a simultaneous co-infection or super-infection alongside hepatitis B virus (HBV). HDV infection, the most aggressive form of viral hepatitis, increases the risk of poor outcomes, including liver cancer and death, compared with HBV alone.

Key Points: 
  • VIR-2218 and VIR-3434 are currently being evaluated for the treatment of HBV in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial.
  • Chronic hepatitis D virus (HDV) infection occurs as a simultaneous co-infection or super-infection with hepatitis B virus (HBV).
  • Chronic hepatitis B virus (HBV) infection remains an urgent global public health challenge associated with significant morbidity and mortality.
  • Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B and hepatitis D viruses, influenza A and human immunodeficiency virus.

Central Lab Global Market Report 2022: Outsourcing Trend to Create Lucrative Growth Opportunities - ResearchAndMarkets.com

Retrieved on: 
Thursday, September 22, 2022
Biotechnology, Temperature, Laboratory, Eurofins Scientific, COVID-19, D, RNA transfection, Industry, Diabetes, USD, Clinical trial, Genetic testing, Key, Science, Research, CAGR, Fine chemical, Coal, Pharmaceutical industry, Service

The global central lab market size is expected to reach USD 5.08 billion by 2030, according to this report.

Key Points: 
  • The global central lab market size is expected to reach USD 5.08 billion by 2030, according to this report.
  • The outsourcing of central lab work is a significant factor driving the market growth.
  • Outsourcing central lab work is a rising trend in the clinical trial industry, which is expected to create lucrative business opportunities for central labs.
  • The investigators and sponsors outsource ~80% of the central lab work and prefer the labs that provide end-to-end integrated services.

Marinus Pharmaceuticals Announces Exercise of First Contract Option by the Biomedical Advanced Research and Development Authority (BARDA)

Retrieved on: 
Thursday, September 22, 2022
Pharmaceutical, Health, Neurology, Biometrics, Adult, Organophosphate, Therapy, RAISE, Safety, Development, IV, COVID-19, Epilepsy, Seizure, GABAA, Brain, FDA, Office of Inspector General, U.S. Department of Health and Human Services, BARDA, Ganaxolone, Administration, Lists of weapons, Private Securities Litigation Reform Act, Forward-looking statement, SE, U.S. Securities and Exchange Commission, Status epilepticus, Patient, Clinical trial, U.S. Department of Defense Strategy for Operating in Cyberspace, Benzodiazepine, Human services, Medication, API, Biomedical Advanced Research and Development Authority, Security (finance), CDKL5, EMA, CV, Pharmaceutical industry, RSE

This contract option was exercised under Marinus ongoing cost-share contract with BARDA awarded in 2020 to support the development of intravenous (IV) ganaxolone for the treatment of refractory status epilepticus (RSE).

Key Points: 
  • This contract option was exercised under Marinus ongoing cost-share contract with BARDA awarded in 2020 to support the development of intravenous (IV) ganaxolone for the treatment of refractory status epilepticus (RSE).
  • Refractory status epilepticus is a life-threatening condition in which a significant number of patients do not respond to first- and second-line anticonvulsant drugs.
  • Ganaxolone development in the RAISE trial is being funded in part with federal funds from BARDA under contract number 75A50120C00159.
  • Any forward-looking statements that we make in this press release speak only as of the date of this press release.