Food and Drug Administration

Accelerate Diagnostics Announces CE Mark and Availability in Europe of Fast Antimicrobial Susceptibility Test for Use with Existing ID Systems

Retrieved on: 
Tuesday, August 3, 2021
Articles, Antimicrobial resistance, Evolutionary biology, Pharmaceuticals policy, Veterinary medicine, Life sciences

This is an important new option for the Company's existing Accelerate PhenoTest BC kit, which already had an ID/AST configuration that is a fully integrated solution for labs needing both fast identification and fast AST.

Key Points: 
  • This is an important new option for the Company's existing Accelerate PhenoTest BC kit, which already had an ID/AST configuration that is a fully integrated solution for labs needing both fast identification and fast AST.
  • The Accelerate Pheno system has been shown to deliver improvements in clinical outcomes including time to results, time to optimal therapy, duration of therapy and hospital length of stay.
  • Accelerate Diagnostics, Inc. is an in vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis.
  • The "ACCELERATE DIAGNOSTICS" and "ACCELERATE PHENO" and "ACCELERATE PHENOTEST" and diamond shaped logos and marks are trademarks or registered trademarks of Accelerate Diagnostics, Inc.
    For more information about the company, its products and technology, or recent publications, visit axdx.com .

CerpassRx Announces Integrated Partnership with Virta Health

Retrieved on: 
Tuesday, August 3, 2021
Virta, Virta, Pharmacy benefit management

DALLAS, Aug. 3, 2021 /PRNewswire/ --Today, CerpassRx, a Texas-based pharmacy benefit management company, announced the launch of its integrated partnership with diabetes reversal leader Virta Health .

Key Points: 
  • DALLAS, Aug. 3, 2021 /PRNewswire/ --Today, CerpassRx, a Texas-based pharmacy benefit management company, announced the launch of its integrated partnership with diabetes reversal leader Virta Health .
  • Through this partnership, Virta will be available to members and eligible dependents who have pharmacy benefits through CerpassRx and are between the ages of 18 and 79.
  • "CerpassRx has long been a leader in connecting its members with innovative healthcare solutions like Virta," said Trent Myers, VP of Commercial at Virta.
  • Through this dynamic partnership, CerpassRx and Virta Health will be able to transform member's lives by reversing type 2 diabetes, while also lowering healthcare costs and placing all program fees 100% at risk.

Rybrevant Amivantamab FDA Approval To Drive Bispecific Antibody Sales To US 20 Billion by 2026

Retrieved on: 
Tuesday, August 3, 2021
Medical specialties, Clinical medicine, Immunology, Medicine, Monoclonal antibody, Antibody, Bispecific monoclonal antibody, Epidermal growth factor receptor, MorphoSys, Monoclonal antibody therapy

https://www.kuickresearch.com/report-global-usa-europe-japan-bispecific-...

Key Points: 
  • Recently, the progress in antibody and recombinant DNA technology, various platforms for generating bispecific antibodies has been developed.
  • In May, 2021 US FDA has granted approval to Rybrevant (Amivantamab) which is a novel bispecific antibody developed by Janssen Pharmaceuticals.
  • Rybrevant is a fully human bispecific antibody which is directed against EGFR and MET receptors.
  • Among region, US is currently dominating the global bispecific antibody market and is expected to lead the market during the forecast period.

MindMed Joins Digital Medicine Society to Improve Health Outcomes and Equity Using Technology

Retrieved on: 
Tuesday, August 3, 2021
Articles, Health, Health care quality, Health equity, Medical sociology, Public health, MindMed

DATAcc members, including Dr. Dan Karlin, Chief Medical Officer of MindMed, will meet for the rst time today, marking the launch of this collaborative community dedicated to realizing the full potential of digital health measurement as a powerful new tool to drive improvements in health outcomes, health economics, and health equity.

Key Points: 
  • DATAcc members, including Dr. Dan Karlin, Chief Medical Officer of MindMed, will meet for the rst time today, marking the launch of this collaborative community dedicated to realizing the full potential of digital health measurement as a powerful new tool to drive improvements in health outcomes, health economics, and health equity.
  • "DATAcc can advance efforts to build the science and evidence generation for all people by keeping health outcomes and health equity front and center."
  • Dr. Daniel Karlin, Chief Medical Officer of MindMed, added, "We are eager to advance the science of digital medicine through cooperation and collaboration.
  • MindMed is a clinical-stage biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental health.

OTC Markets Group Welcomes Microbix Biosystems Inc. to OTCQX

Retrieved on: 
Tuesday, August 3, 2021
OTC Markets Group, OTC

NEW YORK, Aug. 3, 2021 /PRNewswire/ -- OTC Markets Group Inc. (OTCQX: OTCM), operator of financial markets for 11,000 U.S. and global securities, today announces that Microbix Biosystems Inc. (TSX: MBX; OTCQX: MBXBF) Microbix, a Canadian life sciences company that creates, manufactures, and markets diagnostics-related products that are innovative, proprietary, and branded, has qualified to trade on the OTCQX Best Market.

Key Points: 
  • NEW YORK, Aug. 3, 2021 /PRNewswire/ -- OTC Markets Group Inc. (OTCQX: OTCM), operator of financial markets for 11,000 U.S. and global securities, today announces that Microbix Biosystems Inc. (TSX: MBX; OTCQX: MBXBF) Microbix, a Canadian life sciences company that creates, manufactures, and markets diagnostics-related products that are innovative, proprietary, and branded, has qualified to trade on the OTCQX Best Market.
  • Microbix Biosystems Inc. has upgraded to OTCQX from the OTCQB Venture Market.
  • About OTC Markets Group Inc.
    OTC Markets Group Inc. (OTCQX: OTCM) operates the OTCQX Best Market, the OTCQB Venture Market and the Pink Open Market for 11,000 U.S. and global securities.
  • OTC Link ATS and OTC Link ECN are SEC regulated ATSs, operated by OTC Link LLC, member FINRA/SIPC.

Regeneron Announces the 2021 Winners of the Regeneron Prize for Creative Innovation

Retrieved on: 
Tuesday, August 3, 2021
Regeneron Pharmaceuticals, Tarrytown, New York, Life sciences, Biotechnology, Monoclonal antibodies, Industry economics)

TARRYTOWN, N.Y., Aug. 3, 2021 /PRNewswire/ --Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced winners of the ninth annual Regeneron Prize for Creative Innovation, a competition designed to recognize creativity and independent scientific thinking among postdoctoral fellows and graduate students focused on biomedical research.

Key Points: 
  • TARRYTOWN, N.Y., Aug. 3, 2021 /PRNewswire/ --Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced winners of the ninth annual Regeneron Prize for Creative Innovation, a competition designed to recognize creativity and independent scientific thinking among postdoctoral fellows and graduate students focused on biomedical research.
  • Each winner received $50,000 in prize money, along with a $5,000 donation to their institution, and ten additional finalists were awarded $5,000 each.
  • "This year's winners and finalists once again demonstrated the power and innovative spirit of the next generation of scientists.
  • For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

Bio-Techne Announces 2021 Investor Day and Webcast

Retrieved on: 
Tuesday, August 3, 2021
New York City, Bio-Techne, NASDAQ, Madison, Wisconsin, Manhattan

MINNEAPOLIS, Aug. 3, 2021 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that management will host its 2021 Investor Day on Friday, September 10, 2021, starting at 9:00 a.m. EDT. The meeting will take place at the Lotte New York Palace Hotel, 455 Madison Avenue, New York City.

Key Points: 
  • MINNEAPOLIS, Aug. 3, 2021 /PRNewswire/ --Bio-Techne Corporation (NASDAQ: TECH) today announced that management will host its 2021 Investor Day on Friday, September 10, 2021, starting at 9:00 a.m. EDT.
  • The meeting will take place at the Lotte New York Palace Hotel, 455 Madison Avenue, New York City.
  • The Investor Day will feature presentations from members of Bio-Techne's senior leadership team followed by Q&A.
  • With thousands of products in its portfolio, Bio-Techne generated approximately $739 million in net sales in fiscal 2020 and has approximately 2,600 employees worldwide.

Medolife Rx Launches Pharmacokinetic Study on Lead Drug Candidate as Next Step in Pre-IND FDA Submission

Retrieved on: 
Tuesday, August 3, 2021
Food and Drug Administration, United States Public Health Service, Clinical research, Health, Articles

The Company is performing a PK and a biodistribution study of Escozine in rodents, which is being conducted by a laboratory in the United Kingdom.

Key Points: 
  • The Company is performing a PK and a biodistribution study of Escozine in rodents, which is being conducted by a laboratory in the United Kingdom.
  • They are part of the requirements outlined by the FDA as next steps for the Companys pre-IND application.
  • The first part is conjugating Escozine-containing peptides with radioactive iodine and performing a stability study of the conjugate in blood products.
  • Medolife Rx, Inc. is a global biotechnology company with operations in clinical research, manufacturing, and consumer products.

Outlook Therapeutics Reports Positive Efficacy and Safety Data from Pivotal Phase 3 NORSE TWO Trial of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD

Retrieved on: 
Tuesday, August 3, 2021
Health sciences, Health, Clinical research, Design of experiments, Clinical trial, Food and Drug Administration, Pharmaceutical industry, Macular degeneration

I would like to thank the trial participants and investigators, our partners, and our employees for their contributions to NORSE TWO.

Key Points: 
  • I would like to thank the trial participants and investigators, our partners, and our employees for their contributions to NORSE TWO.
  • The NORSE TWO pivotal Phase 3 clinical trial enrolled a total of 228 subjects with wet AMD across 39 clinical trial sites in the United States.
  • The safety results demonstrated in NORSE TWO are consistent with previously reported safety results from Outlook Therapeutics NORSE ONE and NORSE THREE clinical trials.
  • NORSE TWO provided pivotal data that demonstrated positive and highly statistically significant and clinically relevant efficacy and safety data for treatment of patients with wet AMD.

CenterWatch Announces -- The PI Trainer: An Interactive Companion to The PI's Guide to Conducting Clinical Research

Retrieved on: 
Tuesday, August 3, 2021
Health sciences, Health, Clinical research, Pharmaceutical industry, Clinical trial, Design of experiments, Food and Drug Administration

As a PI, one is responsible for all aspects of a study and must gain proficiency in each of them to do the job well.

Key Points: 
  • As a PI, one is responsible for all aspects of a study and must gain proficiency in each of them to do the job well.
  • The PI Trainer a new visual, interactive online course empowers one to do just that and earn 3.0 continuing education units at the same time.
  • This companion to The PI's Guide to Conducting Clinical Research enables readers to conduct better, safer and more efficient clinical trials by providing self-paced training.
  • Also available: Take advantage of our site licenses of The PI Trainer, so one will have the most-informed PI's!