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Emmes, a global, full-service Clinical Research Organization dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced its role as a Data Coordinating Center on a team whose work has accelerated pediatric COVID-19 research through the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02).  The team, led by the Pediatric Trials Network at Duke University, also includes the Gabriella Miller Kids First Data Resource Center (DRC) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

POP02 is one of several cohort studies within the Collaboration to Assess Risk and Identify LoNG-term outcomes for Children with COVID, known as CARING for Children with COVID.  The National Institutes of Health (NIH) initiated the CARING for Children with COVID program to collect clinical data and samples that would advance the understanding of SARS-CoV-2 infections in children.  The program seeks to provide information to help healthcare providers and parents make informed decisions when caring for children infected with either COVID-19 (acute coronavirus disease) or who have MIS-C (multisystem inflammatory syndrome).  

WASHINGTON — A new research agency aimed at developing breakthrough medical technologies won’t be housed within the National Institutes of Health, a key lawmaker said on Wednesday.

Instead, the agency, known as ARPA-H, will exist as a distinct unit within the Department of Health and Human Services, said Rep. Anna Eshoo (D-Calif.).

Image: https://eshoo.house.gov/about-anna/biography

On Saturday, January 29, the World Health Organization (WHO) Executive Board approved the renewal of official relations with the United States Pharmacopeial Convention (USP) through 2023. As an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines, USP is honored to continue our longstanding partnership with the WHO and contribute our expertise to shape and advance policies and strategies to improve the health and wellbeing of people around the world.

Image: https://www.linkedin.com/

When scientists in South Africa noticed an uptick in Covid-19 cases in the Gauteng Province last November, they began investigating the source. These researchers and others in Botswana quickly discovered the Omicron variant and heroically shared their discovery with the rest of the world. And yet it was still too late — Omicron was already rapidly infecting people across the globe.

Navigating the pandemic has been an all-encompassing, once-in-a-lifetime challenge. Globally, life sciences companies responded with leadership and are emerging stronger. How will life sciences companies continue to respond and what areas can they build resiliency going forward?

The life sciences sector has played a pivotal role amid the COVID-19 pandemic. To cope with the global crisis, traditional competitors partnered to accelerate research and develop the fastest novel vaccine in the history. Governments, health systems, payers, retail pharmacies, and nonprofits are now working collaboratively with the sector to provide widespread distribution and administration.

January 31, 2022 at 7:00 AM EST

Enrollment in 48-week Phase 2 clinical trial expected to begin in Q1 2022

GAITHERSBURG, Md., Jan. 31, 2022 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its Phase 2 clinical trial of pemvidutide for obesity. Pemvidutide is an investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH). Altimmune expects to initiate the Phase 2 trial in obesity in the first quarter of 2022. The Company previously received IND clearance for pemvidutide in NASH and is currently enrolling subjects with nonalcoholic fatty liver disease (NAFLD) in a Phase 1b trial.

“This Phase 2 trial in obesity represents an important milestone toward developing a safe and effective treatment option for people with obesity,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “Results from a recently completed Phase 1 study of pemvidutide in Australia showed that 12 weekly subcutaneous doses of pemvidutide at the 1.8 mg dose level resulted in an average weight loss of 10.3% in overweight and obese subjects. Importantly, there were no study discontinuations due to adverse events. We believe these results rank among the best in terms of the rate and magnitude of weight loss and tolerability among drugs in development for obesity.”

BETHESDA, Md., Jan. 31, 2022 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”), a biotechnology company transforming the drug discovery paradigm with structurally targeted allosteric regulators identified with its proprietary computational discovery platform, today announced additional details on its R&D Day being held virtually on Friday, February 4, 2022 from 10:00 am – 12:00 pm Eastern Time.

The R&D Day Event, entitled “Neuroscience and Beyond: Harnessing Computational Technology and Allosteric Modulators to Drug the Undruggable” will feature presentations from several Key Opinion Leaders (KOLs):

Zoe Cournia, PhD (Biomedical Research Foundation Academy of Athens) will discuss the role of supercomputing in novel allosteric target discovery. Samuel Broder, MD (former Director of the National Cancer Institute and Scientific Advisor of Gain Therapeutics) will discuss the role of allosteric drug discovery in targeting undruggable proteins in Oncology. Tiago Fleming Outeiro, PhD (University Medical Center Göttingen) will discuss protein misfolding in neurodegenerative diseases. Ricardo A. Feldman, PhD (University of Maryland School of Medicine) will present recent data generated in patient-derived iPSCs with Gain Therapeutics’ structurally targeted allosteric regulators for the treatment of GBA1-associated neurodegeneration in Parkinson’s and Gaucher Disease. Joanne Taylor, PhD (former Director of Neuroscience at Eisai and Scientific Advisor of Gain Therapeutics) will serve as moderator. The Gain Therapeutics management team will present on the following topics:

Intima Bioscience to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to accelerate the development of its solid tumor cell-therapy candidates NEW YORK and GAITHERSBURG, Md., Jan. 31, 2022 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT, MXCN), a leading provider of enabling platform technologies for ex-vivo cell engineering, today announces the signing of a strategic platform license (SPL) with Intima Bioscience, Inc., a clinical stage biotechnology company developing genetically engineered cell therapies for solid tumor cancer. Intima joins a group of 15 other leading cell therapy companies who have partnered with MaxCyte.

Under the terms of the agreement, Intima obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related milestone payments.

Intima is currently running a Phase 1/2 clinical study (NCT04426669) of its lead checkpoint cell therapy candidate, which targets the immune checkpoint CISH in patients with gastrointestinal and colon cancers.