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Preclinical animal and cellular models are notoriously bad at predicting drug candidate toxicity in humans. Animal biology is often fundamentally different on this front than in humans, while cells in the lab can't be counted on routinely to replicate the bodily response.
DUBLIN – Hamlet Pharma AB is about to embark on the next phase in the clinical development of its novel cancer therapy, a constituent of human breast milk that has a selective effect on disrupting the membranes of cancer cells.
With a $17 million series A fundraiser completed, Pinteon Therapeutics Inc., of Cambridge, Mass., is keeping its eyes on the phase I trial it started in September testing PNT-001, a tau antibody that targets cis-pT231 tau, a toxic epitope that drives neurodegenerative disease.
MELBOURNE, Australia – Brisbane-based Kira Biotech Pty Ltd. is poised to enter the clinic after raising AU$20 million (US$13.72 million) in series A funding to develop therapies targeting immune system disorders.
HONG KONG – South Korean startup Rznomics Inc. has recently secured ₩12 billion (US$10 million) in a series A investment. The Gwangju-based company focuses on cancer treatment development based on RNA platform technology.
BEIJING – Hightide Therapeutics Inc., of Shenzhen, China, and Rockville, Md., said it finished the enrollment in phase IIa trials for its lead asset, HTD-1801, which is a potential first-in-class new molecular entity for primary sclerosing cholangitis (PSC) and nonalcoholic steatohepatitis (NASH).
Allievex Corp., a new company advancing an enzyme replacement therapy for Sanfilippo syndrome type B licensed from Biomarin Pharmaceutical Inc. through a registrational phase II trial, has marked the first close of a series A financing co-led by Novo Holdings and the startup's founder, Pappas Capital.
BEIJING – Hightide Therapeutics Inc., of Shenzhen, China, and Rockville, Md., said it finished the enrollment in phase IIa trials for its lead asset, HTD-1801, which is a potential first-in-class new molecular entity for primary sclerosing cholangitis (PSC) and nonalcoholic steatohepatitis (NASH).
HONG KONG – South Korea's biopharmaceutical venture Genome & Co. Ltd. recently secured KRW30.2 billion (US$25.2 million) in series C investment with an IPO and global clinical trial plans for next year.
It took newly launched Plexium Inc. CEO Kandaswamy (Swamy) Vijayan a few years to figure out where he needed to focus his creative energies. With an engineering background, he helped develop diagnostic tools. But he wanted to take the skill further.
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic...
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention....
Like so many other ventilator providers in recent days, Resmed Inc. has committed to ramping up production. It aims to triple its ventilator output and multiply...
Mallinckrodt plc is engaging with the U.S. FDA, NIH and the Biomedical Advanced Research and Development Authority to address the potential use of its INOmax...
DUBLIN—Can high-dose inhaled nitric oxide (NO) make a meaningful contribution to patients with COVID-19 infection? The FDA was sufficiently persuaded by the data...
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