I have a post on LinkedIn where I share a few thoughts about the benefits and limitations of developing drugs using the 505(b)(2) regulatory pathway. Hardly a week goes by without a pharmaceutical company expressing the desire to reap the benefits of developing a drug using the “505(b)(2) regulatory pathway”. What are 505(b)(2) new drug applications (NDAs) and do they really provide a meaningful advantage to pharmaceutical companies?
For the full post on LinkedIn, please see: http://tinyurl.com/j9fh2zn
Congratulations to ALT Lab Equipment San Diego on their recent expansion to a 14,000 sq ft site at 6444 Nancy Ridge Dr! ALT is a great resource for local biotech startups looking for affordable refurbished lab equipment. Check out this article for more details. Want to see the facility and meet the staff? Join the ALT launch party and ribbon cutting November 30 at 4-6:30 pm.
Congratulations to SDEE member, CureMatch, for being named one of Xconomy's 12 San Diego tech startups to follow in 2017! CureMatch Inc. is a startup company founded in 2015 and currently incubating at JLABS San Diego. They have developed a "decision support software platform" to assist physicians in selecting the optimal treatment for cancer patients. The program provides a personalized medicine approach to cancer patient therapeutics.
Crinetics Pharmaceuticals recently announced the appointment of Dr. Anne Klibanski as a new member of their Scientific Advisory Board. Dr. Klibanski is the director of the Neuroendocrine and Pituitary Tumor Clinical Center and chief of the Neuroendocrine Unit at Massachusetts General Hospital, and the Laurie Carrol Guthart Professor of Medicine at Harvard Medical School. She is a clinical researcher who studies pituitary tumor pathogenesis and the impact that pituitary and hypothalamic disorders have on body composition, including low bone mass.
Scott Struthers, PhD, Founder & CEO of Crinetics commented, “We are excited to welcome Dr. Klibanski to the scientific advisory board of Crinetics Pharmaceuticals. She is an internationally-recognized leader in neuroendocrinology and complements our team as we grow Crinetics into a clinical-stage therapeutics company.”
Crinetics Pharmaceuticals Inc. discovers and develops novel therapeutics targeting peptide hormone receptors for the treatment of endocrine-related diseases and cancers.
Allele Biotechnology and Pharmaceuticals is pleased to announce receiving NIH grants to develop antibody therapies for Alzheimer's Disease and to develop a novel manufacturing system producing stem cells for clinical therapy.
Allele Biotechnology and Pharmaceuticals, Inc. is a private, San Diego-based company that explores the mechanisms of biological processes to develop technologies and products for biomedical research and therapy development.
Our mission is to increase accessibility to innovative molecular biology research tools by offering cutting edge technologies in individual products and fully integrated platforms. Allele utilizes proprietary non-integrating cellular reprogramming methods to enable drug discovery and cell therapy, including human and non-human primate iPS cells, GMP-grade human iPS cells and their derivatives, and differentiated cell types. With additional expertise in genome modification and cell-based sensors/reporters, Allele provides advanced cell and assay development solutions. Allele also has developed a wide variety of reagents including superior fluorescent proteins, highly efficient luciferase assay substrates, genotyping kits, and camelid antibodies. The company has also been a leader in the RNAi field with its patents in Pol III promoter-driven siRNA, shRNA, and miRNA.
SAN DIEGO, September 13, 2016 -- Neuropore Therapies, Inc. (NPT) announced today that they have successfully achieved a key program milestone in their collaboration with UCB. After successful completion of a randomized, double-blind, placebo controlled single ascending dose clinical study and additional non-clinical studies, UCB has awarded NPTTM a progression milestone of $5 million.
"We are very pleased with UCB’s decision to proceed with the development of this novel therapeutic candidate that initially arose from Neuropore’s drug-discovery platform. This is an important milestone for Neuropore and reflects UCB’s continued commitment to a promising therapeutic opportunity for the treatment of Parkinson’s disease,” commented Doug Bonhaus, Ph.D., Neuropore’s COO.
New Online location: new website at http://www.curematch.com
Crinetics Pharmaceuticals announced the addition of Ajay Madan, PhD, DABT, as the Vice President of Development. Dr. Madan has a distinguished career in drug development as former VP of Preclinical Development at Neurocrine Biosciences and CSO at XenoTech. “It’s exciting to join the company at such a crucial time as we prepare to move our first program into the clinic,” said Dr. Madan. Crinetics Pharmaceuticals, Inc. is a San Diego company that discovers and develops novel therapeutics targeting peptide hormone receptors for the treatment of endocrine-related diseases and cancers.
Congratulations to SDEE members Reveal Biosciences and Explora BioLabs on receiving a National Institute on Aging (NIA) contract to to develop and maintain an Aged Rodent Tissue Bank. This is a prestigious contract award from the NIA, a National Institutes of Health agency supporting research on aging and Alzheimer's disease research.
“We are excited to build upon our strong relationship with Explora BioLabs and combine our expertise to develop and maintain the Aged Rodent Tissue Bank. This tissue source has become a game-changing tool for research on aging, as investigators are no longer required to wait months or years to study their tissue of interest, significantly accelerating their research,” said Dr. Claire Weston, CEO and founder of Reveal Biosciences.
Reveal Biosciences is a leading San Diego-based CRO specializing in Advanced Tissue Technologies such as IHC, ISH, digital pathology & biomarker quantification.
Explora BioLabs is a San Diego-based preclinical CRO that provides discovery pharmacology and contract vivarium services to the biotech, pharmaceutical and academic communities.