The latest global regulatory news, changes and updates affecting biopharma, including: FDA, industry prepare for vaccine; FDA updates trial guidance; Labeling changes for diabetes drugs.
PERTH, Australia – Immutep Ltd. completed a AU$29.6 million (US$21.72 million) placement that will allow the immunotherapy company to accelerate and broaden clinical development of its immuno-oncology and autoimmune programs.
With its acquisition of privately held Oncoimmune Ltd. for an up-front $425 million in cash, Merck & Co. Inc. ups its COVID-19 game with CD24Fc, a recombinant fusion protein targeting the innate immune system that is faring well in treating pandemic patients.
Olema Pharmaceuticals Inc., a company looking to improve on current endocrine therapies with an oral estrogen receptor antagonist and degrader of its own, has filed for a $170 million IPO on Nasdaq. The offering follows an $87.4 million series C round, closed in September and a $54 million series B financing closed not long before in July.
In another multibillion-dollar bid to further strengthen its oncology pipeline, Merck & Co. Inc. is set to acquire privately held Velosbio Inc. for $2.75 billion in cash. Velosbio is developing cancer therapies targeting receptor tyrosine kinase-like orphan receptor 1. The company’s follow-on programs include next-generation antibody-drug conjugates and bispecific immune-engagers targeting ROR1, which it has been developing for nearly two years.
DUBLIN – The global product development pipeline for COVID-19 is now twice as big as for any particular cancer indication, a major disease like Alzheimer’s or any other infectious disease indication.
While the ultimate goal is increased diversity in clinical trials so as to improve health equity, a great start is making diversity a priority and a part of the research plan, Luther Clark, deputy chief patient officer at Merck & Co. Inc., said during an FDA Office of Minority Health and Health Equity webinar Sept. 22.
The importance of the stimulator of interferon genes (STING) pathway in orchestrating the body’s innate response to pathogenic, tumor or self-DNA in the cytoplasm has made it a hot target in immunology research and drug discovery, and several biopharma companies have started programs dedicated to that area, spanning infectious and inflammatory diseases as well as cancer. The second part of this feature examines the products undergoing preclinical development as well as the ones that are now in clinical testing.
Given the minimal accountability written into the 340B prescription drug discount program, a few biopharma companies recently began taking oversight into their own hands by demanding data claims or refusing to extend the mandated discounts to contract pharmacies.
