The recent phase III win with Libtayo (cemiplimab-rwlc) in cervical cancer by Regeneron Pharmaceuticals Inc. and partner Sanofi SA turned more eyes to an indication hotly pursued in phase III by a handful of players large and small. Although the World Health Organization has said that, with a comprehensive approach to prevent, screen and treat the disease, cervical cancer could be “eliminated as a public health problem within a generation,” it’s still the fourth most common cancer in women. The U.S. records about 14,000 new cases every year.
Induced blastocysts are model for earliest development stages
LONDON – The alchemy of induced pluripotent cells has broken another barrier, delivering a model of the earliest preimplantation stages of human development, when fertilized eggs form a blastocyst. Two groups report taking slightly different routes to generating the blastocyst-like structures they call blastoids in a pair of papers published back-to-back in Nature on March 17, 2021.
Greater data access to boost real-world evidence opportunities
A new data-blocking rule going into effect April 5 in the U.S. should make it easier for sponsors to get the real-world data they need to demonstrate post-market evidence of the safety and efficacy of their drugs and devices. The rule will make it harder for health care providers to deny researchers access to data in patients’ electronic health records, Deven McGraw, chief regulatory officer for Ciitizen Corp., told BioWorld. Having that access will make real-world evidence an enormous opportunity for sponsors, she said.
Merck and Amathus collaborating on neurodegenerative therapies
Amathus Therapeutics Inc. and Merck & Co. Inc. will collaborate to develop small molecules to treat neurodegenerative disease. Amathus is handling identification of chaperone activators and then ushering them through preclinical studies. Amathus will get an up-front payment and is eligible for milestone payments of more than $500 million per program. In return, Merck retains an option to acquire Amathus and its pipeline of mitochondrial candidates for treating neurodegenerative disorders and renal diseases. Should the option be exercised, Merck becomes responsible for clinical development and commercialization of candidates.
Promising RNA-targeted therapies emerging
The rapid development of mRNA vaccines to combat COVID-19 has highlighted the importance of this single-stranded molecule. Although there have been some costly developmental bumps along the way, interest in RNA-targeted therapies is once again surging. The fact that RNA is known to directly regulate many important cellular processes, including transcription, splicing, translation and epigenetic modifications, the misregulation of these processes in disease has led to an expanding level of research on RNA. There are a number of promising therapeutic strategies that are now emerging and being pursued by biopharma companies and some these were highlighted in a recent Demy-Colton Virtual Salon Series webinar, Targeting mRNA: The New Frontier of Tailored Therapeutics.
Uni-Bio and Dotbio to co-develop multispecific Dotbodies for retinal diseases
HONG KONG –Uni-Bio Science Group Ltd. and Dotbio Pte. Ltd. formed a partnership to develop therapeutics for patients with retinal diseases, such as age-related macular degeneration, diabetic macular edema, retinal vein occlusion and myopic choroidal neovascularization.
Also in the news
4D Pharma, Abbvie, Alessa, Algernon, Ambrx, Anchiano, Apabetalone, Beigene, Biobohemia, Cannabics, Chemomab, Cyclacel, ERX, Eyenovia, Fujifilm, GT, Harmony, Imara, Innocan, Lilly, Maat, Marker, Mediar, Merck, Pfizer, Phoenix, Probiogen, Prometheus, Retrotope, Rubius, Sage, Sana, Sanofi, Seekyo, Spruce, T-Cure, Timber, Tonix, Vaccitech, Valence, Verrica, Versantis, Wuxi