Blue chip biopharma equities closed out the month of November on a high note with the BioWorld Biopharmaceutical index up almost 6 percent, which appeared to have helped erase the memories of a tough October that saw the index fall 10 percent in the wake of a general market correction. (See BioWorld Insight, Nov. 5, 2018.)
With the FDA closing out the month of November with three approvals in the last week – Vitrakvi (larotrectinib) from Bayer AG and Loxo Oncology Inc., Xospata (gilteritinib) from Astellas Pharma Inc. and Firdapse (amifampridine phosphate) from Catalyst Pharmaceuticals Inc. – the industry surpassed the high-water mark for the number of new molecular entities (NMEs) approved in one year in the U.S., previously set in 1996 when the agency approved 53 NMEs. (See BioWorld Insight, Jan. 8, 2018.)
With the FDA closing out the month of November with three approvals in the last week – Vitrakvi (larotrectinib) from Bayer AG and Loxo Oncology Inc., Xospata (gilteritinib) from Astellas Pharma Inc. and Firdapse (amifampridine phosphate) from Catalyst Pharmaceuticals Inc. – the industry surpassed the high-water mark for the number of new molecular entities (NMEs) approved in one year in the U.S., previously set in 1996 when the agency approved 53 NMEs.
The heightened attention that biopharma companies are paying to hot new technologies in the immuno-oncology and gene and cell therapy areas is translating to a significant increase in research and development investments being made by the sector. Drug discovery, however, does not come cheap, as evidenced from an in-depth analysis conducted by BioWorld.
The heightened attention that biopharma companies are paying to hot new technologies in the immuno-oncology and gene and cell therapy areas is translating to a significant increase in research and development investments being made by the sector. Drug discovery, however, does not come cheap, as evidenced from an in-depth analysis conducted by BioWorld Insight.
Since the initiation of the Human Microbiome Project and the more recent National Microbiome Initiative (NMI) created in 2016 by the White House Office of Science and Technology Policy (OSTP), in collaboration with federal agencies and private-sector stakeholders, our understanding of the role that the microbiome plays in health and disease is steadily increasing. Although we are still a very long way from fully understanding its role, new research has indicated that the microbiome not only primarily affects the health and function of the gastrointestinal tract but also has a strong influence on general body health.
Since the initiation of the Human Microbiome Project and the more recent National Microbiome Initiative (NMI) created in 2016 by the White House Office of Science and Technology Policy (OSTP), in collaboration with federal agencies and private-sector stakeholders, our understanding of the role that the microbiome plays in health and disease is steadily increasing. Although we are still a very long way from fully understanding its role, new research has indicated that the microbiome not only primarily affects the health and function of the gastrointestinal tract but also has a strong influence on general body health.
The regenerative medicine sector that embraces gene and cell therapies continues to expand, particularly on the business and clinical development fronts. For example, a panel at the Neurosciences 2018 conference discussed just how rapidly the science is evolving and now beginning to take on harder-to-treat diseases, with gene therapies already in early stage development targeting amyotrophic lateral sclerosis, Parkinson's disease and Batten disease.
Now that the votes are in, the midterm election gives the U.S. a House/Senate outcome that will likely maintain the political status quo. It is predicted that for the next two years at least, with the Democrats controlling the House of Representatives and the Republicans in control of the Senate, implementation of new policies will be a challenge in Washington.
