Following shrinking sales for its wet AMD drug Lucentis, Novartis is back with convincing Phase III results of its anti-VEGF-A singe chain antibody fragment brolucizumab. In two pivotal studies the drug proved to be non-inferior to Regeneron/Bayers Eylea (aflibercept). With 25 million patients affected worldwide, age-related macular degeneration (AMD) is a highly lucrative market. For years, Novartis first-in-class drug Lucentis (ranibizumab) was dominant in the large US market, but now Regenerons competing drug Eylea (aflibercept, 2026 sales: US$3.3bn, +24%) has overtaken Lucentis (2016: US$2bn, -11%) in US sales, mostly because it is not administered once monthly as Lucentis, but once every two months and has a lower price (US$1,850 per intravitreal injection). However, results of two pivotal Phase III studies suggest Novartis could return to its former leadership with its next generation anti-VEGF-A-antibody fragment brolucizumab, which has to be administered only once quarterly. In both trials, the HAWK and the HARRIER study, brolucizumab met the primary endpoint of non-inferiority versus aflibercept in best corrected visual acuity after 48 weeks of treatment and the secondary endpoint of mean change in visual acuity. Whats more, the two drugs had comparable side-effect profiles. Novartis plans to submit a BLA next year. Analysts say … Continue reading →

About Lilly's Biotechnology Center and the Company's Presence in San DiegoThe center features a new technologically-advanced laboratory and an additional 180,000 square feet of working space, which is an increase of 145 percent compared to the former facility. In addition to the center's established presence in preclinical and clinical immunology research, the new space allows for closer partnership between Lilly experts in biotechnology, discovery chemistry and research technologies while also fostering external collaborations. "Being in the San Diego area for the last 13 years has been a game changer for us, specifically in the arena of discovering medicines for hard-to-treat autoimmune conditions," said Thomas F. Bumol, Ph.D., senior vice president of biotechnology and immunology research at Lilly. "With compounds such as Taltz (ixekizumab) for psoriasis, we've not only provided patients with a new treatment option, but we've also moved the needle for advancing science." As a pioneer in automated organic synthesis, Lilly is creating the Lilly Life Science Studio in San Diego. Building upon Lilly's Automated Synthesis Laboratory in Indianapolis, the new facility will allow researchers across the globe to remotely design, synthesize and screen investigational molecules in an unprecedented manner. Using the power of automation, the Lilly Life Sciences … Continue reading →

It is critical that humanity meet the food needs of a growing population and relieve the increasing pressures on natural systems. Environmental Defense Fund supports the coexistence of diverse farming systems to ensure a sustainable future for farmers, society, and our environment. Achieving these goals will require a comprehensive strategy that draws on a wide range of approaches and technologies, including biotechnology. EDF recognizes the use of biotechnology as a legitimate deployment of science in the search for effective solutions, and also recognizes that past deployment of some biotechnology products has caused legitimate concerns. For that reason, we will support or oppose specific biotechnology products or processes based on transparent assessments of their health, environmental, social, and economic risks and benefits.The risks and benefits of biotechnology products will often vary by organism, geography and other variables, and need to be assessed at relevant temporal and spatial scales. The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post:Our position on biotechnology Continued here: Environmental Defense Fund: Sustainable farming, feeding growing population require biotechnology - Genetic Literacy Project … Continue reading →

Evotec and co-investors support Dutch Facio Therapies BV with 4.8m to push development of Dux4 inhibitors to treat facioscapulohumeral dystrophy (FSHD), one of the most common forms of muscular dystrophy. With its investement alongside unnamed Australian and North American investors, Evotec enters the field of musculoskeletal diseases. Currently there is no causative treatment for the muscle wasting disease that affects 700,000 people worldwide. In a patient cell-based screening, Evotec and Facio Therapies (Leiden) have already identified some FSHD candidate drugs, which block the overexpression of the DUX4 protein in skeletal muscle cells that causes muscle atrophy and oxidative stress, hallmarks of the disease. About 20% of people with FSHD end up in a wheelchair. Facio announced it will use the proceeds to select pre-clinical lead candidates for further development. According to the NIH, the field of muscular dystrophies received US$80m in funding in 2017. One tenth of the amount has been channeled into FSHD research. Some companies have already started clinical testing of candidate drugs for treating FSHD. aTyr Pharma, Inc. is in Phase I/IIa testing of the protein drug Resolaris in early onset FSHD. Acceleron Pharma, Inc. has recently started Phase II testing of ACE083, an inhibitor of proteins … Continue reading →