A phase III trial of AZD-1222, an experimental coronavirus vaccine developed by Astrazeneca plc and Oxford University, has been paused due to an unexplained illness that occurred in the U.K., the company said on Sept. 8. Read More
With phase III COVID-19 vaccine trials each enrolling 30,000 participants or more in the U.S. and randomizing half of them to a placebo arm, only 150 incidents of the coronavirus infection are needed in a trial to show if the vaccine is at least 50% effective, NIH Director Francis Collins testified at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing Sept. 9. Read More
Recursion Inc.’s combination of machine learning and artificial intelligence, coupled to its wet lab work, caught Bayer AG’s attention so solidly that its investment unit, Leaps by Bayer, led the charge on Recursion’s new and oversubscribed $239 million series D financing. Read More
DUBLIN – Shares in Amryt Pharma plc surged by more than 36% Sept. 9 on news that Filsuvez (AP-101, Oleogel-S10) attained the primary endpoint of a phase III trial in epidermolysis bullosa. Read More
As biopharma deal values continue to rise above recent years, a growing percentage of the funds are coming through partnerships with companies headquartered in Asia and nearby countries. The $48.5 billion reported so far in 2020, for deals in which at least one party is based in either Asia, Australia or New Zealand, represents 37% of the global deal value. Read More
Shares of Intra-Cellular Therapies Inc. (NASDAQ:ITCI) climbed 72.8% to $31.86 on Sept. 9 following news that its FDA-approved schizophrenia drug, Caplyta (lumateperone), could also help improve bipolar depression. Read More
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), drug-induced liver injury (DILI) is the leading cause of acute liver failure in the U.S. It is also a leading cause of drug failure in clinical trials. Now, researchers have used liver organoids to develop a polygenic risk score that could predict the risk of liver toxicity for multiple different drugs, regardless of the underlying mechanism. Read More
Favorable conditions in China encouraged biotech veterans Jerry Wang, Bing Yan and Lihua Zheng to co-found Anheart Therapeutics Co. Ltd. in November 2018 to focus on oncology. On Monday, the Chinese startup in-licensed a mIDH-1 inhibitor and an AXL inhibitor from Daiichi Sankyo Co. Ltd. to expand its pipeline, less than two years after it obtained the global rights of its first asset, AB-106 (taletrectinib), from the Japanese firm to establish its footing. Read More
HONG KONG – The Korean 2020 KoNECT-MOHW-MFDS International Conference, which is taking place online this year due to the COVID-19 pandemic, faced a challenging start. Technical difficulties hampered some of the early proceeding. However, technology took focus again later in the day in a more positive, with an exploration of artificial intelligence (AI). Read More
BioWorld looks at translational medicine, including: Angiopoietin trouble can lead to lymphedema; Toxicity, infectivity separate issues for prion protein. Read More
New hires and promotions in the biopharma industry, including: Adagio, Agios, Allovir, Anika, Atbtherapeutics, Black Diamond, Cognition, DBV, Diffusion, Discgenics, Eli Lilly, Forma, Kymera, Maxcyte, Recode, Starton. Read More
Biopharmas raising money in public or private financings, including: Albireo, Athenex, Grail, Greenwich, Metacrine, Oncoimmune, Pfizer, Sernova, Trillium. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Apros, Ascendis, Beigene, Biomarin, Canbridge, Moleculin, Nanomab, Peptilogics, Precision, Reneo, Sellas. Read More
