As 2020 approaches its last quarter, scientists around the globe continue their all-consuming efforts to find effective therapeutics and vaccines to fight the deadly COVID-19 pandemic, which currently has a 3.35% fatality rate and has been plaguing the world for more than half a year. While the fight rages on, people are growing weary of political posturing and community debates. They face a serious conundrum of how to best protect those vulnerable to the virus, while still considering the psychological and economic impacts of societal lockdowns. Read More
DUBLIN – Sanofi SA and Regeneron Pharmaceuticals Inc. are terminating all further development in COVID-19 of their interleukin-6 receptor inhibitor, Kevzara, following the antibody’s failure to meet the primary endpoint, as well as a key survival endpoint. Read More
The massive deal Jounce Therapeutics Inc. has cut with Gilead Sciences Inc., an agreement that could eventually add up to about $805 million, will strengthen Jounce’s ability to develop its pipeline and choose new partners, the company’s CEO and president told BioWorld. Read More
With a potential COVID-19 vaccine moving closer to reality and the U.S government signing contracts for millions of potential doses, an unresolved question is who should be at the front of the line to get those first doses. Read More
Although investors’ enthusiasm has cooled toward the biopharma sector, particularly large cap companies, over the past couple of months, they haven’t neglected it entirely and have been willing to reward those companies reporting positive news about their pipeline progress. As a result, a number of companies returned significant gains in their share valuations in August, contributing to the BioWorld Drug Developers index pushing more than 4% higher in the period and up 6% year-to-date. Read More
Two days ahead of its Sept. 3 PDUFA date, Bristol Myers Squibb Co. received the FDA’s approval for Onureg, an oral form of azacitidine, for continuing treatment of adults with acute myeloid leukemia (AML). The indication is specifically for patients achieving first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy. BMS said Onureg is the first and only FDA-approved continued AML treatment for patients in complete remission. Read More
The first weekly therapy for adult growth hormone deficiency (GHD) has arrived in the U.S. with FDA approval for Novo Nordisk A/S' Sogroya (somapacitan). It’s the first of Novo's regulatory filings for the medicine, also submitted in the EU and Japan, to win approval. Sogroya replaces endogenous growth hormone in adults who don't produce enough of it. Novo said it is working to finalize plans to make the therapy available and has not yet disclosed pricing. Read More
Ever since the Hong Kong Stock Exchange (HKEX) overhauled its listing rules to welcome pre-revenue biotech companies in April 2018, Hong Kong has become the largest biotech fundraising hub in Asia, and the second largest in the world after Nasdaq, HKEX executives said Tuesday at the bourse’s biotech summit. The biotech IPO pipeline continues to grow and pre-revenue companies are more accepted into the city’s financial system. Read More
New hires and promotions in the biopharma industry, including: Acepodia, Adamas, Blueprint Medicines, Cytodyn, Egenesis, Liminal, Oculis, NPC, Sumitomo Dainippon, Ultragenyx, Zentalis. Read More
Biopharmas raising money in public or private financings, including: Bioversys, Cocrystal, Iterum, Kintara, Lumen, Luca, Painreform, Selecta, Zosano. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alimera, Annovis, Aptevo, Arena, Astrazeneca, Biophytis, BMS, Cartesian, Clear Creek, Genfit, Hepion, Immunomic, Innovent, Iveric, Kuros, Orchard, Oxurion, Sanofi, Transcenta. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch, Astrazeneca, Athenex, BMS, GSK, Inmune, Mirum, Nkmax, Novo, Plus, Vertex. Read More
