By a unanimous 12-0 vote, the U.S. FDA’s Oncologic Drugs Advisory Committee concluded that new evidence support the use of minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma (MM) clinical trials. The FDA will now consider the recommendation, which, if incorporated into future studies, could dramatically shorten some drug developer timelines and offer more options for treating the aggressive bone marrow cancer. Read More
Samsung Bioepis Co. Ltd., of Incheon, South Korea, is the latest to announce a win in the biosimilar space, gaining MFDS approval of Epyztek (SB-17) as the country’s first biosimilar to Stelara (ustekinumab, Janssen Pharmaceutical Inc.) on April 11. Read More
SARS-CoV-2 could proliferate in the lungs causing severe COVID-19 through a special type of immune cell. A group of scientists from Stanford University observed how this coronavirus infected interstitial macrophages through a CD209 receptor, triggering the inflammatory response observed in hospitalized patients. Read More
In March, biopharma deals reached $8.29 billion, slightly higher than February’s $7.76 billion. Meanwhile, biopharma M&As amounted to $22 billion for the month. In terms of volume, March saw 104 biopharma deals, up from the 100 recorded in February, yet lower than January’s 158 and the 2023 monthly average of 115 deals. Read More
The Hatch-Waxman Act provides a safe harbor that allows importation of an FDA-regulated article that would otherwise be deemed a case of patent infringement so long as the importation is for purposes reasonably related to obtaining regulatory approval. Edwards Lifesciences Corp. sued Meril Life Sciences Pvt Ltd. for importation of heart valves in a manner that Edwards argued was infringement under Hatch-Waxman, but while the Federal Circuit ruled 2-1 against Edwards, the dissenting opinion recommended an appeal to a full 12-judge panel that could reverse this outcome. Read More
Research in the Alzheimer’s disease and dementia space has advanced in recent years, but it still has a long way to go. In a recent three-part series, BioWorld’s Anette Breindl delves into some of the biggest questions, such as the hallmarks of aging and the role of amyloid in Alzheimer’s disease, and reports on the latest efforts by researchers and industry players to accelerate R&D efforts. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algiax, Allay, Alpine, Boundless, Enliven, Enlivex, Exeliom, Lipocine, Mei, Stamford. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptimmune, Anheart, Bausch, Bioprojet, Harmony, Kiora, Norwich, Nuvation, Ose, Pfizer, Roche, Theramex, Viatris. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, BLR, Candel, Italfarmaco, Lamassu, Oncolytics, Puretech, Soligenix, SK. Read More
