Bristol Myers Squibb Co.'s ongoing investment in protein degradation, a field electrified by both high scientific interest and potentially big-dollar deals, expanded Oct. 4 to include a new research collaboration with Synthex Inc. Valued at up to $550 million for Synthex, plus possible royalties, the license agreement will see the pair use genetic engineering technologies to develop small-molecule degraders across multiple targets. BMS also made an up-front payment and investment in Synthex of undisclosed value. Read More
Although U.S. President Joe Biden suggested in September that the pandemic is over, health officials insist there is still much to do in preparation for an endemic stage of the SARS-CoV-2 virus. The number of weekly COVID-19 confirmed cases both globally and in the U.S. is similar with each of the last two years, but deaths from the virus are at some of the lowest levels since the pandemic began. Still, the virus will continue to evolve and circulate, and the biopharma industry will need to develop new booster vaccines, antivirals and monoclonal antibodies, among other candidates, to prepare for upcoming battles. Read More
At first glance, Cellarity Inc. might appear as one more company harnessing the computational power of AI and machine learning to boost drug discovery efforts. A closer look, however, reveals a different approach, one that looks at cells and cellular behavior to address disease rather than the traditional method of seeking out molecular targets. Read More
Sibylla Biotech Srl raised €23 million (US$22.9 million) in series A funding to progress its two lead programs in targeted protein degradation, to broaden its pipeline, and to enhance its computationally intensive discovery platform. The company is expanding the druggable proteome in a highly original fashion. It applies mathematical techniques originally developed in theoretical physics to simulating the intermediate folding states of target proteins that have no obvious drug-binding pockets. These may well have transient structures that a small molecule can bind. So instead of drugging the native, biologically active molecule, it aims to develop small-molecule drugs that lock them into an intermediate state. They are then eliminated by the usual protein degradation pathways that operate within cells. Read More
Tumor mutational burden (TMB), a biomarker used to assess whether a patient will respond to immunotherapy, needs to be recalculated in order to be useful for patients of Asian or African descent. Scientists at the Dana-Farber Cancer Institute found a significant bias in the estimated TMB values affecting these populations and adjusted them for those patients. Read More
Paradigm Biopharmaceuticals Ltd. reported top-line data from its phase II trial of Zilosul (pentosan polysulfate/PPS) that suggest the non-opioid treatment for knee osteoarthritis is effective in navigating pain management but also has the potential to be disease modifying. Read More
Teva Pharmaceuticals USA Inc.’s quest to get the U.S. Supreme Court to overturn the Federal Circuit and preserve label carveouts, or so-called skinny labels, continued Oct. 3 with the high court asking the solicitor general to weigh in. Read More
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) announced recently that it is considering an increase in the fees it levies on industry for a variety of services and actions, such as premarket applications. One of these is a 10% indexation increase in all statutory fees, but there are also some proposed increases in cost recovery charges and an additional 22 new fees for cost recovery that would be new to applicants seeking access to the U.K. market. Read More
Although it’s a make-or-break market for many novel drugs, the U.S. is still testing the waters with biosimilars to some extent. That’s expected to change when at least seven biosimilars, including an interchangeable, referencing Abbvie Inc.’s Humira (adalimumab) are set to launch in the U.S. within the first seven months of next year. Next week, BioWorld will look at the significance of that looming competition and how the global biosimilars market is evolving amid a changing landscape of players, policies and pipelines. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abcuro, AC Immune, Aeglea, Aivita, Connect, Cyclo, Freeline, Mind, Myrtelle, Nascent. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adamis, Adaptive Phage, Amidebio, Astellas, Cidara, Mundipharma, Pantherna. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeglea, Calithera, Eagle, Mesoblast, Poxel, Prometheus, Santhera, Seneca, Taiho, Tonix. Read More
