Featured Story | By Nick Paul Taylor A phase 2b trial of NGM Biopharmaceuticals’ aldafermin in nonalcoholic steatohepatitis has missed its primary endpoint, sending shares in the biotech tumbling. NGM has pulled plans to enter phase 3 in light of the midstage failure of the FGF19 analog. read more |
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Top Stories By Amirah Al Idrus With filings under way in Europe, Brazil, and a trio of Southeast Asian nations, Takeda unveiled long-term data for its dengue vaccine, showing the shot’s efficacy waned over time but that it was still "robust” at keeping people out of hospital. The two-dose vaccine was 62.0% effective at preventing dengue infection three years after participants received the second dose, the latest data show. read more By Amirah Al Idrus Johnson & Johnson finished the FDA filing for its anti-BCMA CAR-T in multiple myeloma last month, but that doesn’t mean it’s letting off the gas. The drugmaker revealed phase 1 data for two bispecific antibodies showing they shrank the tumors of about 70% of patients whose cancer got worse despite trying several other treatments, including the three main types of myeloma-fighting drugs. read more By Kyle LaHucik Centessa Pharmaceuticals, with four clinical and a dozen preclinical programs, expects its initial public offering to be slightly over the $250 million raised in a January series A. The largest single recipient of Centessa’s IPO proceeds and existing cash will be a phase 3 safety study and pivotal trial for lixivaptan, which will consume about $110 million. read more By Nick Paul Taylor Eliem Therapeutics has raised $60 million to advance treatments for neuronal excitability disorders. The series B round equips Eliem to take its lead candidates to multiple clinical readouts in patients with chronic pain, depressive disorders and epilepsy. read more By Angus Liu In the brain, microglia cells are responsible for removing unwanted debris, and their dysfunction is known to play a part in Alzheimer's disease. Now, an international group of scientists have identified the expression of the Hif1a gene as characteristic of actively garbage-engulfing microglia, suggesting it could offer a new target for developing drugs against the disorder. read more By Fraiser Kansteiner As COVID-19 vaccines and therapeutics reach the public, the companies involved in the pandemic fight have laid out some eye-popping pay packages for their chief executives. One in particular, coming in at more than $135 million, will likely set a benchmark for years to come. Meanwhile, pandemic players weren't the only ones to reward their helmsmen handsomely in 2020. read more By Andrea Park Singapore’s Ministry of Health will use the BreFence Go system to test incoming travelers at the Tuas Checkpoint between Singapore and Malaysia, where a negative test is required to enter the city-state. read more Resources Sponsored by: BBK Worldwide Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning about the barriers to participation and the strategies to overcome them. Sponsored by: Thermo Fisher Scientific Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process. 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Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. | 
