AstraZeneca's cancer R&D chief Baselga passes away, as industry chiefs lead mourning Pfizer/Eli Lilly’s anti-NGF osteoarthritis drug works, but FDA says safety risks ‘remained concerning’ Odonate abandons breast cancer chemo drug, closes its doors Sponsored: NK Cells are Now Better Serial Killers Biotech's top 10 money raisers of 2020 Sponsored: Avoiding Gene Therapy CMC and Clinical Supply Issues Daiichi takes mRNA COVID-19 vaccine into clinic as Japanese R&D belatedly fires up With early phase 2 data, BridgeBio plots next steps for hypoparathyroidism drug XyloCor bags $23M to expand heart disease gene therapy R&D Stroke-spotting software maker Viz.ai raises $71M to expand clinical reach Targeted drug prevents heart failure in mouse models of heart attack AstraZeneca preps COVID-19 vaccine for FDA filing armed with 79% efficacy stat Featured Story | By Ben Adams AstraZeneca’s executive vice president of oncology R&D José Baselga, M.D., Ph.D., 61, has passed away. read more |
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Top Stories By Ben Adams Pfizer and Eli Lilly’s long journey to a potential FDA approval for tanezumab still looked rocky today after review documents from the regulator cast doubt over its safety. read more By Amirah Al Idrus Odonate Therapeutics is ending development of its oral chemotherapy drug and closing up shop after the FDA deemed the drug’s clinical data “unlikely to support FDA approval.” As it winds down its operations, the company will work with clinical sites to switch patients participating in its clinical trials to alternative treatments. read more Sponsored By: GT Biopharma, Inc. Could native, non-functioning NK cells in cancer patients be rescued and revived by a novel, off-the-shelf immuno-oncology therapeutic that is also a pervasive serial cancer killer? The Data Says Yes. read more By Amirah Al Idrus Private biopharma companies raised nearly $20 billion in 2020, blowing past the record $17.9 billion set in 2018. Here are the top 10 fundraising rounds, which include some "truly monstrous" financings like Sana Biotechnology's eye-watering $700 million series and Lyell Immunopharma's $493 million raise. read more Sponsored By: Catalent Cell & Gene Therapy Gene therapy manufacturing and clinical supply strategies should be in place early to avoid potential late-stage development delays. read more By Nick Paul Taylor Daiichi Sankyo has begun a phase 1/2 clinical trial of an mRNA vaccine against COVID-19. The vaccine is set to come to market well after leading prophylactics but gives Japan a chance to establish its own countermeasures for COVID-19 and future health crises. read more By Amirah Al Idrus BridgeBio Pharma’s treatment for a rare hormonal disorder helped patients reach normal levels of that hormone as well as of calcium, phosphorus and magnesium in their blood, early phase 2 data show. The company’s next stop will be a meeting with regulators ahead of a phase 3 study to figure out the treatment’s path to patients. read more By Nick Paul Taylor XyloCor Therapeutics has raised $22.6 million to study a gene therapy designed to deliver VEGF to heart cells. The financing, which swells the series A to $41.9 million, positions XyloCor to study its lead candidate in patients undergoing coronary artery bypass graft surgery. read more By Conor Hale Stroke-spotting software developer Viz.ai has raised $71 million to help expand its artificial intelligence programs into other acute care areas—including cardiovascular, pulmonary and trauma care—amid plans to take its business to new global markets. read more By Arlene Weintraub People who suffer heart attacks frequently progress to chronic heart failure due to scarring and inflammation that hampers heart function. Researchers at Baylor College of Medicine showed that a small-molecule inhibitor of steroid receptor coactivators could prevent that progression in mice. read more By Eric Sagonowsky With the U.S. racing against new COVID-19 variants, a fourth shot looks to be on its way. In a phase 3 trial in the U.S., Peru and Chile, AstraZeneca’s vaccine—authorized in Europe and beyond, but not yet in the U.S.—posted 79% efficacy against symptomatic COVID-19 and 100% against severe disease. read more Resources Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: TAC Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously. 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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. 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Pharma PR & Communications Virtual Summit April 20–22, 2021 | Virtual Event Learn the science driving biopharma. Specific for the non-scientist. April 20-21, 2021 | 12 p.m. EST / 9:00 a.m. PST Vaccines, cell and gene therapy, therapeutic antibodies and RNA drugs May 20-21, 2021 | 12 p.m. EST / 9 a.m. PST Vaccines, cell and gene therapy, antibodies, and RNA-based drugs June 10-11, 2021 | 9 a.m. EST / 6 a.m. PST | 