WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST While a Toronto condo developer may want to advertise spectacular views, that’s just what Sanofi is worried about. Windows of the planned towers would overlook the Big Pharma’s vaccine manufacturing plant—and with an $850 million contract to supply Canada with future shots, the drugmaker is claiming the high-rises could pose a threat to the nation’s pandemic security. Meanwhile, the FDA imposed a partial clinical hold on Gilead’s blood cancer drug magrolimab, an antibody acquired in its $4.9 billion takeover of Forty Seven. Those stories, plus Fierce’s top reads of the week, follow below. | |
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Featured Story | By Kevin Dunleavy A Toronto builder is planning a high-rise condo development next door to a Sanofi vaccine manufacturing complex. But the company isn't happy about future neighbors with a bird's-eye view of goings-on at the plant. read more |
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| Webinar: Apollo’s 2022 Healthcare Predictions Wednesday, February 9, 2022 | 1pm ET / 10am PT Amid continued pandemic-related disruption, this year’s global insights will share provider views on the last year, thoughts on coming change in the industry, and their hopes for 2022. This year’s findings place a specific focus on a few key therapeutic areas—oncology, rheumatology, and neurology. Register now. |
Top Stories Of The Week By Nick Paul Taylor Gilead’s $4.9 billion oncology bet has hit a late-phase setback. Spooked by an “apparent imbalance” in adverse reactions between study arms, the FDA has imposed a partial clinical hold on a handful of trials of magrolimab—raising questions about the program and the billions biopharma has bet on CD47. read more By Nick Paul Taylor The shock waves caused by the success of AstraZeneca’s TOPAZ-1 clinical trial have reached Norway. After reviewing the results, PCI Biotech has decided to scrap its own pivotal advanced biliary tract cancer trial in the belief it may struggle to complete the study and win approval. read more By Kevin Dunleavy With the omicron variant accounting for more than 99% of COVID-19 infections in the U.S., the FDA has revised authorizations for the Eli Lilly and Regeneron antibodies, prohibiting their use in patients who have been infected with the variant. read more By Kyle LaHucik Mirati Therapeutics' KRAS drug adagrasib led to a 41% response rate in patients with pancreatic and other gastrointestinal tumors, the latest in the biotech's efforts to eke out an edge against the big winner in the drug class, Amgen. read more By Angus Liu Back in 2014, Gilead Sciences’ Zydelig became the first PI3K inhibitor cleared by the FDA for certain B-cell blood cancers. Fast forward to today, and the company has found itself withdrawing two indications gained under the accelerated approval pathway as more treatments have become available. read more By Angus Liu GlaxoSmithKline and Vir Biotechnology are rushing to speed up production of their COVID-19 therapy, now that they're the only companies with an antibody that appears to be truly effective against omicron. read more By Andrea Park Recovery from Philips’ difficult 2021 will require at least static sales growth, since, for the full year, the company reported a year-over-year sales decline of 1%. read more By Fraiser Kansteiner The FDA gave Lilly a slap on the wrist for an Instagram post about its top-selling diabetes med, Trulicity. This marks the second round of advertising trouble since December for the Indianapolis-based drugmaker. That prior entanglement centered on TV spots for Lilly's migraine treatment Emgality and was quickly resolved. read more By Kyle LaHucik In the 41-year HIV epidemic, no treatments have been approved to completely clear the virus largely because of its ability to live on in hidden form in the genomes of T cells. Now, researchers say an approved cancer drug might help flush the dormant HIV from immune cells, potentially paving the way for new treatment options. read more Resources Sponsored by: WIRB-Copernicus Group Sites receiving augmentation support enroll more than 30,000 patients in just over three months. See how additional site resources can make a difference. Sponsored by: Thermo Fisher Scientific Learn how a CDMO partnered with Thermo Fisher Scientific to manage high-volume process liquid and buffer preparation scale-up. Download the free case study from Thermo Fisher Scientific Sponsored by: Thermo Fisher Scientific A variety of genetic analysis methods are valuable in ensuring that ex vivo human cells to be used for cell-based therapies are correctly identified, have the correct characteristics, and are free of contaminants. Sponsored by: IQVIA Learn how to elevate your omnichannel marketing strategy with Next Best - a combination of data and analytics, deployed to facilitate decision making. Sponsored by: Catalent Biologics Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. | 