WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST COVID-19 drove the industry to breakneck speeds, with unheard-of collaborations to deliver vaccines and therapies across the finish line. And more than a few of those players handed their chief executives serious pay bumps for that work—with the top 15 bringing in a total of $470 million in salaries and bonuses. One of those companies, Johnson & Johnson, this week secured the first FDA drug approval for patients with a specific genetic mutation in their EGFR-positive lung tumors. The drugmaker also outlined data slated for next month’s ASCO meeting, showing its bispecific antibodies delivered responses in 65% of multiple myeloma patients. Those stories, plus our top reads of the week, follow below. | |
|
Featured Story | By Fraiser Kansteiner,Angus Liu Just a few short months after Johnson & Johnson's Janssen unit sent its targeted non-small cell lung cancer drug amivantamab to the FDA, the regulator has come back with a green light—an extremely specific one. read more |
| |
|---|
|
Top Stories Of The Week 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 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 Fraiser Kansteiner Johnson & Johnson's immunology med Stelara went head-to-head against AbbVie's stalwart Humira in Crohn's disease, looking for bragging rights to help it compete in that market. It didn't work—at least not in the way J&J might have hoped. read more By Fraiser Kansteiner GlaxoSmithKline's fate has looked uncertain ever since aggressive activist investor Elliott Management took a major stake in the U.K.-based pharma last month. Now, after winning the support of several prominent investors, GSK has the British government watching its back. 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 Arlene Weintraub BI and OSE unveiled data from a phase 1 trial of BI 765063, a SIRP-alpha inhibitor, reporting that 45% of evaluable patients derived some clinical benefit from the drug. BI 765063 is among an emerging class of immuno-oncology drugs that target “don’t eat me” signaling, which is a strategy used by tumors to escape immune destruction. read more By Fraiser Kansteiner Once a likely contender to produce Novavax's late-stage COVID-19 vaccine in Australia, local biotech CSL now says it'll be too busy manufacturing AstraZeneca's shot. Novavax, meanwhile, is in the "early stages" of a search for long-term production. read more By Nick Paul Taylor A phase 3 clinical trial of BeiGene’s anti-PD-1 antibody in patients with nasopharyngeal cancer (NPC) has met its primary endpoint. The success at the interim analysis tees BeiGene up to expand use of the Novartis-partnered drug into a disease that is relatively common in its native China. 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 By Sharon Klahr Coey Not making the bed during the pandemic is fine. But skipping important vaccines for your kids is not, say actress Gabrielle Union-Wade and her husband, former NBA star Dwyane Wade. The celebrity parents star in a new public service announcement from Merck & Co and non-profit organization Vaccinate Your Family. read more Resources Sponsored by: BBK Worldwide Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning 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. Sponsored By: Veeva Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. Sponsored By: Veeva One top 10 pharma outlines three key steps to launching a modular content strategy to generate localized content faster. Sponsored By: Blue Matter This 77-page e-book explores 7 keys to success that any biopharma company needs to keep in mind as it enters Europe. Sponsored by: Datacubed Health The average clinical trial spends $40,000 per patient. Yet despite these high costs, most trials struggle to retain patients. Sponsored By: AmerisourceBergen Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success. Sponsored By: WCG Trifecta The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: August Bioservices How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond? Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 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: Catalent Hear industry experts discuss the recent advances, challenges and considerations in pediatric drug development. Real-life examples presented by the experts illustrate the impact of age-appropriate dose forms for pediatrics and highlight insights into the caregiver perspectives. 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 proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. | 