WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST The first two years of the COVID pandemic forced the entire medtech industry to try something new, whether it was working remote, dealing with supply chain snafus or pivoting their businesses to the coronavirus. So how do you spotlight the most innovative companies? This year’s Fierce 15 stand out because they’re building new ways to approach the day to day. Meanwhile, innovation is on the minds of Big Pharma leaders as much as ever, as drugmakers stare down a patent cliff facing 10 medicines that account for more than $17 billion in annual sales. Those special reports, plus our top stories of the week, follow below. | |
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Featured Story | By Fraiser Kansteiner Pfizer issued a second round of Canadian recalls this week as the country’s drug regulator continues to weed out meds with an excess of potential cancer-causing impurities. read more |
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Top Stories Of The Week By Conor Hale,Andrea Park,Heather Landi,Rebecca Torrence,Kyle LaHucik,Max Bayer In one way or another, the Fierce 15 has always been about celebrating those who are finding new ways of doing things. This year's 10th annual selections stand out from the pack because they are working to build new ways to approach the day to day. read more By Eric Sagonowsky,Kevin Dunleavy,Fraiser Kansteiner With AbbVie’s megablockbuster Humira set to face an onslaught of biosimilars next year, industry watchers have long circled 2023 as the year of the major pharma patent cliff. But this year’s slate of top losses of exclusivity covers a hefty slate of brands worth more than $17 billion in annual sales. read more By Nick Paul Taylor A patient has died in a clinical trial that is testing Alpine Immune Sciences’ davoceticept in combination with Merck’s Keytruda. The death in the study of adults with advanced malignancies triggered a partial clinical hold—and raised the specter of an earlier tragedy. read more By Fraiser Kansteiner Back in 1971, Johnson & Johnson funded a study that injected 10 Pennsylvania prisoners with asbestos, newly unsealed court documents show, as first reported by Bloomberg. When asked for comment on the latest reporting, J&J stressed its focus on bioethics but also defended its testing as acceptable at that time. read more By Kevin Dunleavy After updating the status of three promising gene therapies in its fourth-quarter and 2021 earnings report, bluebird bio illuminated its dire financial situation, saying that its cash needs “raise substantial doubt about its ability to continue to do business this year. The company also announced the departure of chief financial officer Gina Consylman, whose duties will be picked up by chief business officer Jason Cole. read more By Nick Paul Taylor BeiGene’s hematology chief medical officer is hitting the exit. Almost six years after joining BeiGene, Jane Huang has handed in her resignation shortly after the replacement of her solid tumor counterpart. read more By Nick Paul Taylor Shionogi’s COVID-19 vaccine candidate has held its own against Pfizer’s Comirnaty in a study of the effect of booster shots on antibody levels, offering the company encouragement as it barrels toward a filing for approval of S-268019 in Japan. read more By Angus Liu When lots of regulatory priorities are given to COVID-19 during the pandemic, the FDA has introduced Opdivo as the first pre-surgery therapy for early-stage non-small cell lung cancer, with an ultrafast approval within the same week of accepting its application. read more By Andrea Park About 100 workers are being laid off as Adaptive reorganizes its business, homing in on just two core areas that can be served by its immune system-focused genetic sequencing technology. read more By Joseph Keenan Moderna said it inked a memorandum of understanding with Kenyan officials to build a state-of-the art mRNA facility, which was first announced in October 2021. The site will focus on producing up to 500 million vaccine doses a year. read more By Angus Liu By leveraging a unique genetic feature that separates tumors from normal cells, scientists at A2 Biotherapeutics designed dual-signal CAR-T cells to tackle solid cancers. They have reported promising early results for two candidates. read more |  | Webinar: The Most Innovative Virtual Engagement Programs of 2021 Wednesday, March 16, 2022 | 11am ET / 8am PT This webinar will share use cases from teams that have embraced technology to enable better engagement during 2021. Learn how the industry has reaped the benefits of adopting a hybrid engagement approach, enabling more precise dialogue, bringing diversity to discussion, and allowing teams to make better, faster decisions. Register now. |
Resources Sponsored by: H1 Read why many MSLs are still challenged in developing integrated strategies to increase the volume of meaningful engagements. Download this industry report to find out what the top challenges are and suggestion strategies to solve them. Download now. Sponsored by: Oracle Health Sciences Learn about ways to break down regulatory roadblocks and get closer to 100% clarity on regulatory positions to advance decentralized clinical trials in research. Sponsored by: Oracle Health Sciences How to overcome top challenges faced in decentralized trials. Sponsored by: United Cargo The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now. Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Blue Matter What’s in store for the CNS therapeutics market in 2022? This paper looks ahead in Alzheimer’s, Parkinson’s, DMD, psychiatric disorders, pain, and more. 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. Drug Development Boot Camp® HYBRID and VIRTUAL in real time November 16-17, 2022 Fierce Drug Safety Summit March 8-9, 2022 | Virtual Webinar: Case Study in Clinical Toxicology March 9, 2022 1:00 PM ET Fierce BD&L Summit for Life Sciences March 15-16, 2022 | San Francisco, CA Fierce Medical Affairs Strategic Summit (MASS East) April 12-14, 2022 | New Brunswick, NJ Fierce Promotional Review Committee Compliance and Best Practices Summit April 12-14, 2022 | New Brunswick, NJ Fierce Trial Master File Summit May 2-4, 2022 | New Orleans, LA & Streaming Live Fierce Health IT Summit May 24, 2022 | Virtual Event Fierce Digital Pharma Engage June 14-15, 2022 | Huntington Beach, CA Fierce Pharma PR & Communications Summit West June 14-15, 2022 | Huntington Beach, CA Fierce Digital Pharma Innovation Week June 21-23, 2022 | Virtual Event Fierce Pharma PR & Communications Summit July 19-20, 2022 | Jersey City, NJ Fierce MedTech Summit August 8-9, 2022 | Minneapolis, MN Promotional Review Committee Compliance and Best Practices Summit West (PRC West) September 2022 | San Diego, CA Medical Affairs Strategic Summit (MASS West) September 2022 | San Diego, CA Fierce Health Payer Summit October 12, 2022 | Complimentary Virtual Event Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Pharma Marketing Awards October 19, 2022 | Philadelphia, PA Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Virtual Event Drug Development Boot Camp® HYBRID/VIRTUAL November 16-17, 2022 Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Virtual Event Fierce New Product Planning Summit November 30 - December 1, 2022 | Boston, MA | 
