| | Webinar: MDR conform development of sterile Medical Devices Wednesday, September 1, 2021 | 10am ET / 7am PT Get insight on MDR requirements and their impact on the development of medical devices, relevance of adequate documentation during MDR conform development of sterile medical devices, and advantages of Contract Manufacturing as strategic partnership to fulfill MDR requirements. Register Now |
WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST While viral-vector vaccines for COVID-19 have had their share of speed bumps, Pfizer, BioNTech and Moderna’s mRNA-based shots have enjoyed a relative cakewalk. But this week Europe’s drug regulator disclosed it’s investigating possible links to side effects, after rare reports of allergic skin reactions and two different kidney disorders amid hundreds of millions of doses delivered. Meanwhile, biopharma companies are making vaccines mandatory for employees, as they look to re-open in the face of the spreading delta variant. But they may be better prepared for any new lockdowns this time around, after being thrust into a virtual world to keep drug development moving and clinical data flowing—and our special report explores how they did it. Those stories follow below. | |
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Featured Story | By Kevin Dunleavy The European Medicines Agency is trying to determine if mRNA vaccines can trigger an allergic skin reaction called erythema multiforme or two kidney disorders. It has requested additional data from Pfizer, BioNTech and Moderna. read more |
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Top Stories Of The Week By Annalee Armstrong Moderna has found a direction to volley its mountain of COVID-19 vaccine cash: gene editing. Executives revealed during a second-quarter earnings call Thursday that Moderna is ready to “expand our horizons” with external technologies or products. Read: They’re ready to start buying. read more By Fraiser Kansteiner Over the past few days, Fierce Pharma asked a range of biopharmas big and small about their evolving vaccination policies. While some companies have already gone public with their plans, others are deliberating how to approach the issue. read more By Kyle LaHucik Novavax hit another roadblock in its COVID-19 vaccine journey in the U.S., with the company pushing back an FDA filing from May to July to now the fourth quarter. The company filed in India, Indonesia and the Philippines this week, and expects more submissions later this year with WHO, UK, EU, Australia, Canada and New Zealand. read more By Kevin Dunleavy Bluebird Bio will concentrate its efforts in the United States, winding down its operations in Europe because the company couldn't agree on pricing for its costly, one-time gene therapies. read more By Kyle LaHucik The Delta variant has sent shockwaves across the world as people began to emerge from more than a year of isolation. The workplace has become a new line of defense against the pandemic. Fierce Biotech surveyed a range of biotechs to see how they are responding to the wave of vaccination mandates. read more By Annalee Armstrong The pharmaceutical industry already knew virtual tools like decentralized studies, telehealth and home health visits could help make clinical trials more diverse. It just took a global pandemic to go all in on fixing the problem. read more By Conor Hale As Philips stares down an international recall of more than 2 million of its CPAP and sleep apnea machines, the respiratory devicemaker ResMed is looking to pick up the slack—but the surge in demand from people looking to regain a healthy night’s sleep has greatly strained an already-crimped supply chain, compelling the company to ration its hardware. read more By Fraiser Kansteiner Looking to get the jump on impurity concerns first raised in Canada and Europe, Sanofi has rescinded a clutch of blood pressure drugs in Asia. It's far from the only company whose meds are under scrutiny, potentially signalling the next widespread recall of the popular hypertension therapy. read more By Angus Liu Combining immunotherapy, anti-angiogenic drugs and chemotherapy to treat non-small cell lung cancer hasn't proven to be all that effective. Now, a new study suggests that a four-drug combination including a CSF1R inhibitor can target tumor-associated macrophages and improve the anti-tumor response. read more By Beth Snyder Bulik COVID-19 vaccine makers' time in the sun is over, says one reputation tracker. The initial reputation boost ignited by companies' rush to find solutions during the pandemic has not only faded but is turning into a liability. read more Resources Sponsored by: Patheon by Thermo Fisher Scientific Learn how a decentralized clinical trial strategy improves patient recruitment, reduces drop-out rates, and ultimately streamlines the path to the next trial phase. Sponsored by: Patheon by Thermo Fisher Scientific Learn how to build a robust packaging strategy and the key technical considerations in packaging design and operational planning to enable rapid commercialization of pharmaceuticals. Sponsored by: Patheon by Thermo Fisher Scientific Learn how regulations are changing and key considerations for commercializing cell and gene therapies without sacrificing quality. Sponsored by: LabVantage Solutions Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. 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. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification 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. | 