| Scout Clinical helps remove the financial and logistical burdens for clinical trial participants. We offer personalized and adaptable patient payment and travel services globally. Learn more: Scout Clinical | Services! | As biotech debates vaccine mandates, one CEO tries to convince the 3% that got away I-Mab thinks cytokine storm drug can take on Humanigen's lenzilumab in sickest COVID-19 patients Fulcrum's early 'proof of biology' data for sickle cell drug breathes life into stagnant shares Purdue subsidiary buys non-opioid pain prospect from PureHealth BioCryst scraps $200M offering after seeing share price slide GentiBio banks $157M to fuel Treg treatment for Type 1 diabetes Eli Lilly takes its trial work on the road, literally, as it loads up RVs to broaden its study reach Novartis, Pfizer and Gilead roll out COVID-19 vaccination rules as delta makes case for mandates Surprise, surprise: AstraZeneca and FibroGen’s once-hyped anemia drug roxadustat hits an FDA wall HIMSS21 Roundup—Olive picks up clearinghouse company; Cox Communications unveils real-time location tech Featured Story 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 |
| |
---|
| Top Stories By Annalee Armstrong I-Mab’s experimental COVID-19 treatment reduced the mechanical ventilation rate in patients, putting the Chinese biotech in the game with Humanigen in trying to improve treatment options for the sickest patients. The ongoing phase 2/3 study is testing I-Mab’s plonmarlimab for the treatment of cytokine release syndrome, an over-active immune response associated with a higher death rate in COVID-19 patients. read more By Annalee Armstrong Fulcrum Therapeutics thinks it has “proof of biology” for an early-stage sickle cell disease treatment, a result that has offered a bit of optimism several weeks after the biotech announced the failure of a fast-tracked, midstage muscle degeneration drug. It’s early days for Fulcrum’s FTX-6058, which is being developed as a potential treatment for inherited hemoglobin diseases such as sickle cell disease and beta thalassemia. read more By Nick Paul Taylor With Purdue Pharma plotting a future beyond the bankruptcy proceedings now consuming the company, its drug development subsidiary Imbrium Therapeutics has secured global rights to a drug candidate that could play a role in the move beyond opioids. read more By Nick Paul Taylor BioCryst has withdrawn a proposed $200 million public offering after seeing its stock fall 14% in the wake of the announcement. The rare disease company made the U-turn after deciding “current market conditions are not conducive to an offering on terms that would be in the best interests of our current stockholders.” read more By Amirah Al Idrus The Treg field is heating up. A week after Sonoma Bio snagged a meaty $265 million round to advance its regulatory T cell (Treg) programs, GentiBio is getting off a $157 million series A to do the same. read more By Ben Adams Eli Lilly is once again taking to the road for its clinical trials, but this time it’s aiming at underrepresented trial subjects as it continues to find workarounds for the COVID chaos. 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 Angus Liu After an overwhelmingly negative opinion from an external FDA advisory panel, AstraZeneca and FibroGen’s potential first-in-class anemia drug roxadustat looked unlikely to pass muster with the U.S. regulators. Now, the second shoe has dropped. As one analyst sees it, a restructuring at FibroGen could be next. read more By Heather Landi,Dave Muoio Here are a few slices of news and life from the first day of the 2021 Healthcare Information and Management Systems Society (HIMSS) Global Health Conference and Exhibition on Monday. read more | Looking for a simple and cost-effective solution to scalable production of ESCs and iPSCs? Learn how growing pluripotent stem cells in suspension enables scaling up without scaling out while saving time and cost. Download our free PSC suspension culture infographic | Resources Sponsored By: Patheon Pharmaceutical Services Inc. 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 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 regulations are changing and key considerations for commercializing cell and gene therapies without sacrificing quality. Sponsored By: LabVantage Solutions, Inc. 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: Evidera, a PDD business Learn about key post-marketing safety study solutions, including registries and REMS, and how they can most effectively help meet regulatory requirements and maximize patient access. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification 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: 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. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Medical Affairs Strategic Summit (MASS) September 13-15, 2021 | New Brunswick, NJ Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA Diversity, Equity & Inclusion Week November 9–11, 2021 | Virtual Event Fierce Biotech Forum Boston, MA | November 16-17, 2021 |