| Whitepaper: Early engagement & regulatory considerations for emerging biotechs Despite robust funding and government initiatives for the development of orphan drugs and personalised medicines, small and emerging biotechs are typically very lean on resources, lacking the infrastructure required to bring their innovation to the market. Gain insight into the common questions small and emerging biotech companies face, and the importance of early engagement and regulatory affairs when developing an asset and considering a drug development partner. Learn more. | Ex-NIH chief Collins returns as science adviser to Biden weeks into retirement Innovent's phase 3 hits tee it up to challenge Amgen and Sanofi for Chinese PCSK9 market After clinical hold, Yumanity to cut 60% of workforce by April and hunt for a buyer Sponsored: A New Way to Access Scientific Papers? NIAID vaccine R&D director who collaborated with Moderna on COVID-19 vaccine to retire Remix Therapeutics signs Janssen licensing deal that could top $1B Billionaire's fund backs Heidelberg to carve out niche in busy BCMA space Outset Medical doubled 2021 revenue to $102M amid widening net loss Applying mRNA to healing broken bones AHIP study claims hospitals charge double for specialty drugs compared to pharmacies Argenx's Vygart launch finds quick neurologist support over AstraZeneca's well-entrenched Soliris for myasthenia gravis Folx Health taps marketing executive as CEO as it eyes national expansion Featured Story By Kyle LaHucik Francis Collins, M.D., Ph.D., after exiting the top perch at the National Institutes of Health in the last weeks of 2021, is back in the upper echelons of U.S. scientific leadership as President Joe Biden's science adviser. read more |
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| Top Stories By Nick Paul Taylor Innovent Biologics is ready to make its play for the Chinese PCSK9 inhibitor market. Having racked up another two phase 3 wins, Innovent is preparing to file for an approval that would position it as a rival to Amgen’s Repatha and Sanofi’s Praluent in China. read more By Max Bayer Yumanity Therapeutics plans to cut 60% of its staff by April and is looking for buyers, the company announced Thursday. The news comes less than a month after the FDA placed a partial hold on its lead candidate for Parkinson's disease. read more Sponsored by: DeepDyve For researchers unaffiliated with an academic library, finding scientific papers can be time-consuming and expensive—and organizing or sharing them can be even harder. Can a new tool address this gap? read more By Max Bayer John Mascola, M.D., director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, is retiring at the end of March after more than eight years at the helm, a stint that most notably included collaboration with Moderna on its COVID-19 vaccine. read more By Max Bayer Remix Therapeutics is teaming up with Janssen Pharmaceuticals in a licensing deal that could exceed more than $1 billion in exchange for using its RNA reprogramming tech on three treatment targets. read more By Nick Paul Taylor Dievini has dug into its sack of cash to keep the lights on at Heidelberg Pharma for another year. The 36 million euro ($41 million) commitment extends Heidelberg’s runway out to mid-2023, setting the biotech up to advance its anti-BCMA antibody-drug conjugate through a phase 1/2a clinical trial. read more By Andrea Park For the full year, the portable dialysis machine maker logged revenues of $102.6 million. That’s more than double the previous year’s tally—specifically, a 105.5% increase compared to the $49.9 million earned in 2020. read more By Angus Liu mRNA technology could have broad applications beyond preventing COVID-19 with vaccines. Besides the infectious disease and cancer areas that industry leaders are already exploring, a research team at Mayo Clinic found mRNA holds promise for regenerating bones. read more By Robert King A new study funded by AHIP claims that hospitals charge patients double for certain pharmaceuticals compared to specialty pharmacies as the FTC considers a probe into pharmacy benefit managers. read more By Ben Adams Argenx nabbed an FDA approval for its rare disease drug Vyvgart just before Christmas for its generalized myasthenia gravis med. While Soliris has several years of a head start on Vyvgart, a new report from Spherix found more than half (51%) of the surveyed U.S. neurologists perceived Vyvgart “to offer a substantial advance over other currently available therapies.” read more By Heather Landi Folx Health launched out of stealth mode in December 2020 as a telehealth platform designed specifically for the queer and transgender communities. The company has tapped marketing and operations executive Liana Douillet Guzmán to lead its continued strong growth as it eyes expansion to all 50 states. read more Resources 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 How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? 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: 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. 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