| 
| Need Turn-Key Microbiome Analysis Services? Utilize streamlined and validated direct-to-consumer microbiome testing workflows. You can economize time and resources working with industry expert scientists. See how Zymo Research’s customizable Microbiome Sequencing Services can help you. Learn More. |
Featured Story | By Nick Paul Taylor Merck has dumped Moderna’s mutant KRAS vaccine mRNA-5671. The action, which comes shortly after Merck closed enrollment in a phase 1 trial, leaves Moderna pondering the next steps for the program. read more |
| |
|---|
|
Top Stories By Max Bayer Less than four months after finalizing its spinoff from bluebird bio, leaders of 2seventy bio say their pipeline's current success stories are not the bar, including FDA-approved Abecma. Instead, those at the helm believe the company's future will be defined by the science it's now chasing. read more By Kyle LaHucik Orphazyme's rare disease drug has encountered yet another rejection, this time from the European Union's regulatory advisers. The setback comes after an FDA rejection in June 2021 and two failed phase 2/3 trials in other diseases last year. read more Sponsored by: Precision for Medicine The use of biomarkers to individualize treatment is a cornerstone of precision medicine. Successful incorporation of biomarkers for effective patient identification and selection requires careful planning. Learn about Precision's recommended strategies for overcoming 4 common challenges in biomarker-driven trials. read more By Nick Paul Taylor Amicus Therapeutics’ plan to spin off its gene therapy assets has run into the reality of the biotech stock market in 2022. With “market conditions” sinking the planned SPAC merger, Amicus plans to prioritize its gene therapy pipeline as part of a push to generate $400 million in net savings through 2026. read more By Kyle LaHucik Takeda's venture arm and Arch have doled out $24 million to bankroll the early days of hC Bioscience, which is going after transfer RNAs. The biotech is led by Leslie Williams, who previously founded and led Arch-backed celiac disease biotech ImmusanT, which disappeared after a scrapped phase 2 in 2019. read more By Andrea Park According to the SEC, from at least 1995 until 2019, Baxter converted its internal foreign transactions, assets and liabilities into U.S. dollars on its financial statements using a method that “was not in accordance with U.S. GAAP or generally accepted accounting principles.” read more By Fraiser Kansteiner This year, Moderna expects revenue from sales of its mRNA-based COVID-19 vaccine to clock in at around $22 billion. The company has locked up advanced purchase agreements worth $19 billion, with additional signed options valued at roughly $3 billion, the company said Thursday. read more By Ben Adams Biosimilars are coming for Regeneron and Bayer’s Eylea’s crown, but the blockbuster reign is under no immediate threat of being overthrown. read more By Robert King Michigan Gov. Gretchen Whitmer signed into law a series of reforms to the pharmaceutical benefit management industry, including installing new requirements for licensure and transparency. read more By Angus Liu After nearly 25 years of operating at a loss, BioMarin hopes to finally turn a corner and post its first profits in 2022 as the commercial launch of dwarfism drug Voxzogo kicks into gear. But some safety concerns might ruin the party. read more By Andrea Park Even without the rollout of the latest model of its tubeless insulin pump system—the Omnipod 5, which was originally poised to receive FDA clearance early last year but didn’t secure the agency’s OK until last month—Insulet still broke new ground in its 2021 earnings. read more By Max Bayer In the wake of the pandemic, decentralized trials became a much larger fixture of the life sciences industry. As sites and sponsors look toward the future, a new survey found many will continue to adopt remote strategies, but challenges remain. read more Resources 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. Fierce Drug Safety Summit March 8-9, 2022 | Virtual Fierce BD&L Summit for Life Sciences March 15-16, 2022 | San Francisco, CA Fierce Promotional Review Committee Compliance and Best Practices Summit April 12-14, 2022 | New Brunswick, NJ Fierce Medical Affairs Strategic Summit (MASS) East 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 Leaders in Life Sciences Forum May 24, 2022 | Complimentary 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 Biotech Next-Gen Week June 29-30, 2022 | Virtual Event Fierce Pharma PR & Communications Summit July 2022 | Location TBD (NYC Metro Area) Fierce MedTech Summit August 8-9, 2022 | Minneapolis, MN Fierce Biotech Summit September 13-14, 2022 | Boston, MA 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 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 Fierce European Trial Master File Summit October 31- November 2, 2022 | London Fierce Diversity, Equity & Inclusion Forum November 15-16, 2022 | Virtual Event 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 | Virtual Event Fierce JPM Week 2023 January 1, 2023 | 
