| 
| 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. |
Featured Story | By Annalee Armstrong In a rare moment of solidarity among fierce competitors, Biogen’s peers Roche and Eli Lilly are rallying behind the company’s troubled Alzheimer’s disease therapy, Aduhelm, in an effort to change the Centers for Medicare and Medicaid Services’ restrictive ruling against monoclonal antibodies for the condition. read more |
| |
|---|
|
Top Stories By Nick Paul Taylor Roivant Sciences has spawned another Vant. The latest addition to the clan is Hemavant, a biotech that starts life with a former Eisai drug and plans to start a study in patients with myelodysplastic syndromes this year. read more By Nick Paul Taylor Denali Therapeutics now knows what it needs to do to get its Alzheimer’s disease drug DNL919 back on track. Almost one month after the FDA informed Denali of a clinical hold via email, the agency has sent a formal letter setting out what needs to happen before it OKs a study of the Takeda-partnered prospect. 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 Kyle LaHucik Metacrine has laid off about half of its staff, mainly in the research department, to save cash as it takes a failed NASH drug into a phase 2 study in people with inflammatory bowel disease. The San Diego biotech also ended work on a preclinical NASH program. read more By Max Bayer 2seventy bio has hired oncologist and former Turnstone Biologics exec Steven Berstein, M.D., to be its chief medical officer, effective Monday. The hire charts the path forward for 2seventy after its recent split from bluebird bio to focus on oncology program. read more By Kevin Dunleavy The FDA has approved Eli Lilly’s new COVID-19 monoclonal antibody treatment bebtelovimab, granting it emergency authorization. Bebtelovimab can be used for the treatment of mild-to-moderate COVID-19 and has been shown to be effective against the omicron variant. read more By Andrea Park When met with a crossroads—that is, Memphis, Tennessee-based CrossRoads Extremity Systems—DePuy Synthes, the orthopedics and neurosurgery division of Johnson & Johnson, opted for a familiar path. read more By Fraiser Kansteiner Moderna has already seized domestic manufacturing opportunities in Canada, Australia and Africa. Now, the mRNA pioneer is setting its sights on the U.K.'s "Golden Triangle" for the next leg of its vaccine journey, the Financial Times reports. read more By Andrea Park The Physicians Committee for Responsible Medicine filed a federal complaint with the USDA regarding the alleged treatment of monkeys at the University of California, Davis in connection with Neuralink’s experiments. read more By Robert King A group of House Republicans wants HHS to end the COVID-19 public health emergency, while hospital groups are hoping it is extended beyond April. read more By Angus Liu In the search for more efficient and safer RNA-editing tools, two research teams from the U.S. and China have developed novel ways to recruit a naturally occurring protein inside the body to repair disease-causing mutations in RNA. 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 What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Blue Matter, strategic consultants in the life sciences 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 Leaders in Life Sciences Forum May 24, 2022 | Complimentary Virtual Event 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 Biotech Next-Gen Week June 29-30, 2022 | Virtual Event Fierce Pharma PR & Communications Summit July 19-20, 2022 | Jersey City, NJ 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 Biotech Cell & Gene Therapy Forum October 19, 2022 | Virtual Event Fierce Pharma Marketing Awards October 19, 2022 | Philadelphia, PA Fierce European Trial Master File Summit October 31- November 2, 2022 | London Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ 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 2023 | San Francisco, CA & Virtual | 
