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| 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 Nick Paul Taylor A patient has died in a clinical trial that is testing Alpine Immune Sciences’ davoceticept in combination with Merck’s Keytruda. The death in the study of adults with advanced malignancies triggered a partial clinical hold—and raised the specter of an earlier tragedy. read more |
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Top Stories By Max Bayer AstraZeneca is budgeting another $100 million in 2022 to wrap up work on its R&D center in Cambridge, U.K. The addition brings the total costs of the over-budget and overdue research hub to $1.3 billion. read more By Conor Hale,Andrea Park,Heather Landi,Rebecca Torrence,Kyle LaHucik,Max Bayer In one way or another, the Fierce 15 has always been about celebrating those who are finding new ways of doing things. This year's 10th annual selections stand out from the pack because they are working to build new ways to approach the day to day. read more By Annalee Armstrong Astellas Pharma has shown its menopause medicine is safe, teeing up regulatory filings in the U.S. and EU—but analysts aren’t sure whether fezolinetant will find a market once approved. read more By Nick Paul Taylor Salubris Biotherapeutics has topped up its bank balance to the tune of $32 million. The U.S.-based offshoot turned to its parent company Shenzhen Salubris Pharmaceuticals for the funding, giving it the financial firepower to study a bispecific antibody in cardiovascular disease. read more By Max Bayer England-based Microbiotica has raised $67 million in a series B round to push two microbiome-based lead assets through phase 1b trials, slated to start this year. read more By Kevin Dunleavy After updating the status of three promising gene therapies in its fourth-quarter and 2021 earnings report, bluebird bio illuminated its dire financial situation, saying that its cash needs “raise substantial doubt about its ability to continue to do business this year. The company also announced the departure of chief financial officer Gina Consylman, whose duties will be picked up by chief business officer Jason Cole. read more By Heather Landi GoodRx is scooping up vitaCare Prescription Services from TherapeuticsMD to beef up its growing pharma manufacturer solutions business. read more By Kevin Dunleavy Former Operation Warp Speed chief Moncef Slaoui, who GlaxoSmithKline fired last year because of a sexual harassment claim, is returning $3.86 million to the company, according to its annual executive compensation report. read more By Joseph Keenan Moderna said it inked a memorandum of understanding with Kenyan officials to build a state-of-the art mRNA facility, which was first announced in October 2021. The site will focus on producing up to 500 million vaccine doses a year. read more Resources Sponsored by: H1 Read why many MSLs are still challenged in developing integrated strategies to increase the volume of meaningful engagements. Download this industry report to find out what the top challenges are and suggestion strategies to solve them. Download now. Sponsored by: Oracle Health Sciences Learn about ways to break down regulatory roadblocks and get closer to 100% clarity on regulatory positions to advance decentralized clinical trials in research. Sponsored by: Oracle Health Sciences How to overcome top challenges faced in decentralized trials. 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: 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 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 Trial Master File Summit May 2-4, 2022 | New Orleans, LA & Streaming Live Fierce Digital Pharma Engage June 14-15, 2022 | Huntington Beach, CA Fierce Pharma PR & Communications Summit West June 14, 2022 | Huntington Beach, CA Fierce Digital Pharma Innovation Week June 21-23, 2022 | Virtual Event Fierce Pharma PR & Communications Summit July 2022 | Location TBD (NYC Metro Area) Fierce MedTech Summit August 8-9, 2022 | Minneapolis, MN 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 Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ Fierce European Trial Master File Summit November 14-16, 2022 | London, UK Fierce New Product Planning Summit November 30 - December 1, 2022 | Virtual Event Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Virtual Event Fierce JPM Week 2023 January 1, 2023 | 
