| | 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. |
Novartis eyes next-gen AAV gene therapies in $1.75B Voyager biobucks pact Sanofi deploying $1B to turn France into 'pioneer mRNA nation' Valneva heads to FDA as durability of chikungunya vaccine holds up in phase 3 Late-stage biotechs, Kurma has €160M to help you clear the final hurdles in the race to market J&J to celebrate Carvykti nod without Janssen oncology chief as Serge Messerlian nabs Teon CEO job Creyon joins wave of AI biotechs with $40M to create 'on demand' RNA-based medicines BioNTech-Regeneron add 3rd tumor type to partnership testing cancer vaccines with Libtayo The top 10 drugs losing US exclusivity in 2022 NuCana's twist on chemo drug Gemzar fails in phase 3 again Be 'recall ready': FDA asks companies to take potentially harmful products off the market faster ViVE 2022: What collaboration looks like across CMS New pinhead-sized beads kill ovarian, colorectal cancers by producing interleukin-2: mouse study Dopamine helps elicit dream time, could pave way to new sleeping disorder drugs Featured Story | By Annalee Armstrong In Novartis’ perennial hunt for innovative therapies to bring under its wing, improving on gene therapy has always been kept top of mind. And the Swiss pharma continues to do just that thanks to a new biobucks deal with Voyager Therapeutics worth up to $1.75 billion. read more |
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Top Stories By Kyle LaHucik Sanofi will invest about $1 billion in its home country to beef up mRNA R&D and vaccines production in France. The move is part of the Big Pharma's broader $2.2 billion mRNA commitment revealed last summer. read more By Nick Paul Taylor The finish line is in sight for Valneva’s chikungunya virus vaccine candidate. With antibody levels holding steady out to six months in the phase 3 clinical trial, Valneva is set to start the pre-submission process with the FDA in the second quarter. read more By Nick Paul Taylor Kurma Partners has rounded up cash to help 15 companies clear the final hurdles in the race to market. Armed with an initial 160 million euros ($174 million), the Paris-based VC shop will primarily support unlisted European companies as they seek to transform from R&D- to commercial-stage organizations. read more By Max Bayer Serge Messerlian is probably missing out on a big celebration back at the offices of his former employer, Johnson & Johnson, after the approval of multiple myeloma med Carvykti last week. But instead, Messerlian has moved on to his next gig: CEO of oncology-focused biotech Teon Therapeutics. read more By Kyle LaHucik Creyon Bio wants to create drugs "on demand" for patient populations that consist of one person with a rare disease, or "millions" of people with common diseases—and a $40 million series A will help get that mission underway. read more By Max Bayer BioNTech wants to run it back with Regeneron, extending a partnership first announced in 2020 to combine a cancer vaccine with the approved treatment Libtayo in the clinic, this time for advanced non-small cell lung cancer. read more By Eric Sagonowsky,Kevin Dunleavy,Fraiser Kansteiner With AbbVie’s megablockbuster Humira set to face an onslaught of biosimilars next year, industry watchers have long circled 2023 as the year of the major pharma patent cliff. But this year’s slate of top losses of exclusivity covers a hefty slate of brands worth more than $17 billion in annual sales. read more By Nick Paul Taylor NuCana’s retooled chemotherapy candidate Acelarin has come up short in phase 3 again. The latest failure wipes out hopes that NuCana’s attempt to improve on gemcitabine, sold by Eli Lilly as Gemzar, will drive improved outcomes in biliary cancer. read more By Andrea Park This month, the FDA finalized guidance outlining how makers of regulated products can become “recall ready” to minimize buyers’ and users’ exposure to any potential health risks. read more By Paige Minemyer MIAMI—Late last year, CMS set a goal of having all Medicare beneficiaries enrolled in both Part A and Part B in an accountable care model by 2030. Central to achieving that goal? The ability to coordinate and collaborate across different parts of the agency, leaders said Monday during a session at the ViVE conference. read more By Kyle LaHucik Researchers at Rice University said they were able to eliminate ovarian cancer and colorectal cancer in mice using a beadlike implant that helped produce the cytokine interleukin-2. Avenge Bio has licensed the tech and will take the drug into the clinic in the second half of this year. read more By Kyle LaHucik Dopamine plays a role in helping transition from non-rapid eye movement sleep to the portion of the night when your dreams come alive, according to new research from a team at University of Tsukuba. The findings could point to a new target for drugs that aim to treat sleeping disorders like narcolepsy. 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 Pharma PR & Communications Summit West June 14, 2022 | Huntington Beach, CA Fierce Digital Pharma Engage June 14-15, 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 Biotech Cell & Gene Therapy Forum October 19, 2022 | Virtual Event Fierce Pharma Marketing Awards October 19, 2022 | Philadelphia, PA 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 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 | 