|  | 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 Venatorx Pharmaceuticals’ mission to start restocking the thinning cupboard of antibiotics has advanced. With its experimental candidate hitting the primary endpoint in phase 3, Venatorx is preparing to file for FDA approval in patients with urinary tract infections by the end of the year. read more |
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Top Stories By Annalee Armstrong The second arm of Moderna’s omicron booster trial has gotten underway with a first patient dosed in the phase 2 study testing a variant-specific vaccine against COVID-19. read more By Kyle LaHucik Intellia Therapeutics' first ex vivo cell therapy, which uses the famed CRISPR-Cas9 gene editing technology, received orphan drug designation from the FDA, unlocking tax credits and potentially seven years of exclusivity should the treatment snag the agency's approval. read more By Nick Paul Taylor Morningside Ventures has rolled up two of its own biotechs to spawn a new startup, combining an Irish microbiome business and a U.S. neutrophil biology specialist to create inflammatory disease player Adiso Therapeutics. read more By Max Bayer The FDA has lifted the clinical hold on Selecta Bioscience’s gene therapy to treat methylmalonic acidemia, a rare disease in children that affects metabolism. The company is now back in the saddle as it preps for a phase 1 trial. read more By Kyle LaHucik Scenic Biotech has scored a $31 million series A financing round and plans to take three drugs into the clinic with a focus on rare genetic diseases. The biotech already has a $375 million deal. read more By Angus Liu Moderna’s business took flight in 2021 thanks to authorizations for its COVID-19 vaccine, and so did its CEO’s pay. CEO Stephane Bancel could be up for bigger pay checks in the future as Moderna has changed its compensation peer group with additions of several Big Pharma companies. read more By Andrea Park About 100 workers are being laid off as Adaptive reorganizes its business, homing in on just two core areas that can be served by its immune system-focused genetic sequencing technology. read more By Fraiser Kansteiner It turns out Novartis has a taste for the contract manufacturing business. After inking a slate of pandemic production pacts last year, the Swiss pharma is back for another—and this time, it’s looking beyond COVID-19. read more By Fraiser Kansteiner The biotech has closed a deal for 27 acres of undeveloped land near its existing facility in Oceanside, California, which it will use to stand up additional manufacturing in the area. The company’s current Oceanside outfit supports clinical manufacturing and process development for Gilead and Kite Pharma, the exec said. read more By Heather Landi MIAMI—International Women's Day was Tuesday and at the ViVE 2022 conference this week, the impact of female founders and executives touched almost every conversation about the future of healthcare and tech. read more By Angus Liu The PD-L1 protein is a popular target for cancer immunotherapies, as tumors use it like a “brake” to dampen immune responses against them. But scientists from Germany and Ireland have evidence that the protein may also act as a protector against obesity. 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: 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 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 New Product Planning Summit September 20-22, 2022 | Boston, MA 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 JPM Week 2023 January 2023 | San Francisco, CA & Virtual | 
