| | 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. |
Sanofi, scarred by Roche scrap, hits goal in once-weekly hemophilia A trial and plots race to regulators J&J's long-acting injectable push barrels forward as it adds 2nd large molecule to Midatech pact BeiGene's hematology CMO jumps to steer pipeline changes at Prelude Twist's antibodies to wind up with Kriya's AAV gene therapies in new pact Enough with data collection, FDA needs diversity policies to boost representation in clinical trials: report India's hesitance to condemn Russia puts the country's pharma industry in compromising position Inspirata's pathology software nets FDA clearance for use with multiple slide scanners AbbVie, Alvotech settle Humira patent and trade secrets disputes, teeing up another biosim rollout next year Saluda's spinal cord stimulation system scores FDA approval for chronic pain That key Gilead breast cancer readout? Try 2024, and don't get your hopes up: analyst Congress to grant 5-month extension for pandemic telehealth flexibilities with omnibus bill Featured Story | By Nick Paul Taylor Sanofi is fighting back against Roche in the hemophilia A market. Having seen Hemlibra eat into sales of its long-acting factor VIII (FVIII) therapy, Sanofi has now posted positive phase 3 data on its once-weekly successor, positioning the French pharma and partner Sobi to start filing for approvals. read more |
| |
|---|
|
Top Stories By Nick Paul Taylor Johnson & Johnson is tightening its ties to Midatech, adding a second experimental large molecule to a collaboration that is using technology from inkjet printers to create long-acting injectable medicines. read more By Kyle LaHucik Prelude Therapeutics will focus its clinical-stage development efforts on two key phase 1 drugs. The biotech also poached ex-BeiGene hematology chief medical officer Jane Huang, M.D. read more By Kyle LaHucik Twist Bioscience will discover new antibodies that could eventually be delivered using Kriya Therapeutics' gene therapies to treat various cancers. read more By Max Bayer Life science consulting firm Trinity Life Sciences is calling on the FDA to implement minimum representation requirements for clinical trials to help boost diversity in studies. read more By Kevin Dunleavy Russia’s invasion of Ukraine has put India in a compromising position. As India is under increasing pressure from the west to condemn Russia, the country’s booming pharma industry also has come under scrutiny. Many pharma companies in India do extensive business with both Russia and Ukraine. read more By Conor Hale According to Inspirata, a more open, scanner-agnostic platform can permit pathology laboratories to select the best hardware that suits their needs. read more By Fraiser Kansteiner Under the deal, Alvotech could launch its Humira copycat as early as next summer. AbbVie will grant Alvotech a license to its Humira-related patents in the U.S., which take effect on July 1, 2023. Alvotech is on deck to pay royalties to AbbVie and it “acknowledges the validity and enforceability of the licensed patents,” AbbVie said in a release. read more By Andrea Park The latest candidate in the search for opioid-free pain relief comes from Saluda Medical and uses spinal cord stimulation rather than prescription medication to lessen the effects of intractable pain in the trunk and limbs. read more By Angus Liu Gilead Sciences just tipped off what sounded like mixed results for Trodelvy, the cornerstone of the Big Biotech’s oncology ambitions. Now, one analyst suggests investors continue to keep their expectations low for the key expansion opportunity—at least for now. read more By Rebecca Torrence The House presented a sweeping funding package early Wednesday morning that includes a five-month extension for telehealth flexibilities introduced during the pandemic. 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 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 | 