Gilead's Kite makes off-the-shelf play with Shoreline Biosciences CAR-NK deal worth as much as $2.3B FDA rejects Orphazyme's rare disease drug, continuing wild ride for Danish meme stock Athira CEO placed on temporary leave following allegations she altered doctoral research images Sponsored: Inside Track: Behind the Scenes of a Major Biotech SPAC Bristol Myers pays $650M for rights to Eisai's phase 1 ADC U.S. injects $3B-plus into COVID-19 research to develop antiviral pill within a year Backed by Boehringer Ingelheim fund, Nuevocor snags $24M to tackle diseased hearts with gene therapy Johnson & Johnson among companies excluding Colorado residents from remote job openings after new state law Sen. Manchin calls for Woodcock's removal as FDA fallout from Biogen Alzheimer's approval heats up New COVID-19 approach exploits protein response in human cells to combat virus Experts: ACA likely safe from large-scale legal attacks after latest Supreme Court win Fierce Pharma Asia—Daiichi Sankyo, AZ's Enhertu trial; Celltrion's COVID antibody win; Zai Lab's MacroGenics deal Chutes & Ladders—Ex-FDA chief Hahn joins Moderna backer Featured Story | By Amirah Al Idrus Gilead’s Kite unit made its name developing autologous CAR-T treatments made from a patient’s own cells. Now, the subsidiary is making another big play in off-the-shelf treatments that can be developed more quickly in a deal with Shoreline Biosciences that could exceed $2.3 billion. The partners will initially work on CAR targets for natural killer cell therapies for blood cancers. read more |
| |
|---|
|
Top Stories By Nick Paul Taylor The FDA has rejected Orphazyme’s Niemann-Pick disease type C drug candidate arimoclomol. Orphazyme said the agency wants additional data on the benefits and risks of the heat shock protein amplifier, leading it to cut costs as it figures out its next steps. read more By Kyle LaHucik Athira Pharma's CEO and President Leen Kawas, Ph.D., has been placed on leave amid reports that she altered images in academic research conducted at Washington State University. The news, which dropped after market Thursday, sunk the company's shares 44% to $10.79 apiece as of 10:50 a.m. ET. read more Sponsored by: RBC Capital Markets Take a closer look at the SPAC phenomenon with Dr. David Hung, Founder and CEO of Nuvation Bio and Michelle Doig, Omega Funds Partner and President of its Omega Alpha SPAC. read more By Nick Paul Taylor Bristol Myers Squibb is paying $650 million to secure rights to Eisai’s folate receptor alpha-targeted antibody-drug conjugate MORAb-202. The deal, which is worth up to $2.5 billion in milestones, sets Bristol Myers up to work with Eisai to get the drug into a registrational study next year. read more By Kyle LaHucik The U.S. government has given nearly $20 billion to COVID-19 vaccines. Now, the focus shifts to oral antiviral pills to help prevent serious illness and hospitalizations of COVID-19 and other potential pandemic viruses. read more By Annalee Armstrong Nuevocor wants to restore cardiac function to diseased hearts through gene therapy and now has the backing of Boehringer Ingelheim through a $24 million series A. The Singapore-based startup's lead candidate is an adeno-associated virus-based gene therapy for patients with dilated cardiomyopathy caused by mutations that aren't eligible for conventional gene therapies. read more By Kevin Dunleavy A new Colorado law, designed to narrow the gender pay gap, requires companies to list salary range on job postings. But Johnson & Johnson and other large companies have responded by excluding candidates from Colorado. read more By Noah Higgins-Dunn Sen. Joe Manchin, a moderate Democrat from West Virginia, told President Joe Biden in a letter that interim FDA Commissioner Janet Woodcock is "not the right person to lead the FDA" following the agency's controversial decision to approve Biogen's Alzheimer's drug Aduhelm. read more By Angus Liu The development of COVID-19 drugs has mostly focused on directly targeting the SARS-CoV-2 coronavirus. But scientists at the University of Cambridge are taking a different approach to treating the disease by looking at an infection response pathway in human cells. read more By Robert King The Supreme Court's latest decision to preserve the ACA likely foretells the end of large-scale legal attacks on the healthcare law, but lawsuits challenging other parts will continue. read more By Angus Liu AstraZeneca and Daiichi Sankyo launched a phase 3 trial for Enhertu in front-line breast cancer. Celltrion's coronavirus antibody helped keep COVID patients outside the hospital. Zai Lab licensed four cancer bispecifics from old partner MacroGenics. And more. read more By Conor Hale Ex-FDA chief Hahn joins Moderna backer Flagship Pioneering; One Drop poaches Sanofi's head of diabetes innovation; J&J's Burton grabs hold of Moderna rocket ship as chief medical officer. read more | | LabConnect is the leader in innovative central laboratory services for cell and gene therapies. Far more than typical central laboratory support, only LabConnect offers comprehensive, specialized services customizable to meet the unique needs of your complex clinical trials. Connect with us today. |
Resources Sponsored by: Thermo Fisher Scientific Learn how the diagnostics industry is being fundamentally transformed with point-of-care molecular testing. Sponsored by: Clinical Ink For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink. Sponsored by SDG Group Discover how Ashfield Healthcare uses the power of data and analytics to enable pre-call planning, inform sales rep actions and drive higher market share for its target pharmaceutical products. Sponsored by: BBK Worldwide Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them. Sponsored by: Thermo Fisher Scientific Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process. Sponsored By: Veeva Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. Sponsored By: WCG Trifecta The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Next Gen: What’s beyond the leading edge of biotech and pharma? June 22-23, 2021 | Virtual Event Biopharma Supply Chain June 29-30, 2021 | Virtual Event | 