Featured Story | By Kyle LaHucik FDA's Oncologic Drugs Advisory Committee voted 13-4 to defer a regulatory decision on Incyte's PD-1, retifanlimab, for anal cancer, citing the need for further data from a confirmatory trial currently underway. read more |
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Top Stories By Kyle LaHucik 4D Molecular Therapeutics is losing a collaboration with Roche but regaining full rights to its phase 1 gene therapy candidate for patients with a blinding disease, for which the company expects to initiate a new clinical trial after speaking with the FDA. read more By Amirah Al Idrus In less than a year, Graphite Bio has sped from series A to Wall Street welcome as it rustles up capital to fund its gene-editing treatments for sickle cell disease, an immune system disorder and Gaucher disease. After filing to raise up to $100 million in its IPO, the company eventually snagged $238 million. read more Sponsored by: Oracle Health Sciences In a recent virtual roundtable discussion, industry experts shared their insight on the challenges faced in implementing decentralized trials and how to address them. read more By Nick Paul Taylor Oxurion is stopping investing in its oncology spinout and narrowing its focus to its two clinical assets. The restructuring will affect “a number” of people who work at Oxurion and put the biotech all in on two potential treatments for retinal vascular diseases. read more Sponsored by Alexion By refocusing company culture around the connection between employees and the rare disease community, Alexion has increased employee engagement and charted a new path for business success. Read more. read more By Kyle LaHucik Fulcrum's losmapimod once again did not perform better than placebo in a phase 2b trial in patients with facioscapulohumeral muscular dystrophy, but the biotech is moving forward in the second half of this year with regulatory discussions based on "strong support" for other endpoints. read more By Nick Paul Taylor Acumen Pharmaceuticals has set the terms for its IPO, teeing it up to raise around $125 million to take an antibody against amyloid-beta oligomers to the end of phase 2 in Alzheimer’s disease. read more By Annalee Armstrong It’s not looking good for Corbus Pharmaceuticals and the autoimmune disease treatment lenabasum. Corbus disclosed another in a long string of failures for the synthetic oral cannabinoid type 2 agonist, this time in a late-stage trial in the rare autoimmune disease dermatomyositis. read more By Angus Liu By performing RNA sequencing on tissue samples, scientists at Mount Sinai have pinpointed the MAGEA3 gene as a driver of progression in liver cancer. GlaxoSmithKline had tried and failed to target the gene in other cancers, but the additional insight could boost future drug discovery, the Icahn team said. read more By Ben Adams Many cancer patients unlikely to survive the disease are often neglected from oncology tests trialing new drugs; the FDA has posted new guidance hoping to boost inclusion of this often omitted group. read more By Fraiser Kansteiner Merck & Co. will slot 23-year veteran Michael Klobuchar into the newly minted role of executive vice president and chief strategy officer July 5—just a few short days after Kenneth Frazier is due to retire as CEO. read more By Robert King A state judge has blocked Missouri's Medicaid expansion, deciding the Aug. 2020 ballot initiative that approved the expansion did not include a directive for funding. read more By Angus Liu Bristol Myers Squibb teamed with Eisai on an antibody-drug conjugate in a potentially $3.1 billion deal. AstraZeneca’s Pulmicort and Bayer’s Xarelto lost important government tenders in China’s latest price cuts on generics. Hutchmed’s AZ-partnered MET inhibitor won its first regulatory go-ahead. And more. read more By Fraiser Kansteiner A longtime Lilly staffer has returned to TRexBio as the company's new CEO. Vedere Bio II snagged a new CSO from rival biotech BioMarin. And Galapagos' CSO is stepping down this year after the company faced a series of R&D setbacks. read more Resources 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: 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: 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. | 
