| Amgen reunites with longtime partner Kyowa Kirin in $400M dermatitis deal Sanofi's venglustat fails another trial, ending pursuit of kidney disease ASCO: J&J's anti-BCMA CAR-T pads its case ahead of speedy review and Bristol Myers showdown Novartis pens buyout pact with fellow Swiss native Cellerys, eyeing midstage MS hopeful Gene editing biotech Verve indicates a swift swerve onto Wall Street, asking for $100M IPO Liminal stops plan to advance fibrosis drug after seeing PK data Surprise! Amgen's hot KRAS drug seals early FDA approval, winning a shot against 'undruggable' cancer Featured Story | By Amirah Al Idrus Amgen and Kyowa Kirin capped off a decadeslong partnership in 2017, when the Big Biotech handed over $780 million to subsume their joint venture. Now, the duo is back at it in a new deal around a phase-3-ready asset worth $400 million upfront. read more |
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Top Stories By Nick Paul Taylor Sanofi has stopped a pivotal clinical trial of venglustat in autosomal dominant polycystic kidney disease (ADPKD) for futility. The setback comes months after venglustat failed a phase 2 Parkinson’s disease trial but still leaves Sanofi with shots on goal. read more By Amirah Al Idrus Just days after moving their multiple myeloma CAR-T into the FDA’s fast lane, Johnson & Johnson and Legend Biotech are unveiling new data to pad its case. The treatment shrank tumors in 98% of very sick patients with multiple myeloma and eliminated them in 80% of patients. read more By Ben Adams Novartis has signed up to a collab pact and possible buyout deal, should all go to plan, for quiet, little-known Swiss biotech Cellerys. read more By Ben Adams Verve Therapeutics, on the march toward the clinic with a next-gen heart drug, wants a piece of the ever-growing biotech IPO pie. read more By Nick Paul Taylor Liminal BioSciences has stopped plans to advance fezagepras in two indications after getting a look at interim pharmacokinetic results. The biotech had planned to move into a phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a phase 1b/2a study in hypertriglyceridemia next year. read more By Noah Higgins-Dunn What was once considered the "Achilles heel" of lung cancer tumors, as Amgen puts it, now has an FDA-approved treatment in the company's KRAS inhibitor, Lumakras. 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: Veeva One top 10 pharma outlines three key steps to launching a modular content strategy to generate localized content faster. Sponsored By: Blue Matter This 77-page e-book explores 7 keys to success that any biopharma company needs to keep in mind as it enters Europe. 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: August Bioservices How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond? 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. Vaccines, cell and gene therapy, antibodies, and RNA-based drugs June 10-11, 2021 | 9 a.m. EST / 6 a.m. PST 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 | 