As J&J eyes approval for its one-shot COVID-19 vax, it sends off phase 3 data for a swift WHO listing Big Pharma-backed antibiotic R&D fund lands another $140M, bringing total haul above $1B No SPAC slack as more shell companies targeting biotech buys hit Wall Street In conversation with John Leonard, CEO of Intellia Immunocore gets FDA breakthrough nod for eye melanoma drug ahead of planned Q3 filing FDA approves patient-specific, 3D-printed ankle bone implant Precision's one-time gene editing treatment lowers cholesterol in monkeys for 3 years Fierce Pharma Asia—Takeda's CMV drug win; Merck and Eisai's kidney cancer showing; Botox rival Jeuveau's settlement Chutes & Ladders—Zimmer Biomet calls on Medtronic vet Jamali to lead spinout Featured Story | By Ben Adams Johnson & Johnson has sent off its phase 3 data package to the World Health Organization for its one-and-done COVID-19 vaccine shot just a few weeks after showing off its efficacy. read more |
| |
|---|
|
Top Stories By Nick Paul Taylor The AMR Action Fund has raised another $140 million to support antibiotic development. The cash adds to the almost $1 billion committed by around 20 biopharma companies, giving the fund the means to work toward its goal of helping up to four antibiotics to market by the end of the decade. read more By Amirah Al Idrus The SPAC attack is not abating. This week alone, Foresite Capital’s second special purpose acquisition company raised $175 million in its IPO, while two other biotech SPACs—European Biotech Acquisition and Frontier Acquisition—filed to raise a total of $300 million in their Nasdaq debuts. read more By Amirah Al Idrus Intellia CEO John Leonard discusses his journey from Abbott and AbbVie to a gene editing biotech and where he sees the field going in the near future. read more By Nick Paul Taylor Immunocore has received FDA breakthrough-therapy designation for tebentafusp in unresectable or metastatic uveal melanoma. The British biotech snagged the status ahead of a planned filing for FDA approval in the third quarter. read more By Conor Hale The FDA has approved its first 3D-printed metal implant designed to replace the main bone in the ankle joint connecting the leg to the foot. read more By Arlene Weintraub Precision BioSciences' gene editing technique produced a stable lowering of PCSK9 protein and LDL cholesterol in nonhuman primates for three years, according to a study led by University of Pennsylvania researchers. The company is developing the one-time treatment as an alternative to drug treatments for familial hypercholesterolemia. read more By Angus Liu Takeda shared details on its maribavir trial win in refractory cytomegalovirus infection. Merck and Eisai's Keytruda-Lenvima combo looks to have the best front-line kidney cancer data, at least in one analyst's eyes. The botulinum toxin legal fight has ended with a settlement. And more. read more By Fraiser Kansteiner Zimmer Biomet tagged a new chief executive for its upcoming spinout. Moncef Slaoui is joining Centessa Pharmaceuticals as chief scientific officer. Affinia bagged two additions to its R&D team. read more Enrollment Showcase | Sponsored by: University of Florida College of Pharmacy Learn about the Top 5-Ranked UF College of Pharmacy’s online graduate programs in pharmaceutical outcomes & policy. Select from five specializations, including the new pharmaceutical value assessment & communication option. Over half of graduates progress to a new role within one year. Register now. |
| |
|---|
|
Resources Sponsored By: Cytiva There has been much progress in moving potentially life-saving gene therapies to the market, but they are extremely costly to produce. Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. Sponsored By: Medidata, a Dassault Systèmes company 8 parameters to optimize your “Path to Virtualization” across site- and patient-centric capabilities in this Sponsor Edition eBook. Sponsored By: LabVantage Solutions Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. Sponsored By: Acorn AI, a Medidata Company Acorn AI has developed a flexible and scalable Commercial Data Model that provides pharmaceutical companies with the data-driven insights required to respond to the industry’s ever-changing landscape. Download the whitepaper to learn how Acorn AI’s intuitive data model enables launch success and more. Sponsored By: Outer Edge Technology Criminals Are Actively Exploiting The CV-19 Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become A Cybercrime Statistic -- Make These Cost-Effective IT Changes Now! Sponsored by: Cytiva It’s an exciting time to pioneer what could be a life-changing medicine. Clear the path to the clinic with pro tips and expert insights from industry leaders. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Premier Research Browse the latest learnings and insights from our clinical development professionals. 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. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Learn what it takes to get a drug developed and approved February 23-24, 2021 | 12 p.m. EST / 9 a.m. PST For non-scientists. Learn the science driving biopharma. February 25-26, 2021 | 9 a.m. EST / 6 a.m. PST Learn what it takes to get a drug developed and approved March 9-10, 2021 | 9 a.m. EST / 6 a.m. PST BD&L Summit for Life Sciences March 9–10, 2021 | Virtual Event Learn the science driving biopharma. Specific for the non-scientist. March 18-19, 2021 | 12 p.m. EST / 9 a.m. PST Learn what it takes to get a drug developed and approved April 13-14, 2021 | 12 p.m. EST / 9 a.m. PST
Learn the science driving biopharma. Specific for the non-scientist. April 20-21, 2021 | 12 p.m. EST / 9:00 a.m. PST Learn what it takes to get a drug developed and approved April 22-23, 2021 | 9:00 a.m. EST / 6 a.m. PST Learn the science driving biopharma. Specific for the non-scientist. May 6-7, 2021 | 9:00 a.m. EST / 6 a.m. PST Vaccines, cell and gene therapy, therapeutic antibodies and RNA drugs May 20-21, 2021 | 12 p.m. EST / 9 a.m. PST Learn what it takes to get a drug developed and approved June 2-3, 2021 | 9 a.m EST / 6 a.m.PST Vaccines, cell and gene therapy, antibodies, and RNA-based drugs June 10-11, 2021 | 9 a.m. EST / 6 a.m. PST Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. | 