Inovio is going after the 'impossible tumor' left in the dust of new cancer meds Galapagos cuts pipeline, targets €150M in savings after setbacks Talaris pulls off $150M IPO to tackle organ rejection, autoimmune disorders Sponsored: Mitotech brings novel approach to treating eye disorders Gene therapy biotech Gyroscope finds unnavigable seas on IPO market Sponsored: Risk Mitigation in Direct-to-Patient Clinical Trials Adcomm experts split on whether to approve ChemoCentryx's avacopan CRISPR therapeutics, Nkarta pen new cutting-edge cancer tech research pact Science 37 taps a SPAC to go public, with siteless trial specialist valued at a cool $1B Chutes & Ladders—Former Merck R&D chief Perlmutter takes reins at Eikon, applying Nobel-winning tech to drug discovery Fierce Pharma Asia—BeiGene touts Q1, PARP inhibitor nod; Astellas culls muscle disease pact Featured Story | By Annalee Armstrong Inovio is hoping to change outcomes for patients with glioblastoma using a new DNA medicine combination of INO-5401, INO-9012 and Regeneron-Sanofi’s PD-1 inhibitor Libtayo. read more |
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Top Stories By Nick Paul Taylor Galapagos is dumping pipeline programs and targeting €150 million ($181 million) in savings as it seeks to bounce back from a bruising nine months. The Belgian biotech is pulling out of metabolic diseases and osteoarthritis R&D to focus on its core therapeutic areas. read more By Amirah Al Idrus Another day, another biotech IPO. This time, its cell therapy player Talaris Therapeutics, which raised $150 million in a Nasdaq debut to fuel its lead asset, an off-the-shelf cell therapy it hopes will transform the standard of care in organ transplant, as well as some disorders of the blood, immune system and metabolism. read more Sponsored By: Mitotech S.A. Mitotech focuses its clinical development efforts on ophthalmology, hoping to deliver its mitochondria targeted therapies to patients suffering from age-related as well as rare genetic eye diseases. read more By Annalee Armstrong Gyroscope Therapeutics has taken a spin around the IPO market, only to find there is no path forward to reach the NASDAQ at this time. read more Sponsored By: Catalent Clinical Supply The COVID-19 pandemic has made society very aware of the need to be flexible in the approach to daily life. Use and acceptance of DTP has grown due to the pandemic, and sponsors quickly began to rethink their Direct-to-Patient (DTP) approach as patients increasingly requested that their study drugs be shipped to their homes. read more By Nick Paul Taylor The question of whether to approve ChemoCentryx’s vasculitis drug avacopan has divided a panel of experts convened by the FDA. Ten experts voted that the benefit-risk profile supports approval, while the other eight voted against authorizing the drug on the strength of the available evidence. read more By Ben Adams Two next-gen biotech pioneers in natural killer cell therapies and gene editing are coming together to battle cancer. read more By Ben Adams Science 37 had a good year in 2020, using its hybrid trial approach to help companies navigate their way through a pandemic; it’s now hoping to top 2020 with a major public listing in 2021. read more By Fraiser Kansteiner Former Merck R&D lead Perlmutter has landed at Eikon Therapeutics, which is using Nobel-winning tech to overhaul drug discovery. Jaguar Gene Therapy has enlisted a new chief medical officer. And a second Novartis oncology R&D exec has jumped ship for the world of biotech. read more By Angus Liu BeiGene more than doubled product sales in the first quarter and won a conditional China nod for self-developed PARP inhibitor pamiparib. Astellas ended a licensing deal with Cytokinetics in muscle disease. Mundipharma is seeking bidders for its China business. And more. read more Resources 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: ClearView Healthcare Partners As clinical treatment options become more patient-centric, digital therapeutics provide forward-looking biopharma players the opportunity to augment the value of their offerings to stakeholders. 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: Datacubed Health The average clinical trial spends $40,000 per patient. Yet despite these high costs, most trials struggle to retain patients. Sponsored By: AmerisourceBergen Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success. 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: TAC Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously. 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: Culture Biosciences Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly. Sponsored By: BC Platforms Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. 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: 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. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. TMF Virtual Summit May 18-20, 2021 | Virtual Event Vaccines, cell and gene therapy, therapeutic antibodies and RNA drugs May 20-21, 2021 | 12 p.m. EST / 9 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 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 | 