UPDATED: Pfizer, BioNTech seek emergency COVID-19 vaccine nod Novartis licenses phase 3 COVID-19 cell therapy from Mesoblast Ahead of possible Japanese approval, Metavant backs away from Poxel-partnered imeglimin Sponsored: It’s never too early to think about automation for your bioprocessing facility Lilly, Precision Biosciences team up on Duchenne gene therapy in $135M deal ADC gets priority review for anti-CD19 blood cancer drug Siemens Healthineers to offer antibody test for quantifying COVID-19 immunity Adagio's COVID-19 antibody protects mice and zaps related viruses in lab tests FiercePharmaAsia—Samsung's Lilly COVID pact, AstraZeneca JV end; ex-AZ exec's $200M startup Chutes & Ladders—Longtime AbbVie commercial chief Alban announces retirement Featured Story | By Amirah Al Idrus Pfizer and BioNTech are off to the races. With early phase 3 data pointing to 95% efficacy, the duo will file for emergency use authorization for its COVID-19 vaccine on Friday, BioNTech CEO Uğur Şahin, M.D., told CNN Wednesday. That could mean an emergency green light in time for the new year. read more |
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Top Stories By Nick Paul Taylor Novartis has secured a global license to Mesoblast’s cell therapy remestemcel-L in the treatment of COVID-19. The deal lands Mesoblast $50 million upfront and the support of a partner that could help address critical quality attribute concerns raised by the FDA. read more By Ben Adams Metavant is giving up on experimental diabetes therapy imeglimin and is looking to sell the unwanted med on. read more Sponsored By Cytiva The right automation design can meet your initial needs and be expanded for your future growth. Planning for success takes a little effort upfront but can pay huge dividends in the long run. read more By Amirah Al Idrus Once wary of inking deals around gene therapy, Eli Lilly is jumping headfirst into developing treatments that edit genes within the body. It’s teaming up with cell and gene therapy biotech Precision Biosciences to develop in vivo gene therapies for three gene targets, starting with Duchenne muscular dystrophy. read more By Nick Paul Taylor The FDA has granted a priority review to ADC Therapeutics’ antibody-drug conjugate Lonca in the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). ADC is set to learn whether it has won approval for a drug it sees as the future standard of care in third-line DLBCL in May. read more By Conor Hale Siemens Healthineers has put forward a quantitative test that measures the antibodies capable of neutralizing the coronavirus, ultimately slowing the infection. read more By Arlene Weintraub A precursor of Adagio Therapeutics' lead drug candidate protected mice from COVID-19, and in lab tests, it neutralized two related coronaviruses known to be circulating in bats. The company aims to show that the antibody could be used to combat future viruses that cross over from animals to people. read more By Angus Liu Samsung Biologics accelerates COVID-19 antibody manufacturing for Eli Lilly, just as the South Korean CDMO unveils a plan to dissolve an AstraZeneca biosimilar joint venture. AstraZeneca's former China R&D head has launched a startup with $200 million in funding. And more. read more By Kyle Blankenship AbbVie commercial head Alban set to step down; Gossamer taps Haisnan as CEO; Flagship brings on Rossetti as CMO. read more Resources Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored By: Veeva New industry-wide research reveals that the quality and breadth of HCP data is imperative as commercial teams adjust to remote engagement and execute a tailored approach. Read the full report to see all findings and benchmark your organization’s progress. 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Sponsored by: Rousselot This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments. Sponsored By: Lonza Liquid-filled hard capsule formulations offer unique options for the manufacture and dosing of highly potent actives. Sponsored By: Thermo Fisher Scientific One of the best ways to stay on-schedule is to start with a solid understanding of the most common API challenges. Awareness will help you choose a development partner with the ability to solve issues before they affect your timeline. Sponsored By: Clinical Ink This white paper covers a Phase III case study; BYOD advantages and misconceptions; and regulatory, copyright, and equivalency considerations. Sponsored By: Thermo Fisher Scientific Anticipate early development challenges to avoid rework and costs. Sponsored By: Cytiva Accelerating the production of viral-vector based therapy requires both understanding of strategies to address viral vector manufacturing and how to select the most cost-effective solution for your therapeutic. Read more in this article. Sponsored by: LexisNexis Risk Solutions Get insights into healthcare decision-makers networks. Sponsored by: Aldevron Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience. Sponsored By: Outer Edge Technology A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely. 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 Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success. Sponsored by: Catalent In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site. Sponsored by: Formedix Learn how to save time and reduce costs and complexity by streamlining the clinical trial process. Sponsored by: Outer Edge Technology Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now! 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 Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. 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 about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. 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. 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