The mRNA era has arrived thanks to COVID-19. What's next in the pipeline? After cutting dose because of deaths, Astellas pauses gene therapy trial as new liver issue arises Mesoblast's Novartis-partnered COVID-19 cell therapy hits a wall as FDA requests new trial Sponsored: Accelerating Outcomes with a Pancreatic Cancer Adaptive Platform through Collaboration and IRT Expertise Parallel Bio is putting the immune system in a dish to improve drug discovery HebeCell lands $53M, Chinese collaborator to make a splash in busy CAR-NK space Brickell Biotech nabs autoimmune, inflammatory program from Voronoi for up to $320M in biobucks Asher Bio snags $108M series B for immunotherapy programs, push into the clinic Thermo Fisher, AstraZeneca team up on multiyear companion diagnostic project for drugmaker's precision medicine pipeline Johnson & Johnson scores an FDA first with nod for twice-yearly schizophrenia drug Invega Hafyera Vanderbilt scientists offer new clues for developing cancer drugs against mutant tumor suppressor protein Massive Bio teams up with veterans nonprofit to increase prostate cancer research, trial enrollment Elizabeth Holmes' fraud trial begins: A timeline of blood-testing startup Theranos' downfall Fitch: Nonprofit children's hospitals poised to ride out COVID-19's financial pressures Featured Story | By Annalee Armstrong COVID-19 wasn’t even in the picture when mRNA was developed, but with the regulatory runway cleared, biotechs that have been working on the tech for years are ready for liftoff. Yes, Moderna and BioNTech are the rock stars in the business—launched to household name status with the COVID-19 vaccines at the end of 2020. But there's more to the pipeline than just these headliners. read more |
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Top Stories By Nick Paul Taylor Astellas’ $3 billion bet on Audentes Therapeutics has hit yet another setback. Months after getting a clinical hold lifted, Astellas has voluntarily paused a gene therapy clinical trial after a patient suffered liver problems at the lower, supposedly safer dose. read more By Kyle LaHucik Mesoblast has been put on blast by the FDA yet again after the agency requested another trial for its failed, Novartis-backed COVID-19 respiratory treatment. The Australian cell therapy biotech will have to conduct another study of remestemcel-L to have a shot at an emergency use authorization from the FDA. read more Sponsored by: Almac Group When your goal is to identify effective and ineffective treatments more quickly than traditional trials through a Complex Innovative Design, the right IRT system is crucial. read more By Amirah Al Idrus It’s no secret that drug development is a tough business, with the majority of efforts never reaching approval. Parallel Bio aims to help with organoids: 3D mini-organs that look and work just like the organs found in people. It's starting out by modeling the human immune system in a dish. read more By Nick Paul Taylor More money is flowing into the natural killer (NK) cell therapy space. HebeCell is the latest biotech to grow its bank balance, raising $53 million in a round led by a Chinese drug developer to advance its off-the-shelf CAR-NK prospects. read more By Kyle LaHucik Dermatology and autoimmune-focused Brickell Biotech will pay $5 million upfront and up to $320 million in biobucks for the exclusive worldwide rights to Voronoi's DYRK1A inhibitor platform. The deal includes an oral treatment for autoimmune and inflammatory diseases that is slated to enter the clinic next year. read more By Kyle LaHucik Asher Bio spent 2020 under wraps working on an interluekin-2 immunotherapy and unveiled itself with $55 million in March. Now, the biotech is back with a whopping $108 million series B, the exact same size as Synthekine, another IL-2 therapeutics startup, raised in June. read more By Conor Hale Currently, more than 90% of AstraZeneca’s clinical drug candidates are based on a targeted approach, spanning its work in cancer and cardiovascular disease as well as kidney, metabolic and respiratory conditions. read more By Noah Higgins-Dunn Johnson & Johnson's Janssen scored an FDA nod on Wednesday for a 6-month formulation of its schizophrenia treatment paliperidone palmitate, making it the first and only twice-yearly injectable for the condition. read more By Angus Liu Scientists at Vanderbilt University Medical Center have uncovered a new mechanism underlying how mutated p53 gains certain cancer-promoting functions. The team suggests targeting mutant p53 gain of function must consider the role of chromosomal alterations. read more By Kyle LaHucik Cancer trial matchmaker Massive Bio is teaming up with two organizations to boost clinical studies and research participation for prostate cancer. Massive Bio, Veterans Prostate Cancer Awareness (VPCa) and Self-Care Catalysts are linking arms to ramp up participation in real-world evidence research and clinical trials. read more By Andrea Park Holmes faces nine counts of wire fraud and two counts of conspiracy to commit wire fraud. The charges carry a maximum sentence of 20 years in prison and fines of $250,000 plus restitution for each of the 11 counts. read more By Dave Muoio Standalone nonprofit children's hospitals' substantial liquidity and other strengths place the sector in an enviable position compared to their adult counterparts, according to a new Fitch Ratings report. read more Resources Sponsored by: XIFIN inc. Download the Value of Precision Medicine Informatics (PMI) Initiatives report to learn about the technology, data types, and the value derived from more than 100 PMI initiatives. Sponsored by: EVERSANA Today’s economics do not allow manufactures to keep making decisions in an antiquated way. They need to challenge tradition & deliver faster, cheaper, successful launches. Learn how. Sponsored by: Thermo Fisher Scientific Thermo Fisher Scientific introduces a new NK cell culture medium designed to support feeder-free, high-yield growth for cell therapy applications. Sponsored by: Blue Matter This white paper provides a concise overview of the trends currently shaping the market access environment in Europe, as well as the implications for biopharma companies. Sponsored by: Cascade Chemistry by Aceto Read four customer success stories and four success factors that helped move pharmaceutical customers of Cascade Chemistry by Aceto quickly and effectively to clinic with trial-ready APIs. Sponsored by: ConnectiveRx Topple barriers to getting patients started on therapy. Guide them with mobile. Sponsored By: LabVantage Solutions, Inc. 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: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. 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. DPHARM: Disruptive Innovations in Clinical Trials September 28-29, 2021 | Boston, MA w/Virtual Option The MedTech Conference 2021 September 27 - 30, 2021 Let A Digital Sherpa Uncomplicate The Path for Patients ODIN – Data Transfer Made Easy Virtual U.S. Healthcare Compliance Certificate Program Announcing the 9th International mRNA Health Conference November 09-10, 2021 | Mercure MOA Berlin & Online Medical Affairs Strategic Summit (MASS) September 13-15, 2021 | New Brunswick, NJ Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA Diversity, Equity & Inclusion Week November 9–11, 2021 | Virtual Event Fierce Biotech Forum Boston, MA | November 16-17, 2021 | 