FDA says Aduhelm approval fit accelerated pathway to a T, as families begged for a shot to halt Alzheimer's decline Eli Lilly's $1B buyout bet for Protomer brings the 'next frontier' in smart insulin tech under the Big Pharma's wing Brii's COVID-19 antibody cocktail remains active against variants, expects Q4 data readout Sponsored: Evaluating current manufacturing platforms for recombinant AAV production Kriya grabs $100M to launch gene therapies into the mainstream, starting with diabetes ACB hires Liu from Eureka Therapeutics to lead push into clinic Ribon, backed by biopharma majors, raises $65M to take PARP7 inhibitor deeper into the clinic Controlling Alzheimer's by targeting immune signaling between brain cells Congress has a 'time-limited window' to shake up drug pricing, employers, health groups say Infectious disease organizations call for mandatory COVID-19 vaccination among all healthcare personnel Featured Story | By Annalee Armstrong The FDA is standing by its approval of Biogen’s Aduhelm. In a new scientific journal article, officials acknowledged the complexity of the data and defended the agency’s use of the accelerated approval pathway. The FDA faces criticism from all sides over its decision to approve the therapy that has yet to be proven effective in clinical trials. read more |
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Top Stories By Ben Adams Eli Lilly is looking to shore up its future diabetes franchise by putting $1 billion on the table to buy out next-gen biotech Protomer. Six-year-old Protomer is engineering protein therapeutics that can sense molecular activators in the body. In a nutshell, this allows the creation of therapeutic peptides and proteins with tunable activity that can be controlled using small molecules. read more By Kyle LaHucik Brii Biosciences, now flush with about $320 million in proceeds from its Hong Kong IPO this week, says that its COVID-19 antibody cocktail remains active against most major variants and expects to have phase 3 data in the fourth quarter of this year. read more Sponsored by: Patheon by Thermo Fisher Scientific Choose the right AAV platform for your viral vector-based gene therapy. read more By Amirah Al Idrus Kriya Therapeutics is looking beyond the bread and butter of gene therapy—rare diseases—to instead focus on programs for more complex and common diseases like diabetes. And now, the Redwood City, California-based company has banked another $100 million to support the work. The new funds will boost Kriya's technology and expand its pipeline, as well as propel assets in oncology, eye diseases and metabolic diseases forward. read more By Nick Paul Taylor Anticancer Bioscience (ACB) has named Hong Liu as VP of clinical development. Liu joins ACB from Eureka Therapeutics, where he took multiple drug candidates from discovery to IND filing in his role as VP of R&D. read more By Nick Paul Taylor Ribon Therapeutics has raised $65 million to advance a pipeline led by a PARP7 inhibitor deeper into the clinic. The financing positions Ribon to build on work to target stress support pathways in cancer and inflammation. read more By Angus Liu In Alzheimer’s disease, an overactive immune system kills off neuronal cells, leading to dementia. Now, scientists at Massachusetts General Hospital have pinpointed a protein involved in immune signaling, IL-3, they believe plays a key role in the progression of Alzheimer's. It could be a prime target for drug development, they said. read more By Fraiser Kansteiner A chance for meaningful drug pricing reform is upon us, dozens of purchasers, healthcare and employer groups contend. But Congress needs to capitalize on its “time-limited” opportunity lest the problem stagnate or worsen. read more By Dave Muoio A new recommendation from seven infectious disease, epidemiology and long-term care organizations condones exemptions for medical purposes and other legal requirements. The consensus statement also outlines clinical, legal, privacy and safety considerations for stakeholders weighing a COVID-19 policy for their facility. read more Resources Sponsored by: WCG Engage Independent Expert Endpoint Adjudication and Data Monitoring Committees in a strategic manner to identify methods for retrospective and prospective evaluations that may improve competitive advantage and bolster regulatory submissions. Sponsored by: Patheon by Thermo Fisher Scientific Take a closer look at your supply chain to ensure it delivers with speed, efficiency, and quality — all within budget. Sponsored by: PA Consulting What does the future of Cell & Gene Therapy look like? Sponsored by: Patheon by Thermo Fisher Scientific Choose the right AAV platform for your viral vector-based therapy Sponsored by: Blue Matter Consulting E-book to get newcomers “up to speed” quickly on digital health and digital therapeutics while also addressing key issues important to those already familiar with the topic. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification 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. Diversity, Equity & Inclusion Week August 9-11, 2021 | Virtual Event Medical Affairs Strategic Summit (MASS) September 13-15, 2021 | New Brunswick, NJ Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA | 