Biogen, fresh off coveted FDA nod for Aduhelm, must now navigate ethics minefield for phase 4 trial Biden officials aim for the stars with new NIH research arm to push bold, risky biomedical ideas New FDA papers reveal internal split over Biogen's Aduhelm approval Sponsored: Addressing Roadblocks in Decentralized Clinical Trials After rebounding from FDA setback, uniQure goes all in on gene therapy with $55M Corlieve buy Sponsored: Culture Drives Employee Engagement, Supports Business Growth Abata hopes to find ‘perfect fit’ with MS cell therapy after $95M series A Galapagos CSO Wigerinck hits the bricks after major setbacks Orum adds $54M to 2019 series B to take antibody drug conjugates for cancer into the clinic Tvardi snags $74M to weed the tumor garden with STAT3 inhibitor Strand snags $52M to develop next-gen mRNA meds for cancer After triumphant pilot, GSK eyes 'digital twins' to fine-tune vaccine production, development Digital therapy maker Pear Therapeutics shakes the money tree, with plans to go public in $1.6B SPAC deal COVID-fighting llamas inspire 'nanobody' treatments to tackle emerging variants Featured Story | By Amirah Al Idrus After the Aduhelm approval set a precedent for FDA clearance based on surrogate endpoints, all eyes will be on Biogen as it conducts a trial in the post-approval environment. The biotech, luckily, has plenty of time to figure things out. read more |
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Top Stories By Annalee Armstrong President Biden has proposed a new research agency to sit within the National Institutes of Health, called the Advanced Research Projects Agency for Health. The program has requested an initial $6.5 billion in funding “to develop breakthroughs—to prevent, detect, and treat diseases like Alzheimer’s, diabetes, and cancer,” according to a paper by several officials published Tuesday. read more By Nick Paul Taylor The FDA has documented the steps leading up to the approval of Biogen’s Alzheimer’s disease drug Aduhelm, revealing how the mixed evidence on the controversial therapy divided its staff. read more Sponsored by: Oracle Health Sciences In a recent virtual roundtable discussion, industry experts shared their insight on the challenges faced in implementing decentralized trials and how to address them. read more By Kyle LaHucik Two months after the FDA lifted a clinical hold on its hemophilia gene therapy, uniQure is throwing down some cash for another. The Dutch biotech will pay 46.3 million euros ($55 million) upfront in cash to acquire French gene therapy company Corlieve Therapeutics. read more Sponsored by Alexion By refocusing company culture around the connection between employees and the rare disease community, Alexion has increased employee engagement and charted a new path for business success. Read more. read more By Kyle LaHucik Abata Therapeutics comes out of stealth after three and a half years to advance regulatory T cells for the treatment of Multiple Sclerosis, Type 1 diabetes and other autoimmune and inflammatory diseases. read more By Nick Paul Taylor Piet Wigerinck is set to step down as chief scientific officer (CSO) of Galapagos later this year. The departure follows a series of setbacks that have left Galapagos struggling to rebuild confidence in its diminished pipeline. read more By Kyle LaHucik A month after hiring a new chief financial officer, Orum Therapeutics has another $54 million to take its targeted protein degraders into clinical trial testing for solid tumors and hematological cancers. read more By Kyle LaHucik Tvardi Therapeutics, an upstart biotech from the brains of MD Anderson Cancer Center leaders, has raised $74 million to prep for a phase 2 trial of an oral, small-molecule inhibitor of STAT3. After adding two members to its board earlier this year, and with “inflection points” in clinical data from a phase 1 trial, Tvardi now has the financial resources from a slate of long-term hedge fund investors to move forward with multiple trials next year. read more By Amirah Al Idrus For many, mRNA-based medicines are synonymous with COVID-19 vaccines, but vaccination is just the tip of the iceberg for the technology. Strand Therapeutics is one of the companies looking below the surface, and it’s raised $52 million to get its first mRNA-based immunotherapy into the clinic. read more By Fraiser Kansteiner After piloting a digital twin of the entire vaccine manufacturing process, "the sky is the limit" in terms of how far the tech could go at GlaxoSmithKline, the company's head of sciences, digital innovation and business strategy said in a recent interview. read more By Conor Hale Pear Therapeutics is taking the SPAC track, with a deal expected to provide about $400 million in new funding as the company looks to expand its prescription apps to a wider range of conditions. read more By Arlene Weintraub Scientists led by Ohio State University identified two types of nanobodies that could bypass mutations and prevent the virus that causes COVID-19 from entering cells. The nanobodies, inspired by tiny antibodies made by llamas, were able to neutralize the alpha, beta and gamma variants of the virus, the researchers reported. read more Resources Sponsored by: Clinical Ink For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink. Sponsored by SDG Group Discover how Ashfield Healthcare uses the power of data and analytics to enable pre-call planning, inform sales rep actions and drive higher market share for its target pharmaceutical products. Sponsored by: BBK Worldwide Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them. Sponsored by: Thermo Fisher Scientific Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process. 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: 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: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule 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. Biopharma Supply Chain June 29-30, 2021 | Virtual Event 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 | 