Ever the optimist, Biogen secures FDA priority review for ALS drug that flunked phase 3 Brooklyn hails immunotherapy for achieving 'primary objective'—but fails the primary endpoint Angion hangs up 'for sale' sign, stops drug development work after flops force search for exit Sponsored: Unlocking the power of AI-driven pathology in drug development: An Interview with Bristol Myers Squibb Ex-FBI trainee made $82K in illegal profits over Merck's $1.9B Pandion acquisition: SEC InflaRx will still ask FDA to greenlight COVID treatment after phase 3 flop Merck strikes 2nd ADC deal with Kelun-Biotech, paying $35M for rights to unnamed asset Who might better benefit from KRAS and PD-1 combos? New Mirati drug study offers a clue Sanofi rolls out new diversity program to hire Howard University grads 'Contagion' meets 'The Matrix': Newly discovered process may hold key to future pandemic-fighting therapies Researchers dive into the biology of acne, illuminating how one common treatment is successful Pfizer, BioNTech rebuff CureVac's 'groundless' patent infringement claims against COVID-19 shot Comirnaty More than just talk: Medidata partners with speech tech firm Aural Analytics Cleerly quadruples previous funding with $192M for heart attack-predicting AI Featured Story | By James Waldron Biogen hasn’t let a phase 3 failure for tofersen hold it back. In fact, the company has used 12-month data to secure priority review status for a new drug application of the amyotrophic lateral sclerosis drug. read more |
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Top Stories By Annalee Armstrong Brooklyn ImmunoTherapeutics says the phase 2 INSPIRE trial “achieved its primary objective” of finding patients that might respond to the immunotherapy IRX-2. Unfortunately, that wasn’t the primary endpoint, rendering the mid-phase study in patients with cancer of the oral cavity a failure. read more By Nick Paul Taylor For sale: one biotech, badly damaged. So starts what could be the final chapter in the story of Angion Biomedica. Weeks after halting a study over a potential safety signal, the biotech has decided to stop most of its development activities to preserve its $60 million-plus cash pile while it seeks strategic alternatives. read more Sponsored by: PathAI Learn how Bristol Myers Squibb is unlocking new insights in translational research and development by transforming pathology with artificial intelligence. read more By Gabrielle Masson Though one would think he would know better, a former FBI trainee has been charged for making $82,000 in illegal stock trading ahead of Merck & Co.’s $1.85 billion acquisition of Pandion Therapeutics in February 2021. read more By Max Bayer InflaRx is forging ahead months after a COVID treatment failed a phase 3 study, saying it plans to still ask the FDA for emergency use authorization. read more By Nick Paul Taylor Merck & Co. has struck an antibody-drug conjugate deal—but not the one everyone is waiting for. With reports swirling about a potentially imminent $40 billion Seagen buyout, the Big Pharma has put up $35 million to secure exclusive rights to a second candidate in development at its partner Kelun-Biotech. read more By Angus Liu Scientists at the Francis Crick Institute have found that using immunotherapy alongside a Mirati KRAS inhibitor in lung cancer might only work for some tumors. The preclinical results could help future clinical trials select patients that are more likely to benefit from such combinations, the team said. read more By Gabrielle Masson Sanofi is partnering with Howard University to hire full-time employees straight from the historically Black college as part of the Big Pharma’s push to address disparities in underrepresented communities. read more By Gabrielle Masson It may sound like a blockbuster movie crossover, but researchers are investigating whether so-called matrix proteins could prevent the sort of global pandemic depicted in the film "Contagion." read more By Max Bayer New research from UCLA dives deeper into the biology of acne, showing how the root issue may be broken macrophages. The science provides clarity into how one common treatment actually works. read more By Fraiser Kansteiner After developing the massively successful COVID shot, Comirnaty, Pfizer and BioNTech are responding to CureVac's litigation, saying they are facing what they call “threats of a groundless patent infringement suit by a company, CureVac, who has been unable to bring to market any product to help in the fight against COVID-19.” read more By Gareth Macdonald Medidata has become the latest trial tech firm to team with speech collection and analysis software developer Aural Analytics to add speech biomarkers to its drug research offering. read more By Andrea Park After proving that its noninvasive artificial intelligence software is comparable to the current gold standard of coronary angiography in spotting signs of heart disease, Cleerly has cleared a path to bring the technology to even more people around the world. read more Resources Sponsored by: Lumanity Join us, as we explore the commercial readiness challenges and practical realities of driving a successful launch in the cell and gene therapy space. Sponsored by: Triangle Insights Group, LLC Discover how the new partnership between TrialCard and Triangle Insights Group can help you bridge the critical gap between strategy and execution, ensuring commercialization success of your product or therapy. Sponsored by: Nexelis Discover Nexelis’ first-hand perspective on how to develop innovative, agile solutions in vaccine efficacy testing in this exclusive e-book. Sponsored by: Cognizant Explore how Cognizant SIP helped Roche streamline its global feasibility process. Sponsored by: Blue Matter Consulting This e-book covers the 12 most common pitfalls for companies entering European markets for the first time, offering guidance to help growing companies avoid them and succeed. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Carla Vozone discusses the significant trends in the OINDP segment including large molecules and novel indications, changes within CDMOs and various challenges facing the industry. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Free Virtual Event Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ | 