Courtship in the Clinic: Seagen unveils positive bladder cancer data for Padcev-Keytruda combo amid merger talks with Merck Ever the optimist, Biogen secures FDA priority review for ALS drug that flunked phase 3 Martin Shkreli wants to be dealt back into the biopharma game, and now he's betting on the blockchain Could the FTC block a Merck-Seagen merger? M&A consultant says no Mayo Clinic, Mercy's new collaboration will mine years of deidentified patient data for clinical insights 3M to peel off $8B healthcare business into standalone public company Pfizer, BioNTech rebuff CureVac's 'groundless' patent infringement claims against COVID-19 shot Comirnaty Major payers including Aetna, UHC sign on to California primary care initiative HHS proposes restoring transgender health protections stripped by Trump-era rule InflaRx will still ask FDA to greenlight COVID treatment after phase 3 flop Brooklyn hails immunotherapy for achieving 'primary objective'—but fails the primary endpoint Baxter begins Class I recall of drug dose calculation software Featured Story | By Kevin Dunleavy Seagen and Astellas revealed some positive data from one of the cohorts in the phase 1b/2 urothelial cancer trial, specifically, the group testing Padcev as a first-line treatment with Merck’s Keytruda for urothelial cancer (la/mUC) patients ineligible for cisplatin-based chemotherapy. read more |
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Top Stories 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 By Conor Hale Two months fresh out of prison—and despite a federal judge banning the famous “pharma bro” from working in the drug industry for the rest of his life—Martin Shkreli is looking to get right back in the mix. read more By Kevin Dunleavy Many in the biopharma industry are under the assumption that the FTC will tighten the screws on mergers and acquisitions, especially large ones like Merck and Seagen that are under consideration. But one M&A industry consultant doesn’t believe the FTC has the legal standing to challenge such mergers. read more By Dave Muoio The two major health systems say new algorithms trained on their shared data set have "the potential to transform medicine worldwide." read more By Andrea Park Much like the mythical hydra, when 3M is sliced apart in the coming months, two separate companies will crop up in its place. 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 Paige Minemyer The California Advanced Primary Care Initiative is jointly backed by the California Quality Collaborative, an arm of the Purchaser Business Group on Health, and the Integrated Healthcare Association. read more By Robert King HHS is proposing to restore nondiscrimination protections for transgender individuals that were stripped by the Trump administration in 2020. 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 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 Andrea Park So far, Baxter and the FDA have reported five complaints linked to the software defect, with no patient injuries or deaths reported. read more Resources Sponsored by: Thermo Fisher Scientific See how integration of innovative genetic analysis techniques into drug development is driving biopharma & biotech companies ahead. 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 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. | 