Checkpoint calls it quits on cancer drug trial, citing enrollment problems stemming from war in Ukraine ViiV sets up monkeypox fund to deliver $500,000 in the US as an 'emergency response' Mount Sinai, Regeneron unveil plans to sequence and study 1M patients' genomes Two deaths after Novartis' Zolgensma put gene therapy’s liver safety in the spotlight once again Pfizer's 20-valent pneumococcal vaccine hits goal in infant trial, teeing up 2022 approval filing FDA urges public to use multiple at-home COVID-19 tests to avoid false-negative results Northwestern Memorial the latest hit with a class action over Meta's alleged patient data mining Larimar's lead candidate still in limbo as company preps FDA response and maybe a new trial, too After billions in legal costs, Johnson & Johnson plans to halt talc sales worldwide Abbott brings €440M and 1,000 jobs to Ireland to ramp up diabetes tech production 'The Top Line' podcast: The brouhaha over the landmark drug pricing bill, what's behind Pfizer's $5.4B Global Blood Therapeutics buyout deal, plus more Walls close in on VistaGen's PALISADE anxiety trial program in wake of phase 3 failure CPAP machine competitor ResMed nears $3.6B revenue in first year of Philips’ ventilator recall More employers to add travel benefits for abortion in wake of Dobbs decision: survey AZ, Daiichi Sankyo's Enhertu breaks more ground, nabbing fast FDA nod in HER2-mutant lung cancer Featured Story | By Max Bayer Checkpoint is calling it quits on a phase 3 combo trial of its lead cancer med because of the ongoing war in Ukraine. The company had the majority of its trial sites in Russia and says it's dealt with a "substantially longer" enrollment period than expected. read more |
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Top Stories By Ben Adams As monkeypox cases continue to climb steeply in the U.S., with the vast majority being men who have sex with men, HIV drug maker ViiV has set up a new fund to help funnel cash into communities hardest hit by the disease. read more By Dave Muoio The Million Health Discoveries Program will recruit consenting patients over the next five years to build a database of sequenced DNA samples that are paired with deidentified patient records. read more By Angus Liu Novartis has recorded two deaths after treatment with its spinal muscular atrophy gene therapy Zolgensma, once again bringing gene therapy’s safety into attention. read more By Nick Paul Taylor Pfizer’s 20-valent pneumococcal conjugate vaccine has taken a step toward approval in infants. After four doses, all 20 serotypes met the statistical noninferiority criteria in a study that compared the candidate to Prevnar 13. read more By Conor Hale The CDC may have loosened up its COVID-19 guidelines this week, but the FDA is still urging people to take extra precautions when it comes to at-home testing. read more By Dave Muoio After an investigation found Facebook's discreet tracker active among 33 of the top 100 hospitals' online scheduling tools, patients are seeking damages on behalf of "millions" whose data was collected through hospital websites. read more By James Waldron It’s been well over a year since the FDA slapped a hold on Larimar Therapeutics’ only clinical asset. Now, after a meeting with the agency, the biotech is preparing to submit a full response, including a phase 2 trial of the drug at a lower dose. read more By Kevin Dunleavy On Friday, when Johnson & Johnson revealed that it will discontinue sales of it's baby powder around the world, it maintained its long-held position that the iconic product was safe and doesn't cause cancer. J&J will replace the talc-based product with a cornstarch-based version. read more By Andrea Park Ireland has found its pot of gold—no leprechaun needed. Abbott laid out plans to expand its production footprint in the country to boost its continuous glucose monitoring technologies. read more By Teresa Carey This week on "The Top Line," we explore what the landmark drug pricing bill that passed in the Senate means for the industry. We also chat about Pfizer's latest buy and what it suggests for M&A trends. read more By Annalee Armstrong After announcing last month that a late-stage trial for a social anxiety nose spray was unsuccessful, VistaGen is pausing another phase 3 trial to see whether it’s worth continuing. read more By Andrea Park Despite supply chain troubles—which ultimately had ResMed shaving off about $100 million from the total it initially expected to reap from the Philips recall—it was still a banner year for the CPAP machine maker. read more By Paige Minemyer As payers grapple with a patchwork of laws on abortion, the number of employers offering travel benefits for abortion services is expected to grow significantly over the next several years, a new survey shows. read more By Zoey Becker Enhertu is on fire with two approvals in as many weeks. Friday, the drug scored an accelerated FDA approval in HER2-mutant non-small cell lung cancer. The nod came just a week after Enhertu nabbed a groundbreaking HER2-low nod in unresectable or metastatic breast cancer. read more Resources Sponsored by: Triangle Insights Group, LLC The TrialCard/Triangle Insights Group platform is uniquely positioned to support you as your asset progresses through the value chain, by integrating strategic commercialization and market access insights with comprehensive patient and provider support services. Sponsored by: Thermo Fisher Scientific See how integration of innovative genetic analysis techniques into drug development is driving biopharma & biotech companies ahead. 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. 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