Pfizer's 20-valent pneumococcal vaccine hits goal in infant trial, teeing up 2022 approval filing Strike 3: Aptinyx's pain prospect flunks third midphase trial, sending stock to the basement Larimar's lead candidate still in limbo as company preps FDA response and maybe a new trial, too Oyster Point plows ahead with 50 layoffs to focus on approved eye drug Walls close in on VistaGen's PALISADE anxiety trial program in wake of phase 3 failure Mount Sinai spins out vaccine Castle, preparing to lay siege to infectious diseases Two deaths after Novartis' Zolgensma put gene therapy’s liver safety in the spotlight once again Diabetes brand awareness in the doldrums despite plowing big bucks into ad campaigns CPAP machine competitor ResMed nears $3.6B revenue in first year of Philips’ ventilator recall Brain immune cells 'listen in' to neurons, offering new direction for neurological drug research Northwestern Memorial the latest hit with a class action over Meta's alleged patient data mining '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 Chutes & Ladders—J&J's Mammen abruptly vacates top R&D post Fierce Pharma Asia—Enhertu's historic nod; Hutchmed's trial wins; BeiGene, Novartis' liver cancer readout Featured Story | 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 |
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Top Stories By Nick Paul Taylor The prospects for Aptinyx’s NYX-2925 keep getting bleaker. Having flunked a phase 2b painful diabetic peripheral neuropathy clinical trial in April, the therapy has now missed the mark in a fibromyalgia study. 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 James Waldron Oyster Point Pharma is powering ahead with plans to lay off around 50 employees as part of cost-cutting measures to claw back up to $16 million by the end of 2023. 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 Max Bayer Mount Sinai has spun out a new company developing vaccines against current and future infections, including the virus causing COVID-19. The new venture, CastleVax, already has clinical trials underway testing a nasal spray version of its COVID-19 vaccine. 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 Ben Adams Diabetes drugs make up one of the biggest selling and competitive markets in the pharma world, but patients struggle to know the names of these drugs, and that can be a problem when it comes to switching patients to newer meds. 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 Angus Liu Microglia's immune functions and roles in maintaining neural circuits have drawn interest in research into neurological disorders. But not all microglia are the same, and neurons have a role to play in what microglia do, scientists from the Broad Institute have found. 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 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 Max Bayer J&J's Mammen abruptly leaves top R&D post after more than four years. Biden taps Bertagnolli to be the first woman to lead the National Cancer Institute. Lilly snags BMS vet to be new COO of oncology wing. read more By Angus Liu AstraZeneca and Daiichi Sankyo's Enhertu received a landmark HER2-low breast cancer approval. Hutchmed reported positive data for two cancer assets, including for a Tagrisso combination. Novartis and BeiGene's PD-1 inhibitor tislelizumab hit its goal in newly diagnosed liver cancer. read more Resources Sponsored by: Speid & Associates, Inc. The total immersion, transformative training will take place at the Harvard Club in Boston. VIRTUAL in real time is also available. Contingencies for COVID19 will apply. Register NOW for a large early bird discount www.drugstomarket.com/drugbootcamp. 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. 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