Pfizer's COVID-19 antiviral is expected to work against the omicron variant Viatris gets shot to shed infringement claims in long-running patent kerfuffle on AstraZeneca's Symbicort CanSino taps Aerogen for development, commercial supply of inhaled COVID-19 vaccine hopeful Aerami Therapeutics, eager to breeze into smart inhaler market, unveils $250M SPAC deal Former Iterum VP returns as medical chief to give ex-Pfizer antibiotic another shot at approval Featured Story | By Annalee Armstrong Pfizer said it expects its antiviral pill Paxlovid to provide protection against the omicron variant of the coronavirus, amid worldwide concern that existing medications and vaccines would not work against the newly mutated version. read more |
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Top Stories By Fraiser Kansteiner The U.S. Court of Appeals for the Federal Circuit has vacated a judgement of infringement against Mylan and its partner Kindeva Drug Delivery after it determined that a federal court in West Virginia misinterpreted part of Symbicort's patents. At the same time, the appeals court upheld the lower court's decision not to invalidate the three AZ patents in question, effectively upholding the IP barrier for Symbicort. read more By Fraiser Kansteiner CanSino and Aerogen are teaming up to develop and market an inhaled version of CanSino's recombinant COVID-19 shot Convidecia, which is already approved in China as a one-and-done injectable. Because aerosol delivery requires a "considerably smaller volume of vaccine," the partners' inhaled prospect could help stretch capacity and enable more patients to access the inoculation, the companies said. read more By Fraiser Kansteiner Biopharma is no stranger to the special purpose acquisition company dealmaking spree of 2020 and 2021. Now, inhaled therapy specialist Aerami Therapeutics is getting in on the action, just in time to ride the SPAC train into the new year. read more By Kyle LaHucik Iterum Therapeutics is hoping it can secure an FDA approval after getting rejected by the agency in July, but first it needs a medical leader in place. The biotech rehired Sailaja Puttagunta, M.D., a former vice president, to get its oral antibiotic through another trial in hopes of scoring an approval. read more Resources Sponsored by: BBK Worldwide New survey results and insights help clinical trial sponsors improve diversity and inclusion, enroll faster, and keep participants engaged longer. Sponsored by: WIRB - Copernicus Group Sites receiving augmentation support enroll more than 30,000 patients in just over three months. See how additional site resources can make a difference. Sponsored by: Thermo Fisher Scientific A variety of genetic analysis methods are valuable in ensuring that ex vivo human cells to be used for cell-based therapies are correctly identified, have the correct characteristics, and are free of contaminants. Sponsored by: Thermo Fisher Scientific Learn how a CDMO partnered with Thermo Fisher Scientific to manage high-volume process liquid and buffer preparation scale-up. Download the free case study from Thermo Fisher Scientific Sponsored by: Thermo Fisher Scientific A variety of genetic analysis methods are valuable in ensuring that ex vivo human cells to be used for cell-based therapies are correctly identified, have the correct characteristics, and are free of contaminants. This whitepaper addresses where AI can make the biggest impact in clinical trials. The stakes are too high for patients to leave decision-making to machines, but AI can lend administrative support that empowers staff and medical experts alike to carry out their jobs more effectively. Sponsored by: Medable, Inc. Find out how to improve clinical protocol adherence, and thus patient outcomes, by 15%+ with Medable’s latest White Paper. Sponsored by: IQVIA Learn how to elevate your omnichannel marketing strategy with Next Best - a combination of data and analytics, deployed to facilitate decision making. Sponsored by: GLG A major Korean biopharmaceutical company wanted to gather unbiased opinions on a new cancer treatment product. Fill out our form to learn more. Sponsored by: GLG Download now to learn how GLG helped a biotech company plan for the demand of a new drug/device combination by commissioning a forecasting study. Sponsored by: Catalent Biologics Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. New market research provides valuable insight into the impact of adaptations made in clinical trials during the pandemic. Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Fierce Virtual Clinical Trials Summit December 6-7, 2021 | Philadelphia, PA Fierce JPM Week 2022 January 11, 2022 | San Francisco, CA
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