Publisher's Note: Join the Fierce Biotech team at the Fierce Biotech Summit on September 19-20 in Boston. This two-day event focuses on innovation in biopharma and highlights the companies who are pioneering innovative ideas and new technologies to drive the industry forward. Learn more here. | | Three unique groups share all they learned about sample collection for COVID-19 testing and research. From a pop-up COVID-19 testing lab to a vehicle catching on fire with COVID-19 samples aboard, read their stories and recommendations. Download Now. 
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Today's Big News Sep 14, 2022 Pfizer begins phase 3 trial of its mRNA influenza vaccine, as it races Moderna to market Bayer, Novartis, Eli Lilly and more back CAR-T focused biotech Capstan Therapeutics to the tune of $165M Larimar’s purgatory ends as FDA removes clinical hold on its only asset Altimmune sees phase 1 success in tricky NASH indication with GLP-1 agonist CSL Behring unveils its largest R&D site yet as company widens ambitions Novartis dodges Gilenya kickback claims—again—after whistleblower lawsuit dismissed COVID-19 tracker: Moderna discussed COVID-19 vaccine supply deal with China HTG, Datavant and Mathematica team up to battle kidney disease and long COVID As Vyvgart launch gains steam, Argenx CEO says his company can achieve 'standalone' success Tasso earns FDA clearance for its home blood collection device for telehealth tests | By Nick Paul Taylor Pfizer has begun a phase 3 clinical trial of its mRNA-based influenza vaccine, keeping it tucked in behind Moderna in the race to upend the seasonal flu market using the technology that defined the response to COVID-19. |
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By Nick Paul Taylor The VC wings of Pfizer, Bayer, Novartis, Eli Lilly and Bristol Myers Squibb have come together to support the birth of a new biotech: Capstan Therapeutics. Armed with $165 million from the companies and VCs, the startup will advance a CAR-T therapy produced inside patients toward clinical development. By James Waldron Larimar Therapeutics held its breath for over a year, but the FDA has finally given the biotech a green light to continue trials of its lead, and only, asset this year. The therapy, CTI-1601, is a recombinant fusion protein intended to deliver human frataxin into the mitochondria of Friedreich’s ataxia patients. Sponsored By Danaher Corporation The rapidly evolving field of genomic medicines has manufacturers scrambling to scale up the production of complex medicines. Flexible, automated and integrated technologies are the solution. By Gabrielle Masson Altimmune’s phase 1b study evaluating its obesity and non-alcoholic steatohepatitis (NASH) treatment has hit its main target, along with a secondary goal. It makes for some welcome topline data in a notoriously tricky indication. By Max Bayer Evidence of the company's expanded pipeline, CSL Behring has unveiled a new site in Marburg, Germany. The facility will be the company's largest single R&D operation. By Fraiser Kansteiner For the second time in as many years, Novartis has dodged claims it paid doctors kickbacks at “sham” speaker programs to boost prescriptions of its multiple sclerosis blockbuster Gilenya. By Zoey Becker,Kevin Dunleavy,Fraiser Kansteiner,Angus Liu Moderna held talks with the Chinese government about supplying its mRNA shot there, but no decisions have been made, its CEO told Reuters. A majority of adults in the U.S. are onboard with annual boosters, a poll found. And more. By Joseph Keenan HHS Techology Group, Datavant and Mathematica are teaming up to provide public and private sector access to a database focused on battling chronic kidney disease and long-term COVID-19. By Fraiser Kansteiner Argenx chief Tim Van Hauwermeiren thinks his company could serve as a “role model” for future biotech innovators amid an era of midsized biopharma buyouts. Argenx has reason to feel confident, too, thanks to a rosy second quarter for its first commercial product Vyvgart. By Conor Hale The Tasso+ lancet can be placed by the user themselves on their upper arm to fill up a small tube of blood drawn from the capillaries. Fierce podcasts Don't miss an episode | This week on "The Top Line," we discuss Sarepta's phase 2 Duchenne muscular dystrophy clinical trial that was green-lit earlier this week after a clinical hold in June. We also chat the opposing results on either side of the pond for Illumina quest for Grail. |
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| Tuesday, September 27, 2022 | 11am ET / 8am PT By standardizing core, repeatable IRT modules, clinical trial organizations can realize consistency and efficiency for all trials. Join The Secrets of Successful IRT Standardization and learn how Bayer did it. Register now. 
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