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We explain what types of agency meetings can be sought in the EU, US, Japan, China, and Canada, and provide details to guide requesting and preparing for agency interactions. Learn more. 
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Today’s Big NewsAug 8, 2023 |
| By Annalee Armstrong Pfizer’s decision to drop an obesity candidate on liver toxicity concerns in June raised a red flag for the analyst community. Could Eli Lilly’s prize-winning obesity portfolio have similar issues? |
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By James Waldron Bayer has dropped an acute respiratory distress syndrome drug in phase 2 development for “scientific reasons,” the German pharma giant revealed in its latest earnings results. |
By Nick Paul Taylor Nektar Therapeutics has accused Eli Lilly of botching the analysis of data from phase 1b trials in eczema and psoriasis. Lilly, which has reportedly confirmed the errors, handed back rights to rezpeg earlier this year. |
By Nick Paul Taylor Vincerx Pharma is rethinking its R&D priorities again after seeing its cash reserves dip below $30 million. The biotech is “pacing investment” in an antibody-drug conjugate candidate that survived its prior pipeline prioritization, freeing up cash to move its two lead programs through early-phase trials. |
By Nick Paul Taylor It turns out FDA concerns were just the start of the problems for Crinetics Pharmaceuticals’ CRN04777. As the biotech worked to resolve a clinical hold on the rare disease drug, it learnt of unrelated problems that prompted it to suspend development of the candidate. |
By Annalee Armstrong Astex Pharmaceuticals knows a thing or two about working with a Big Pharma from lab to blockbuster status, and, now, the U.K. company is adding another line to a Merck & Co. cancer collaboration. |
By Helen Floersh Preventing malaria infection from turning into disease is one thing, but preventing transmission between mosquitoes and humans in the first place is another. Now, scientists have discovered a strain of bacteria that may be able to do just that. |
By Annalee Armstrong,Max Bayer,Gabrielle Masson Fierce Biotech's M&A Tracker, your one-stop shop for dealmaking in the biopharma universe. |
By Helen Floersh A fat in human breast milk could open the door to a much-needed treatment for the neurodevelopmental disorder cerebral palsy. |
By Joseph Keenan Curebase, a San Francisco-based clinical trial company, has let go of an undetermined number of employees in a pivot away from decentralized and hybrid clinical trials to focus on software products. |
By Zoey Becker Under the agreement, Ginkgo will seek to streamline production and boost output through cell engineering and protein characterization, the companies said in a Monday release. |
By Fraiser Kansteiner In a large phase 3 trial, Wegovy cut the risk of major adverse cardiovascular events by 20% compared with placebo and standard of care, Novo said Tuesday. Specifically, investigators measured Wegovy's 2.4-mg dose for its ability to cut the risk of a cardio death, heart attack or stroke. |
By Heather Landi Hims & Hers boosted the lower end of its revenue guidance by $20 million to between $830 million and $850 million for the year and also announced it was jumping into the booming weight loss market. |
By Ayla Ellison Innovation is all about solving problems, and, in healthcare and biopharma, there is an unlimited supply of challenges in need of solutions. |
Fierce podcasts Don’t miss an episode |
| This week on "Podnosis," we take a critical look at value-based care. Also under discussion is the top nonprofit health systems of 2022. |
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