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Regulatory
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Regulatory actions for April 29, 2022

April 29, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Beigene, Cara, CNS, Janssen, Jasper, Moderna, Mycovia, Nevakar, SQZ, Timber, Vifor, Xbiotech.
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Camzyos bottle

BMS wins FDA approval for chronic HCM drug mavacamten

April 29, 2022
By Lee Landenberger and Richard Staines
Bristol Myers Squibb Co.’s audacious $13.1 billion 2020 takeover of Myokardia Inc. appears to have paid off with U.S. FDA approval of the drug at the heart of the deal, mavacamten. The medicine, a cardiac myosin inhibitor for treating adults with obstructive hypertrophic cardiomyopathy (HCM), will be marketed under the brand name Camzyos.
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Feet and scale

Lilly may seek expedited approval for weight loss drug

April 28, 2022
By Michael Fitzhugh
Eli Lilly and Co.'s tirzepatide, a high-profile entrant in the global anti-obesity race, hit a key milestone, becoming the first investigational medicine to deliver more than 20% weight loss on average for non-diabetics in a phase III study, said Jeff Emmick, vice president of product development at the company.
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Mycovia’s Vivjoa wins FDA nod as first therapy for RVVC

April 28, 2022
By Jennifer Boggs
Mycovia Pharmaceuticals Inc. is prepping to launch its first commercial product following U.S. FDA approval of oral antifungal oteseconazole for use in recurrent vulvovaginal candidiasis (RVVC). Branded Vivjoa, the drug is expected to be available to patients during the second quarter.
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Regulatory actions for April 28, 2022

April 28, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nano-X, Nocira, Onera, Transmedics.
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Regulatory actions for April 28, 2022

April 28, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Allogene, Alterity, Antengene, Astrazeneca, Aviadobio, Bayer, Biocryst, Biohaven, Direct, Fennec, Maia, Molecular Partners, Novartis, Orexo, Pfizer, Prothena, Renovion, Treadwell.
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Becerra on the hot seat in US House budget hearing

April 27, 2022
By Mari Serebrov
Making his first in-person appearance April 27 before the House Energy and Commerce Subcommittee on Health, U.S. Health and Human Services Secretary Xavier Becerra was prepared to answer questions about President Joe Biden’s fiscal 2023 budget that would increase HHS’ discretionary budget to $127 billion, nearly a 27% increase over the 2021 enacted level.
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Stock prices with loss/gain arrows

Possible EUA hitch and Amgen give-back dent Molecular Partners

April 27, 2022
By Jennifer Boggs
Within just a few hours, Molecular Partners AG reported both a potential snag in securing emergency use authorization (EUA) for its Darpin antiviral, ensovibep, and the loss of a half-billion-dollar partnership with Amgen Inc. for the phase I-stage 4-1BB-targeting compound MP-0310. While neither update is likely to dampen prospects for the company’s overall Darpin pipeline, the near-term investor disappointment was enough to send shares (NASDAQ:MOLN) closing 37% lower April 27, after dropping to their lowest point since the Zurich, Switzerland-based firm priced its $63.8 million IPO on Nasdaq in June 2021.
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Regulatory actions for April 27, 2022

April 27, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biotronik.
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Regulatory actions for April 27, 2022

April 27, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Editas, Evoke, Gamdia, Gilead, Lemonex, OncoC4, Pharming, VBL.
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