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BioWorld - Monday, April 27, 2026
Breaking News: Best of BioWorld: Q1Breaking News: Best of BioWorld: Q1
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In the clinic for March 9, 2021

March 9, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Aeon, Biontech, Biovie, Canbridge, Clene, Edesa, Gannex, Graybug, Irlab, Metacrine, Molecular Partners, Novartis, Oncosynergy, Orca, Oryzon, Pfizer, Rhovac, Rocket, Sagimet, TG, VBI, Xenon.
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Financings for March 9, 2021

March 9, 2021
Biopharmas raising money in public or private financings, including: Hoth, Mesoblast, Pepticom, Salarius, Ventyx, Visus.
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Appointments and advancements for March 9, 2021

March 9, 2021
New hires and promotions in the biopharma industry, including: Apollomics, Artelo, Eli Lilly, Enara, Mimedx, Qualigen, Tollys.
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Regulatory actions for March 8, 2021

March 9, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abcellera, Biomarin, Caladrius, Cara, Cytodyn, Gilead, J&J, Junshi, Lee's, Lilly, Nervgen, Passage, RDIF, Roche, Saniona, Sesen, Soleno, Sorrento, Steba, Tissuetech, Ultragenyx, Vifor.
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ICER panel: Where’s the data?

March 8, 2021
By Mari Serebrov
The Institute for Clinical and Economic Review (ICER) took Fibrogen Inc., of San Francisco, to task for not disclosing data from completed roxadustat trials.
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U.K. flag on stethoscope

U.K.’s NHS agrees to reimburse world’s most expensive drug

March 8, 2021
By Nuala Moran
LONDON – The National Health Service (NHS) in the U.K. has agreed to reimburse Zolgensma, the one-off gene therapy treatment for spinal muscular atrophy billed as the most expensive drug in the world, after a confidential deal was struck with Novartis Gene Therapies.
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Hair and scalp under magnifying glass

SALT lick? Concert not cowed by big pharma players in alopecia

March 8, 2021
By Randy Osborne
Concert Pharmaceuticals Inc. CEO Roger Tung said determining who leads isn’t easy in the phase III race that pits his firm against Eli Lilly and Co. and Pfizer Inc. in alopecia areata. That’s because neither of the other companies has “been very direct about the timelines they’re on,” he told BioWorld. “We’ve been pretty clear that our goal is to have an NDA filing in early 2023.”
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Anaptysbio’s phase III of imsidolimab misses primary endpoint

March 8, 2021
By Lee Landenberger
Anaptysbio Inc. is calling it quits for developing imsidolimab in treating moderate to severe palmoplantar pustulosis (PPP) after its phase II Poplar trial failed to hit its primary endpoint. However, the company said it would continue imsidolimab development for five other indications, including a phase III trial in treating generalized pustular psoriasis (GPP) that’s set to begin in mid-2021.
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Medicare puzzle

$1.9T stimulus package could trigger 4% Medicare sequester

March 8, 2021
By Mari Serebrov
The voluminous American Rescue Plan – the second largest stimulus package in U.S. history – has something for everyone. Almost. The $1.9 trillion package that passed the Senate over the weekend and is expected to be passed by the House March 9 failed to extend the current moratorium, set to expire April 1, on the 2% Medicare sequestration.
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COVID-19 market impact illustration: coronavirus, currency symbols, line graph

Shares of Abivax, Cytodyn fall as investors take stock of COVID-19 developments

March 8, 2021
By Michael Fitzhugh
Shares of Paris-based Abivax SA (Paris:ABVX) fell 25.4% to €21 (US$25.07) on March 8 after the company said it would halt a phase IIb/III trial of its lead candidate, ABX-464, in high-risk COVID-19 patients for lack of efficacy. The decision was based on a data safety monitoring board analysis that Abivax said revealed a "lower than expected rate (10.1%) of progression to severe disease or death with no difference between ABX-464 and placebo groups," each of which also received standard-of-care therapy.
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