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Home » Newsletters » BioWorld

BioWorld

March 8, 2021

View Archived Issues
Coronavirus-financial-markets

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

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. Read More

Anaptysbio’s phase III of imsidolimab misses primary endpoint

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. Read More
Hair and scalp under magnifying glass

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

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.” Read More
U.K. flag on stethoscope

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

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. Read More
Antibodies

After phase III failure, Bio-Thera drops batansine technology in favor of new ADC platform

Days after taking the unusual step, for a Chinese company, of terminating a couple of clinical programs, Bio-Thera Solutions Ltd. said it still plans to continue R&D in antibody-drug conjugates, but with a new technology platform, the company told BioWorld. Read More
CMS-medicare-reimbursement.png

$1.9T stimulus package could trigger 4% Medicare sequester

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. Read More

ICER panel: Where’s the data?

The Institute for Clinical and Economic Review (ICER) took Fibrogen Inc., of San Francisco, to task for not disclosing data from completed roxadustat trials. Read More

WHO to tackle breast cancer globally

The latest global regulatory news, changes and updates affecting biopharma, including: PhRMA urges Biden to stand by IP rights. Read More
ICYMI illustration

ICYMI: Week in review, March 1-5, 2021

A quick look back at top stories. Read More

Appointments and advancements for March 8, 2021

New hires and promotions in the biopharma industry, including: Arsenalbio, Athira, Baudax, Chemocentryx, Claritas, Gritstone, Moderna, Noveome, Rezolute, Skye, Storm, Spybiotech, Synlogic, Tracon. Read More

Earnings for March 8, 2021

Quarterly snapshots from biopharma companies with marketed products, including: Insmed, La Jolla. Read More

Financings for March 8, 2021

Biopharmas raising money in public or private financings, including: Algernon, Azurrx, Lineage, Longboard, Prometheus. Read More

In the clinic for March 8, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abivax, Aim, Alteogen, Anaptysbio, Aravive, Atea, Cytodyn, Gilead, Imara, Immunitybio, Innovation, Mayne, Merck & Co., Nantkwest, Oncoinvent, Pfizer, Ridgeback, Roche, Seres, Valneva. Read More

Other news to note for March 8, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alpha, Adaptvac, Aligos, Amryt, Bavarian Nordic, Baxter, Betterlife, CASI, Cleave, Cortexyme, Exelixis, Fairjourney, Galectin, GT, Iontas, Iqvia, Johnson & Johnson, Medincell, Medison, Moderna, Pathios, Quell, Wugen, Wuxi. Read More

Regulatory actions for March 8, 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. Read More

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