Autoimmune Disorders Archives - Page 4 of 15

AbbVie’s Skyrizi and Rinvoq Show Promise in Quest to Succeed Humira

AbbVie, Analysis, Atopic Dermatitis, Blockbusters, Clinical Trial Endpoints, Clinical Trials, Crohn's Disease, Humira, Immunology, Janssen, Johnson & Johnson, Plaque Psoriasis, R&D, The Lancet, Therapeutics

During the Digestive Disease Week meeting, AbbVie presented late-breaking data analyses that showed both doses of Skyrizi met the co-primary endpoints of clinical remission and endoscopic response at week 12 compared to placebo in two Phase III studies. The Lancet published results from pivotal global Phase III clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating Rinvoq (upadacitinib) in adults and adolescents with mild to severe atopic dermatitis who were candidates for systemic treatment.

May 25, 2021/by Andrew Humphreys

FDA Blocks Biogen sBLA for MS Drug

Biogen, Clinical Data, Complete Response Letter, FDA, Immunosuppressants, Relapsing Multiple Sclerosis (RMS), Supplemental Biologics License Application (sBLA), Therapeutics

In a Complete Response Letter to Biogen, the U.S. Food and Drug Administration said the regulatory agency is unable to approve the company’s supplemental Biologic License Application for subcutaneously delivered Tysabri (natalizumab) for the treatment of relapsing multiple sclerosis, at least while the sBLA remains in its present form.

April 29, 2021/by Andrew Humphreys

Eli Lilly Scraps Psoriasis Drug

Blockbusters, Business, Clinical Trial Endpoints, Clinical Trials, Eli Lilly, Primary Endpoints, Psoriasis, Quarterly results, R&D, Secondary Endpoints, Therapeutics

Eli Lilly released the company’s first-quarter 2021 financial report and is abandoning plans to submit mirikizumab to health regulators for psoriasis.

April 27, 2021/by Andrew Humphreys

Roche, Novartis approvals in Europe signal more head-to-head competition

Approvals, Blockbusters, European Commission, Infants, Multiple Sclerosis, Novartis, Rivalries, Roche, Spinal Muscular Atrophy (SMA), Therapeutics

Swiss drugmakers Roche and Novartis each won European approval for drugs on March 30 in a sign that the rival Basel-based companies are increasingly competing for the same patients.

March 30, 2021/by Andrew Humphreys

BrainStorm Trial Shows Promising Top-Line Results for Progressive MS

Clinical Trials, Neurodegenerative Diseases, Progressive Multiple Sclerosis (MS), R&D, Stem Cell Therapy, Topline Data

BrainStorm Cell Therapeutics, one of the leading developers of adult stem cell therapies that mainly focuses on adult neurodegenerative diseases, reported that the company’s 28-week-long Phase II clinical trial for progressive multiple sclerosis (MS) came to a close.

March 24, 2021/by Andrew Humphreys

U.S. FDA approves J&J’s multiple sclerosis treatment; launch in April

Adults, Approvals, FDA, Immune System, Janssen, Johnson & Johnson, Neurological Conditions, Relapsing Multiple Sclerosis (RMS), Rivalries, Therapeutics

Johnson & Johnson will launch the newly approved drug Ponvory for adults with relapsing multiple sclerosis (MS) in the United States during early April 2021 at a similar price point to rival treatments, the company’s Janssen Pharmaceutical unit said on March 19.

March 19, 2021/by Andrew Humphreys

FDA Approves Humira for Pediatric Ulcerative Colitis

AbbVie, Approvals, Blockbusters, Clinical Trials, FDA, Inflammatory Bowel Disease, New Indications, Pediatric Ulcerative Colitis, R&D, Therapeutics

The U.S. Food and Drug Administration approved AbbVie’s biologic therapy Humira (adalimumab) as a treatment for moderate-to-severe active ulcerative colitis in children aged 5 years and older.

February 25, 2021/by Andrew Humphreys

Merck Snaps Up Pandion in $1.85 Billion Deal

Acquisitions, Autoimmune Diseases, Business, Clinical Trials, Deals, Immune Modulation, R&D, Shares, Stocks, Trading, Ulcerative Colitis

Shares of Pandion Therapeutics soared more than 131 percent in trading after pharma giant Merck announced the acquisition of the autoimmune-focused company for up to $1.85 billion.

February 25, 2021/by Andrew Humphreys

FDA Approves Biogen’s Plegridy Intramuscular Administration for Multiple Sclerosis

Autoimmune Disorders, Biogen, Blockbusters, FDA, Intramuscular Injection, Relapsing-Remitting Multiple Sclerosis

The U.S. Food and Drug Administration approved Biogen Inc.’s new intramuscular injection route of administration for Plegridy (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis.

February 1, 2021/by Andrew Humphreys

GSK’s Challenging Week: Halted Study, Delayed FDA Decision and Departing Exec

Business, Checkpoint Inhibitors, Clinical Trials, Coronavirus Disease 2019 (COVID-19), Departures, EvaluatePharma, FDA, GlaxoSmithKline, Inspections, People on the Move, R&D, Ulcerative Colitis, Vaccines

GlaxoSmithKline discontinued a Phase II clinical trial evaluating an anti-LAG3 cell depleting monoclonal antibody aimed at treating ulcerative colitis licensed from Australia-based Immutep Limited following an interim assessment of an Independent Data Monitoring Committee.

January 22, 2021/by Andrew Humphreys