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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog: Biosimilars

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. We will continue to monitor these developments as they come.

Drugs 59
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Building the requisite clinical development infrastructure for medical innovation to thrive

Drug Target Review

They wait for the therapies that could significantly improve their quality of life or even save it knowing approval could be years or decades away. We are at a pivotal moment where we must consider how to improve these systems and ways of working to ensure critical therapies reach those who need them most.

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The Competitive Edge of Biosimilars

DrugBank

Biosimilars  Biosimilars, while highly similar to their reference biopharmaceuticals, offer distinct advantages that position them as preferred therapeutic options in many cases. This is because biosimilars are not new drugs but highly similar versions of already approved therapies with established safety and efficacy profiles.

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ACR Response Criteria in Rheumatoid Arthritis Clinical Trials

Quanticate

In rheumatoid arthritis (RA) clinical trials, accurately measuring the effectiveness of treatments is critical for determining their value in managing this chronic and debilitating condition.

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Biogen’s Statement on the Final National Coverage Determination for Amyloid-Beta Targeting Therapies for the Treatment of Alzheimer’s Disease

The Pharma Data

This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). About Biogen.

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Pfizer Announces Positive Top-Line Results for Phase 3 Trial of Etrasimod in Ulcerative Colitis Patients

The Pharma Data

Statistically significant improvements were achieved in all key secondary endpoints in the trial as well. The global phase 3 multi-center, randomized, double-blind, placebo-controlled study, also known as ELEVATE 12, enrolled 354 UC patients who had previously failed or were intolerant to at least one conventional, biologic, or JAK therapy.

Trials 52
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New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis

The Pharma Data

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

Vaccine 52