pharmaphorum

DECEMBER 22, 2022

The FDA and EMA have formally started their review of the drug, which analysts have suggested could become a $3 billion blockbuster for Pfizer if it reaches the market for UC and other immuno-inflammatory diseases. In ELEVATE UC 12, etrasimod achieved a 25% clinical remission rate after 12 weeks, compared to 15% for a matched placebo group.

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Pharmacology Safety Patients Marketing 52

pharmaphorum

DECEMBER 20, 2022

Earlier this year, Madrigal reported positive results in another phase 3 trial of resmetirom called MAESTRO-NAFLD-1, including some patients with NASH, and said a filing in the lead indication of non-cirrhotic NASH with liver fibrosis hinged on a positive readout in MAESTRO-NASH.

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Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 months for lecanemab and 5.5

Food and Drug Administration 82

Food and Drug Administration Safety Patients Leads 82

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma.

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Food and Drug Administration FDA Medicine Patients 122

Medgadget

MAY 2, 2023

The system uses the patient’s EEG data to calculate a value for the amygdala-derived-EFP biomarker, and meanwhile the patient tries various mental strategies that may help to reduce the value. These treatments at times come with a long list of side effects, leaving many patients in search of an effective long-term solution.

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Pharmaceutical Technology

OCTOBER 10, 2022

The company is aiming to enrol the first patient in the ALETTA Phase III trial in Q1 or Q2 of 2023, says Dr. Jan van der Mooren, Freya’s chief medical officer (CMO). The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds. But these treatments have their own limits.

Pharmacology 59

Pharmacology Side effects FDA Safety 59

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new. What is drug dose optimisation?

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FDA Side effects Pharmacology Patients 115

Pharmaceutical Technology

MARCH 16, 2023

However, health specialists refute most safety concerns for the use of drug classes as part of gender affirming care, citing years of research and care. Dr. Barry DeCoster, PhD, an associate professor of bioethics at the University of Michigan, describes gender affirming care as “safe and effective” for most patients.

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Ethics Prescription Safety Healthcare 144