Drug Target Review

NOVEMBER 30, 2023

From an early age, I’ve been passionate about finding cures for difficult-to-treat diseases. Then I was approached to co-found AC Immune in 2003. I accepted and I’ve been CEO ever since; our goal, from the beginning, was to pioneer new ways to diagnose, treat and prevent neurodegenerative diseases.

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Disease Therapies Laboratories Treatment 95

The Pharma Data

DECEMBER 23, 2020

Eligible patients enrolled in the trial receive treatment with AIM’s flagship pipeline drug Ampligen. The Ampligen EAP protocol is authorized to enroll up to 100 active trial participants, 20 of whom may be Long Haulers. Centers for Disease Control and Prevention’s criteria for chronic fatigue syndrome. See: PLOS ONE ).

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Drug Target Review

FEBRUARY 28, 2024

Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers. from 2003 to 2006, covering the biotechnology and life-science tools sectors. Cells 9(40):800 (2020).

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The Pharma Data

FEBRUARY 12, 2022

The BLISS-LN phase III trial is the largest and longest trial conducted in active LN, involving 448 adult patients. Belimumab is also approved in China for five-year-old and older patients with active, autoantibody-positive SLE with high disease activity (e.g., About the BLISS-LN trial. About lupus.

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Production Therapies Trials Disease 52

The Pharma Data

NOVEMBER 18, 2020

. “I think it would make my mother so happy to know that I’m doing something to help other families who are going through what my family went through because it was the greatest trial of our lives,” Kaling said. PanCAN estimates that of the more than 57,000 people diagnosed with the disease in 2020, about 47,000 will die.

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The Pharma Data

JUNE 26, 2021

Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 “Alzheimer’s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones,” said Patrizia Cavazzoni, M.D.,

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The Premier Consulting Blog

JANUARY 17, 2023

The Pediatric Research Equity Act (PREA) was signed into law in 2003 to increase pediatric use information in product labeling and close knowledge gaps regarding the safety, efficacy, and appropriate dosing of drugs to treat children.

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Production FDA Clinical Trials Disease 52

The Pharma Data

JANUARY 18, 2021

About Biophytis Biophytis SA is a clinical-stage biotechnology company specialized in the development of therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19.

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Regulations Clinical Trials Disease Production 40

NIH Director's Blog: Drug Development

MAY 21, 2020

Science, 2020 We now know that the immune system of nearly everyone who recovers from COVID-19 produces antibodies against SARS-CoV-2, the novel coronavirus that causes this easily transmitted respiratory disease [1]. In the U.S.

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The Pharma Data

FEBRUARY 25, 2021

5 The European Centre for Disease Prevention and Control (ECDC) currently recommends TBE vaccination for people who live in or are traveling to these risk areas. For many years, our TBE vaccine has helped protect millions of people in Europe from this potentially serious disease. European Centre for Disease Prevention and Control.

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FDA Vaccine Virus Clinical Trials 52

NIH Director's Blog: Drug Development

MARCH 18, 2021

He’s also a member of the international research team that identified a human antibody, called S309, from a person who’d been infected with SARS in 2003. This antibody is showing promise for treating COVID-19 [3], now in a phase 3 clinical trial in the United States.

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Virus Immune Response Clinical Trials Treatment 52

The Pharma Data

MAY 5, 2021

Benlysta is the first biologic approved to treat lupus and lupus nephritis, representing a significant new treatment option for patients and physicians across Europe dealing with this complex autoimmune disease.”. 2] LN can lead to end-stage kidney disease, which could require dialysis or a kidney transplant.

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Therapies Disease Treatment International 52

The Premier Consulting Blog

DECEMBER 28, 2023

3] Understanding Medicare Coverage for IDE Studies The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) allows for Medicare coverage of the routine costs of care provided to Medicare beneficiaries in certain categories of Investigational Device Exemption (IDE) studies. [4]

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Regulations FDA Clinical Trials Packaging 52

The Pharma Data

DECEMBER 15, 2020

About Actinic Keratosis Actinic keratosis or solar keratosis is a chronic and precancerous skin disease that occurs primarily in areas that have been exposed to ultraviolet (UV) radiation for a long period of time. Founded in 2003, Athenex, Inc. 2%) were local skin reactions, application site pruritus, and application site pain.

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FDA Approval FDA Treatment Small Molecule 52

The Pharma Data

NOVEMBER 5, 2020

Prior to Akcea, she was senior vice president and General Manager of Cardiometabolic and Rare Disease Businesses and Strategic Alliances at Moderna, Inc. Sussman has also had leadership experience in industry as the founder and vice president of both Amphioxus Cell Technologies from 1995 to 2003 and Hepatix, Inc. from 1993 to 1995.

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Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

Agency IQ

APRIL 8, 2024

When the document was taken back to the drawing board again in 2003, it remained on hold for more than a decade until a final version was agreed upon in 2012, with the FDA officially adopting it in 2014. That revised version remains in use today ( more on this below ). database-to-database submissions).

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The Pharma Data

MARCH 8, 2021

We are very pleased to share our initial Phase 2 infectivity data at this important conference, which remains at the forefront for critical clinical scientific information in infectious diseases,” shared Dr. Wendy Painter, Chief Medical Officer of Ridgeback Biotherapeutics. “At About Ridgeback Biotherapeutics. Source link:[link].

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Agency IQ

SEPTEMBER 15, 2023

The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. Both trials showed no difference between phenylephrine and placebo.

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The Pharma Data

OCTOBER 1, 2021

The phase IV clinical trials , multicenter, controlled, cross-over study with corresponding blinded image evaluations met its primary endpoint, showing that a 75 percent dose of gadobutrol (0.075 mmol/kg) is non-inferior to a one hundred pc dose of gadoterate (0.1 mmol/kg) for CNS imaging. mmol/kg weight. “At

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Clinical Trials Disease Production Hospitals 52

Agency IQ

FEBRUARY 21, 2024

In 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the “strongly recommended format” for submission of applications to the FDA. The top request to TGA from stakeholders was for increased international harmonization and cooperation.

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New Drug Approvals

JULY 10, 2023

1] Zavegepant is an antagonist of the calcitonin gene-related peptide (CGRP) receptor currently in phase 3 trials in an intranasal formulation for the treatment of migraine. The clinical trial is expected to complete in September 2020. Zavegepant is indicated for the acute treatment of migraine with or without aura in adults. [1]

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Codon

NOVEMBER 1, 2024

Amodei also imagines the ways AI could accelerate biological research and yield miraculous cures in the 21st century; everything from the prevention and treatment of nearly all infectious and inherited diseases to the elimination of most cancers. Human constraints also play a role at a later stage, when clinical trials are involved.”

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