2018, Disease, FDA Approval and Small Molecule

2018

Disease

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Metabolism of 2022 FDA approved small molecule drugs PART 1

Metabolite Tales Blog

JANUARY 26, 2023

Metabolism of 2022 FDA approved small molecule drugs – Part 1 Does CYP3A4 still rule? By Julia Shanu-Wilson It won’t come as much surprise to learn that of the 17 small molecules* approved by the FDA in 2022, CYP3A4 was the major player in drug metabolism. Sugano, 2018.

Small Molecule

Small Molecule FDA Approval FDA Drugs

Taking a new approach to tackle neurodegenerative diseases

Drug Discovery World

OCTOBER 4, 2022

William Erhardt , President, Head of Development & Operations of biotech Oligomerix, tells Lu Rahman about the company’s differentiated approach to developing disease-modifying therapeutics for neurodegenerative diseases. . Global dementia prevalence is expected to increase to 152 million in 2050, a 204% increase compared to 2018.

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Trending Sources

A new drug approval for the vanguard of RNA-targeted small molecules

Dark Matter Blog

AUGUST 27, 2020

A few years ago, at Arrakis Therapeutics, we set out to conquer a strange new territory, drugging RNA structures with small molecules. The efficiency of exon 7 inclusion in the mature SMN2 mRNA varies significantly among patients and poor inclusion efficiency correlates with higher disease severity.

Small Molecule

Small Molecule RNA Clinical Trials Drugs

Three trends in the antibody-drug conjugate (ADC) market

Drug Discovery World

JUNE 1, 2023

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1.

Marketing

Marketing FDA Approval Licensing Licensing

Metabolism of 2023 FDA Approved Small Molecules – PART 1

Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. References [1] 2023 Novel Small Molecule FDA Drug Approvals.

Small Molecule

Small Molecule FDA Approval FDA Pharmacokinetics

The evolution of the RNA therapeutics landscape

Drug Discovery World

JULY 8, 2024

While mRNA vaccines and RNA interference therapies have garnered much attention, a new class of RNA therapeutics known as aptamers is gaining momentum, particularly to address acute diseases. By silencing transthyretin (TTR) mRNA, patisiran decreases the production of TTR protein, the molecule responsible for causing the disease.

RNA

RNA Small Molecule Vaccine FDA Approval

Analysis Life Sciences Thank You The U.S. regulatory landscape for probiotics and other microbiome-based therapies

Agency IQ

NOVEMBER 3, 2023

Synthetic biotics have been engineered to perform a variety of functions: “ Several classes of effectors have been engineered into bacteria, including enzyme pathways that metabolize disease-causing toxins, production of protein effectors, and production of small-molecule effectors,” according to a recent article on the topic.

Therapies

Therapies Science FDA Production

Lineage Cell Therapeutics Provides End of Year Shareholder Letter

The Pharma Data

DECEMBER 27, 2020

This year has been difficult, but it has reinforced the importance of our mission: to treat and potentially even reverse the effects of serious diseases and conditions by advancing our novel cell therapy product candidates through clinical trials and into the hands of physicians.

Therapies

Therapies Production Clinical Trials Treatment

FDA accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI

The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. In the U.S.,

FDA

FDA FDA Approval Small Molecule Drugs

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

This is a significant jump from any previous year, with the former peak at 15 in FY 2018, followed by several years in the 10-14 range. Taking a closer look, nearly half of the products were reviewed by the Office of Oncologic Diseases. FDA approved 13 NMEs through the AA pathway in FY 2023, making up 25.5%

FDA

FDA Biosimilars Science Production

Roche to present new data in multiple sclerosis and neuromyelitis optica spectrum disorder at MSVirtual2020

The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase III clinical trial programme for fenebrutinib, an investigational medicine designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, which may offer novel approach to suppress disease activity and slow disease progression in MS.

Clinical Trials

Clinical Trials Disease Treatment Therapies

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

Rare Disease. Others Rare Disease. Total Rare Disease. In the first quarter, Rare Disease sales increased 4.4% At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. Net sales (€ million). Change at CER. Fabrazyme ®.

Vaccine

Vaccine Production FDA FDA Approval

AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results

The Pharma Data

FEBRUARY 4, 2021

AbbVie announced positive top-line results from the Phase 3 ADVANCE and MOTIVATE studies, which evaluated the efficacy and safety of Skyrizi (risankizumab) for induction therapy in adult patients with moderate to severe Crohn’s disease (CD). and by AbbVie outside of the U.S. AbbVie announced that the U.S.

Production

Production International Clinical Trials Small Molecule

The role of anti-viral drug development in a new pandemic era

Drug Target Review

FEBRUARY 15, 2024

Rising demand for animal protein has led to more factory farming, increasing the likelihood that diseases can spread among these animals then into humans. 5 Furthermore, ever larger numbers of humans are living in cities or travelling across borders, increasing the risk of diseases being transmitted person-to-person over a long range.

Drug Development

Drug Development Virus Vaccine Government

Drug Discovery Digest

Metabolism of 2022 FDA approved small molecule drugs PART 1

Taking a new approach to tackle neurodegenerative diseases

Trending Sources

A new drug approval for the vanguard of RNA-targeted small molecules

Three trends in the antibody-drug conjugate (ADC) market

Metabolism of 2023 FDA Approved Small Molecules – PART 1

The evolution of the RNA therapeutics landscape

Analysis Life Sciences Thank You The U.S. regulatory landscape for probiotics and other microbiome-based therapies

Lineage Cell Therapeutics Provides End of Year Shareholder Letter

FDA accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Roche to present new data in multiple sclerosis and neuromyelitis optica spectrum disorder at MSVirtual2020

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results

The role of anti-viral drug development in a new pandemic era

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