2018, Clinical Development, Pharmacokinetics and Treatment

2018

Clinical Development

Pharmacokinetics

Treatment

AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

The Pharma Data

DECEMBER 14, 2020

The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. CIPN is a leading cause for modification or interruption of chemotherapy.

Clinical Development

Clinical Development Clinical Supply Pharmacokinetics Packaging

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

Treatment

Treatment FDA Approval Pharmacokinetics FDA

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Trending Sources

FDA Action Alert: MacroGenics and Amgen

The Pharma Data

DECEMBER 13, 2020

We will continue to work closely with the Agency to potentially bring margetuximab as a treatment option to patients with HER2-positive metastatic breast cancer.”. Zai Labs obtained regional development and commercialization rights for the programs in mainland China, Hong Kong, Macau and Taiwan.

FDA

FDA Action Alert: Supernus, Adamis, Alkermes, Amgen, BMS and Eiger

The Pharma Data

NOVEMBER 8, 2020

Supernus Pharmaceuticals has a target action date of November 8, 2020 for SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD). Alkermes has a target action date of November 15 for ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder.

FDA

FDA Trials Pharmacokinetics Pharmaceuticals

Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020

The Pharma Data

SEPTEMBER 19, 2020

Results from the Phase III IMpassion131 study, evaluating Tecentriq in combination with paclitaxel for the treatment of people with metastatic TNBC and whose tumours expressed PD-L1, did not meet its primary endpoint of progression-free survival . Roche’s Chief Medical Officer and Head of Global Product Development. “We

Treatment

Treatment Disease Pharmaceuticals Therapies

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

SEPTEMBER 15, 2023

developing or amending a monograph) or sponsor-initiated operations (e.g., Background on oral phenylephrine as a nonprescription nasal decongestant Phenylephrine is an alpha-1 adrenergic agonist that is approved as a nonprescription oral treatment for temporary relief of nasal congestion , sinus congestion and pressure.

Science

Science FDA Clinical Trials Pharmacy

Ascentage Pharma’s Licensee UNITY Biotechnology Announces Milestone Reached in Clinical Development of Treatments for Age-Related Disease, Leading to Milestone Payment

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

Clinical Development

Clinical Development Disease Treatment Licensing

2021 AAN highlight impact and breadth of expanding neuroscience portfolio

The Pharma Data

APRIL 8, 2021

today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. Spinal Muscular Atrophy (SMA). Alzheimer’s Disease (AD). Abstract Title.

Clinical Trials

Clinical Trials Trials Disease Nurses

Metabolism of 2023 FDA Approved Small Molecules – PART 1

Metabolite Tales Blog

JANUARY 23, 2024

Patented active metabolites Gepirone’s metabolites have been patented for “the manufacture of a medicament for the treatment of psychological disorders” [9]. Veozah (Fezolinetant): A Promising Non-Hormonal Treatment for Vasomotor Symptoms in Menopause. Pharmacokinetics and Metabolism of Nirmatrelvir. Health Sci Rep.

Small Molecule

Small Molecule FDA Approval FDA Pharmacokinetics

Metabolism of 2022 FDA approved small molecule drugs PART 2

Metabolite Tales Blog

APRIL 4, 2023

3 Metabolism differences at steady state Adagrasib, Mirati’s irreversible KRASG12C inhibitor for treatment of non-small cell lung cancer is mainly metabolised by CYP3A4. link] [2] Zhang and Tang, 2018. Drug metabolism in drug discovery and development. 2018 Sep;8(5):721-732. Dermavant’s tapinarof is one such friend.

Small Molecule

Small Molecule FDA Approval FDA Drugs

The evolution of assays for immuno-oncology research

Drug Discovery World

FEBRUARY 15, 2023

The number of new cases recorded between 2016 and 2018 was 375,400, with 167,142 deaths caused by cancer between 2017 and 2019. Another revolutionary discovery was the elucidation of the role of IL2 in T cell growth and activation in the 1970s, that later paved the way for the treatment of patients with metastatic melanoma and renal cancer.

Research

Research Therapies Immune Response Clinical Trials

Evrysdi approved by European Commission as first and only at home treatment for spinal muscular atrophy

The Pharma Data

MARCH 30, 2021

More than 3,000 patients now treated with Evrysdi in clinical trial, compassionate use and real-world settings. Roche’s Chief Medical Officer and Head of Global Product Development. Roche’s Chief Medical Officer and Head of Global Product Development. “By About FIREFISH.

Treatment

Treatment Pharmacokinetics Clinical Trials Trials

New four year data for Roche’s Evrysdi reinforce long-term efficacy and safety profile in some of the most severely affected people with types 2 and 3 spinal muscular atrophy (SMA)

The Pharma Data

MARCH 20, 2023

These latest data make us confident that the improvement observed during the first year of treatment is sustained during four years which contrasts with the decline we would observe in the absence of treatment.” No treatment-related AEs led to withdrawal from the study. Evrysdi was well-tolerated over the four-year time period.

Pharmacokinetics

Pharmacokinetics Treatment Clinical Trials Trials

demonstrate improvement or maintenance of motor function in people aged 2-25 with Type 2 or Type 3 Spinal Muscular Atrophy (SMA)

The Pharma Data

MARCH 16, 2021

Evrysdi is the first and only at home SMA treatment approved by the FDA, and has proven efficacy across adults, children and infants 2 months and older. More than 2,500 patients now treated with Evrysdi in clinical trial, compassionate use and real-world settings. Department of Pediatric Neurology, Catholic University, Rome, Italy. “In

Pharmacokinetics

Pharmacokinetics Treatment Clinical Trials Disease

Roche presents new 2-year data for Evrysdi (risdiplam) in infants with Type 1 spinal muscular atrophy (SMA)

The Pharma Data

SEPTEMBER 27, 2020

In August, the FDA approved Evrysdi for the treatment of SMA in adults and children 2 months and older. After two years of treatment with Evrysdi, 71% (12/17 vs. 10/17 at 1-year) of infants achieved a CHOP-INTEND* score of 40 points or more and all infants increased their score from month 12 to month 24. months and the oldest was 45.1

Pharmacokinetics

Pharmacokinetics FDA Approval Treatment Clinical Trials

Drug Discovery Digest

AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

Trending Sources

FDA Action Alert: MacroGenics and Amgen

FDA Action Alert: Supernus, Adamis, Alkermes, Amgen, BMS and Eiger

Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Ascentage Pharma’s Licensee UNITY Biotechnology Announces Milestone Reached in Clinical Development of Treatments for Age-Related Disease, Leading to Milestone Payment

2021 AAN highlight impact and breadth of expanding neuroscience portfolio

Metabolism of 2023 FDA Approved Small Molecules – PART 1

Metabolism of 2022 FDA approved small molecule drugs PART 2

The evolution of assays for immuno-oncology research

Evrysdi approved by European Commission as first and only at home treatment for spinal muscular atrophy

New four year data for Roche’s Evrysdi reinforce long-term efficacy and safety profile in some of the most severely affected people with types 2 and 3 spinal muscular atrophy (SMA)

demonstrate improvement or maintenance of motor function in people aged 2-25 with Type 2 or Type 3 Spinal Muscular Atrophy (SMA)

Roche presents new 2-year data for Evrysdi (risdiplam) in infants with Type 1 spinal muscular atrophy (SMA)

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