2018, Clinical Development and Pharmacokinetics

2018

Clinical Development

Pharmacokinetics

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. More information at www.algotx.com.

Clinical Development

Clinical Development Clinical Supply Pharmacokinetics Packaging

FDA Action Alert: MacroGenics and Amgen

The Pharma Data

DECEMBER 13, 2020

Zai Labs obtained regional development and commercialization rights for the programs in mainland China, Hong Kong, Macau and Taiwan. Zai Lab is leading clinical development in its territory. “We That collaboration was to develop and commercialize four oncology antibody biosimilar therapies.

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Trending Sources

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

The Pharma Data

NOVEMBER 8, 2020

The submission includes data from the ENLIGHTEN clinical development program in schizophrenia, and pharmacokinetic (PK) bridging data comparing ALKS 3831 and Zyprexa (olanzapine), to support an indication for schizophrenia. Celgene acquired it in 2018 from bluebird bio, who originally developed the therapy.

FDA

FDA Trials Pharmacokinetics Pharmaceuticals

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

The Pharma Data

AUGUST 19, 2021

Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “We In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. **In 2018, Janssen Biotech, Inc. 8] , [9] , [10] , [11] , [12]. **In

Treatment

Treatment FDA Approval Pharmacokinetics FDA

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

Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. When looking at several pharmacokinetic studies, the FDA found that the 10 mg oral dose of phenylephrine has a very low bioavailability of less than 1% and, subsequently, low systemic alpha-1 adrenergic activity.

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

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

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Treatment

Treatment Disease Pharmaceuticals Therapies

Metabolism of 2023 FDA Approved Small Molecules – PART 1

Metabolite Tales Blog

JANUARY 23, 2024

Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development. Pharmacokinetics and Metabolism of Nirmatrelvir. [link] [9] Patent EP1242061B1. link] [10] FDA prescribing information for gepirone. link] [11] Zheng et al., Blood 129(13): 1823-1830.

Small Molecule

Small Molecule FDA Approval FDA Pharmacokinetics

2021 AAN highlight impact and breadth of expanding neuroscience portfolio

The Pharma Data

APRIL 8, 2021

Roche will present data from five studies from the EVRYSDI clinical development programme, which was designed to represent a broad spectrum of people living with SMA. The full range of data from Roche’s clinical development programme in neuroscience being presented at 2021 AAN include: Medicine and/or Therapeutic Area.

Clinical Trials

Clinical Trials Trials Disease Nurses

Metabolism of 2022 FDA approved small molecule drugs PART 2

Metabolite Tales Blog

APRIL 4, 2023

link] [2] Zhang and Tang, 2018. Drug metabolism in drug discovery and development. 2018 Sep;8(5):721-732. The Pharmacokinetics, Metabolism, and Clearance Mechanisms of Abrocitinib, a Selective Janus Kinase Inhibitor, in Humans. Br J Pharmacol. 2008 Mar;153 Suppl 1(Suppl 1):S82-9. Acta Pharm Sin B. link] [3] Bauman et al.,

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. These models have greatly contributed to the clinical development of several tumour immunotherapies. Great strides have been made in this journey during the last decade.

Research

Research Therapies Immune Response Clinical 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

“The longer-term results of this study add to the robust body of findings from our broad clinical trial programme evaluating Evrysdi across a variety of ages, disease severities and treatment histories.” Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by the U.S.

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

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. and 10%, respectively), nasopharyngitis (21.7%

Pharmacokinetics

Pharmacokinetics Clinical Trials Treatment Disease

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

The Pharma Data

MARCH 30, 2021

Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation in 2019. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Enrolment for Part 2 was completed in November 2018. About FIREFISH.

Treatment

Treatment Pharmacokinetics Clinical Trials Trials

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

The Pharma Data

SEPTEMBER 27, 2020

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Risdiplam was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. The study met its primary endpoint.

Pharmacokinetics

Pharmacokinetics FDA Approval Treatment Clinical Trials

Drug Discovery Digest

AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

FDA Action Alert: MacroGenics and Amgen

Trending Sources

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

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

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

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

Metabolism of 2023 FDA Approved Small Molecules – PART 1

2021 AAN highlight impact and breadth of expanding neuroscience portfolio

Metabolism of 2022 FDA approved small molecule drugs PART 2

The evolution of assays for immuno-oncology research

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)

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

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

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