The Pharma Data

JULY 2, 2023

In 2019, a team of researchers around Marcus Conrad, Director of the Institute of Metabolism and Cell Death at Helmholtz Munich, had already identified the first FSP1-specific inhibitor, known as iFSP1. Notably, during de-differentiation or metabolic rewiring, certain malignant cancer cells acquire an intrinsic vulnerability to ferroptosis.

Therapies 40

Therapies Small Molecule Pharmacokinetics Disease 40

PerkinElmer

JANUARY 7, 2022

There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity. Sci Rep 9, 18911 (2019). With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved.

Drugs 52

Drugs Pharmacokinetics FDA Approval Drug Development 52

Drug Target Review

OCTOBER 4, 2023

7 These inhibitors have faced challenges such as dose-limiting toxicity and poor pharmacokinetics, but geldanamycin ADCs have demonstrated increased survival in mice. Cancers 11 , 394 (2019). 161 , 416–432 (2019). 23 , 4854–4865 (2019). DNA damaging agent-based antibody-drug conjugates for cancer therapy. Dragovich PS.

Small Molecule 126

Small Molecule Drugs Immune Response Targeted Protein Degradation 126

The Pharma Data

MARCH 9, 2022

Sanofi and Swedish Orphan Biovitrum AB (publ) (Sobi ® ) (STO:SOBI) today announced positive topline results from the pivotal XTEND-1 Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients ?12 12 years of age with severe hemophilia A.

Treatment 52

Treatment Pharmacokinetics Therapies FDA 52

Drug Target Review

SEPTEMBER 25, 2024

2019 Dec 13 [cited 2024 Sep 4];122(4):465–72. A phase 1, first-in-human, open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of TT125-802 in patients with advanced solid tumors. Nature Reviews Drug Discovery [Internet]. 2022 Dec 12 [cited 2024 Sep 4];22(3):213–34. Available from: [link] 2.Bell

Small Molecule 105

Small Molecule Therapies Regulations Treatment 105

The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. Spero plans to initiate additional Phase 1 studies to assess the penetration of SPR206 into the pulmonary compartment and pharmacokinetics in subjects with renal impairment in 2021. SHANGHAI , Jan.

Clinical Trials 52

Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies 52

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

In 2019, FDA formed an agency-wide Alternative Methods Working Group indicating that it viewed the applicable scope of alternative methods to go beyond just toxicology research. 42 U.S.C. § 262(k)(2)(A)(i)(I).

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

The Pharma Data

AUGUST 22, 2021

Safety, Tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial virus prefusion F-targeting monoclonal antibody with an extended half-life, in healthy adults. 2019; 10: 548. Griffin MP, et al. Antimicrob Agents Chemother. 2017; 61(3): e01714-16. Yu XQ, et al. Antimicrob Agents Chemother. 2016; 61 (1): e01020-16.

Trials 52

Trials Virus Vaccine Pharmacokinetics 52

New Drug Approvals

SEPTEMBER 13, 2024

14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] “Safety, tolerability, and pharmacokinetic evaluation of single- and multiple-ascending doses of a novel kappa opioid receptor antagonist LY2456302 and drug interaction with ethanol in healthy subjects” Journal of Clinical Pharmacology. nM vs. 24.0

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

The Pharma Data

NOVEMBER 8, 2020

The resubmission came after a meeting with the FDA in February 2020 and addresses issues raised by the agency’s Complete Response Letter (CRL) in November 2019. “We The NDA was resubmitted on May 2020. We have been encouraged by our interactions with the FDA following our CRL and are pleased to resubmit our Zimhi NDA,” said Dennis J.

FDA 52

FDA Trials Therapies Pharmaceuticals 52

The Pharma Data

DECEMBER 13, 2020

The companies filed in December 2019, and included analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data from two clinical trials. The biosimilar is a collaboration between Amgen and Allergan, which was formed when Allergan was Watson Pharmaceuticals in December 2011.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

The Pharma Data

FEBRUARY 25, 2022

The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines. The company anticipates submitting study results for presentation at an upcoming medical congress.

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

Agency IQ

JULY 28, 2023

During the COVID-19 pandemic, the number of opioid-involved deaths climbed sharply, with mortality rates increasing by 38% between 2019 and 2020. The second wave aligned with an increase in deaths involving heroin, which was followed by a third wave of increased mortality associated with synthetic opioids like illicitly manufactured fentanyl.

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

New Drug Approvals

OCTOBER 24, 2023

June 2019). . | twitter +919321316780 call whatsaapp EMAIL. “Velsipity (etrasimod) tablets, for oral use” (PDF). . “Modulation of sphingosine-1-phosphate in ulcerative colitis” Expert Opin Biol Ther. 20 (4): 413–420. doi : 10.1080/14712598.2020.1732919. PMID 32093531. ^ 369 (3): 311–317. doi : 10.1124/jpet.118.254268.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. A Phase 2b study was initiated in July 2019 (ICONA) to study the efficacy of icosabutate in NASH.

Trials 40

Trials Engineering Pharmacokinetics Therapies 40

The Pharma Data

JANUARY 26, 2021

Previous human pharmacokinetic (PK) study showed significantly better PK profile when compared to market leading product. Total net sales for 2019 amounted to SEK 844.8 Patent protection until 2039. UPPSALA, Sweden , Jan. million and the number of employees was 127.

Drugs 52

Drugs Pharmacokinetics Production FDA 52

The Pharma Data

JANUARY 4, 2021

Cell 2019 ). Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2019, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company.

Drugs 52

Drugs Cell Biology Pharmacokinetics Clinical Trials 52

Alta Sciences

APRIL 17, 2024

Ketamine is a dissociative anesthetic approved in 2019 by the U.S. The theory is that if the brain settles into this state, some of the circuitry responsible for depression or anxiety may be altered and reform around a new perspective. Food and Drug Administration (FDA) as a nasal spray called esketamine, for treatment-resistant depression.

Drug Development 52

Drug Development Treatment FDA Approval Therapies 52

The Pharma Data

OCTOBER 27, 2020

2019. 2019. million for the three months ended September 30, 2020 , compared to the same period in 2019. In addition, as previously disclosed, our 2019 revenues were impacted by a mistake by one of our U.S. million in total, during the third quarter of 2019. 2019.

FDA 40

FDA Production Licensing Licensing 40

Molecular Design

MARCH 26, 2024

With apologies to Manfred Eigen (1927 - 2019) I've just returned to Cheshire from the Caribbean and, to kick off blogging from 2024 I'll share a photo of the orchids at Berwick-on-Sea on the north coast of Trinidad. A theory has only the alternative of being true or false. A model has a third possibility: it may be true, but irrelevant.

Drugs 79

Drugs Pharmacokinetics Cell Based Assays Treatment 79

The Pharma Data

DECEMBER 21, 2020

As UNITY reported in its press release, this “Phase I, first-in-human, open-label, single-ascending dose study being conducted by UNITY is designed to evaluate the safety, tolerability, and pharmacokinetics of UBX1325 in patients with advanced DME. Ascentage Pharma (6855.HK)

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

The Pharma Data

SEPTEMBER 26, 2021

The positive CHMP opinion was supported data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA® (dimethyl fumarate) to determine bioequivalent exposure of monomethyl fumarate, the active metabolite, and relied partially on the well-established long-term safety and efficacy profile of TECFIDERA. for TECFIDERA.

Treatment 40

Treatment Clinical Trials Virus Pharmacokinetics 40

Drug Target Review

JULY 12, 2023

The goal of DCI in preclinical and clinical assessments is to achieve a manyfold higher drug free-fraction pharmacokinetic (PK) C max level (the plasma concentration of therapy in a specific area of the body) to break tumour addiction to the MAPK signalling pathway followed by a rapid drop off of drug levels enabled by a short plasma half-life.

Biochemical Assays 98

Biochemical Assays Treatment Bioinformatics Disease 98

The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

Clinical Trials 40

Clinical Trials Trials Pharmaceuticals Pharmacokinetics 40

The Pharma Data

JULY 11, 2021

The complete results were based on data collected between May 2016 and October 2019 and included 109 rollover patients who were originally evaluated in the HELP Study, and 103 eligible non-rollover patients who did not participate in the initial study but had experienced at least one HAE attack within the previous 12 weeks. Interactions.

Treatment 52

Treatment Pharmacokinetics Production Disease 52

The Pharma Data

DECEMBER 28, 2020

The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2019 and other periodic reports filed with the Securities and Exchange Commission.

Clinical Trials 40

Clinical Trials Trials Pharmaceuticals Treatment 40

Metabolite Tales Blog

APRIL 4, 2023

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. link] [2] Zhang and Tang, 2018. Drug metabolism in drug discovery and development. Acta Pharm Sin B. 2018 Sep;8(5):721-732. link] [3] Bauman et al., 6] Grillo et al.,

Small Molecule 52

Small Molecule FDA Approval FDA Drugs 52

Agency IQ

SEPTEMBER 22, 2023

An AgencyIQ analysis from May 2020 found that a quarter of all New Molecular Entities (NMEs) approved since 2011 had relied upon a single pivotal trial, and that this reliance had remained relatively stable between 2011-2019 despite some year-to-year variability.

FDA 40

FDA Science Trials Clinical Trials 40

Metabolite Tales Blog

MARCH 1, 2023

2019, 14, 2, 142–16 [link] 10 Chem. 2010, 75, 9, 3141–3143 [link] 22 Clin Pharmacokinet. 2000, 2, 195-201 [link] 6 Biochem. 1966 98, 266-277 [link] 7 Metabolites. 2023, 13, 1, 92- [link] 8 J. 2018, 61, 5, 2041–205 [link] 9 ACS Chem. 1993, 6, 2, 174–179 [link] 11 Xenobiotica. 1991, 21, 1179-1183. link] 12 Biochim.

Metabolic Stability 52

Metabolic Stability Pharmacokinetics Drugs Science 52

The Pharma Data

APRIL 27, 2021

In 2019, the U.S. The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). About the Phase 1/2 Trial.

FDA 52

FDA Treatment Pharmaceutical Companies Therapies 52

The Pharma Data

SEPTEMBER 19, 2020

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 Secondary endpoints include OS, event-free survival, disease-free survival and quality of life measures. billion in R&D and posted sales of CHF 61.5

Treatment 52

Treatment Disease Therapies Pharmaceuticals 52

The Pharma Data

APRIL 11, 2021

Use of Retevmo for these indications is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 12 years and older. Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing Retevmo if abnormalities occur.

Research 52

Research Therapies Treatment Trials 52

The Pharma Data

FEBRUARY 8, 2021

The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure. For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg.

Clinical Trials 52

Clinical Trials Treatment Therapies Production 52

Agency IQ

JULY 26, 2024

The new draft guidance also points applicants to 2019 draft guidance on the Development of Therapeutic Protein Biosimilars (comparative analytical assessments) and the ICH Q6B guidance on test procedures and acceptance criteria. Comparisons of analytical data “from the postchange material to the historical analytical data (i.e.,

Biosimilars 40

Biosimilars Science FDA Production 40

The Pharma Data

MAY 4, 2021

There are limited clinical data available for baricitinib use in coronavirus 2019 (COVID-19). volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. Junshi Biosciences leads development in Greater China, while Lilly leads development in the rest of the world.

Therapies 52

Therapies Hospitals Treatment FDA Approval 52

The Pharma Data

SEPTEMBER 15, 2020

Of note, The Phase 1b study is a double-blind, placebo-controlled clinical trial evaluating the safety, tolerability and pharmacokinetics of PF-07304814, a phosphate prodrug that when administered intravenously is metabolized to the active compound PF-00835321, shown to be a very potent inhibitor of the SARS-Cov2 3CL protease in preclinical studies.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

Agency IQ

FEBRUARY 2, 2024

In 2019 more than one in four (28%) of deaths in the E.U. EMA floated these updates through a Concept Paper in 2019 and subsequently issued a draft updated guideline for public consultation in late 2020. after ischemic heart disease and stroke. were from cancer. Even under the shadow of the Covid-19 pandemic, 1.2

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40