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These data were shared as a late-breaking oral presentation during the virtual 11 th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021).
Based on these findings, Merck plans to initiate a Phase 2 trial to further explore the potential of a subdermal implant containing islatravir as a long-acting option for PrEP for up to 12 months. “We Phase 1 Implant Study Results for Investigational Anti-HIV agent Islatravir.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Week 96 Metabolic and Bone Outcomes of a Phase 2b Trial of Islatravir and Doravirine.
The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.
The data builds on the primary outcome analysis of the positive Phase 3 monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 The monarchE trial is ongoing and patients will continue to be followed to assess safety, PROs and other endpoints. had fatal outcomes.
Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community.
Sanofi highlights scientific innovations in the field of rare blood disorders at I STH 2021. Population pharmacokinetic and pharmacodynamic modeling data to characterize the antithrombin (AT) lowering dynamics in hemophilia patients treated with fitusiran will be shared in a poster presentation. FDA for ITP.
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. Multiple Sclerosis (MS). Neuromyelitis Optica Spectrum Disorder (NMOSD).
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United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application.
04, 2021 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. The Company expects to enroll the first subject in the first half of 2021 and provide preliminary safety and biomarker data in the second half of 2021.
Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial.
18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset.
The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR. was approved by the European Commission in February 2021. About LIBRETTO-001.
20, 2021 11:00 UTC. Dr. Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented, “The clearance of our CTA application for ALS-4 drug represents a significant milestone for the company and one of a number of targeted strategic goals for 2021. About ALS-4.
The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. Given a positive outcome of the approved Phase 1 study, the company intends to initiate Phase 2 by the end of 2021.
puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Prior to this European Union Parliament, in 2021, voted for animal testing phase out. Human In Silico Drug Trials Demonstrate Higher Accuracy than Animal Models in Predicting Clinical Pro-Arrhythmic Cardiotoxicity.
Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
ALLSCHWIL, Switzerland, Dec.
Takeda Pharmaceutical Company Limited ( TSE: 4502 /NYSE:TAK) (“Takeda”) today announced the results of a phase 3 trial investigating the efficacy and safety of recombinant von Willebrand factor (rVWF) prophylaxis, 1 one of the 12 abstracts being presented at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress 2021.
With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties?
The publication includes safety and efficacy data for 323 relapsed or refractory patients (including 170 with CLL/SLL, 61 with MCL, 26 with Waldenström’s macroglobulinemia and 66 with other B-cell lymphomas) that were enrolled to the BRUIN Phase 1/2 trial as of September 27, 2020. About the BRUIN Phase 1/2 Trial.
The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.
Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy.
The action date under the Prescription Drug User Fee Act (PDUFA) for the BLA has been updated to April 27, 2021.
CARMIEL, Israel and BOSTON , Dec. 30, 2020 /PRNewswire/ — Protalix BioTherapeutics, Inc.
The AMBITION trial is the first placebo-controlled study of CRV431 in NASH patients with evidence of moderate-to-severe fibrosis. The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. To date, there are no approved drugs to treat NASH.
SCYNEXIS has successfully completed preclinical testing of its liposomal IV formulation of ibrexafungerp and is advancing the program into human trials in healthy volunteers. SCYNEXIS has been granted approvals from the health authority and ethics committee, with dosing anticipated to start in the first quarter of 2021. (2)
This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. The Company’s third SEFA, 6179, is expected to enter the clinic in the first half of 2021, targeting IFALD, for which no treatment is currently available.
Findings Two Phase 1 trials of atuzaginstat were completed by June 2019. The pharmacokinetic profiles of COR388 in AD and controls were reported to be similar. A Phase 2/3 trial (GAIN) evaluating a 48-week course of COR388 in 643 people with mild to moderate AD began in April 2019. This trial involves 93 sites in the U.S.
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.
8 Preliminary data from the trial have shown good safety and tolerability for TT125-802, with confirmed preliminary target engagement in surrogate tissues such as hair follicles and peripheral blood mononuclear cells. 2021 Oct 11 [cited 2024 Sep 4];13(20):5081. 2021 Apr [cited 2024 Sep 4];2(4):377–91. Cancers [Internet].
–Results from a post-hoc analysis of the Phase 3 PREEMPT trials evaluate the use of BOTOX® (onabotulinumtoxinA) for chronic migraine –These data further demonstrate AbbVie’s commitment to harnessing and sharing innovative science and working to advance treatment options for people with migraine across the migraine spectrum.
It was developed for schizophrenia and anhedonia in depression but trials were unsuccessful and its development was discontinued in 2023. [1] Cilia, Jackie; Hitchcock, Stephen (12 August 2021). Zelatriazin, C 18 H 15 F 3 N 4 O 3 , 392.3 X H NMR (500 MHz, DMSO-i¾) δ ppm 1.40 (d, J=6.8 Hz, 3 H), 4.98 (quin, J=7.1 49 (2): 121–132.
Spero has previously reported data from a Phase 1 double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of SPR206 suggesting that SPR206 is well-tolerated at doses that are likely to be within a therapeutic range for targeting MDR Gram-negative bacterial infections. SHANGHAI , Jan.
“Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. World Health Organization (2021). 1] It is a transthyretin-directed antisense oligonucleotide. [1] PMC 10540057. PMID 37768671.
This trial is the first to evaluate nasally administered Foralumab to improve the immune system’s fight against coronaviruses.
The last patients in the trial received their final dose on 21 December 2020. The topline data from the trial is expected to be available in January 2021.
Dr. .
There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity. 2 Toxic to the Heart One of the top reasons for drug withdrawal from clinical trials and the market is cardiotoxicity, which can be defined as toxicity that has a detrimental impact on the heart.
The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. About COMET-ICE.
Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D.,
Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. Canada and Europe.
The New Drug Application (NDA) for the drug is based on data from four Phase III trials in pediatric patient populations from the age of 6 to 17 years, two Phase II trials, several Phase I trials, a long-term open label extension study, preclinical testing, and drug manufacturing data. This is under Priority Review.
For example, for a combination product including one or more already-approved drugs, the WoE surrounding potential pharmacodynamic or toxicological interactions must be assessed, to determine whether the combination can be tested in clinical trials without a nonclinical toxicity study. Epub 2021 Nov 1. J Toxicol Pathol.
It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . The approval was based on results in a prespecified interim analysis of the first 264 patients of the ongoing KEYNOTE-811 trial. controlled trial had not received previous systemic therapy for metastatic disease.
“Notably, the 70 percent decrease in risk of hospitalizations or death seen in this Phase 3 trial of bamlanivimab and etesevimab together is consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone in the Phase 2 trial. INDIANAPOLIS, Jan. See Limitations of Authorized Use.
Safety and Pharmacokinetics of Antisense Oligonucleotide STK-001 in Children and Adolescents with Dravet Syndrome: Single and Multiple Ascending Dose Design for the Open-Label Phase 1/2a MONARCH Study. Clinical Trials. Patient enrollment and dosing in MONARCH is ongoing and preliminary safety and PK data are anticipated in 2021.
Basel, 22 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the decision to discontinue dosing in the Phase III GENERATION HD1 study of tominersen in manifest Huntington’s disease (HD). About tominersen and the clinical trials. No new safety signals were identified for tominersen in the iDMC’s review. .
The FDA extended the PDUFA action date by three months to April 27, 2021, from January 27, 2021.
Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters.
About Pegunigalsidase Alfa.
Galactosidase-A enzyme.
10, 2021 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, will provide an update on Vision 3×3 and the company’s 2021 key milestones at the 39 th Annual J.P.
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