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Disease Events Pharmacokinetics Therapies 
Drug Discovery World
SEPTEMBER 3, 2024
Join DDW and Lonza for this free event ‘ Building advanced cell models for toxicity testing ’. The event will take place on 19 September at 3pm GMT / 4pm CET / 10am EST / 7am PST. The post Free event: Next generation predictive in vitro ADMET solutions appeared first on Drug Discovery World (DDW).
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Drug Discovery World
MARCH 15, 2024
Biotechnology company Allyx Therapeutics has reported positive Phase Ib clinical data for its lead compound, ALX-001, a first-in-class, synapse-targeted, disease-modifying oral therapy in development for neurodegenerative diseases. All doses were well-tolerated and there were no serious adverse events.
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Drug Discovery World
SEPTEMBER 17, 2024
Join DDW and Lonza for this free event ‘ Building advanced cell models for toxicity testing ’. The event will take place on 19 September at 3pm GMT / 4pm CET / 10am EST / 7am PST.
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Drug Discovery World
SEPTEMBER 10, 2024
Join DDW and Lonza for this free event ‘ Building advanced cell models for toxicity testing ’. The event will take place on 19 September at 3pm GMT / 4pm CET / 10am EST / 7am PST.
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Drug Discovery World
MAY 24, 2023
Moderna has reported encouraging interim data from its Phase I/II trial of mRNA-3927, an mRNA therapy for rare metabolic disorder propionic acidemia (PA). The data was presented at the 2023 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting.
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Drug Discovery World
AUGUST 27, 2024
Join DDW and Lonza for this free event ‘ Building advanced cell models for toxicity testing ’. The event will take place on 19 September at 3pm GMT / 4pm CET / 10am EST / 7am PST.
130 
Drug Discovery World
AUGUST 20, 2024
Join DDW and Lonza for this free event ‘ Building advanced cell models for toxicity testing ’. The event will take place on 19 September at 3pm GMT / 4pm CET / 10am EST / 7am PST.
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Drug Discovery World
APRIL 3, 2024
We will now complete efficacy, toxicity, pharmacodynamic and pharmacokinetic studies in several preclinical models required by regulatory agencies. The post Validating a revolutionary therapy against lethal haemorrhage appeared first on Drug Discovery World (DDW).
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Drug Discovery World
DECEMBER 12, 2023
Exonate, an mRNA therapy company focused on treatments for diabetic complications, has announced that its lead ophthalmology asset, EXN407, has achieved its prespecified endpoints in a Phase Ib/IIa study. During the trial, EXN407 met all safety and pharmacokinetic parameters and displayed encouraging signals of biological activity.
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Drug Discovery World
JANUARY 31, 2024
Breye Therapeutics, a clinical-stage biopharmaceutical company developing novel oral therapies for retinal vascular diseases within ophthalmology, has started a Phase Ib/IIa clinical trial to investigate danegaptide, following oral administration, in patients suffering from diabetic macular oedema (DMO).
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Drug Discovery World
OCTOBER 13, 2022
DDW’s Megan Thomas comments on the presentations, posters and booths at the event and the new addition of the ELRIG Tech Theatre, supported by DDW. . When it comes to metrics of success for an event such as Drug Discovery 2022, the numbers speak for themselves. Over the two days at ExCel, 1554 delegates attended the event.
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The Pharma Data
OCTOBER 14, 2021
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.
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Drug Target Review
SEPTEMBER 25, 2024
Most targeted cancer therapies used today operate by inhibiting targets along well-known oncogenic signalling cascades. The reactivation of oncogenic signalling upstream or downstream of the driving oncogene is a well-studied source of resistance to targeted cancer therapies.
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The Pharma Data
MAY 4, 2021
INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic.
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Drug Discovery World
AUGUST 10, 2022
But decades of research led to improvements in cancer therapy, centred around the idea that one’s immune system could aid in treatment. Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic.
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The Pharma Data
MAY 5, 2021
It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . Farxiga use expanded for reducing risks in patients with chronic kidney disease. A total of 197 patients in the study arm had at least one of the composite endpoint events, compared with 312 patients in the placebo arm.
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Drug Target Review
JUNE 12, 2023
TEAD proteins are known to be very important in cancer progression TEAD proteins are known to be very important in cancer progression, and there are a number of therapies in development. What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties?
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 years of age with severe hemophilia A.
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The Pharma Data
NOVEMBER 6, 2020
The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”, Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease.
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The Pharma Data
MARCH 13, 2021
Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE).
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Drug Discovery World
SEPTEMBER 9, 2024
Vesper Bio has completed a Phase I study for its lead candidate, VES001, a potentially disease-modifying treatment for frontotemporal dementia patients with mutations in the progranulin gene (FTD(GRN)). Frontotemporal dementia is the most common cause of dementia in people under the age of 60.
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The Pharma Data
AUGUST 19, 2021
3] While MET inhibitors have recently received accelerated approval in this setting in some regions, the vast majority of patients eventually acquire resistance to these therapies, thus underscoring the need for new treatment options. [4] The majority of treatment-related adverse events (AEs) were Grade 1-2. 4] , [5] , [6].
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The Pharma Data
APRIL 14, 2021
government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. who require oxygen therapy due to COVID-19, OR. who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity. Adverse Events.
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The Pharma Data
APRIL 11, 2021
In this cohort, the most common treatment-emergent adverse events of any grade (?20%) No patients in this cohort discontinued treatment due to treatment-related adverse events. 50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity. Initiate or adjust anti-hypertensive therapy as appropriate.
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The Pharma Data
JANUARY 3, 2021
Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. We are initially focused on developing a novel therapy to treat ENPP1 and ABCC6 deficiencies.
The Pharma Data
SEPTEMBER 26, 2021
With MS, finding the proper treatment option is the maximum amount about managing the clinical aspects of the disease because it is about how treatment fits into a person’s life,” said Simon Faissner, M.D., Food and Drug Administration in October 2019 and is currently the amount one prescribed oral MS therapy within the country.
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The Pharma Data
AUGUST 29, 2020
Oral, investigational complement factor B inhibitor LNP023 substantially improved hematological response as add-on therapy to eculizumab. FDA and EMA have granted orphan drug designations to LNP023 for PNH and the rare renal disease complement 3 glomerulopathy (C3G). Peffault de Latour.
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The Pharma Data
JANUARY 3, 2021
Preclinical data from our laboratory have shown that the nasal administration of anti-CD3 stimulates Tregs that can suppress inflammation and ameliorate inflammatory diseases. Dr. Kimble Matos, the lead coordinating physician of the study, commented: “The observations made during the Clinical study did not show any adverse events.”.
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.
The Pharma Data
JULY 22, 2021
The prospective, phase 3, open-label, international multicenter study included 23 patients with severe von Willebrand disease (VWD). No new risks were identified, with no serious adverse events related to rVWF reported. About von Willebrand Disease (VWD). The sABR was reduced by 91.5% population.
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The Pharma Data
SEPTEMBER 1, 2020
months, 2,039 participants (81.8%) had any treatment-emergent adverse event (TEAE), 236 (9.5%) had a serious TEAE (SAE) and 56 (2.2%) discontinued the study due to a TEAE. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod. Author: Zhang.
The Pharma Data
DECEMBER 13, 2020
AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. NASH Investor Event Information. A replay of the event will be available on Poxel’s website following the presentation.
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The Pharma Data
SEPTEMBER 19, 2020
While we have made great progress in the treatment of many forms of breast cancer, TNBC remains an aggressive and difficult-to-treat disease,” said Levi Garraway, M.D., 2.80] in the PD-L1 positive population, based on 21% of patients with an event; updated HR=1.12 [95% CI: 0.76-1.65]), pCR was observed in 57.6% (95% CI: 49.7–65.2)
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The Pharma Data
APRIL 16, 2021
who require oxygen therapy due to COVID-19, OR. who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity. Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together.
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The Pharma Data
JULY 27, 2021
The acquisition includes Teneobio’s proprietary bispecific and multispecific antibody technologies, which will enable significant acceleration and efficiency in the discovery and development of new molecules that have the potential to treat a wide range of important diseases across Amgen’s core therapeutic areas. Reese, M.D.,
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The Pharma Data
DECEMBER 5, 2020
” In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. 57% of evaluable patients (4 of 7 patients) were minimal residual disease (MRD) negative.
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The Pharma Data
JULY 11, 2021
years with TAKHYZRO is Consistent with Initial Period of Treatment, Building on Growing Body of Evidence on the Long-term Safety and Efficacy Final Patient Subgroup Analysis Suggests Reductions of HAE Attacks Across Range of Patient Demographics and Disease Characteristics with TAKHZYRO. Analysis of Safety and Efficacy for up to 2.5
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The Pharma Data
FEBRUARY 8, 2021
IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy. 2,3 In the U.S.,
The Pharma Data
OCTOBER 25, 2020
Treatment choices are limited, and commonly used off-label therapies are not always effective or may result in prolonged, deep sedation. This condition may be caused by numerous underlying pathologic processes and disease states. NEW HAVEN, Conn., 26, 2020 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (“BTI”
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The Pharma Data
JULY 21, 2021
Most adverse events (AEs) were mild and there were no serious drug-related AEs in people who received islatravir. After 24 weeks, once-monthly oral islatravir was generally well tolerated versus placebo. For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn.
The Pharma Data
OCTOBER 27, 2020
Tyvaso in pulmonary hypertension due to interstitial lung disease (PH-ILD). Tyvaso also showed benefits across several key subgroups, including etiology of PH-ILD, disease severity, age, gender, baseline hemodynamics, and dose. our initial phase 1 study of OreniPro , which has since been completed.
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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. “We
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LifeSciVC
APRIL 24, 2024
Target validation : Do we believe the target(s) plays a central role in disease biology and that modulation will modify disease? There is nothing more exciting than digging into a new target and trying to develop a thesis on whether modulation may be impactful in disease. Is the functionality of mutations known?
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The Pharma Data
NOVEMBER 17, 2020
The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. All adverse events (AEs) that were possibly or probably related to LYT-100 were mild and transient and there were no discontinuations.
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