Drug Discovery World

JANUARY 10, 2024

The acquisition includes Aiolos’ AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter Phase II clinical development for asthma, with potential for additional indications.

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Drug Discovery World

AUGUST 14, 2023

Research partners in the UK are progressing their orally available small molecule cancer immunotherapy drug into clinical development as a treatment for advanced solid tumours. HTL0039732 works by blocking signalling through a specific type of prostaglandin receptor, the prostaglandin E2 (PGE2)-type prostanoid receptor 4 (EP4).

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Drug Discovery World

DECEMBER 21, 2022

The Phase II study is a multicentre, randomised, double-masked, placebo-controlled, parallel-arm study to evaluate the safety, efficacy, and pharmacokinetics of RZ402 as monotherapy over a 12-week treatment period in participants with DME who are naïve to or have received limited anti-VEGF injections. .

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Sygnature Discovery

JANUARY 26, 2024

Leveraging years of experience, we efficiently advance your compounds through preclinical studies and reduce risks as you move into clinical development. Our talented team of scientists can assist you in crafting robust pre-clinical development strategies.

Process Chemistry 52

Process Chemistry Pharmacokinetics Clinical Development Laboratories 52

Drug Target Review

APRIL 22, 2024

What are the primary methods used for bioconjugation in antibody drug-conjugate (ADC) development, and how do they influence the stability and efficacy of the resulting ADCs? Site-specific conjugation methods are primarily utilised for a significant portion of ADCs in clinical developments.

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Pharmacokinetics Organic Chemistry Drugs Engineering 75

Drug Discovery World

JUNE 27, 2023

This gap exists between fundamental drug discovery biology programmes and the generation of defined and optimised candidate drug molecules that have the potential to attract the commercial partnerships required to support formal clinical development programmes.

Medical Chemistry 130

Medical Chemistry Drugs Pharmacokinetics Science 130

Drug Discovery World

DECEMBER 14, 2023

“We are thrilled to see this level of clinical activity in such a heavily pre-treated patient population,” said John Houston, Chairperson, Chief Executive Officer and President at Arvinas. Vepdegestrant is the only PROTAC ER degrader in late-stage clinical development.

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Drug Discovery World

APRIL 3, 2024

million from the Spanish Research Agency (AEI), under the call for grants for Public-Private Collaboration Projects, to accelerate the development of an innovative treatment aimed at controlling disabling and lethal haemorrhage.

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Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Watch the video. Watch it now. The Altascientist : Issue No.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. 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

JUNE 6, 2023

Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy. We are currently selecting our lead IL-18 variant on the basis of potency for the IL-18 receptor, optimal pharmacokinetic profile and in vivo efficacy for inhibiting tumour growth.

Engineering 98

Engineering Immune Response Biochemical Pharmacology Clinical Trials 98

The Pharma Data

OCTOBER 27, 2020

Sirnaomics is the only biopharma conducting R&D and clinical development in the field of RNAi therapeutics in both the U.S. Primmune aims to advance the development of their novel orally-administered, small molecule toll-like receptor 7 agonists as therapeutic-adjuvants for acute viral diseases and cancer.

Small Molecule 52

Small Molecule Immune Response Pharmacokinetics Clinical Development 52

Sygnature Discovery

NOVEMBER 29, 2023

It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists. The Phase 1a clinical trial involves a small group of patients who will be given carefully monitored doses of the drug.

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 52

Advarra

JUNE 20, 2023

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 Typical clinical development timelines for anticancer drugs average an estimated 6.7

Trials 52

Trials Clinical Trials FDA Approval Animal Testing 52

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.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

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. ‘SEFA’ stands for Structurally Engineered Fatty Acid, i.e. chemically engineered fatty acids, to generate compounds with differentiated physiochemical properties.

Trials 40

Trials Engineering Pharmacokinetics Therapies 40

Sygnature Discovery

NOVEMBER 29, 2023

It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists. The Phase 1a clinical trial involves a small group of patients who will be given carefully monitored doses of the drug.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40

The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. The study will be conducted in South Africa. For more information, visit www.scynexis.com.

Hospitals 52

Hospitals Pharmacokinetics Clinical Trials Treatment 52

Drug Discovery World

AUGUST 14, 2024

The first subjects have been dosed in two separate Phase I clinical trials evaluating the safety, tolerability, and pharmacokinetics of Sionna Therapeutics’ SION-719 and SION-451 in healthy volunteers.

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Trials Clinical Trials Pharmacokinetics Clinical Development 130

The Pharma Data

NOVEMBER 5, 2021

About the study NCT03832114 is a Phase II, open- marker, two cohort,non-randomized study assessing the efficacity, safety and pharmacokinetics of iptacopan in cases with C3 glomerulopathy (C3G) ( cohort A) and cases who have experienced order transplantation and have posterior C3G rush in the transplanted organ ( cohort B).

Disease 52

Disease Pharmacokinetics Treatment FDA 52

PPD

MAY 11, 2023

Historically, the elderly have been under-represented in clinical trials that include study participants 18 years of age and older. However, due to the pharmacokinetic and pharmacodynamic physiological changes that come with age and the presence of multi-morbidity, this type of extrapolation is not entirely appropriate.

Vaccine 52

Vaccine Clinical Trials Long-Term Care Facilities Trials 52

The Pharma Data

NOVEMBER 9, 2021

We ’re agitated to partake data from our robust clinical development programs at AASLD’s The Liver Meeting ®, including the rearmost data demonstrating the positive impacts of bulevirtide for people living with HDV.”.

Disease 52

Disease Clinical Trials Treatment Pharmacokinetics 52

The Pharma Data

APRIL 11, 2023

Bayer will present the first clinical Phase 1 results on aryl hydrocarbon receptor (AhR) inhibitor BAY 2416964, the company’s most advanced Immuno-Oncology program. The company has the passion and determination to develop innovative medicines that help improve and extend the lives of people living with cancer.

Research 40

Research Clinical Trials Small Molecule Pharmacokinetics 40

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.

FDA 52

FDA Trials Pharmacokinetics Pharmaceuticals 52

The Pharma Data

AUGUST 19, 2021

Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “We 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 In 2018, Janssen Biotech, Inc.

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

Drug Discovery World

MAY 12, 2023

FSD Pharma has dosed the first cohort of patients in its Phase I clinical trial evaluating Lucid-MS for the treatment of multiple sclerosis (MS). Lucid-MS is a patented first-in-class, new chemical entity and a neuroprotective compound with a novel mechanism of action for the treatment of MS.

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Trials Clinical Trials Pharmacokinetics Clinical Development 221

The Pharma Data

JANUARY 3, 2021

The Phase 1/2 clinical trial will primarily investigate the safety and tolerability of INZ-701 and characterize its pharmacokinetic and pharmacodynamic profile, including plasma pyrophosphate (PPi) and other biomarker levels, to establish a recommended dosing regimen for further clinical development.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

Drug Discovery World

DECEMBER 13, 2023

It demonstrated a differentiated in vitro activity profile across several assays compared with small molecule and antibody inhibitors of CD73 in clinical development. Cidara is currently advancing its dual CD73/PD-1 inhibitor DFC and CBO421 in preclinical studies.

Small Molecule 130

Small Molecule Biosimilars Pharmacokinetics Drugs 130

PPD

SEPTEMBER 19, 2023

Whichever route a company takes, deliberate decision-making around the nature and timing of early phase studies is important to manage risks in the clinical development process. Benefits of Early Drug Development Services Early development studies include many elements that set them apart from those in later development.

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Clinical Trials Pharmacokinetics Clinical Development Drug Development 98

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 40

Science FDA Clinical Trials Pharmacy 40

Drug Discovery World

JANUARY 31, 2024

Onward Therapeutics has announced the Phase I clinical trial of OT-A201, a first-in-class bispecific antibody targeting two immune checkpoints is in progress. With the drug development expertise and successful track records of the Onward Therapeutics team, we have moved forward from the cell line development, scale up, 1,000-litre?

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The Pharma Data

JANUARY 3, 2021

The pharmacokinetics of nasally administered Foralumab will also be evaluated. Patient reported outcome to assess clinical responses related to COVID-19 symptoms, as per the FDA guidelines, will also be collected.

Clinical Trials 40

Clinical Trials Science Treatment Trials 40

The Pharma Data

OCTOBER 25, 2020

In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.

Treatment 52

Treatment Trials FDA Hospitals 52

Drug Discovery World

MAY 19, 2023

The study aims to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of KNS366 in healthy adult participants. We are not aware of any other KMO inhibitors in clinical development and look forward to generating data in humans with this first-in-class mechanism.

Pharmacokinetics 130

Pharmacokinetics Clinical Development Clinical Trials Trials 130

Drug Discovery World

APRIL 17, 2023

The Phase I clinical trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TOS-358 as a single agent in 241 trial participants with select solid tumours. The study will be conducted in two parts.

Clinical Trials 130

Clinical Trials Pharmacokinetics Trials Clinical Development 130

Drug Discovery World

OCTOBER 11, 2023

The secondary objective is to evaluate the pharmacokinetics of SAD and MAD dose levels to identify a maximum tolerated dose (MTD) and identify recommended doses for further clinical development.

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Drug Discovery World

JANUARY 4, 2024

In the study, ANX1502 achieved target serum levels and demonstrated pharmacokinetic (PK) measures that support advancement into a proof-of-concept clinical study to assess pharmacodynamics (PD) and efficacy in patients with cold agglutinin disease (CAD) in 2024.

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Small Molecule Pharmacokinetics Clinical Development Disease 130