Drug Discovery World

APRIL 3, 2024

We will now complete efficacy, toxicity, pharmacodynamic and pharmacokinetic studies in several preclinical models required by regulatory agencies. Obtaining these results will allow us to reach a key milestone of the project: approval from the health authorities to test CM-352 in a Phase I clinical trial.

Therapies 130

Therapies Laboratories Pharmacokinetics Treatment 130

Drug Discovery World

DECEMBER 14, 2023

Vepdegestrant is currently being evaluated as a monotherapy in the second-line setting in the ongoing Phase III VERITAC-2 trial and in the first-line setting in combination with palbociclib in the ongoing study lead-in cohort of the Phase III VERITAC-3 trial. The results show a 25.1%

Therapies 130

Therapies Trials Pharmacokinetics Treatment 130

Drug Discovery World

FEBRUARY 2, 2024

Sunday 4 February is World Cancer Day, an international awareness day led by the Union for International Cancer Control (UICC), so the round-up this week will focus on oncology, including the UK approval of a rare blood cancer drug and a novel production process for CAR-T therapies.

Pharmacokinetics 130

Pharmacokinetics Drugs International Clinical Trials 130

Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions. Click to learn more!

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52

Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 52

Drug Discovery World

SEPTEMBER 6, 2022

Avacta has an ongoing Phase I clinical trial to assess the safety and pharmacokinetics of AVA6000, which has potential as a treatment for patients with a range of cancer types. Despite the successful advancement of localised therapies, such as surgery and radiotherapy, these tumours can recur, often with metastatic disease. .

FDA 130

FDA Pharmacokinetics Drugs Clinical Trials 130

Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40

Alta Sciences

OCTOBER 30, 2023

TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. The Altascientist : Issue No. Read or listen now. Read the fact sheet. Read or listen now. Watch it now. The Altascientist : Issue No.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

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.

Small Molecule 130

Small Molecule Trials Pharmacokinetics Treatment 130

The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

Drug Discovery World

SEPTEMBER 26, 2022

A report by the medical charity LifeArc 1 puts the timeframe for a therapy brought to market through repurposing methods at anywhere from one to three years. Indeed, having a safety profile already established could entice patients to enter clinical trials more readily than with ‘unknown’ compounds. . Diving into data .

Pharmaceutical Companies 130

Pharmaceutical Companies Drugs Pharmaceuticals Clinical Trials 130

Drug Discovery World

NOVEMBER 29, 2022

This ranges from understanding disease processes and identifying possible drug targets, to organising testing, rolling out clinical trials, negotiating complex regulations and licensing and finally, treating patients. Pharmacokinetics: How the body handles drugs. Providing a broad view. Starting with the drug.

Clinical Pharmacology 130

Clinical Pharmacology Clinical Trials Drugs Drug Development 130

DrugBank

MARCH 7, 2024

Moreover, Novo Nordisk and Eli Lilly are expected to unveil new clinical trial data that could highlight additional health benefits of their drugs beyond weight loss and diabetes management, potentially paving the way for broader insurance coverage. While challenges persist, the weight loss drug boom shows no signs of waning.

Pharmaceutical Companies 82

Pharmaceutical Companies Pharmaceuticals Clinical Trials Pharmacokinetics 82

PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

Laboratories 52

Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

Advarra

JUNE 20, 2023

Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. cell and gene therapies), with other therapeutic areas then pushing it further. Barriers to Enrollment Recent findings indicate significant barriers to enrolling patients remain in clinical trials.

Trials 52

Trials Clinical Trials FDA Approval Animal Testing 52

Drug Discovery World

JUNE 29, 2023

To mark the occasion, this article summarises the most recent news about the ways drug discovery is improving wellbeing and mental health through innovative new treatments and therapies. The Phase IIa proof-of-concept trial will evaluate short-term changes in anxiety-related patient reported outcomes in approximately 50 healthy volunteers.

Drugs 130

Drugs Pharmacokinetics Trials FDA 130

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. ” About Hepion Pharmaceuticals.

Clinical Trials 40

Clinical Trials Pharmaceuticals Trials Pharmacokinetics 40

The Pharma Data

MARCH 25, 2021

Real-world evidence is woven into the fabric of how we innovate and advance care for patients with breast cancer, supporting our randomized clinical trials,” said Chris Boshoff, M.D., However, this observational analysis differs from the randomized clinical trial in several ways. Since the initial approval by the U.S.

Therapies 52

Therapies Clinical Trials Trials Treatment 52

Drug Discovery World

AUGUST 22, 2023

So, there is a huge potential for generics companies to take the lead in relieving this burden and driving sustainable access to advanced therapies, particularly for currently underserved patient populations. These advanced therapies are transforming the medical landscape and are emerging as the future of patient care.

Production 130

Production Pharma Companies Clinical Trials FDA 130

The ChEMBL-og

APRIL 16, 2024

The data in MOLECULE_DICTIONARY.MAX_PHASE now includes consideration of: EMA approved drugs (max_phase=4 for human drugs), USAN clinical candidate drugs (assigned as max_phase = 1 based on USAN guidance that states “Firms usually apply for a USAN when the investigational therapy is in Phase I or Phase II trials”.

Clinical Trials 108

Clinical Trials FDA Cell Based Assays Packaging 108

Drug Target Review

JUNE 6, 2023

We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. For the last several years, the field has worked to unlock the potential of IO therapies for additional tumour types, and has explored options beyond checkpoint inhibitors.

Engineering 98

Engineering Immune Response Biochemical Pharmacology Clinical Trials 98

New Drug Approvals

DECEMBER 24, 2023

“Characteristics of Patients with Hereditary Transthyretin Amyloidosis-Polyneuropathy (ATTRv-PN) in NEURO-TTRansform, an Open-label Phase 3 Study of Eplontersen” Neurology and Therapy. 12 (1): 267–287. doi : 10.1007/s40120-022-00414-z. PMC 9837340. PMID 36525140. Coelho, Teresa; Marques, Wilson; Dasgupta, Noel R.; PMC 10540057.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

Drug Target Review

JUNE 12, 2023

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?

Metabolic Stability 92

Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

The Pharma Data

APRIL 11, 2023

Bayer is advancing its oncology R&D efforts in three scientific areas that have the potential to address unmet needs in cancer patients: next-generation Immuno-Oncology, Targeted Radionuclide Therapies and Precision Molecular Oncology. Data from all three areas of scientific focus will be showcased during this year’s meeting.

Research 40

Research Clinical Trials Small Molecule Pharmacokinetics 40

Drug Discovery World

AUGUST 3, 2023

Significantly, in January 2023, the FDA finalised a 2020 draft guidance outlining how sponsors and investigators can conduct clinical trials for certain drugs containing cannabis or cannabis-derived compounds without running afoul of federal law 2.

Clinical Trials 130

Clinical Trials Regulations Production FDA 130

The Pharma Data

JANUARY 3, 2021

Dr Thais Moreira, the lead scientist and coordinator of the clinical trial, stated: “We are delighted to receive positive feedback from patients treated in the clinical trial. The pharmacokinetics of nasally administered Foralumab will also be evaluated.

Clinical Trials 40

Clinical Trials Science Treatment Trials 40

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.

Therapies 246

Therapies Virus Treatment Engineering 246

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.

Clinical Trials 130

Clinical Trials Trials Treatment Pharmacokinetics 130

The Pharma Data

NOVEMBER 5, 2020

As we had previously indicated, we believe an SVR24 rate of at least 15% would have marked a meaningful first advance in HBV finite therapy, but preliminary results have shown that we will fall short of that mark. ABI-H0731 is a first-generation core inhibitor that is typically administered with NrtI therapy. Assembly Biosciences, Inc.

Virus 40

Virus Clinical Trials Therapies Pharmacokinetics 40

The Pharma Data

DECEMBER 15, 2020

16, 2020 (GLOBE NEWSWIRE) — Arecor Limited (“Arecor” or “the Company”), the biopharmaceutical company advancing today’s therapies to enable healthier lives, today announces that Diabetes Care has published data for the Phase I clinical trial of AT247, its ultra-rapid acting insulin product candidate.

Pharmacokinetics 40

Pharmacokinetics Clinical Trials Therapies Trials 40

The Pharma Data

DECEMBER 13, 2020

About 15 to 20% of breast cancers cases are HER2+, and antibody-based therapies targeting HER2 have significantly improved outcomes of patients with HER2+ breast cancer. That collaboration was to develop and commercialize four oncology antibody biosimilar therapies. But metastatic breast cancer is still an unmet need.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

The Anticancer Fund

APRIL 1, 2022

Top story Inflammatory fibroblasts mediate resistance to neoadjuvant therapy in rectal cancer Published in Cancer Cells Inflammatory cancer-associated fibroblasts (iCAFs) are associated with poor chemoradiotherapy response in rectal cancer. A small phase I clinical trial (NCT04942626) is testing this hypothesis in rectal cancer patients.

Clinical Trials 40

Clinical Trials Drugs Trials Pharmacokinetics 40

The Pharma Data

MARCH 22, 2021

GENERATION HD1 is the largest clinical trial in Huntington’s disease to date and we do know that the data generated will significantly advance our understanding of huntingtin-lowering as a potential treatment approach. About tominersen and the clinical trials. said Levi Garraway, M.D., About Roche in Neuroscience.

Disease 52

Disease Clinical Trials Pharmacokinetics Licensing 52

The Pharma Data

JULY 6, 2021

New research from first-in-class marketed and investigational therapies in hemophilia, immune thrombocytopenia and acquired thrombotic thrombocytopenic purpura will be presented. Sanofi’s two marketed extended half-life factor replacement therapies shifted a two-decades-old treatment paradigm when launched in 2014.

Pharmacokinetics 52

Pharmacokinetics Therapies RNA Treatment 52

Drug Target Review

OCTOBER 24, 2023

Could you elaborate on the drug being developed by Microbiotica to stimulate cancer patients to respond favourably to immune checkpoint inhibitor therapy? It is likely the combination of these mechanisms of action that will make MB310 an effective therapeutic. How does it work and what are the potential benefits?

Treatment 122

Treatment Pharmacokinetics Pharmaceuticals Production 122

Drug Discovery World

SEPTEMBER 9, 2024

Study details The Phase I study was a two-part trial in 78 healthy volunteers investigating safety, tolerability, pharmacokinetics and pharmacodynamic target engagement endpoints across a range of separate dose levels.

Treatment 147

Treatment Pharmacokinetics Small Molecule Trials 147

The Pharma Data

NOVEMBER 17, 2021

The EC’s blessing of VUMERITY is grounded on data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA to establish bioequivalent exposure of monomethyl fumarate, the active metabolite, and reckoned in part on the well- established long- term efficacity and safety profile of TECFIDERA. Encyclopedically, an estimated2.8

Treatment 52

Treatment Marketing Clinical Trials Biosimilars 52