Drug Discovery World

DECEMBER 14, 2023

PROTAC ER degrader vepdegestrant Arvinas and Pfizer presented interim data from a Phase Ib trial of vepdegestrant, a novel oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in combination with palbociclib (Ibrance). The data revealed an overall response rate of 42% and median progression-free survival of 11.1

Therapies 130

Therapies Trials Pharmacokinetics Treatment 130

Drug Discovery World

DECEMBER 4, 2023

Qnovia has announced positive results from its first in-human study of QN-01, an inhaled smoking cessation therapy. QN-01 is designed to meet the urgent need for new safe and effective pharmacotherapies that address the shortcomings of currently available nicotine replacement therapies (NRTs).

Therapies 130

Therapies Treatment Pharmacokinetics Clinical Development 130

Drug Discovery World

JUNE 26, 2024

Spinogenix has initiated a Phase II trial to evaluate SPG302 for the treatment of adult participants with mild-to-moderate Alzheimer’s disease (AD), following approval for the trail in Australia. The study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of SPG302 in adult AD participants.

Small Molecule 189

Small Molecule Pharmacokinetics Drugs Clinical Trials 189

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 21, 2022

Biopharmaceutical company Rezolute has initiated a Phase II proof-of-concept study for RZ402, a plasma kallikrein inhibitor (PKI) being developed as an oral therapy for the treatment of diabetic macular oedema (DMO). . The post Oral therapy for diabetic macular oedema progresses to Phase II appeared first on Drug Discovery World (DDW).

Therapies 130

Therapies Pharmacokinetics Clinical Development Treatment 130

Drug Discovery World

DECEMBER 22, 2023

Neuroscience drug discovery company Sapient Therapeutics successfully completed Part B of the Phase I trial comparing its CBD therapy SAP021 with Epidiolex. When SAP021 was given with food the data were in alignment with both our expectations from Part A of the study and with previously published trial results.

Pharmacokinetics 130

Pharmacokinetics Clinical Development FDA Trials 130

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).

Treatment 130

Treatment Clinical Trials Pharmacokinetics Trials 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

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

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

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

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. Tags Clinical Trials Weight 1

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52

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. Read it now. The Altascientist : Issue No. The Altascientist : Issue No. Read or listen now. Watch the video. Read the fact sheet. Read or listen now.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

Drug Discovery World

MARCH 10, 2023

“Enfortumab vedotin has become a second- and third-line treatment option for many patients around the world with previously treated locally advanced or metastatic urothelial cancer, and an approval in China may bring this therapy to those patients.”

Pharmacokinetics 130

Pharmacokinetics Drugs Licensing Licensing 130

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. . However, challenges remain.

Pharmaceutical Companies 130

Pharmaceutical Companies Drugs Pharmaceuticals 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 52

Clinical Trials Treatment Trials Small Molecule 52

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

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., The findings from this landmark real-world study align with the positive impact that I have seen in my own patients treated with IBRANCE combination therapy.”.

Therapies 52

Therapies Clinical Trials Trials Treatment 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 40

Clinical Trials Treatment Trials Small Molecule 40

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

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.

Vaccine 52

Vaccine Therapies Immune Response Disease 52

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

The Pharma Data

OCTOBER 15, 2020

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. James Miessler. Source link.

Disease 52

Disease Small Molecule Pharmacokinetics 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. 19, 2020 09:00 UTC. SEFA-1024 is one of NST’s three SEFA programs. NST’s lead program, icosabutate, is currently in a phase 2b ‘ICONA’ study for the treatment of NASH.

Trials 40

Trials Engineering Pharmacokinetics Therapies 40

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 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

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

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. “We

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

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

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. Eplontersen , sold under the brand name Wainua , is a medication used for the treatment of transthyretin-mediated amyloidosis. [1] 12 (1): 267–287.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

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. The trials are being conducted in Australia under the Clinical Trial Notification (CTN) process.

Trials 130

Trials Clinical Trials Pharmacokinetics Clinical Development 130

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. Jazz Pharmaceuticals has supplied the cannabidiol for the trials at no cost.

Clinical Trials 130

Clinical Trials Regulations Production FDA 130

Agency IQ

AUGUST 16, 2024

However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect. While the ability to describe and specify aspects of the therapy is limited, the agency can specify the number and licensure of therapists who would participate in the MDMA treatment.

FDA 40

FDA Trials Regulations Therapies 40

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

MAY 5, 2021

It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . Farxiga received fast track, breakthrough therapy and priority review designations for the current indication. . controlled trial had not received previous systemic therapy for metastatic disease.

FDA Approval 52

FDA Approval FDA Therapies Pharmacokinetics 52