Alta Sciences

OCTOBER 30, 2023

Discover the considerations and assessments necessary for performing preclinical research for ophthalmic therapies in this new eBook, that covers everything you need to know, from species selection and routes of administration, to preparing for first-in-human trials. Watch the video. Listen here. Watch it now. The Altascientist : Issue No.

Science 52

Science Clinical Trials Pharmacokinetics Clinical Pharmacology 52

The Pharma Data

APRIL 11, 2023

Bayer is progressing novel research around its prostate cancer treatment darolutamide. 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.

Research 40

Research Clinical Trials Small Molecule Trials 40

The Pharma Data

DECEMBER 14, 2020

Preclinical research suggests that this antibody against the target can potentially address the existing pandemic, as well as escape mutants. . The Phase I trial is a randomized, double-blind, placebo-controlled study that is meant to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending doses of ABBV-47D11.

Licensing 52

Licensing Licensing Pharmacokinetics Clinical Trials 52

The Pharma Data

NOVEMBER 11, 2020

These data provide further evidence of efficacy and high potency of SLV213 against SARS-CoV-2 and support the clinical development of SLV213 as a potential oral treatment for COVID-19,” said Ted Daley, President and CEO, Selva Therapeutics. “As Cofounder and Chief Scientific Officer of Selva Therapeutics. About SLV213.

Treatment 52

Treatment Small Molecule Virus Pharmacokinetics 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 FDA Approval Pharmacokinetics Drug Development 52

The Pharma Data

MARCH 5, 2021

Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. Secondary endpoints include duration of response (DOR), overall survival (OS), safety, and pharmacokinetics (PK). Overall Response Rate (ORR) and Duration of Response, as determined by appropriate histology-specific response criteria).

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials Therapies 52

The Pharma Data

DECEMBER 21, 2020

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.

Clinical Trials 40

Clinical Trials Trials Pharmacokinetics Clinical Development 40

The Pharma Data

OCTOBER 27, 2020

AavantiBio’s strategic partnership with University of Florida’s Powell Gene Therapy Center provide their foundational research in rare genetic disorders. Sirnaomics is the only biopharma conducting R&D and clinical development in the field of RNAi therapeutics in both the U.S. The company’s $27.4 Source link.

Small Molecule 52

Small Molecule Immune Response Therapies Clinical Development 52

Advarra

JUNE 20, 2023

According to a 10-year oncology research study conducted by the Biotechnology Innovation Organization (BIO), only 5.1% 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

Trials 52

Trials Clinical Trials FDA Approval Therapies 52

The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. Use of Retevmo for these indications is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 12 years and older.

Research 52

Research Treatment Therapies Trials 52

PPD

MAY 11, 2023

The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when. Sharing information about the research, including risk and benefits, tailored to the patient’s level of understanding.

Vaccine 52

Vaccine Clinical Trials Long-Term Care Facilities Trials 52

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. Asia, and Europe.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

The Pharma Data

APRIL 8, 2021

“We are proud to collaborate with patient advocates, academia, industry and the broader healthcare community through cutting-edge research and partnerships to advance the scientific understanding of neurological conditions, which have historically been among the hardest disorders to study, diagnose and treat.”. Spinal Muscular Atrophy (SMA).

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

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 Treatment Pharmacokinetics FDA 52

The Pharma Data

JANUARY 3, 2021

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. Exploratory objectives include obtaining baseline measurements of calcification, patient reported outcomes and quality of life.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

Drug Target Review

JULY 1, 2024

SRP-001 is a novel non-opioid pain relief candidate that works centrally in the brain, offering robust pharmacokinetics without the adverse effects of current medications. He is spearheading the scientific and clinical development and fundraising of South Rampart Pharma and technology development efforts.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

The Pharma Data

AUGUST 19, 2021

FACP, Director of the Virginia Cancer Specialists Research Institute, Co-Chair U.S. 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.

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

DECEMBER 15, 2020

Researchers are aware of more than 80 diseases that occur when the immune system attacks the body’s own organs, tissues and cells. Many drug makers are investing in new science and hope to develop new therapeutics that address autoimmune disease. Treatment induced sustainable clinical responses and reduced systemic inflammation.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

DECEMBER 29, 2020

(NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases , a business unit of Chiesi Farmaceutici S.p.A., About Chiesi Group.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

JANUARY 10, 2021

“We expect 2021 will mark a number of key clinical and commercial milestones. By the end of the year, we expect to have five independent TransCon product candidates in clinical development leveraging TransCon technologies through our algorithm for product innovation. Pipeline Updates. •. .

Clinical Trials 40

Clinical Trials Clinical Development Trials Small Molecule 40

The Pharma Data

NOVEMBER 4, 2020

Key findings of the research showed that patients with alopecia areata suffer significantly increased burden of illness, including a negative impact on many aspects of daily life, extending considerably beyond the cosmetic concerns of hair loss. Research and development expenses were $16.3 R&D Expenses. .

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Treatment 52

The Pharma Data

AUGUST 29, 2020

3,4 LNP023 is currently in clinical development for PNH and a number of renal conditions with complement system involvement where significant unmet needs exist, including IgA nephropathy, complement 3 glomerulopathy (C3G), atypical hemolytic uremic syndrome and membranous nephropathy.

Treatment 52

Treatment Disease Small Molecule Production 52

Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. Of the other three comments on the Citizen Petition docket, one supportive comment came from researchers who conducted studies supportive of the petitioner’s assertion of lack of symptomatic efficacy for phenylephrine.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

OCTOBER 18, 2020

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML.

Clinical Trials 40

Clinical Trials Small Molecule Trials Therapies 40

The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Treatment 52

Treatment Disease Therapies Pharmaceuticals 52

The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

Production 40

Production Trials Treatment Disease 40

The Pharma Data

DECEMBER 13, 2020

The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. Harrison, MD, Director, Summit Clinical Research. The Phase 2b trial is expected to begin during the second half of 2021.

Trials 40

Trials Disease Treatment Pharmacokinetics 40

Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Read AgencyIQ’s extensive analysis of the draft guidance here.]

Science 40

Science FDA Production Trials 40

PPD

APRIL 14, 2025

Medical researchers and practitioners see in their own patients how these ailments interconnect and overlap, as do the pharmaceutical and biotech companies working to develop GLP-1 therapeutics. Were applying that expertise and commitment to every aspect of developing and running successful GLP-1 studies.

Clinical Trials 52

Clinical Trials Trials Clinical Development Disease 52

The Pharma Data

JULY 21, 2021

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). Our Commitment to HIV.

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials International 52

Drug Target Review

OCTOBER 16, 2024

It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinical development process.

Clinical Development 52

Clinical Development Drug Development Therapies Disease 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 Science 52

The Pharma Data

OCTOBER 14, 2020

AOP anticipates new opportunities in Austria as a hub for research and business. Priothera will use the funds to progress the clinical development of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogeneic hematopoietic stem cell transplantation (HSCT) for treating AML.

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Therapies 52

Agency IQ

SEPTEMBER 22, 2023

When looking at all drugs approved between 2011 and May 2020, 136 drugs were approved on the basis of a single pivotal trial, according to AgencyIQ’s research. 7) Evidence from expanded access use of an investigational drug can serve as confirmatory evidence even though the purpose of these programs is not primarily for research.

FDA 40

FDA Science Trials Clinical Trials 40

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. Most Read Today.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

Sygnature Discovery

NOVEMBER 29, 2023

QN-302 has been conceived to work by selectively stabilizing G-quadruplex complexes prevalent in the promoter region of cancer-related genes in many tumor types, impeding the function of these cancer genes, and may therefore potentially offer a tumor-selective clinical approach to treatment. Qualigen Therapeutics’ Chief Medical Officer.

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 52

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. Reese, executive vice president of Research and Development at Amgen.

FDA 52

FDA Trials Therapies Pharmaceuticals 52