The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

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 This means study startup times can vary greatly.

Trials 52

Trials Clinical Trials FDA Approval Therapies 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. The Many Considerations of Pediatric Vaccine Clinical Trials Childhood vaccines are highly effective in the prevention of many diseases.

Vaccine 52

Vaccine Clinical Trials Long-Term Care Facilities Trials 52

Drug Target Review

JUNE 6, 2023

However, the protein’s preclinical promise has not yet been replicated in clinical trials, where systemic administration is associated with dose-limiting toxicities and a narrow therapeutic index. Some approaches have already reached the clinical trial stage, with others not far behind.

Engineering 98

Engineering Immune Response Biochemical Pharmacology Clinical Trials 98

The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections.

Clinical Trials 52

Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies 52

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 Target Review

JULY 1, 2024

Overall, SRP-001’s modulation of pain signalling genes and pathways through endocannabinoid enhancement and FAAH inhibition supports its potential as an effective non-opioid pain therapeutic, validating the planned clinical trials. It addresses both acute and chronic pain, avoiding the addiction risks associated with opioids.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

The Pharma Data

MARCH 5, 2021

We are focused on quickly advancing the pirtobrutinib development program, including through a series of Phase 3 studies that will be initiated over the course of 2021.” About the BRUIN Phase 1/2 Trial. Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e.

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials Therapies 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. These results, along with a mathematical model-informed approach have supported the currently ongoing dose expansion for BAY 2416964.

Research 40

Research Clinical Trials Small Molecule Trials 40

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

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

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

Trials 40

Trials Clinical Trials Pharmacokinetics Small Molecule 40

PPD

JUNE 20, 2023

Go deeper with our experts on rebadging advantages and best practices in this Applied Clinical Trials article. We have you covered in our comprehensive overview of outsourced clinical trial models. The drug development industry is undoubtedly in a season of change. Does your CRO have a pulse on the issues?

Clinical Trials 52

Clinical Trials Drug Development Trials Clinical Research 52

The Pharma Data

DECEMBER 14, 2020

AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S. 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 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

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. million in 2015.

Small Molecule 52

Small Molecule Immune Response Therapies Clinical Development 52

Alta Sciences

APRIL 17, 2024

Our experts align the appropriate bioanalytical approach with the goals of the oligonucleotide drug development program, based on its size/type, the sensitivity and specificity required, as well as throughput needed based on the preclinical or clinical phase of the drug in development. Asia, and Europe.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 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 Small Molecule Trials 40

The Pharma Data

DECEMBER 15, 2020

SetPoint Medical received FDA Investigational Device Exemption (IDE) approval for a multicenter, double-blind, randomized, sham-controlled pivotal trial that will enroll up to 250 patients at 40 clinical trial sites in the U.S. The secondary outcome involves pharmacokinetic endpoints. Small Molecule Inhibitors.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

DECEMBER 9, 2020

SCYNEXIS has successfully completed preclinical testing of its liposomal IV formulation of ibrexafungerp and is advancing the program into human trials in healthy volunteers. The study will be conducted in South Africa. President and Chief Executive Officer of SCYNEXIS. For more information, visit www.scynexis.com. Forward Looking Statement.

Hospitals 52

Hospitals Pharmacokinetics Treatment Trials 52

Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40

Agency IQ

DECEMBER 11, 2023

So far in 2023, the Office has co-authored fifteen guidance documents—the majority of which were drafts—offering insight into the agency’s thinking on several key policy issues, such as clinical trial diversity and the accelerated approval pathway. These issues are especially apparent in treatments that are intended for chronic use.

FDA 40

FDA Science Clinical Trials Trials 40

The Pharma Data

OCTOBER 18, 2020

The 450mg starting dose in AML patients was selected because that dose, when administered to CLL patients being treated in a separate Phase 1 a/b trial, appeared safe, well tolerated and achieved plasma exposure levels that effectively inhibited phospho-FLT3 activity, which is a key driver of AML.”. Forward Looking Statements.

Small Molecule 40

Small Molecule Clinical Trials Trials Therapies 40

LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s).

Production 114

Production Small Molecule Regulations Trials 114

Agency IQ

SEPTEMBER 22, 2023

Traditionally, FDA has interpreted the need for “well-controlled investigations” to mean at least two clinical trials for new drugs, or applications for supplemental indications. The FDA has just elaborated on considerations for applications relying on a single clinical trial and confirmatory evidence in a new guidance document.

FDA 40

FDA Science Trials Clinical Trials 40

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]. 8] , [9] , [10] , [11] , [12]. **In

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

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

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

The Pharma Data

JULY 21, 2021

Islatravir (MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation in clinical trials for the treatment of HIV-1 infection in combination with other antiretrovirals, including the ILLUMINATE clinical trials program for once-daily treatment. Our Commitment to HIV.

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials International 52

Agency IQ

JUNE 9, 2023

However, nonclinical studies are not conducted exclusively before human trials begin; they usually continue throughout the early phases of clinical trials to further assess a product’s performance on different metabolic pathways and at different doses.

FDA 40

FDA Small Molecule Science Immune Response 40

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

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

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

The Pharma Data

SEPTEMBER 15, 2020

The company announced the initiation of its Phase 1b clinical trial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814. In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

The Pharma Data

APRIL 11, 2021

The Phase 1/2 LIBRETTO-001 trial is the largest clinical trial of patients with RET -driven cancers treated with a RET inhibitor. The trial, which spans 16 countries and 89 sites, included a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2). Retevmo (marketed as Retsevmo ® outside the U.S.)

Research 52

Research Therapies Treatment Trials 52

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. No Pharmacokinetic Interaction Between Novel NNRTI MK-8507 and Islatravir.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

MARCH 17, 2021

In adjuvant breast cancer trials, this includes the length of time before any cancer comes back, a new cancer develops or death. Secondary objectives include distant relapse-free survival, overall survival, safety, pharmacokinetics and health outcomes. Across clinical trials (MONARCH 1, MONARCH 2, MONARCH 3), 3.3%

Trials 52

Trials Therapies Treatment Pharmacokinetics 52