Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Speak with an expert today to discuss your next clinical program. Watch the webinar.

Drug Development 40

Drug Development Clinical Trials Biosimilars Pharmacokinetics 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. Catch up on what you may have missed below! Watch the video. Watch it now. The Altascientist : Issue No.

Science 52

Science Clinical Trials Pharmacokinetics Clinical Pharmacology 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

DECEMBER 14, 2020

The product is designed for the prevention and treatment of COVID-19, along with related coronaviruses. AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S. ” Under the license agreement, the development of ABBV-47D11 will be greatly advanced.

Licensing 52

Licensing Licensing Pharmacokinetics Clinical Trials 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

Drug Target Review

OCTOBER 3, 2024

These assays may include pharmacokinetic (PK) assays, which provide information on the drug’s properties, and immunogenicity assays for the detection of anti-drug antibodies (ADA), which can lead to adverse events and reduced efficacy. References Köhler G, Milstein C. Journal of Molecular Biology. 2011 Oct 1;413(1):261–78.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. Food and Drug Administration cleared Investigational New Drug Application. BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

Alta Sciences

APRIL 17, 2024

Our preclinical and bioanalytical experts have extensive experience in leading-edge technologies to support sponsors in the advancement of their gene therapy products. Gene Therapy resources Watch our on-demand webinar, “ Nonclinical Safety Assessment for Gene Therapy Products ”. Asia, and Europe.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 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

The Pharma Data

JANUARY 10, 2021

10, 2021 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, will provide an update on Vision 3×3 and the company’s 2021 key milestones at the 39 th Annual J.P. COPENHAGEN, Denmark, Jan.

Clinical Trials 40

Clinical Trials Clinical Development Small Molecule Trials 40

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

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

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.,

Clinical Trials 52

Clinical Trials Disease Treatment Trials 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 Therapies 52

The Pharma Data

APRIL 8, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. “We Roche will present data from five studies from the EVRYSDI clinical development programme, which was designed to represent a broad spectrum of people living with SMA. P15: MS Clinical Trials and Therapeutics. Spinal Muscular Atrophy (SMA).

Clinical Trials 52

Clinical Trials Trials Disease Therapies 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.”. Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium. The Company plans to initiate a Phase 2 trial within the next several months.

Treatment 40

Treatment Trials FDA Hospitals 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

Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes. switching studies).

Biosimilars 40

Biosimilars Science FDA Production 40

PPD

MAY 11, 2023

Additionally, the European Medicines Agency offers guidance specific to the clinical investigation of medicinal products in pediatric populations. Historically, the elderly have been under-represented in clinical trials that include study participants 18 years of age and older.

Vaccine 52

Vaccine Clinical Trials Long-Term Care Facilities Trials 52

Agency IQ

SEPTEMBER 15, 2023

The monographs functioned as rule books for specific classes of OTC drugs, describing active ingredients, doses, indications, labeling and tests requires for covered OTC products to be generally recognized as safe and effective (GRASE). developing or amending a monograph) or sponsor-initiated operations (e.g.,

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

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

Metabolite Tales Blog

JANUARY 23, 2024

Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development. Momelotinib inhibits ACVR1/ALK2, decreases hepcidin production, and ameliorates anemia of chronic disease in rodents. Pharmacokinetics and Metabolism of Nirmatrelvir.

Small Molecule 52

Small Molecule FDA Approval FDA 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 Trials 40

Metabolite Tales Blog

APRIL 4, 2023

Tapinarof (3,5-dihydroxy-4-isopropylstilbene) is actually a natural product which was found serendipitously when investigating the secondary metabolites of Photorhabdus luminescens , a bioluminescent, Gram-negative bacillus, which lives symbiotically within a soil-living entomopathogenic nematode. 8 This is not the only point of interest.

Small Molecule 52

Small Molecule FDA Approval FDA Drugs 52

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. What programs or products need a DAP? Read AgencyIQ’s extensive analysis of the draft guidance here.]

Science 40

Science FDA Production Trials 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

DECEMBER 15, 2020

Anokion is responsible for preclinical activities and Phase I clinical development of partnered programs, and Bristol Myers Squibb will fund subsequent trials and commercial activities at clinical proof-of-concept. The secondary outcome involves pharmacokinetic endpoints. Receptor Inhibitors. Anti-CD40L Antibody.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

APRIL 11, 2021

There are no data on the presence of selpercatinib or its metabolites in human milk or on their effects on the breastfed child or on milk production. If coadministration cannot be avoided, follow recommendations for CYP2C8 and CYP3A substrates provided in their approved product labeling. About Lilly Oncology.

Research 52

Research Treatment Therapies Trials 52

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 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. Imeglimin , Poxel’s first-in-class lead product, targets mitochondrial dysfunction. NASH Investor Event Information.

Trials 40

Trials Disease Treatment Pharmacokinetics 40

The Pharma Data

JULY 21, 2021

There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties.

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

Agency IQ

JUNE 9, 2023

BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development? However, even the most innovative in vitro assays still present major limitations when it comes to fully understanding and assessing the risks of a product. Pivotal (i.e.,

FDA 40

FDA Science Small Molecule Immune Response 40

Agency IQ

SEPTEMBER 22, 2023

BY AMANDA CONTI, ALEXANDER GAFFNEY, MS, RAC SEP 18, 2023 9:24 PM CDT Background: FDA’s standards for evidence When seeking approval from the FDA, companies are required to demonstrate that their product is safe and effective when used as intended. In one landmark case, Warner-Lambert Co. When should this occur?

FDA 40

FDA Science Trials Clinical Trials 40

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.”. See below forU.S. Important Safety Information. Long- term Treatment With Vemlidy in HBV.

Disease 52

Disease Clinical Trials Treatment Science 52

Agency IQ

DECEMBER 11, 2023

BY RACHEL COE, MSC | DEC 6, 2023 5:27 PM EST The push and pull: Trends in oncology After the creation of the Accelerated Approval Pathway, several policies in the early 2000s were put in place with the goal of getting cancer products to patients faster. OCE has also been busy this year.

FDA 40

FDA Science Clinical Trials Trials 40

The Pharma Data

OCTOBER 14, 2020

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. Talking Medicines – Scotland’s Talking Medicines will join Tech Nation’s Applied AI 2.0

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Therapies 52