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.”. About Gilead Sciences in Liver Disease. About Gilead Sciences. Gilead Sciences, Inc.

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Agency IQ

SEPTEMBER 22, 2023

The guidance concludes with a brief section on “process considerations” that strongly emphasizes the importance of rationalizing the chosen approach to establishing efficacy with high specificity early in the clinical development process. When should this occur? at the end-of-phase 2 meeting).

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Agency IQ

JULY 26, 2024

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling.

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Agency IQ

AUGUST 9, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time.

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Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical 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.

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Agency IQ

DECEMBER 11, 2023

The notice described FDA’s search for a vendor to “provide analyses in the development of physiologically-based pharmacokinetic (PBPK) models to determine the optimal safe and appropriate dose of oncology drugs for pregnant women with cancer.” In July, a new contract notice indicated that this is an area of interest for FDA as well.

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PPD

MAY 11, 2023

Having the protocol endorsed by an ethics committee with pediatric expertise or ensuring it takes advice in clinical, ethical and psychosocial problems in pediatrics. Placing the interests of the patient over those of science and society. Prohibiting any additional incentives or financial inducements beyond compensation.

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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. •. .

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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.

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The Pharma Data

DECEMBER 15, 2020

On top of this, another 8 million carry auto-antibodies, blood molecules that indicate a person’s chance of developing an autoimmune disease. Many drug makers are investing in new science and hope to develop new therapeutics that address autoimmune disease. The secondary outcome involves pharmacokinetic endpoints.

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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.

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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.

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The Pharma Data

DECEMBER 5, 2020

Senior Vice President, Translational & Clinical Sciences, Hematology at Regeneron. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. Andres Sirulnik , M.D.,

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The Pharma Data

SEPTEMBER 15, 2020

I am proud of the truly transformational science that our research and clinical teams are bringing to the fight against disease, as well as the unprecedented speed with which we are advancing our clinical programs in the battle against COVID-19. About Pfizer: Breakthroughs That Change Patients’ Lives.

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Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. When looking at several pharmacokinetic studies, the FDA found that the 10 mg oral dose of phenylephrine has a very low bioavailability of less than 1% and, subsequently, low systemic alpha-1 adrenergic activity.

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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. Late Breaking Oral Presentation OALC01LB03. Abstract 2361. Abstract 1914.

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The Pharma Data

APRIL 8, 2021

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. Roche is continuing to advance the science in MS and is exploring the investigational medicine fenebrutinib. P15: MS Clinical Trials and Therapeutics.

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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).

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Agency IQ

AUGUST 16, 2024

Another addition to FDA’s general advice is a recommendation for sponsors to engage early with the FDA “early in clinical development” (as opposed to “at relevant milestone meetings”).

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Alta Sciences

OCTOBER 30, 2023

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Watch the video. Watch it now.

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The Pharma Data

MAY 7, 2021

About the Sotrovimab Clinical Development Program. GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us. About Vir Biotechnology.

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The Pharma Data

MARCH 16, 2021

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Neuroscience is a major focus of research and development at Roche. and 10%, respectively), nasopharyngitis (21.7% and 16.7%, respectively), pyrexia (13.3% and 10%, respectively), vomiting (11.7%

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The Pharma Data

MARCH 30, 2021

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Neuroscience is a major focus of research and development at Roche. Evrysdi has been approved in 38 countries and submitted in a further 33 countries. About FIREFISH. The study met its primary endpoint.

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The Pharma Data

SEPTEMBER 1, 2020

“Alongside our industry-leading collaborators, we are investigating novel endpoints, brain volume and cognition, which may help to further our understanding of the safety and efficacy profile of Zeposia and can advance transformational science for multiple sclerosis patients experiencing this unpredictable, debilitating disease.”.

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The Pharma Data

SEPTEMBER 27, 2020

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. About Roche in Neuroscience Neuroscience is a major focus of research and development at Roche. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement.

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Agency IQ

JUNE 28, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. representative population.

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