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! Read it now. The Altascientist : Issue No.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

New Drug Approvals

DECEMBER 24, 2023

“Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85” WHO Drug Information.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

The Pharma Data

FEBRUARY 15, 2022

– La te-breaking data from Cohort H of EV-103 trial to be presented at the 2022 ASCO Genitourinary Cancers Symposium –. Activity, tolerability of enfortumab vedotin support ongoing investigation in Phase 3 trials–. Half (50%) of all patients had a pathological downstaging, or reduction in tumor size, a secondary endpoint of the trial.

Clinical Pharmacology 52

Clinical Pharmacology Trials Treatment Therapies 52

Agency IQ

MAY 3, 2024

FDA’s Diversity Action Plan guidance: The FDA’s hotly-anticipated revised draft guidance document is currently under review at the White House’s Office of Information and Regulatory Affairs (OIRA), and we anticipate that it will be published over the next two months.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

DECEMBER 1, 2023

However, the revision provided much more detail given the amount of information on Covid-19 that was gained between May 2020 and February 2021. Further, a “trial should aim to minimize missing data” by distinguishing between discontinuation from the study drug and withdrawal from study assessments.

FDA 40

FDA Clinical Trials Vaccine Trials 40

Agency IQ

FEBRUARY 2, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires. Note: If a link no longer works, it is likely because OIRA has since deleted it.)

FDA 40

FDA Science Clinical Trials Regulations 40

The Pharma Data

OCTOBER 1, 2021

Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials show that response rates for deucravacitinib continued to extend through Week 24 and were maintained through Week 52 in patients with moderate to severe plaque psoriasis. CESTidentified through 52 weeks of knowledge.

Disease 52

Disease Laboratories Clinical Pharmacology Treatment 52

Agency IQ

MARCH 1, 2024

District Court March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires. FDA) FDA required to have resolved dispute with Vanda Pharmaceuticals or hold a hearing. Must also provide list of recommended documentation for AI contracts.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

SEPTEMBER 15, 2023

The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. 25 mg)” — such doses had been suggested in the Citizen Petition.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

OCTOBER 20, 2023

Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process. MAM technology (e.g.,

Science 40

Science Biosimilars FDA Production 40

The Pharma Data

MAY 2, 2022

Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package. For more information, please visit www.sagerx.com.

Treatment 52

Treatment Clinical Pharmacology Drugs Clinical Development 52

Agency IQ

JUNE 2, 2023

We’re expecting that there are a lot of companies that aren’t aware of this requirement, but we’re also expecting that this information will be hugely helpful to the FDA and its ability to even know what it regulates. government’s way of informing stakeholders of the regulations that are under active development.

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FDA Science Regulations Production 40

Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. We await to see what other biotransformation data emerges on synthetic macrocycles as more information is publicly disclosed as they advance through development. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. We await to see what other biotransformation data emerges on synthetic macrocycles as more information is publicly disclosed as they advance through development. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

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FDA Science Regulations Production 40

Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52

FDA Law Blog: Drug Discovery

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

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FDA Disease Clinical Pharmacology Science 105

The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52

Agency IQ

OCTOBER 6, 2023

AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. There’s also a requirement for the FDA to “promptly” post this information publicly.

FDA 52

FDA Biosimilars Science Production 52

Agency IQ

FEBRUARY 23, 2024

On the first day, discussants looked at how to tackle first-in human trials, weighed the importance of the maximum tolerated dose, and looked at the evolving concept of the clinical utility index. Read AgencyIQ’s analysis of the draft guidance document here , and the two FDA-ASCO meetings here and here.]

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Science FDA Trials Clinical Pharmacology 40

Alta Sciences

MAY 15, 2023

New technology has given us adaptive trial designs; novel drug delivery mechanisms; better understanding and integration of biomarkers, surrogate markers, imaging; and more, all of which are constantly evolving the landscape. And integration with our CDMO ensures the clinical trial drug product is available on time.

Drug Development 52

Drug Development Clinical Trials Compounding Pharmacies Laboratories 52

Agency IQ

FEBRUARY 12, 2024

to analyze data, generate summaries of certain information, or other tasks of interest to companies in the interest of efficiencies. A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

DECEMBER 11, 2023

For example, FDA’s Project Renewal was announced in 2021 as a concerted effort to update labeling information for “older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date.” These issues are especially apparent in treatments that are intended for chronic use. What’s ahead?

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. the drug and device) of the combination product.

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FDA Science Regulations Production 40

The Anticancer Fund

JUNE 7, 2022

This is another study that is strongly supportive of replication and further development, including clinical trial development. In both newly diagnosed and recurrent PDX models the drug was shown to be non-toxic and to have meaningful anti-GBM activity - including a survival benefit.

Clinical Trials 40

Clinical Trials Drugs Trials Treatment 40

The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] v] ERLEADA ® is being studied in five Phase 3 clinical trials. For more information about ERLEADA ® , visit www.ERLEADA.com. *©

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

The Pharma Data

DECEMBER 17, 2020

Patient enrollment of EXCELLENCE pivotal trial reaches 98%. The trial remains on-track to complete enrollment of all 500 patients in the United States and Australia before the end of 2020, despite the worsening of the COVID-19 pandemic. The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021.

Clinical Trials 40

Clinical Trials Trials Pharmaceutical Companies Clinical Pharmacology 40

New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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FDA Science Biosimilars Clinical Trials 40