Alta Sciences

OCTOBER 9, 2024

Setnik in an exclusive interview , highlighting her contributions to the life sciences field, and deeper insights into her visionary leadership and expertise. Each winner represents progress toward a healthier future for everyone that is bolstered by science and technological advancements.

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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.

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Agency IQ

SEPTEMBER 15, 2023

FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. First, Cathy Gelotte, a clinical pharmacology consultant, made the case that low bioavailability does not necessarily indicate a lack of efficacy.

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Agency IQ

JULY 8, 2024

In early June, we’re expecting to see what the FDA will allow life sciences companies to do in this fight as it releases a new draft guidance document. Medical Misinformation : FDA Commissioner ROBERT CALIFF has been heavily focused for much of the last two years on what he calls the negative health effects of medical misinformation.

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The Pharma Data

NOVEMBER 9, 2020

Löbenberg is a director of XPhyto and is the founder and director of the Drug Development and Innovation Centre, Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Canada. XPhyto Therapeutics Corp. ON BEHALF OF THE BOARD. “Hugh Rogers” Hugh Rogers, CEO and Director.

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Agency IQ

FEBRUARY 23, 2024

I’m not going to say which one is better,” said JIANG LIU, scientific lead at the FDA’s Division of Pharmacometrics in the Office of Clinical Pharmacology. Then, a bit later but still in early-phase studies, developers can leverage this pharmacology information in innovative approaches that may incorporate modeling.

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The Pharma Data

DECEMBER 17, 2020

. The newly established subsidiary, InspirMed, will focus on inhalable liposomal treatments in both acute and chronic lung diseases. The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021. Cautionary Note on Forward-Looking Statements.

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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]

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Agency IQ

DECEMBER 11, 2023

Diagnostic and therapeutic advances in oncology have moved many cancer types into the categories of curable or treatable diseases. That’s why, according to FDA’s Oncology Center of Excellence, the determination of an appropriate endpoint in oncology is based on the specific disease and is highly dependent upon numerous factors.

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Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

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Agency IQ

JUNE 2, 2023

July 1, 2023 MDUFA Finalize the draft guidance, “Content of Premarket Submissions for Device Software Functions,” by 18 months from close of the comment period.

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Agency IQ

JUNE 16, 2023

This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat diseases or conditions and would harmonize, to the extent practicable and consistent with statutory provisions, with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies.

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Agency IQ

OCTOBER 6, 2023

Taking a closer look, nearly half of the products were reviewed by the Office of Oncologic Diseases. The largest portion of reviews after that were 14% (3 NMEs) each with the Office of Neuroscience and the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine.

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Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

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Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Agency IQ

JULY 28, 2023

The Centers for Disease Control and Prevention (CDC) explains that the first wave began with increased prescription of opioids in the 1990s. This proposal is an exciting example of how new approaches at the forefront of clinical pharmacology can be leveraged to address the problems being discussed in other forums (e.g.,

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Eye on FDA

JANUARY 5, 2022

And speaking of divergent outcomes – one of the most notable occurrences in 2020 was the number of resignations that occurred in the wake of FDA’s decision to approve Aduhelm for Alzheimer’s Disease after an overwhelming committee vote recommending the agency decline to approve.

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The Pharma Data

OCTOBER 15, 2020

Assembly Biosciences – Former Gilead Sciences CEO John McHutchison, currently president and CEO of Assembly, was named the recipient of the Advance 2020 Global Impact award. Prior to joining Inozyme, Sabbagh served as the head of rare renal and musculoskeletal diseases research at Sanofi. Farrell Simon joins Trevi as head of U.S.

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The Anticancer Fund

JUNE 7, 2022

This is another study that is strongly supportive of replication and further development, including clinical trial development. In particular this study focuses on the role of the arginine-ornithine-polyamine axis, which is highly upregulated in GBM.

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Agency IQ

SEPTEMBER 29, 2023

This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat diseases or conditions and would harmonize, to the extent practicable and consistent with statutory provisions, with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies.

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Agency IQ

DECEMBER 1, 2023

Comments on LDT Proposed Rule: On December 4, the comment period on the FDA’s Laboratory Developed Test proposed rule will close, and we will get a fuller picture of the extent to which the life sciences industry opposes the FDA’s proposal. This is already proving to be one of the FDA’s most-opposed actions in years.

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Agency IQ

DECEMBER 1, 2023

Following this announcement, the FDA developed a transition plan that explained what would happen to its extensive catalogue of PHE-related guidance documents, 60 of which were related to life sciences policy. The agency has also taken a stronger stance on enrolling patients with organ impairment.

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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.

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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.

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The Pharma Data

FEBRUARY 8, 2021

In our commitment to advance the science and treatment of prostate cancer, these findings will help inform our research efforts in developing novel approaches and combinatory regimens to improve outcomes for these patients.”. v] ERLEADA ® is being studied in five Phase 3 clinical trials. © National Comprehensive Cancer Network, Inc.

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Agency IQ

JULY 12, 2024

Specifically, FDA is proposing to classify blood irradiators intended for the prevention of transfusion-associated graft versus host disease into Class II and blood irradiators intended for prevention of metastasis by irradiating intra-operatively salvaged blood of cancer patients undergoing surgery into Class III.

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Drug Target Review

MARCH 25, 2025

A strategic pivot back to DDR The need to refocus on DDR extends beyond science it is driven by an urgent necessity in patient care. the perfect intersection of science & technology Several factors have aligned to make this an ideal moment to refocus on DDR.

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Drug Target Review

NOVEMBER 27, 2024

For example, the European Medicines Agency (EMA), in its Regulatory Science Strategy to 2025 , has highlighted the critical role of biomarker discovery, qualification and utilisation in accelerating precision medicine. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences. 2008 Aug 1;63(8):879–84.

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Drug Target Review

JANUARY 20, 2025

Basket Trials and the Evolution of Clinical Trial Design in an Era of Genomic Medicine. Journal of Clinical Oncology, 33 (9), 975977. Adaptive Clinical Trial Design in Oncology: An Overview. Clinical Pharmacology & Therapeutics, 86 (1), 97100. Barker, A. Food and Drug Administration. FDA.gov biotx.ai

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New Drug Approvals

APRIL 21, 2025

1] [6] [10] ATTR-CM is a rare and serious disease that affects the heart muscle. [6] “AG10 inhibits amyloidogenesis and cellular toxicity of the familial amyloid cardiomyopathy-associated V122I transthyretin” Proceedings of the National Academy of Sciences of the United States of America. 110 (24): 99929997. 1300761110.

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