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Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA 40

FDA Science Regulations Clinical Trials 40

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.

FDA 52

FDA Biosimilars Science Production 52

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

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June, we’re expecting to see what the FDA will allow life sciences companies to do in this fight as it releases a new draft guidance document.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.

FDA 40

FDA Science Regulations Production 40

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.

FDA 40

FDA Science Clinical Trials Trials 40

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.

FDA 40

FDA Science Regulations Production 40

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.

FDA 40

FDA Science Regulations Production 40

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.

Science 40

Science FDA Trials Clinical Pharmacology 40

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.

Pharmaceuticals 52

Pharmaceuticals Clinical Pharmacology Medical Schools Therapies 52

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 (..)

FDA 40

FDA Science Regulations Production 40

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.

Regulations 40

Regulations FDA Science Production 40

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.

Clinical Trials 40

Clinical Trials Trials Pharmaceutical Companies Clinical Pharmacology 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 particular this study focuses on the role of the arginine-ornithine-polyamine axis, which is highly upregulated in GBM.

Clinical Trials 40

Clinical Trials Drugs Trials Treatment 40

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.,

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

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.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

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.

FDA 40

FDA Clinical Trials Vaccine Trials 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

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.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Alta Sciences

JULY 25, 2024

Top 10 Life Science Resources for Summer 2024 pmjackson Thu, 07/25/2024 - 14:44 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 your convenience. Tags Science and Health Weight 16

Science 52

Science Clinical Trials Clinical Pharmacology FDA 52

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.

FDA 40

FDA Science Regulations Production 40

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 (..)

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

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.

FDA 40

FDA Science Biosimilars Clinical Trials 40

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

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 40

FDA Science Clinical Trials Regulations 40

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.

Drug Development 40

Drug Development Drugs Clinical Pharmacology Pharmaceuticals 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.

FDA 40

FDA Science Clinical Trials Regulations 40

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.

Regulations 40

Regulations FDA Science Production 40

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.

Drug Development 52

Drug Development Regulations Laboratories FDA 52