Drug Discovery World

SEPTEMBER 14, 2023

Oral presentation at ASCO 2023 www.cancer.net/cancer-types/bladder-cancer/introduction#:~:text=Urothelial%20carcinoma%20(or%20UCC)%20accounts,that%20line%20 the%20urinary%20tract Loriot Y, et al. Prognostic value and clinical significance of FGFR genomic alterations (GAs) in metastatic urothelial cancer patients. J Clin Med.

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Treatment Clinical Pharmacology FDA Approval Therapies 130

New Drug Approvals

DECEMBER 24, 2023

2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] 7 March 2023. Archived from the original on 26 September 2023. Retrieved 21 December 2023 – via PR Newswire. February 2023). October 2023). 21 December 2023. 22 December 2023. Retrieved 22 December 2023.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

Alta Sciences

JUNE 14, 2023

Rapid High-Precision Flow Cytometry Solutions rmaloney Wed, 06/14/2023 - 14:00 HTML Customized Panels for Optimal Results Experience Altasciences’ exceptional flow cytometry services! We provide accurate cell counting, biomarker detection, and innovative protein engineering for your nonclinical and clinical studies. jpg Weight 3

Clinical Pharmacology 40

Clinical Pharmacology Engineering 40

Alta Sciences

SEPTEMBER 22, 2023

Mastering Drug Safety: Your Passport to Successful Pharmacology tchichekian Fri, 09/22/2023 - 13:36 HTML Navigating the Depths of Safety Pharmacology Altasciences can help you assess the impact of your therapeutic entity on vital organ systems before first-in-human trials begin.

Clinical Pharmacology 40

Clinical Pharmacology Drugs International Pharmaceuticals 40

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The Agenda is typically updated twice per year, and it was last released in early January 2023.

FDA 40

FDA Science Regulations Compliance 40

Alta Sciences

DECEMBER 14, 2023

A Closer Look At Our On-Site Compounding Pharmacies shajjar Thu, 12/14/2023 - 21:30 HTML Altasciences' dedicated pharmacists bring a wealth of expertise in controlled substances and complex compounding, ensuring maximum precision and safety standards. Electronic security access to the pharmacy and video monitoring. -

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Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

Drug Target Review

JULY 4, 2023

2022 Nov 14 [cited 2023 Apr 6];40(11):1255–63. Translational and Clinical Pharmacology [Internet]. 2022 [cited 2023 Feb 10];30(2):71. Clinical Pharmacology & Therapeutics. The therapeutic window of antibody drug conjugates: A dogma in need of revision. Cancer Cell [Internet]. 2021 Jul 8;110(5):1216–30.

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Drug Discovery World

NOVEMBER 8, 2023

On Day 1, Tuesday 14 November 2023, the tracks include: Display of biologics, antibody-based cancer therapies, safety and efficacy of bispecific antibodies, modulating the tumour microenvironment, optimisation and developability, and cell line and systems engineering. from engineered peptide and antibody libraries’.

Engineering 162

Engineering Protein Expression Therapies Science 162

Drug Discovery World

NOVEMBER 9, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Iain Moal, PhD, Scientific Leader, Computational Antibody Engineering, GSK, on: ‘Learning antibody binding affinity using FACS and NGS’.

Engineering 130

Engineering Protein Production Therapies Science 130

Agency IQ

MAY 3, 2024

12/29/2023 FDORA, Section 2512 Shortages : FDA must review its policies related to drug or biologic expiration dates and issue draft guidance or revise existing guidance on stability testing data in drug and biological product submissions. The guidance will include information for sponsors regarding both formatting and content.

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FDA Science Regulations 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 or listen now.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

Agency IQ

FEBRUARY 2, 2024

Medical device sterilization : Under a consent decree signed in August 2023, the Environmental Protection Agency (EPA) agreed to finalize its draft regulation on emission standards for ethylene oxide (EtO) by March 1, 2024. The documents describe all the guidance documents that are under development and that may be published in a given year.

FDA 40

FDA Science Clinical Trials Regulations 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.

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The Pharma Data

MAY 2, 2022

The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Sage Therapeutics, Inc. Nasdaq: SAGE) and Biogen Inc. Nasdaq: BIIB) initiated a rolling submission of a New Drug Application (NDA) to the U.S.

Treatment 52

Treatment Clinical Pharmacology Drugs Biosimilars 52

Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. On March 21, 2023, the CHPA issued a press statement applauding the FDA’s actions.

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Agency IQ

MARCH 1, 2024

12/29/2023 FDORA, Section 2512 Shortages : FDA must review its policies related to drug or biologic expiration dates and issue draft guidance or revise existing guidance on stability testing data in drug and biological product submissions. The guidance will include information for sponsors regarding both formatting and content.

FDA 40

FDA Science Clinical Trials Regulations 40

Metabolite Tales Blog

JULY 5, 2023

Drug Hunter article, June 2023. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S). Garcia Jimenez et al., 20 (March 20, 2014). Gangl et al.,

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Drug Hunter article, June 2023. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S). Garcia Jimenez et al., 20 (March 20, 2014). Gangl et al.,

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

Agency IQ

DECEMBER 1, 2023

BY RACHEL COE, MSC | NOV 27, 2023 8:24 PM CST FDA’s transition away from public health emergency (PHE)-related guidance documents The Covid-19 Public Health Emergency (PHE) was activated on January 31, 2020. In January 2023, the White House announced that the federal Covid-19 national emergency and PHE would officially end on May 11, 2023.

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FDA Clinical Trials Vaccine Trials 40

Agency IQ

JULY 28, 2023

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., AgencyIQ walks through the new projects below. Read the full AgencyIQ analysis here.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. AgencyIQ October 1 Nitrosamine testing due to FDA.

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FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Science Regulations Production 40

Agency IQ

DECEMBER 11, 2023

The FDA and oncology: 2023 year in review As we round the corner into the last few weeks of 2023, AgencyIQ has taken a look back at a very busy year for the FDA’s oncology staff, and for sponsors. OCE leadership and staff also kept AgencyIQ staff very busy in 2023 as they attended and presented at countless meetings.

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FDA Science Clinical Trials Trials 40

Alta Sciences

AUGUST 28, 2023

Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI) pmjackson Mon, 08/28/2023 - 14:04 Laval, Québec, August 30, 2023 – Altasciences is pleased to have completed a Phase I trial on Ischemix, Inc.’s Ischemix Inc. Learn more about the company at www.ischemix.com.

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Trials Treatment Clinical Pharmacology Pharmacokinetics 40

Alta Sciences

SEPTEMBER 20, 2023

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses pmjackson Wed, 09/20/2023 - 13:48 Laval, Québec, September 21, 2023 - Altasciences is pleased to have been chosen by Virpax Pharmaceuticals, Inc.

Virus 40

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Agency IQ

OCTOBER 6, 2023

FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms AgencyIQ analyzed CDER’s novel drug approvals in Fiscal Year 2023, identifying a recovery in approval numbers as the agency resumes a new normal following the pandemic. CDER approved 51 new molecular entities in FY 2023.

FDA 52

FDA Biosimilars Science Production 52

Agency IQ

FEBRUARY 12, 2024

In total, since August 2023, there have been 34 new guidances added to the agenda, 58 that have been carried over to the new calendar year, and 28 which were removed (most—but not all—of which were published since the last guidance agenda update). This week, CDER published its guidance agenda for 2024.

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Biosimilars Science Clinical Pharmacology FDA 40

Drug Discovery World

AUGUST 15, 2023

The pre-clinical pharmacological effects observed in such experimental model systems need to translate meaningfully into human clinical data to guide effective decision making in drug discovery. DDW Volume 24 – Issue 3, Summer 2023 References Scannell et al. Clinical Pharmacology & Therapeutics.

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Drugs Clinical Pharmacology Disease Engineering 130

Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The latest update, announced this week, is known as the Spring 2023 Unified Agenda.

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The Premier Consulting Blog

JUNE 18, 2023

Figure 1: Comparison of Clinical Trial Designs The Prelude to Applying In Silico Trials for Rare Diseases In silico clinical trials have been recognized by the FDA as useful tools in advancing personalized treatment and streamlining randomized controlled trials. Accessed April 4, 2023, at: [link] [2] Russo et al.

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52

Alta Sciences

MAY 15, 2023

TOP 5 WAYS INTEGRATED DRUG DEVELOPMENT SOLUTIONS SAVE YOU TIME AND MONEY aasimakopoulos Mon, 05/15/2023 - 16:06 Since 2004, the average cost of bringing a new drug to market has increased from $800 million to about $2.6 billion , without, for the most part, shorter development timelines.

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Agency IQ

FEBRUARY 23, 2024

The discussions in this workshop incorporated the content of a draft guidance document on the topic released by the FDA in 2023, as well as the information shared in another series of workshops co-hosted by the FDA and the American Society of Clinical Oncology (ASCO), which occurred in 2022 and 2023.

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Science FDA Trials Clinical Pharmacology 40

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Select Updates for the 506J Guidance: Voluntary Notifications of Discontinuance or Interruption of Device Manufacture CDRH Draft 12/29/2023; overdue FDA must issue final guidance within one year after the close of comments for the draft guidance. New on CDRH’s guidance agenda. Priority A List.

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