Drug Discovery World

MAY 6, 2024

In 2022, the continent held a 22.4% Study 2022-503113-31-00-IN-002 is a multi-centre clinical trial to investigate the efficacy of Orexa’s lead compound ORE-001 in the prevention of postoperative ileus. Europe is traditionally a life sciences powerhouse, with a strong tradition in pharmaceutical discovery.

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Drugs Molecular Biology Science Clinical Trials 147

Agency IQ

JANUARY 4, 2024

Swissmedic reorg adds new focus on medical device market surveillance The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. Read more about what the regulator plans for its database here.]

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Marketing Regulations Clinical Trials International 40

FDA Law Blog: Biosimilars

APRIL 25, 2024

While the Federal Food, Drug & Cosmetic Act does not explicitly define “advertisement,” FDA provides several examples in its regulations at 21 CFR § 201.1(l)(1) l)(1) (e.g., Comments to the revised draft guidance are due to the docket by June 25, 2024.

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Drug Discovery World

JANUARY 31, 2023

But first, there is the urgency of getting the new drug application (NDA) or biologics license application (BLA) filing into the hands of the respective regulatory authorities. Mature organisations must race to deliver key new patient therapeutics while meeting market revenue expectations.

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Drug Discovery World

SEPTEMBER 26, 2022

Improvements in technology and changes to worldwide regulations in life sciences has led to an increase in the availability of clinical data. Volume 23 – Issue 4, Fall 2022. Remote trials, wearable devices and advancements in genomic sequencing means that clinical data is now more abundant than ever and is only set to grow. .

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Drug Discovery World

NOVEMBER 29, 2022

This ranges from understanding disease processes and identifying possible drug targets, to organising testing, rolling out clinical trials, negotiating complex regulations and licensing and finally, treating patients. Providing a broad view. Breaking down barriers.

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Perficient: Drug Development

JANUARY 24, 2024

Before I begin, I just want to caveat everything with the fact that HIPAA is a complex regulation open to interpretation, and in the end your legal and compliance teams need to be comfortable with how you handle data and the risk associated with those methods. The other part of the definition is what constitutes “health information.”

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Licensing Licensing Production Regulations 96

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. In 2022 and 2021, the Spring Unified Agenda was released in early/mid June.

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Agency IQ

FEBRUARY 15, 2024

MHRA selects eight technologies to help it test its new innovative devices pathway The British regulator and its partners just released the list of products and companies chosen to participate in the pilot of its Innovative Device Access Pathway (IDAP). device regulations and the pilot for innovative products. and abroad.

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Regulations Production Science Vaccine 40

FDA Law Blog: Biosimilars

JUNE 27, 2024

After issuing an Order to Show Cause and Immediate Suspension of Registration in September 2022, and an administrative hearing in March 2023, DEA adopted the hearing Administrative Law Judge’s (“ALJ’s”) Recommended Decision to revoke Coconut Grove’s registration based on the public interest factors of 21 U.S.C. By Larry K. a), 1306.06.

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Pharmacy Drugs Regulations Compliance 52

Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. FDA-2022-E-3124 ). 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. 156(d) (and the PTO’s PTE regulations at 21 C.F.R. The PTE application states “[u]nder the terms of the AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION LICENSE AGREEMENT between Pfizer Inc. exclusively licensed U.S. 27, 1995); aff’d , 109 F.3d

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Therapies FDA FDA Approval Treatment 119

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Science Regulations Clinical Trials 40

Drug Discovery World

MARCH 29, 2023

What is likely to be the cumulative effect on innovation of the different losses in exclusivity, also given the forthcoming Patent Package which could link the review’s rules on product shortages to EU-wide compulsory licensing? She also does not believe that the problems with Europe’s medicines can be solved with regulation.

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Clinical Trials Biosimilars Pharma Companies Production 130

Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. According to Downey, the timeline of pre-license inspections for biologics can create challenges.

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Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group. What are the risks?

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Drugs Licensing Licensing Regulations 237

Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Science Clinical Trials Regulations 40

New Drug Approvals

OCTOBER 24, 2023

July 2022). “The Selective Sphingosine 1-Phosphate Receptor Modulator Etrasimod Regulates Lymphocyte Trafficking and Alleviates Experimental Colitis” J Pharmacol Exp Ther. . | Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL. 401 (10383): 1159–1171.

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FDA FDA Approval International Pharmacokinetics 57

The Pharma Data

NOVEMBER 24, 2020

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. The study aims to conclude in the beginning of 2022.

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Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K.

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Regulations Compliance Government International 40

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 anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Regulations FDA Science Production 40

Agency IQ

MAY 10, 2024

That EO included some life sciences-specific standards and strategy development, including directing HHS to develop a new strategy on regulating the use of AI or AI-enabled tools in drug development and establish an HHS AI task force, which would focus on safety related to the various health-related uses of AI (e.g.,

Science 40

Science FDA Production Regulations 40

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

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Agency IQ

NOVEMBER 3, 2023

Although this guidance document is mostly focused on chemistry, manufacturing and control (CMC) information, it clarifies that LBPs are considered biologics, and will thus need to utilize the Biologics License Application (BLA) pathway. The regulation of dietary supplements in the U.S.

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Therapies Science FDA Production 40

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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Drug Discovery World

FEBRUARY 20, 2023

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, according to a recent report by analytics company Phesi. Here, we take a look at the top four disease areas and some of the key developments in 2022. Capivasertib could offer a completely new treatment option for these patients.

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Trials Drug Trials Disease Clinical Trials 130

The Pharma Data

AUGUST 3, 2021

Top-line results from the event-driven confirmatory Phase 3 study comparing LUMAKRAS to docetaxel in patients with KRAS G12C-mutated advanced NSCLC are expected in H1 2022. Data from the Phase 2 monotherapy study in patients with KRAS G12C-mutated solid tumors other than NSCLC and CRC are expected in H1 2022. Bemarituzumab.

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LifeSciVC

SEPTEMBER 15, 2022

By Joshua Brumm, CEO of Dyne Therapeutics, as part of the From The Trenches feature of LifeSciVC By all accounts, 2022 did not start according to plan for the biotech industry. Generating robust preclinical data to share with global regulators supports alignment on your trial design.

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Trials Clinical Trials Clinical Development Therapies 52

The Pharma Data

JANUARY 27, 2021

Entered an exclusive license and supply agreement with Accord Healthcare for ZUBSOLV® covering 29 European countries. If the Fast Track application is approved we will be ready to submit an application for approval in Q1 2022. is obliged to make public pursuant to the EU Market Abuse Regulation. Summary and Outlook.

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Production Therapies FDA Licensing 52

Codon

JANUARY 21, 2024

A 2022 survey identified 284 human challenge trials that have been conducted since 1980. We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. Sign up to receive articles from Asimov Press. Why are challenge trials becoming more popular?

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Vaccine Trials Disease Virus 132

Agency IQ

SEPTEMBER 29, 2023

Regulators wanted input on questions related to data access and re-use, to inform its legislative framework on common European data spaces. Two intertwined proposals have been laid out – a regulation on data governance and the proposed data act. Data intermediation service is defined in Regulation (EU) 2022/868.

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Regulations Government Production International 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. The December calendar is packed with regulatory and industry meetings.

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Agency IQ

APRIL 26, 2024

For context, while prescription drug products are required to comply with FDA’s regulatory requirements around labeling and approval (see 21 CFR 201 ), promotional materials and advertisements are regulated differently (under 21 CFR 202.1(1)(2) The reactions to this shift in policy were varied.

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Biosimilars Science FDA Licensing 40

Agency IQ

MARCH 7, 2024

DAVID GREENBERG of Sanofi provided perspective based on an industry questionnaire , saying the transition will require industry to “re-activate or re-submit more than 300 TIV licenses, submit nearly 1500 variations, and update quality data in 174 countries.”

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Vaccine FDA Virus Licensing 40

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.

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