PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.

Regulations 52

Regulations Pharmaceutical Companies Pharmaceuticals International 52

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 Government Compliance Marketing 40

Agency IQ

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

International 40

International Regulations Licensing Licensing 40

The Pharma Data

NOVEMBER 4, 2020

5, 2020 /PRNewswire/ — Bactiguard presents updated financial targets for 2025 in connection with the company’s financial report for the third quarter of 2020. We have several interesting licensing projects ongoing and see new, exciting business opportunities. STOCKHOLM , Nov. Profitability. unchanged).

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Licensing Licensing Production Marketing 52

Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. on June 20, 2023 and will apply starting January 1, 2025. on June 20, 2023 and will apply starting January 1, 2025. The agreement between the European Commission (EC) and the U.K.

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Packaging Licensing Licensing Regulations 40

National Institute on Drug Abuse: Nora's Blog

JANUARY 3, 2025

A new roadmap for cannabis and cannabis policy research mfleming Fri, 01/03/2025 - 11:38 Nora's Blog January 14, 2025 Image Getty Images/ Fiordaliso The greatly increased availability of cannabis over the last two decades has outpaced our understanding of the public-health impacts of the drug.

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The Pharma Data

DECEMBER 12, 2020

Double-digit revenue growth through 2025; acquisition strengthens AstraZeneca’s broad-based revenue and the company will further globalise Alexion’s portfolio . The combined company is expected to deliver double-digit average annual revenue growth through 2025. Dedicated rare disease unit to be headquartered in Boston.

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Regulations International Disease Small Molecule 75

Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. from the E.U. pharmaceutical law ceased to apply to the U.K.

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Agency IQ

JULY 22, 2024

AgencyIQ provides a status update for regulated industry. Intro: The FDA’s rule on diagnostics and what it means for developers A quick intro about how FDA regulates In vitro diagnostics (IVDs) and Laboratory Developed Tests (LDTs): In the U.S., diagnostic products are regulated as medical devices. The rule amends 21 CFR 809.3(a)

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 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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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. This study is planned to start in late 2024 and conclude in late 2025.

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The Pharma Data

FEBRUARY 4, 2021

As part of the event, AbbVie raised its 2025 risk-adjusted combined sales guidance for Skyrizi and Rinvoq to greater than $15 billion , above previous guidance of greater than $10 billion. The company reiterated its expectation for greater than $15 billion of risk-adjusted combined Rinvoq and Skyrizi global sales in 2025.

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Production Clinical Trials International Small Molecule 52

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

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

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Compliance Drugs Pharmacy Licensing 105

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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Agency IQ

AUGUST 9, 2024

Most research to date has provided doses in a highly controlled, positive environment, often with a licensed mental health practitioner present to help guide the participant through the experience. The April 2024 multi-day workshop showcased presentations and panels from various regulators, trade groups, academics and patient advocates.

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Agency IQ

MARCH 7, 2024

flu vaccines Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) weighed in on strains for seasonal influenza vaccines for the Northern hemisphere 2024-2025 season. Vaccines advisory panel endorses move to trivalent formulation for U.S. Advisory committee members were less convinced.

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Vaccine FDA Virus Licensing 40

Agency IQ

JULY 22, 2024

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). The regulators were off to a slow start, with just three total approvals in the first two months of 2024. Most NMEs approved so far this year relied on one pivotal trial.

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Clinical Trials Trials Science FDA 52

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 Science Production Vaccine 40

Agency IQ

FEBRUARY 15, 2024

CDER, CBER Draft 12/29/2025 FDA must issue final guidance no later than 18 months after the close of the public comment period for draft guidance. Priority B List. use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

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FDA Science Biosimilars Clinical Trials 40

Agency IQ

JUNE 21, 2024

Sponsors would , if selected for the pilot, “receive more frequent advice related to such specific issues through additional interactions to facilitate novel drug and biological product program development and generate high quality and reliable data intended to support a Biologics License Application (BLA) or New Drug Application (NDA).”

Disease 40

Disease Science FDA Production 40

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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Regulations Compliance Production Science 40

FDA Law Blog: Biosimilars

JUNE 10, 2025

23,711 (June 4, 2025). Propionyl Chloride, A Proposed List I Chemical DEA issued a notice of proposed rulemaking on June 3rd, following its October 12, 2023, advanced notice of proposed rulemaking (“ANPRM”) to regulate propionyl chloride as a List I chemical. 23,483 (June 3, 2025). 23,477 (June 3, 2025).

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Laboratories Regulations Production International 69

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

The Pharma Data

MAY 4, 2021

Even excluding the growth provided from BNT162b2, our revenues grew 8% operationally, which aligns with our stated goal of delivering at least a 6% compound annual growth rate through 2025. 7) BNT162b2 has not been approved or licensed by the U.S. CAPITAL ALLOCATION. If approved, TicoVac would be the first vaccine in the U.S.

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Vaccine Production FDA Clinical Trials 40

BioPharma Drive: Drug Pricing

JUNE 9, 2025

Originally designed to regulate blood sugar in type 2 diabetes, GLP-1 receptor agonists have evolved into groundbreaking treatments for obesity, cardiovascular disease and even neurodegenerative conditions. By Ben Fidler • March 4, 2025 Permission granted by Daiichi Sankyo ASCO25 Daiichi Sankyo struck gold with ‘ADC’ cancer drugs.

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Clinical Trials Drugs Therapies Clinical Supply 141

BioPharma Drive: Drug Pricing

JUNE 5, 2025

Published June 5, 2025 Amy Baxter Staff Reporter post share post print email license FDA Commissioner Martin Makary attends a Senate Appropriations Committee hearing May 22, 2025. While it offered the first look at a possible framework for how pharmas using AI will be evaluated by regulators, many AI experts want more details.

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Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

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Regulations FDA Science Production 40

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Published June 23, 2025 Ned Pagliarulo Lead Editor post share post print email license A sign for the Food and Drug Administration is seen outside of the agency's headquarters on July 20, 2020 in White Oak, Maryland. medical regulation. The turnover is occuring as Makary and his boss HHS Secretary Robert F. Kennedy Jr.

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FDA Law Blog: Biosimilars

MAY 13, 2025

FDA may issue such waivers by regulation or on a case-by-case basis. FDA recognized that there are pharmacy websites that operate legally and offer convenience, privacy, and safeguards for purchasing medicines, but there are many that fail to adhere to safeguards followed by pharmacies licensed in the U.S. FDC Act 804(j)(1), (2).

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Online Pharmacies FDA FDA Approval Pharmacy 59

Codon

APRIL 24, 2025

Large pharmaceutical companies in-license about a third of their experimental molecules from Chinese laboratories (meaning they purchase the rights to molecules developed by other research groups rather than discover them in-house), according to a report by Stifel. . regulators hoping to speed up drug development, too. Cite: Jain, H.

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Clinical Trials Trials Pharmaceutical Companies Licensing 125

Drug Target Review

MARCH 13, 2025

The journey from distrust to collaboration among industry, academia and regulators will expedite integration, minimise clinical failures and enhance economic sustainability. Surveys (eg, 2024 State of Tech in Biopharma Report ) predict a doubling of R&D data year-over-year in 2025, highlighting the continued growth of available data.

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Drug Development Science Clinical Trials Drugs 59

New Drug Approvals

MAY 11, 2025

10] Nrf2 transcriptionally regulates multiple genes that play both direct and indirect roles in producing antioxidative potential and the production of cellular energy ( i.e. , adenosine triphosphate or ATP ) within the mitochondria. Retrieved 17 April 2025. 2] [5] It is taken by mouth. [2] 9] SYNTHESIS PATENT Sheikh, AY et al.

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FDA FDA Approval Disease Production 57

FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

temporary exceptions from some of the requirements of the Ryan Haight Act of 2008) are extended for an additional year, until December 31, 2025. Thus, while continuing to review industry feedback, DEA is still working on promulgating a more workable final set of telemedicine regulations. The federal telemedicine flexibilities (i.e.,

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FDA Approval Regulations Pharmacy Licensing 52

Codon

MAY 29, 2025

The way we typically prepare white beans completely deactivates the mild toxin that could otherwise cause food poisoning, the highly venomous cone snail that produced that shell was long gone by the time you picked it up, and Botox has been safe to inject by licensed healthcare professionals since FDA approval in 1991. Cite: Whiteman, N.

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Codon

JANUARY 8, 2025

As we enter 2025, we’ve noticed that our list of ideas has ballooned into the hundreds. In ideal circumstances, our circadian rhythms work well and regulate our hormonal cycles and mood. What other discoveries might move us closer to being able to regulate our sleep cycles at the molecular level without damaging our health?

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