Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely 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 European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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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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Drug Discovery World

MARCH 7, 2023

The Middle East represents one of the world’s most lucrative markets for pharmaceuticals. Along with Africa, the Middle East stands as fifth largest pharmaceutical market in the world 1. By 2025, it’s estimated that Qatar’s drug market will reach a compound annual growth rate (CAGR) of 3.9%

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The Premier Consulting Blog

DECEMBER 14, 2022

By 2025, funding for DTx is expected to reach $56 billion. DTx require both clinical evidence and real-world outcomes and must be cleared or certified by regulators to support claims of intended use, risk, and efficacy.

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Agency IQ

NOVEMBER 3, 2023

The Pharmaceutical Group of the European Union (PGEU) conducted a survey finding shortages worsened in 2022 compared to 2021, with most European countries reporting worsening. The Pharmaceutical Strategy document notes that Covid-19 just compounded medicines shortages that had already impacted patient health and the E.U. wide level.

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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

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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Agency IQ

JANUARY 4, 2024

For regulators, there are two primary concerns associated with impurities – that they may cause a drug substance to degrade (thereby reducing its efficacy or safety) and that the impurities (or their effects on the drug substance) may be harmful to patients. Read AgencyIQ’s analysis of the ICH guideline here ].

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Agency IQ

NOVEMBER 20, 2023

Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. If the ePI is approved by the regulator, then it will be made publicly available in the ePI database.

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Drug Discovery World

JULY 11, 2022

It has been estimated that by 2025 the FDA will be approving 10 to 20 cell and gene therapy products per year 2. As the field matures and the risks are better understood, regulators continue to streamline duplicative and burdensome oversight efforts 5. A quality system that is set up to handle both is required.

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

JULY 5, 2023

What we expect the EPA to do in July 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

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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.

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Drug Discovery World

MARCH 8, 2024

MSRD, a member of the Otsuka family of pharmaceutical companies, identifies and supports early-stage opportunities that can change the landscape of treatments for mental illness and renal disorders. FIB918 is now in the IND-enabling phase and Phase I clinical trials of the monoclonal antibody are targeted to start in late 2025.

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Agency IQ

MARCH 7, 2024

British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. post-market regulation here.]

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The Pharma Data

JANUARY 3, 2021

Nanoform also reiterated its previously announced “First Biologics PoC 2 project in 2021″, as well as its 2025 mid-term business targets of: to nanoform at least 50 new APIs 3 annually. 3 Active Pharmaceutical Ingredient. Nanoform’s Q4/2020 report is due February 26 th , 2021. hvh@nanoofrm.com. +46

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The Pharma Data

MAY 18, 2021

Kundl, Austria further strengthens production for oral antibiotics while facility in Palafolls, Spain expands for sterile active pharmaceutical ingredients. Sterile API production is planned to transfer from Kundl to the new facility at Palafolls in 2025. About Sandoz.

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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 . 12, 2020– AstraZeneca and Alexion Pharmaceuticals, Inc. The combined company is expected to deliver double-digit average annual revenue growth through 2025.

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The Pharma Data

JANUARY 12, 2021

12, 2021– Alexion Pharmaceuticals, Inc. The company has the ambition to deliver double-digit topline growth through 2025, targeting $9 to $10 billion in global revenue. Source: Alexion Pharmaceuticals, Inc. Continued Pipeline Progress. Alexion : Media. Megan Goulart , 857-338-8634. Chris Stevo , 857-338-9309.

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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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Agency IQ

JUNE 21, 2024

Commission proposes guidelines to flesh out the newly finalized Variations Regulation This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024.

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Agency IQ

JULY 28, 2023

Carbon tetrachloride has minor laboratory, petroleum refining, and pharmaceutical manufacturing applications. Regulation of CTC under TSCA On June 22, 2016, the “ Frank R. The ban would take effect one year after publication of the final rule, indicating that this rule likely wouldn’t take effect until at least early 2025.

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Drug Discovery World

JULY 17, 2024

MR: Cancer immunotherapy has transformed oncology in the last 10 years and has become a major growth driver of the pharmaceutical industry, with predicted revenues of $143bn in 2025. DS: How can NK cell therapy tackle the limitations of cancer immunotherapy?

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Agency IQ

AUGUST 4, 2023

pharmaceutical law ceased to apply to the U.K. s Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. on June 20, 2023 and will apply starting January 1, 2025. as of January 1, 2021.

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Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

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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. state pharmaceutical assistance programs).

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Agency IQ

JANUARY 19, 2024

With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals. The ensuing Chemicals Strategy expounded upon the 1S1A concept further, presenting it as the definitive approach to heighten the efficiency, consistency, and transparency of European chemical regulation.

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Agency IQ

APRIL 26, 2024

Regulation (EU) 2022/123 became applicable on March 1, 2022, except for most provisions related to medical devices. The regulation expanded EMA’s mandate to monitor and mitigate shortages at the E.U.-level, The regulation set up the MSSG to ensure a robust response during public health emergencies and major events.

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Conversations in Drug Development Trends

MAY 23, 2024

The CRO landscape is rapidly evolving with the recent implementation of the EU Clinical Trials Regulation No 536/2014 (EU-CTR) and the launch of the Clinical Trials Information System (CTIS). This blog delves into the key aspects of the EU regulatory space and provides insights into navigating these changes effectively.

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Agency IQ

JANUARY 26, 2024

regulators considered the highest-risk IVD devices, and these and devices for self-test by the patient required Notified Body oversight. The IVDR originally gave stakeholders 5 years to comply with the regulation (May 26, 2022). The directive used a list-based system – List A and List B outlined what E.U. In-house tests (in the U.S.

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Drug Discovery World

SEPTEMBER 16, 2022

Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. . Last year, Pfizer opened a $68.5 million facility in Durham North Carolina to support the company’s gene therapy capabilities.

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Drug Discovery World

AUGUST 1, 2023

As such, through collaboration with the biotechnology company Ionis Pharmaceuticals and the University of Gothenburg, AstraZeneca are developing an ASO that can target liver cells to ‘silence’ PNPLA3 with the aim of restoring fat break down in the liver. Though some genetic mutations are harmful, others can be protective.

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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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Agency IQ

AUGUST 11, 2023

BY KARI OAKES AUG 7, 2023 10:20 PM CDT Quick background on nitrosamines in pharmaceutical products Nitrosamines are a large and diverse class of chemicals, with more than 300 different structurally distinct species known today. In 2018, NDMA was first detected in the active pharmaceutical ingredient (API) for valsartan, a blood pressure drug.

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The Premier Consulting Blog

APRIL 27, 2023

Then, in 1997, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) formed the ICH M8 Expert Working Group/Implementation Working Group (EWG/IWG). Premier Consulting has been a trusted eCTD vendor for small to midsize pharmaceutical, biotech, and medical device companies since 1995.

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