Fierce BioTech

OCTOBER 31, 2024

The tools developed function entirely post-translationally, enabling synergistic strategies with engineerable regulation across multiple levels of the central dogma. The tools developed function entirely post-translationally, enabling synergistic strategies with engineerable regulation across multiple levels of the central dogma.

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DNA Regulations 64

Agency IQ

JULY 22, 2024

The 103 regulations the EPA is currently working on On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

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Regulations Production Engineering International 40

Perficient: Drug Development

NOVEMBER 15, 2024

Our experts are closely monitoring eight healthcare trends that are shaping industry leaders’ strategies in 2025. election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. And this year is especially interesting, as 2024’s U.S. billion by 2030.

Regulations 64

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Agency IQ

JULY 22, 2024

BY COREY JASEPH, MS, RAC The new EUDAMED roadmap includes updates accounting for the recent amendments to the European medical device and diagnostics regulations, which allow for a phased rollout of the different functional modules of the database.

Regulations 59

Regulations 59

FDA Law Blog: Biosimilars

JULY 6, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this year, neither the Quality System Regulation (QSR) nor the Quality Management System Regulation (QMSR) were referenced in the semiannual regulatory agenda.

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Regulations FDA Drugs 52

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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BioPharma Drive: Drug Pricing

DECEMBER 19, 2023

A decision by European regulators to revoke approvals for five generic versions of Biogen's multiple sclerosis medicine helps cement the drug's monopoly there through early 2025.

Marketing 69

Marketing Regulations Drugs 69

thought leadership

MAY 7, 2024

Are You Ready for Mandatory EU Health Technology Assessment Regulation (HTAR) Implementation Beginning January 2025? Pharmaceutical companies need to be prepared for the new European Health Technology Assessment Regulation (HTAR), which will take effect in January 2025.

Pharmaceutical Companies 59

Pharmaceutical Companies International Regulations Pharmaceuticals 59

Agency IQ

JULY 22, 2024

Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025 The new EUDAMED roadmap includes updates accounting for the recent amendments to the European medical device and diagnostics regulations, which allow for a phased rollout of the different functional modules of the database.

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.

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Clinical Trials Trials Regulations Pharmaceutical Companies 52

Perficient: Drug Development

NOVEMBER 15, 2024

Our experts are closely monitoring eight healthcare trends that are shaping industry leaders’ strategies in 2025. election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. And this year is especially interesting, as 2024’s U.S. billion by 2030.

Regulations 52

Regulations Compliance Production Nurses 52

Agency IQ

MAY 17, 2024

The bill will set a variety of timelines for state regulators to identify industrial uses of PFAS and develop action levels for PFAS in state waters by mid-2025. BY WALKER LIVINGSTON, ESQ On May 9, 2024, Maryland Governor WES MOORE approved the Protecting State Waters From PFAS Pollution Act.

Regulations 59

Regulations 59

thought leadership

JUNE 4, 2024

Health technology developers (HTD) planning submission of a centralized Market Authorization Application (MAA) to the European Medicines Agency (EMA) should being preparing today for the implementation of the European Health Technology Assessment Regulation (HTAR).

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Therapies Regulations Production Marketing 59

Antidote

NOVEMBER 15, 2024

Looking toward 2025, clinical trial sponsors must plan now and rethink their patient recruitment strategies to stay ahead of evolving technologies, regulations, and shifting patient expectations.

Clinical Trials 52

Clinical Trials Trials Regulations 52

Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 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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Regulations Clinical Trials Production Trials 40

Agency IQ

NOVEMBER 10, 2023

The still-pending agreement seems likely to soon be adopted, which would trigger an application date of January 1, 2025. The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers.

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Regulations Pharmaceuticals Government Therapies 40

Agency IQ

AUGUST 9, 2024

Commission proposes exemptions to UV-328 ban under POPs Regulation The European Commission plans to implement exemptions introduced under the Stockholm Convention’s 2023 ban of UV-328, an ultraviolet-light absorbing persistent organic pollutant (POP). This exemption is in accordance with Article 4(1)b of the POPs Regulation.

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Regulations Production International Marketing 40

Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 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.

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

Agency IQ

SEPTEMBER 15, 2023

PFAS regulation in California (late 2023 edition) California consistently maintains its status as both one of the most important economies in the world as well as one of the most regulated states in the United States. In 2019, the state began to significantly ramp up its PFAS regulation and research.

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Regulations Packaging Production Organic Chemistry 40

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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Regulations Marketing Production Vaccine 40

Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 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.

Regulations 40

Regulations Pharmaceuticals Production Vaccine 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 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.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

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.

Regulations 40

Regulations Production Clinical Trials Biosimilars 40

FDA Law Blog: Biosimilars

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

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Production Compliance Regulations FDA 64

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. Final Guidance at 2.

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Compliance Drugs Pharmacy Licensing 105

Agency IQ

APRIL 12, 2024

EPA releases final PFAS drinking water regulations – with five-year compliance timeline The EPA has released its much-awaited National Primary Drinking Water Regulation for six different PFAS. Part 141 and contains the implementing regulations from the act. The SDWA is administered by the EPA at 40 C.F.R.

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Compliance Regulations Treatment Production 40

Perficient: Drug Development

NOVEMBER 21, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

Regulations 52

Regulations Government Compliance 52

Agency IQ

JULY 21, 2023

New EPA regulations to sweep up lead levels in many structures The Environmental Protection Agency has announced new dust-lead hazard standards and clearance levels, which regulate levels of lead dust on floors and windowsills. New proposed EPA regulations On July 12, 2023, the EPA announced that it was reducing both the DLHS and DLCL.

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Regulations Compliance Laboratories 40

Covalent Modifiers

DECEMBER 21, 2024

Hsieh, Chin-Chung Wu, Wei-Jan Huang, European Journal of Medicinal Chemistry , 283, 2025 , 117169 [link] Protein disulfide isomerase (PDI) regulates multiple protein functions by catalyzing the oxidation, reduction, and isomerization of disulfide bonds. The enzyme is considered a potential target for treating thrombosis.

Metabolic Stability 52

Metabolic Stability Regulations 52

FDA Law Blog: Biosimilars

DECEMBER 12, 2024

Last weeks prehearing conference set the parameters for the hearing on the merits, scheduled to begin January 21, 2025. A limited number of affidavits may be received into the record subject to the evidentiary weight adjustment specified in the regulations. Prehearing Ruling (Dec. 4, 2024), at 1.

Testimonials 52

Testimonials Regulations Drugs 52

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.

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

The Pharma Data

SEPTEMBER 16, 2020

SLB linked to 2025 Patient Access Targets to increase patients reached in low- and middle-income countries (LMICs) with strategic innovative therapies by 200% and the Novartis Flagship Programs by 50%. Novartis is taking bold steps to increase patient reach in LMICs with its strategic innovative therapies by at least 200% by 2025.

Therapies 52

Therapies Regulations Government Disease 52

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.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

FDA Law Blog: Biosimilars

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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Compliance Laboratories FDA Regulations 64

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. Updated long-term financial targets for the period up to 2025: Growth. EBITDA margin of at least 30 percent at the end of the five-year period 2025 (unchanged).

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Licensing Licensing Production Marketing 52

Agency IQ

MAY 17, 2024

The bill will set a variety of timelines for state regulators to identify industrial uses of PFAS and develop action levels for PFAS in state waters by mid-2025. In another contrast to federal legislation and regulation on PFAS, the bill seeks to target PFAS as a class, rather than as individual compounds.

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Regulations Organic Chemistry Laboratories Treatment 40