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

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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The Pharma Data

JUNE 11, 2023

Boehringer Ingelheim and Zealand Pharma announce phase II trial showed 14.9% The phase II clinical trial evaluating the effect of different doses of the novel glucagon/GLP-1 receptor dual agonist BI 456906 in people living with obesity or overweight without type 2 diabetes (NCT04667377) met its primary endpoint.

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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

JULY 7, 2023

building off the EMA’s Strategy through 2025. Just as a quick reminder: Real-world Data (RWD) is data generated by the health care system outside clinical trials. Regulators have been investing in ways to understand better how RWE can be used and how RWD is generated. What is real-world data (RWD) and evidence (RWE)?

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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. FDA accepted the Lykos NDA in February 2024, and the submission received priority review.

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Agency IQ

MAY 10, 2024

The proposal for a regulation on the sustainable use of pesticides (SUR), however, died in European Parliament in November 2023. Again, it emphasized a goal of reducing pesticide use by half, this time by 2025. The newest iteration of Ecophyto again seeks to cut pesticide use in half, though this time by 2030 rather than 2025.

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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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The Pharma Data

NOVEMBER 10, 2020

Billion by 2025. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. billion by 2025, according to Grand View Research 1. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. Crohn’s Disease Therapeutics Market Size $4.7

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Agency IQ

AUGUST 23, 2024

EMA issues more updates to prepare for clinical trials transition Offices throughout the EU—including those of the EMA—have slowed operations for the summer holiday, but that didn’t keep the EMA from publishing a stack of updated documents. Per the CTR, all clinical trials are to be moved over to the CTIS by January 30, 2025.

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Agency IQ

JUNE 7, 2024

FDA’s new guidance explains what to do during a BIMO inspection Under the FDA’s Bioresearch Monitoring (BIMO) program, the agency oversees the operation of regulated research. In short, the BIMO program oversees regulated research – both human and animal – in a variety of ways. the first day of federal fiscal year 2025).

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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

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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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. Nanoform’s Q4/2020 report is due February 26 th , 2021. over 90 percent gross margin. 46 7686 650 11. Finnish time.

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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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Conversations in Drug Development Trends

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. Increased Transparency : Ensures that information on clinical trials is more accessible.

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The Pharma Data

JANUARY 4, 2021

SENS-401 has demonstrated highly encouraging efficacy in preclinical models and we are excited to progress this small molecule towards clinical trials to address this significant unmet medical need in cancer patients undergoing cisplatin treatment. Further details on the trial design will be communicated in H2 2021.

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The Pharma Data

JANUARY 12, 2021

The company has the ambition to deliver double-digit topline growth through 2025, targeting $9 to $10 billion in global revenue. Continued progress in advancing Phase 3 ULTOMIRIS trials in NMOSD and amyotrophic lateral sclerosis (ALS), which are now over 80 percent and 50 percent enrolled, respectively. Continued Pipeline Progress.

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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).

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The Pharma Data

MAY 18, 2021

Sterile API production is planned to transfer from Kundl to the new facility at Palafolls in 2025. As part of this network modernization plan, Sandoz will phase out the current production of oral APIs at the Les Franqueses site in Spain, which it plans to close in 2024.

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Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

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The Pharma Data

JUNE 18, 2021

The MOTIVATE trial evaluated only bio-IR patients. During the 12-week induction period, the safety profile of risankizumab in both studies was generally consistent with the known safety profile of risankizumab from previous clinical trials. The global burden of IBD: from 2015 to 2025. NORTH CHICAGO, Ill. , percent on placebo.

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The Pharma Data

JUNE 18, 2021

“In our global clinical trial program to-date, risankizumab has shown clinically meaningful rates of endoscopic response and clinical remission among patients living with moderate to severe Crohn’s disease,” said Michael Severino, M.D., 1 Both patients continued in the trial. vice chairman and president, AbbVie.

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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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Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. The regulators were off to a slow start, with just three total approvals in the first two months of 2024.

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FDA Law Blog: Biosimilars

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. In FY 2025, continue to support products enrolled in previous fiscal years and expand to enroll up to 65 additional products in at least four OHTs (i.e.,

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Drug Target Review

JULY 1, 2024

SRP-001 targets the central nervous system (CNS) by producing N-arachidonoylaminophenol (AM404) in the midbrain’s periaqueductal grey (PAG) region, crucial for pain sensation and regulation. In Phase I clinical trials, SRP-001 showed no serious adverse events among 56 healthy volunteers, highlighting its safety.

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Agency IQ

AUGUST 9, 2024

The actual legal definition of a Phase 3 study can be found at 21 CFR 312.21 , and the DAP authority references this specific definition: “Phase 3 studies are expanded controlled and uncontrolled trials. Combination products are defined by the FDA as : “A product comprised of two or more regulated components (i.e.,

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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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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 Law Blog: Drug Discovery

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. We’ve blogged about some of FDA’s efforts to increase diversity in clinical trials previously, and the Draft Guidance itself describes a variety of these efforts. 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)).

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Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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Agency IQ

JUNE 21, 2024

BY ALEXANDER GAFFNEY, MS, RAC | JUN 20, 2024 10:53 AM CDT Peter Marks on the START Pilot Program: Goals and future PDUFA plans The Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot was formally unveiled in September 2023.

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The Pharma Data

FEBRUARY 4, 2021

billion increase in the Skyrizi contingent consideration liability due to higher estimated future sales driven by stronger market share uptake and favorable clinical trial results as well as lower interest rates. Recorded a $4.7

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Agency IQ

AUGUST 9, 2024

The EMA lays out several challenges in studying psychedelics, including the risk of functional unblinding and difficulty choosing a placebo or comparator, finding an appropriate dose, showing maintenance of effect, and establishing a safe trial environment. Although the E.U.

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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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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. Vaccine effectiveness in the study will be inferred through immunobridging to the 16 to 25 year-old population in the pivotal Phase 3 trial.

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