Vial

DECEMBER 7, 2023

billion by 2027 , at a compound annual growth rate (CAGR) of 45.7% In this article from Vial CRO (Contract Research Organization , we take a deeper look into comparing AI-based drug design with the traditional approach to drug discovery, as well as the pros and cons of each. billion in 2022 and is expected to grow to US$4.0

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The Pharma Data

JANUARY 25, 2021

This activity could increase (or reduce the size of any decrease in) the market price of the Company’s common stock, the notes or the Company’s 2.50% Convertible Senior Notes due 2027 at that time.

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The Premier Consulting Blog

NOVEMBER 20, 2023

Breakdown of FDA’s New Proposed Rule Premier Research has identified five essential modifications that regulatory and clinical development specialists must acquaint themselves with. years after publication; no earlier than October 1, 2027) End of Enforcement Discretion for: Premarket review for high-risk IVDs. billion each year.

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Agency IQ

MAY 17, 2024

GDUFA III), which reauthorized the program through 2027. ROBERT LIONBERGER , the Director of OGD’s Office of Research and Standards, clarified why certain changes have been made to the scope and format of the meeting and how they are intended to impact applicants.

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Agency IQ

FEBRUARY 2, 2024

In some less common cases, a test or diagnostic may be technically classified as a biological product and regulated under the Center for Biologics Evaluation and Research (CBER) (e.g., Featuring previous research and expert analysis by Corey Jaseph. In the U.S., IVDs used in blood donation screening/processing).

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Agency IQ

AUGUST 25, 2023

The FDA requires extensive testing to support the approval of a biosimilar product, including comparative clinical studies and other human research. The most recent reauthorization, BsUFA III, extended the program for fiscal years 2023 through 2027, and was authorized at the end of 2022. Featuring previous research by Rachel Coe.

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Agency IQ

FEBRUARY 21, 2024

Given the widespread use of CDISC for clinical research and HL7 for electronic health record (EHR) data, the two organizations have partnered to create mapping guides to streamline the flow of data from EHRs to CDISC submission-ready datasets, and vice versa. CMS in the United States ).

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Agency IQ

FEBRUARY 23, 2024

In 2019, the state began to significantly ramp up its PFAS regulation and research. DTSC would be required to adopt regulations by January 1, 2027, to administer the bill. Featuring previous research by Walker Livingston. To contact the author of this analysis, please email Walker Livingston ( wlivingston@agencyiq.com ).

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Agency IQ

APRIL 8, 2024

billion pre-tax, followed by a gradual reduction in payments (excluding 2027, which will include $2.6 The PFAS remediation sector is expanding, and both private industry and the federal government are spending considerable sums of money on research to destroy and remediate PFAS more cheaply and at scale. billion in payments).

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Agency IQ

AUGUST 18, 2023

We haven’t yet seen a formal definition for an orphan medical device , promised in the 19-point plan last August; just a few weeks ago, providers and researchers sent an open letter to the Commission asking for action on just this subject.

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Drug Target Review

JUNE 5, 2023

With a commitment to advancing novel medicines and leveraging strategic partnerships, he provides valuable insights into their cutting-edge research and development efforts. No single therapeutic mode has cured all cancers, so diversification in research and treatment is warranted.

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Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. million (IQR: $18-36.7

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Advarra

JUNE 13, 2023

Research in gene therapies and genetically engineered drugs and vaccines are growing exponentially, and will only continue to become more popular. between 2020-2027. This was just one of many questions we explore in our comprehensive survey of research sites and their internal activation practices.

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Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2027 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Digital Health Technologies Publish draft guidance describing a process to evaluate a predetermined change control plan for digital health devices. primary and secondary). primary and secondary).

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Agency IQ

AUGUST 4, 2023

Article 13 requires the EU and member states to “pay full regard to the welfare requirements of animals” during policy development addressing areas including research and technological development. The EU has provided significant funding for research in non-animal testing and alternative measures.

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Agency IQ

AUGUST 2, 2024

legislation The list below includes legislation proposed by the European Commission that is yet-to-be-published.

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The Pharma Data

DECEMBER 14, 2020

Market researchers expect the global market for gene and cell therapy to grow at a CAGR of over 25% through 2027. 1 Allied Market Research, September 2020. In the medium term, however, c-LEcta’s management expects demand to develop dynamically, especially from gene and cell therapy. Source link.

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Agency IQ

JULY 5, 2023

The Senate Committee on Environment and Public Works has published a draft version of PFAS legislation that would set enforceable deadlines for the EPA to finish rulemaking for PFAS contaminants in drinking water as well as expanding PFAS research. To contact the editor of this analysis, please email Patricia Iscaro.

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The Pharma Data

FEBRUARY 8, 2021

RE47,739 (‘739) by more than four years until March 5, 2027. Patent Term Extension (PTE) certificate for IBRANCE® (palbociclib). The certificate extends the term of U.S. The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984.

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Agency IQ

JULY 28, 2023

Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation. October 1, 2023 Featuring research from Kari Oakes, Amanda Conti and former researcher Kedest Tadesse.

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The Pharma Data

DECEMBER 30, 2020

Propanc Biopharma – Australia-based Propanc Biopharma announced the Proenzymes Optimization Project 1 (POP1) joint research and drug discovery program advanced towards producing commercial scale quantities of the two proenzymes trypsinogen and chymotrypsinogen. billion by 2027.

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Agency IQ

NOVEMBER 20, 2023

During an annual update on the program and its various workstreams, regulators and researchers discussed ongoing projects at Sentinel, its work under the current Prescription Drug User Fee authorization (PDUFA) program and next steps in using active surveillance for regulatory purposes.

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Codon

OCTOBER 6, 2024

Several research groups are busily developing artificial wombs to replicate the basic life-support functions of the uterine environment for extremely premature infants — that is, babies born at or before 28 weeks of the typical 37-42 week pregnancy. All humans begin their lives in this sturdy chamber. At least for now.

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Agency IQ

MARCH 1, 2024

March 2024 Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles—Phase 3 (Final Rule Stage) 2060-AV50 On April 12, 2023, EPA announced a proposal for more stringent standards to reduce greenhouse gas emissions from HD vehicles beginning in model year (MY) 2027. 7521(a), starting with model year 2027.

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Regulations Compliance Government Production 40

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Few would oppose FDA-approved marijuana-derived medications if marijuana compounds are found to have medical value; the National Institute of Health should continue to fund research on any potential medical value of marijuana and on the harms of highly potent products.

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Agency IQ

DECEMBER 1, 2023

The standards would begin with model year 2027 heavy-duty vehicles, with stringency levels through model year 2030 and beyond. This action is also supported by the President’s Executive Order 14037, titled “Strengthening American Leadership in Clean Cars and Trucks.

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Agency IQ

MARCH 29, 2024

March 2024 Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles—Phase 3 (Final Rule Stage) 2060-AV50 On April 12, 2023, EPA announced a proposal for more stringent standards to reduce greenhouse gas emissions from HD vehicles beginning in model year (MY) 2027. 7521(a), starting with model year 2027.

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Regulations Compliance Production Government 40

Drug Target Review

MARCH 20, 2025

These studies, anticipated to complete in 2027, could open doors for abelacimab’s approval in this indication. “We anticipate ASTER will complete in early 2027 and could form the basis for approval in the treatment and prevention of venous thrombotic events in patients with cancer,” Bloomfield said.

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The Pharma Data

MAY 4, 2021

RE47,739 for Ibrance by more than four years until March 2027. The findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research. Clinical and Research Developments.

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The Pharma Data

NOVEMBER 25, 2020

The most-favored-nation (MFN) model will be in place between January 1, 2021, and December 31, 2027, allowing time for CMS to evaluate its effect on access to therapeutics, their costs, and quality of care. When this model was issued as an Executive Order on September 13, 2020, the Alliance for Aging Research called it “ a scam for seniors.”

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