Pharma in Brief

MAY 29, 2023

The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices. Certificate of Supplementary Protection Regulations , SOR/2017-165

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Drug Discovery World

MAY 17, 2024

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. MIT research 4 tells us a hard truth: about 95% of these trials fall short, leaving behind a trail of broken hopes for cancer patients each year.

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FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Part 814), and for conducting clinical trials (21 C.F.R. By Adrienne R.

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pharmaphorum

DECEMBER 13, 2022

This precipitated a shift from a centralised trial experience to a decentralised one, resulting in participants communicating electronically. BYOD in clinical trials. Historically, equivalency presented a primary hurdle in the adoption of eCOA BYOD for clinical trials. Statistics show there are 6.5

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Advarra

OCTOBER 26, 2023

Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines. The containment must then prevent spills or leaks if the IP is dropped. Size matters.

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Cloudbyz

MARCH 30, 2023

Ensure Compliance: Life sciences organizations are subject to various data protection regulations, including GDPR, HIPAA, and CCPA. AI/ML-based redaction solutions can help organizations comply with these regulations by ensuring that sensitive data is not disclosed or transmitted in violation of regulatory requirements.

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Advarra

DECEMBER 15, 2022

As the research community continues to seek clinical trial efficiencies designed to bring therapies to patients faster, more governing bodies are pushing for single institutional review board (single IRB) review as one way to streamline efforts. Policies and Regulations Affecting Single IRB Review. Basics of Single IRB Overview.

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FDA Law Blog

JANUARY 1, 2024

Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators. If FDA wanted to create that impression, it likely succeeded. They have great impact on most companies that receive them.

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Camargo

NOVEMBER 11, 2020

Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks. The generic drug must also have the same labeling as the RLD (except for differences permitted under the Agency regulations). Manager of Regulatory Compliance. Co-Authors: Jenny Fielder.

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XTalks

APRIL 25, 2024

The efficacy of the Revivent TC system is being evaluated through clinical trials, namely the LIVE trial and the ongoing ALIVE trial. The LIVE trial showcased the system’s potential to reduce ventricular volumes by approximately 25 percent and improve left ventricular ejection fraction by about 16 percent.

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Intouch Solutions

APRIL 11, 2024

Pre-Clinical : Deeper comprehension of the impacts and outcomes associated with a particular drug. Clinical : Optimized efficiency, inventory management, and service quality of clinical trials. Facilitating cost containment and expediting the content approval process in accordance with regulatory compliance.

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WCG Clinical

NOVEMBER 20, 2023

FDA SR Device PMA Database FDA NSR Device 510K Database FDA Device Search FDA Medical Device Databases Class I and Class II Exempt Device listing If your device meets another exemption under the investigational device exemption (IDE) regulations, please provide a rationale for why your device qualifies as IDE exempt. a) (1) to (4).

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The Pharma Data

NOVEMBER 10, 2020

However, severe toxicities and poor patient compliance limit the long-term use for intravenous immunotherapies. Additionally, oral capsules provide the convenience of home use, and increase patient compliance by eliminating the need for infusions in a clinic or hospital setting.

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Advarra

SEPTEMBER 29, 2022

Informed consent is one of the central protections the regulations provide to research subjects. The regulatory requirements for informed consent will vary depending upon which regulations apply to the conduct of a particular study. The regulations are very specific regarding what to include in the ICF and what to exclude.

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The Pharma Data

DECEMBER 20, 2020

Transcend is a research focused biotechnology company creating and clinically validating an evolving IP portfolio of novel molecules and drug delivery mechanisms for clinical trials and commercialization. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

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The Pharma Data

DECEMBER 14, 2020

Transcend is a research focused biotechnology company creating and clinically validating an evolving IP portfolio of novel molecules and drug delivery mechanisms for clinical trials and commercialization. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

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The Pharma Data

MAY 15, 2023

The Sandoz Board of Directors will have 10 members in total and 3 sub-committees: a Science, Innovation & Development Committee, a Human Capital & ESG Committee and an Audit, Risk & Compliance Committee. He will be Chair of the Audit, Risk & Compliance Committee of Sandoz.

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FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. As part of the Accelerated Approval, Oncopeptides was required to conduct “further adequate and well-controlled clinical trials to verify and describe clinical benefit.” That did not happen.

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Delveinsight

JANUARY 22, 2021

There are newer agents coming to the market, for instance, Fc receptor via monoclonal IgG antibodies mechanism, BTK [Bruton tyrosine kinase] inhibition, and so on, however, the real challenge lies in the compliance in terms of patients perspectives such as cost and tolerance.

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The Pharma Data

JULY 27, 2021

Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future.

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pharmaphorum

MAY 5, 2022

Why CDISC standards should never be ignored in any clinical trial: The use of CDISC standards allows externals to understand clinical trial data FAST. This increases the amount of useful clinical data that can be derived from a single study. Enhance the interoperability of clinical research systems.

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The Pharma Data

SEPTEMBER 17, 2020

Amgen Forward Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities.

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The Pharma Data

NOVEMBER 24, 2020

The Notice of Compliance was granted under priority review and marks the first Health Canada approval of a PARP inhibitor in prostate cancer. Based on the available clinical trial data, a causal association between Lynparza treatment and VTE including pulmonary embolism has not been established.

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FDA Law Blog

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. FDA extended PMTA compliance deadlines for years so it could figure out appropriate application instructions and so that manufacturers could figure out how to comply. FDA failed on each count.

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The Pharma Data

AUGUST 13, 2020

person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S. Forward-Looking Statements.

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The Pharma Data

AUGUST 13, 2020

person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S. Forward-Looking Statements.

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pharmaphorum

SEPTEMBER 1, 2021

CDISC has partnered with the National Cancer Institute (NCI) to help bring consistency to terminology in clinical trials. The blue line represents the code list that contains all the individual codes. The submission value is what must be submitted to a regulator. ADaM terminology contains terms for use in ADaM datasets.

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Cloudbyz

JUNE 1, 2023

Compliance: Salesforce’s data centers comply with a number of industry standards, including ISO 27001, SOC 2, and PCI DSS. Comprehensive Compliance Salesforce offers a comprehensive suite of compliance features to ensure data privacy, security, and adherence to various industry regulations. government data).

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The Pharma Data

JANUARY 9, 2021

RECONCILIATION OF NON-GAAP MEASURES (unaudited) This press release contains two financial measures (Adjusted Net Income and Adjusted EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization)) that are considered “non-GAAP” financial measures under applicable Securities and Exchange Commission rules and regulations.

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The Pharma Data

MAY 7, 2021

GSK and Vir continue discussions with global regulators to make sotrovimab available to patients with COVID-19. The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The EMA will assess the medicine’s compliance with the usual standards for efficacy, safety and quality.

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The Pharma Data

SEPTEMBER 16, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen’s investigational drug sotorasib is designed to treat patients with multiple KRAS G12C -mutant solid tumors and address the longstanding unmet medical need for these cancers. Additional information about CodeBreaK clinical trials can be found at [link].

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The Pharma Data

SEPTEMBER 20, 2020

About KRAS The RAS gene family, which has been the subject of almost four decades of research, contains some of the most frequently mutated oncogenes in human cancers. The Phase 2 CRC trial is expected to have a data readout in 2021. Additional information about CodeBreaK clinical trials can be found at [link].

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XTalks

FEBRUARY 4, 2021

Moreover, when the foundation initiated their flagship observational clinical trial —the Parkinson’s Progression Markers Initiative or PPMI in 2010 — there weren’t really clear examples in the field of standardized longitudinal sample collection across multi-international sites. Genotype Data Curation and Return of Results.

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The Pharma Data

OCTOBER 29, 2020

We remain focused on continuing to serve patients, protecting the health and safety of our employees and the communities in which we live and work, and supporting patients in clinical trials. The COVID-19 impact has varied by study and program, but there has been little timing impact on fully-enrolled trials.

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The Pharma Data

NOVEMBER 9, 2020

NAVIGATOR and the PATHFINDER clinical trial program Building on the Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, NAVIGATOR and SOURCE. 4,5 The program includes additional planned mechanistic and long-term safety trials.

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The Pharma Data

DECEMBER 21, 2020

PATHFINDER Clinical Trial Program Building on the positive Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, the registrational NAVIGATOR study and SOURCE. 12-15 The program includes additional planned mechanistic and long-term safety trials.

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The Pharma Data

AUGUST 6, 2020

All clinical trial activities are planned to resume by the end of the year where local country restrictions have been lifted. We may use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Use of Non-GAAP Financial Information.

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