News & Analysis as of

Clinical Trials

Bevacizumab Biosimilar Update

by Goodwin on

There has been some recent activity regarding proposed biosimilars to Roche’s Avastin (bevacizumab). Avastin is indicated for the treatment of various types of cancers, including colorectal, lung, and kidney cancer....more

FDA Issues Immediately Effective Guidance Allowing Waiver of Informed Consent for Minimal Risk Research

by Ropes & Gray LLP on

The United States Food & Drug Administration (FDA) has issued a guidance document announcing its intention not to object to an IRB’s waiving or altering the informed consent requirements for an FDA-regulated clinical...more

OIG Approves Cost-Sharing Arrangement Involving Clinical Research Study

by Baker Ober Health Law on

The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable advisory opinion, No. 17-02, regarding a proposed arrangement under which the cost-sharing amounts owed by...more

FDA Issues New Guidance on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

As July comes to an end, the Food and Drug Administration (FDA or agency) has issued a new guidance document for “immediate implementation” entitled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations...more

Review Article Supports Interchangeability of Infliximab and CT-P13

by Goodwin on

Last week, an article reviewing the literature comparing infliximab biosimilar CT-P13 (Celltrion) with infliximab (Janssen Biotech) for the treatment of rheumatologic diseases was published in Drug Design, Development and...more

Follow the Money: FDA Issues New Procedures for Evaluating Financial Ties Between Application Sponsors and Clinical Investigators

by Hogan Lovells on

In a potential sign of renewed interest in financial ties between industry and clinical investigators, the Food and Drug Administration’s (FDA) Office of New Drugs (OND) recently issued a new Manual of Policies and Procedures...more

EMA Calls for Public Consultation on Clinical Trial Protocol, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more

EMA Green Lights New EudraVigilance System for Adverse Reactions, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...more

Guidance for Companies Picking a State for Operations in the U.S.

New District Court Opinion Discussing the Scope of Specific Jurisdiction After Bristol-Myers Squibb Co. v. Superior Court of San Francisco County,582 U.S. ____ (2017) – Wow, that was quick! A District Court Judge from the...more

New French Decree Clarifies the Scope of Biomedical Research, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

French Decree n° 2017-884 of May 9, 2017, was adopted to implement certain provisions of the Legal Ordinance of June 16, 2016, with respect to biomedical research. Such research should now be referred to as "research...more

Here’s why you’re getting those unsolicited mailings about clinical trials

When consumers around the country started getting letters from a company that they had never heard of, inviting them to participate in clinical trials for medical conditions that they hadn’t disclosed to many or didn’t even...more

HHS Subjects Human Research to an Updated Common Rule

by Alston & Bird on

The Department of Health and Human Services has taken a step toward harmonizing the complex regulatory requirements for federal human subjects research. Our Health Care Group breaks down the changes to the Common Rule due to...more

NIH Begins Beta Test of Million Patient Cohort

by Foley & Lardner LLP on

The National Institutes of Health announced the enrollment of the first participants as beta testers of the “All of Us” research program. Initially branded as the “Precision Medicine Initiative®” Cohort Program, “All of Us”...more

Adalimumab Biosimilar Demonstrates Non-Inferiority For Efficacy and Safety

by Goodwin on

At the EULAR Annual Congress this week, Rieke H.E. Alten, MD, working at the University of Berlin, presented data from a randomized, double-blind, Phase III study comparing adalimumab and FKB327, Fujifilm Kyowa Kirin...more

All or Nothing at All: Brexit Update for Life Sciences Companies

by Arnall Golden Gregory LLP on

A lot of ink has been spilled in projecting what Brexit (the UK’s withdrawal from the European Union) might look like, including in this space by this author. The simple fact is that we don’t know what Brexit will actually...more

New Data Supports Efficacy and Safety of Celltrion’s Rituximab Biosimilar

by Goodwin on

Celltrion Healthcare presented new data on their Rituximab biosimilar Truxima® (CT-P10) at the International Conference on Malignant Lymphoma (ICML) in Switzerland and the European League Against Rheumatism (EULAR) Congress...more

To certify or not to certify? FDA has answered the question

by Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

Biosimilar Development Updates: Infliximab, Ranibizumab, Etanercept, Filgrastim & Trastuzumab

by Goodwin on

According to a May 7, 2017 record on ClinicalTrials.gov, Celltrion is conducting a Phase 1/3 clinical trial to evaluate efficacy and safety between a subcutaneous biosimilar of infliximab (“CT-P13 SC”) with its currently...more

EMA publishes a Draft Guideline on Trial Master Files to facilitate the conduct and management of clinical trials

by Hogan Lovells on

In April 2017, the European Medicines Agency (EMA) issued a draft guideline (“Draft Guideline“) concerning the Trial Master Files (“TMF”) for public consultation. The Draft Guideline updates the previous guideline on TMF that...more

Personalised Medicines at the top of the European Agenda

by Hogan Lovells on

In March 2017, the European Medicines Agency organised a workshop concerning personalised medicine. The results of the workshop have just been published. The workshop discussed the views of patients, healthcare...more

Celltrion to Begin Remsima (infliximab) Clinical Trials in China

by Goodwin on

Sources are reporting that Celltrion has received clearance from the China Food and Drug Administration (CFDA) to conduct clinical trials of Remsima (infliximab), a biosimilar of Janssen’s Remicade. This is the first time a...more

Japan Legal Update - Volume 25 | May 2017

by Jones Day on

Bill to Partially Amend the Civil Code was Passed by the House of Representatives - On April 14, 2017, the House of Representatives passed a bill to partially amend the Civil Code ("Bill"). The Bill is under deliberation in...more

Cinfa Biotech Announces Positive Clinical Trial Results for Neulasta Biosimilar

by Goodwin on

Cinfa Biotech, a Spanish company focusing on the development of biosimilars, announced positive results from their second clinical trial evaluating a biosimilar version of Amgen’s Neulasta (pegfilgrastim). According to the...more

AGG Food and Drug Newsletter - May 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Let’s Get Clinical: ClinicalTrials.gov Reporting Requirements Now in Effect

by Arnall Golden Gregory LLP on

The compliance date for the Final Rule implementing the clinical trial reporting requirements of Section 801 of the Food and Drug Administration Amendments Act (FDAAA), also known as FDAAA 801, arrived on April 18, 2017. The...more

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