News & Analysis as of

Clinical Trials Pharmaceutical Industry

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

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

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

Results of Danish Infliximab Biosimilar Switching Study Published

by Goodwin on

Researchers in Denmark recently published a report from an observational study of 802 Danish patients who switched from Remicade to the biosimilar infliximab product Remsima for the treatment of rheumatoid arthritis,...more

Glenmark Pharmaceuticals Begins Clinical Investigation for Omalizumab Biosimilar

by Goodwin on

In a press release, Glenmark Pharmaceuticals announced today that the U.S. FDA has cleared Glenmark’s Investigational New Drug (IND) application of GBR 310, a proposed biosimilar of XOLAIR® (omalizumab), to initiate a...more

Compliance Deadline for New ClinicalTrials.gov Regulations is Tuesday April 18 2017

by Hogan Lovells on

On 21 September 2016, the Department of Health and Human Services (HHS) published a final rule that clarified and expanded the requirements for clinical trial registration and results submission on the ClinicalTrials.gov...more

GCP Renovation ICH Reflection on "GCP Renovation"

by Jones Day on

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH") has released a reflection paper on Good Clinical Practice ("GCP") "Renovation," which contains the ICH proposal...more

China’s FDA Accepts JHL Biotech’s Clinical Trial Application for Rituximab Biosimilar in NHL

by Goodwin on

JHL Biotech announced today that China’s FDA has accepted its application for the use of JHL1101 in Phase 1 and Phase 3 clinical trials in non-Hodgkin’s lymphoma patients. JHL1101 is a rituximab biosimilar candidate that JHL...more

Orphan Drug Designation

by Knobbe Martens on

“Orphan drug” is a designation given to certain pharmaceutical and biological products (drugs) that would likely not be developed due to a relatively small patient population and limited potential for profitability. In the...more

The MHRA issues new guidance concerning common issues in clinical trial applications

by Hogan Lovells on

On 22nd March 2017, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a guidance (“Guidance“) identifying the most common issues that the Agency has encountered during the validation and review of...more

Alteogen Reportedly Transferring Biosimilar to Qilu Pharmaceutical

by Goodwin on

Korean Biomedical Review is reporting that Alteogen will transfer technology related to its ALT-L2, a biosimilar of Herceptin, to Qilu Pharmaceutical of China. According to the article, Alteogen and Qilu will “jointly...more

Pro Te: Solutio - Vol.9 No.3 – Fall 2016

by Butler Snow LLP on

The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices. In EMA Guidance on Clinical Data Publication, we discuss recent guidance...more

Coherus Announces Humira Biosimilar PK Clinical Bioequivalence Results

by Goodwin on

Yesterday, Coherus announced that CHS-1420, its proposed biosimilar of Humira® (adalimumab), met the primary endpoint in a clinical pharmacokinetic (PK) bioequivalence study that compared CHS-1420 to Humira. According to...more

Insider Trading Around Private Placements: Was Tom Price’s Investment Down Under Above Board?

On February 10, the Senate confirmed Representative Tom Price (R-GA) as Secretary of Health and Human Services, where he will oversee the U.S. Food and Drug Administration (FDA). His nomination has not been without...more

Six Key Changes to the Common Rule

by Epstein Becker & Green on

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

Aurobindo Pharma Acquires Four Biosimilar Products from TL Pharmaceutical

by Goodwin on

On February 9, 2017, Aurobindo Pharma Limited announced that it acquired four biosimilar products, including a biosimilar of Bevacizumab, from TL Biopharmaceutical AG. TL Biopharmaceutical is to supply developmental data for...more

EMA Update concerning EU Clinical Trials portal and database

by Hogan Lovells on

Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was adopted and entered into force in 2014. The...more

Coherus Announces Positive Topline Phase III Results for its Humira Biosimilar

by Goodwin on

Coherus Biosciences announced “positive topline 24-week treatment phase three results” in patients with psoriasis for CHS-1420, its proposed biosimilar to Humira® (adalimumab). Coherus stated that it anticipates filing its...more

Pfizer Announces Results from Trial With its Proposed Humira Biosimilar

by Goodwin on

Pfizer announced today that PF-06410293, its proposed biosimilar to Humira® (adalimumab), has demonstrated equivalent efficacy to Humira® in a clinical study. The clinical study gathered data from a 12 week trial in which...more

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