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Clinical Trials Pharmaceutical Industry

Sandoz Announces New Data For Its Adalimumab And Rituximab Biosimilars

by Goodwin on

On November 14, 2017, Sandoz announced data from four clinical trials comparing its proposed adalimumab and rituximab biosimilars to their reference drugs, Humira® and Rituxan®. We previously reported that the Sandoz...more

New rules for expanded access in Italy

by Hogan Lovells on

Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more

New Data Supports Efficacy and Safety of Boehringer Ingelheim’s Cyltezo, a Humira Biosimilar

by Goodwin on

Today, Boehringer Ingelheim announced new one-year data for their adalimumab biosimilar, Cyltezo®. VOLTAIRE®-RA, a 48 week Phase III clinical trial, compared Cyltezo® (adalimumab-adbm) to Humira. The results showed that...more

Momenta’s Orencia (abatacept) biosimilar candidate M834 does not meet primary endpoints in Phase I study

by Goodwin on

Yesterday, Momenta and Mylan reported that initial results obtained from their proposed abatacept biosimilar M834 did not meet primary pharmacokinetic endpoints in a Phase I study comparing the pharmacokinetics, safety and...more

Pfizer and Celltrion Healthcare Reveal New Data For infliximab biosimilar Inflectra®

by Goodwin on

Last year we reported the FDA approval and then U.S. launch of Inflectra®, a biosimilar of Remicade® (infliximab). This week, Pfizer and Celltrion Healthcare have reported that the results of a Phase 3 study of Inflectra...more

Study concludes that data supports switching from Remicade® to biosimilar Renflexis®

by Goodwin on

A recent study evaluated the efficacy, safety, and immunogenicity of switching from reference infliximab (Remicade®, Janssen Biotech), to the biosimilar SB2 (Renflexis®, Samsung Bioepis), in patients with moderate to severe...more

Clinical trials Part I: The upcoming clinical trials reporting rule

by Thompson Coburn LLP on

In 2007, Congress passed the “Food and Drug Administration Amendments Act of 2007,” the purpose of which was, in part, to update the FDA’s rules surrounding clinical trials. The FDA took nearly a decade to review the law,...more

Alert: China Issues New Policy for Drug and Medical Device Approvals

by Cooley LLP on

On October 8, 2017, the General Office of the CPC Central Committee and the General Office of China's State Council jointly issued Opinions of the State Council on Promulgating the Reform of Review and Approval System for...more

Swissmedic updates requirements concerning the Fast-Track Authorisation Procedure

by Hogan Lovells on

On 1 October 2017, the Swiss Agency for therapeutic products (“Swissmedic”) updated its guidance document concerning the Fast-Track authorisation procedure (“FTP”). The modified guidance document replaced the formerly...more

FDA Simplifies and Clarifies Expanded Access Program

by Hogan Lovells on

Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment...more

Canada Institutes Certificates of Supplementary Protection for Approved Drug Products

On September 21, 2017, the Comprehensive Economic and Trade Agreement (CETA) signed between the European Union (EU) and Canada provisionally entered into force in Canada.  Among other things, this agreement seeks to harmonize...more

FDA Finalizes Guidance on Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies

by Hogan Lovells on

On September 12, 2017, the U.S. Food and Drug Administration (FDA) released the final guidance that outlines the agency’s expectations and recommendations for the evaluation and reporting of age-, race-, and...more

Samsung Bioepis Biosimilar Updates

by Goodwin on

We previously reported that, according to a May 10, 2017 record on ClinicalTrials.gov, Samsung Bioepis planned to start a Phase 3 clinical trial in September 2017 on SB11, its biosimilar of Roche’s Lucentis® (ranibizumab...more

Sandoz Announces New Data For Its Adalimumab Biosimilar

by Goodwin on

Last week, Sandoz announced new data reportedly showing that its proposed adalimumab biosimilar matches the safety and efficacy profile of Humira®. The data was obtained from a long term study of patients with...more

Research into Cannabidiol (CBD) Progresses

by Knobbe Martens on

Kalytera Therapeutics, clinical-stage pharmaceutical company, recently announced plans for clinical trials focused on the treatment of Graft versus Host Disease using Cannabidiol (CBD), a compound found in cannabis. This...more

Amgen/Allergan and Pfizer Present Positive Phase 3 Data For Two Investigational Trastuzumab Biosimilars

by Goodwin on

At the European Society for Medical Oncology (“ESMO”) 2017 Congress, which was held over the past several days in Madrid, Spain, companies presented Phase 3 clinical data regarding two investigational biosimilars of...more

Coherus Announces Positive Results for CHS-1420, Humira Biosimilar Candidate

by Goodwin on

Coherus reported that its proposed adalimumab (Humira) biosimilar candidate demonstrated clinical equivalence on all endpoints compared to the European marketed Humira. The candidate in this study also did not show any...more

Boehringer Ingelheim Announces Start Of Adalimumab Biosimilar Interchangeability Study

by Goodwin on

Last week, Boehringer Ingelheim announced that it had enrolled the first patient into its VOLTAIRE-X interchangeability study. This Phase 3 study will investigate the interchangeability of BI’s adalimumab biosimilar...more

How Not To Create an “Exception” to the Learned Intermediary Rule

by Reed Smith on

We’ve heard more about the constitutional “emoluments clause,” Art 1 §9, clause 8, this year than during the entire rest of our legal careers. But while it’s illegal for anybody working for the U.S. government to accept...more

EMA’s revised Guideline on first-in-human trials increases the level of protection of trial participants

by Hogan Lovells on

The European Medicines Agency (EMA) has released a new Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. The Guideline was adopted by...more

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

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

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