News & Analysis as of

Clinical Trials

EMA launched improved version of EudraVigilance

by Hogan Lovells on

The European Medicines Agency (“EMA”) has launched a new and improved version of EudraVigilance. EudraVigilance is the system for managing and analysing information concerning suspected adverse reactions to medicinal products...more

Plaintiff Awarded $27.8 Million in First Xarelto Pennsylvania State Trial

On Tuesday, a jury entered a verdict of $27.8 million against Johnson & Johnson’s Janssen Pharmaceuticals, Inc. and Bayer AG’s Bayer Pharmaceuticals Inc. in the first state court trial out of the Philadelphia County Court of...more

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

Clinical trials Part II: Privacy, cybersecurity risks, and managing ePHI

by Thompson Coburn LLP on

The ongoing digitization of the drug and medical device industries continues, and, as a result, new considerations have come to the forefront for companies engaged in clinical trials. In Part 1 of this series, we described a...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

Get your Single IRB lined up for Multi-Site Research

by Akerman LLP - Health Law Rx on

Changes to the federal regulations governing the protection of human subjects participating in research (known as the Common Rule) were amended earlier this year. The changes to the Common Rule impact research conducted,...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 and OHRP Finalize Joint Guidance on IRB Meeting Minutes

by Hogan Lovells on

Ongoing Effort to Harmonize Human Subject Research Regulations The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services (HHS),...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

Keeping Pace in Clinical Research: The Common Rule Picks up Speed

by Dickinson Wright on

In recent years, the world of human subjects research has expanded not only with regard to the number of clinical research trials being conducted and the array of drugs and devices being tested, but also with respect to the...more

Federal Right To Try Legislation – Is It Any Better?

by Reed Smith on

We’ve generally been skeptical of state “Right To Try” statutes, for several reasons. First, to the extent that they try to circumvent the FDCA, they’re likely to be preempted. Second, drugmakers aren’t likely to distribute...more

CRISPR Therapeutics Announces Two-Year Collaboration Agreement with Massachusetts General Hospital

by Allen & Overy LLP on

CRISPR Therapeutics and Massachusetts General Hospital Cancer Center (MGHCC) have entered into a two-year research collaboration and license option agreement to develop novel T-cell therapies for cancer. CRISPR/Cas9 gene...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

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