Clinical Trials

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Pfizer Announces Results from Trial With its Proposed Humira Biosimilar

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

FDA Issues New Guidance on Use of Clinical Pharmacology Studies to Show Biosimilarity

The FDA issued a new Guidance today, titled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.” The Guidance is intended to “assist sponsors with the design and use of clinical...more

21st Century Cures: Examining Provisions for Streamlining FDA Regulations for Clinical Research in Title III

The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more

21st Century Cures Act Becomes Law

On December 13, 2016, President Obama signed the 21st Century Cures Act (H.R. 34) into law. The act's 312 pages contain a variety of provisions, including nearly $5 billion in funding for scientific research, $1 billion in...more

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

Health Alert (Australia) December 12, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Federal Circuit Court 5 December 2016 - Singh v Minister For Immigration & Anor [2016] FCCA 3061 - MIGRATION –...more

Better Healthcare Newsletter from Patrick Malone - December 2016

Give a lasting holiday gift of health: Volunteer for a medical research study - That toy the kids whined about for weeks may be broken hours after emerging from the box. The gift card you gave will be frittered away,...more

Health Canada releases revised guidance on the submission requirements for biosimilar biologic drugs

On December 2, 2016, Health Canada released the revised Guidance Document Information and Submission Requirements for Biosimilar Biologic Drugs. The Guidance is intended to assist biosimilar companies to navigate the...more

Mylan-Biocon Publish Positive Results for Proposed Trastuzumab Biosimilar

Earlier this year, we reported that Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Earlier this week, an article published in the Journal of the American...more

New HHS clinical trials registry regulations set to go into effect in January 2017: top points in one chart

Nearly a decade after Congress directed significant expansion of the national clinical trials database, www.ClinicalTrials.gov, the US Department of Health and Human Services (HHS) has issued final implementing regulations...more

Success for Pfizer’s Trastuzumab Biosimilar in Phase 3 Clinical Trials

Today, Pfizer reported that their trastuzumab biosimilar to Roche’s Herceptin® has shown equivalence in a Phase 3 clinical trial measuring objective response rate (ORR) when taken in combination with paclitaxel to treat...more

Momenta Announces Positive Phase III Results For Its Humira biosimilar

Today Momenta Pharmaceuticals announced that M923, a biosimilar candidate of AbbVie’s Humira (adalimumab), met the primary endpoint in a Phase III trial of M923 for treatment of patients with moderate-to-severe chronic plaque...more

Sandoz: Etanercept biosimilar switch has no impact on safety and efficacy

Novartis announced on Friday that the EGALITY study, analyzing the clinical safety and efficacy of Sandoz’s etanercept biosimilar, was published in the British Journal of Dermatology. The 52-week EGALITY study involved...more

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

Celltrion Publishes Data on CT-P10 (Rituximab) and CT-P13 (Infliximab)

On this blog, we have been following two Celltrion biosimilars: CT-P10 (rituximab) and CT-P13 (infliximab, the subject of the Janssen v. Celltrion litigation). According to a Celltrion press release, new data released today...more

Ninth Circuit Smells a Rat and Reinstates Claim That Pharmaceutical Company Failed to Disclose Cancers in Animal Testing

The Ninth Circuit recently revived a securities class action against Arena Pharmaceuticals, issuing a decision with important guidance to pharmaceutical companies speaking publicly about future prospects for FDA approval of...more

Celltrion’s Herceptin Biosimilar Submitted For Approval in Europe

According to The Korea Herald, the South Korean biopharma company Celltrion submitted their Herceptin biosimilar, Herzuma, to the European Medicine Agency for approval. Herzuma, a biosimilar to Roche’s breast cancer drug...more

New Clinical Trial Rule Alters Reporting Requirements

New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health...more

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more

Fujifilm Kyowa Kirin Biologics Announces Successful Adalimumab Biosimilar Trial Results

On October 19, Fujifilm Kyowa Kirin Biologics (a joint venture between Fujifilm and Kyowa Hakko Kirin), announced successful results in the global Phase 3 study of its Humira® (adalimumab) biosimilar candidate, FKB327. ...more

More Than the Leaves Are Changing: Clinical Trial Research Regulations and Policies Get a Fall Makeover

The Food and Drug Administration (FDA) and National Institutes of Health (NIH) have recently finalized or signaled intent to finalize numerous proposals that promise to change the landscape of clinical trial reporting,...more

CT-P10 Shows Equivalent Pharmacokinetic and Comparable Efficacy with Rituximab

Last month, researchers published results from a randomized phase I clinical trial of CT-P10, a biosimilar candidate to rituximab, comparing the pharmacokinetics parameters and safety profiles in patients with rheumatoid...more

NIH Finalizes New Drug and Device Clinical Trial Reporting Requirements

The National Institutes of Health (NIH) has finalized the requirements for submitting clinical trial information for applicable clinical trials of drug products (including biological products) and device products on...more

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