News & Analysis as of

Medical Research

Health Alert (Australia) 23 October 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Australian Capital Territory 19 October 2017 - Medical Board of Australia v Helmy (Occupational Discipline) [2017] ACAT 85 -...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

Health Alert (Australia) 16 October 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales (NSW) 6 October 2017 - City of Ryde Council v Principal Healthcare Finance Pty Ltd (No 2) [2017] NSWLEC 134 -...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

TGA response: Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes...

by Dentons on

In March 2017, the TGA invited responses to the public consultation paper, ‘Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS)’. The TGA responded on 9...more

The Joshua Frase Foundation For Congenital Myopathy Research, Inc.

by Fox Rothschild LLP on

I recently attended the 2017 National Animal Interest Alliance (NAIA) Conference, titled “Animal Nation.” There, I heard the remarkable, heart-wrenching but uplifting story about the life of Joshua Frase and the challenges...more

Health Alert (Australia) 2 Oct 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland 22 September 2017 - Sarvestani v State of Queensland (Metro South Hospital and Health Service) [2017] QIRC 085 -...more

Health Alert (Australia) 25 September 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland 20 September 2017 - Non-inquest findings into the death of RO'H 2013/761 - 'Mr RO'H died at Logan Hospital after being...more

Another Successful IACUC Conference Presented By The New Jersey Association For Biomedical Research

by Fox Rothschild LLP on

On September 22, 2017, the New Jersey Association for Biomedical Research (NJABR) offered its 24th Annual IACUC Conference, – “the region’s premier training conference for Institutional Animal Care and Use Committee members,...more

Health Alert (Australia) 18 September 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 6 September 2017 - Finding of inquest into death of Phillip William Michell - Phillip William Michell died on 11 July 2015 at the...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

Takeda Pharmaceuticals Explores GI Devices in New Partnership with Nanotechnology Company

by Knobbe Martens on

Takeda Pharmaceutical Company, a Japan-based global pharmaceutical company, recently announced an agreement with BioSurfaces Inc., a small Massachusetts research company, to research the development of medical devices for the...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

Developments in Regenerative Medicine: FDA Announces Plans to Clarify Its Oversight of Cellular Therapy Products and Approves...

by Holland & Knight LLP on

FDA Commissioner Scott Gottlieb, on Aug. 28, 2017, announced steps the agency is taking to begin rolling out policies and guidance documents to clarify its oversight over regenerative medicine products. Dr. Gottlieb...more

0.44% of NFL Brains

by Wilson Elser on

When The New York Times reports that 110 out of 111 NFL brains (99.09%) have chronic traumatic encephalopathy (CTE), everyone pays attention. Mothers worry about their kids. Some worry about their jobs. Senate subcommittees...more

August 2017 – Regulating CRISPR genome editing in humans: where do we go from here?

by Allen & Overy LLP on

The use of genome-editing techniques in medical therapies has proved to be a promising development in the treatment of certain diseases, such as cancer, HIV and rare diseases, by genetically altering specific types of cells....more

Human Germline Genome Editing – Genetics bodies weigh in on debate with position paper

by Allen & Overy LLP on

In an article published in American Journal of Human Genetics on 3 August 2017, an international group of 11 organisations with genetics expertise has issued a joint position statement, setting out 3 key positions on the...more

Health Alert (Australia) 7 August 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 26 July 2017 - Spragg and Australian Health Practitioner Regulation Agency [2017] WASAT 103 - The applicant made a complaint to the...more

FDA Clarifies Consent Requirements for Certain Minimal Risk Clinical Investigations

by Morgan Lewis on

FDA’s guidance, which permits institutional review boards to waive informed consent for certain clinical investigations, may facilitate valuable personalized medicine research....more

Health Alert (Australia) 31 July 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 24 July 2017 - Medical Board of Australia v Soo [2017] SAHPT 10 - In this proceeding, the respondent, a physiotherapist, was alleged to have...more

FDA User Fee Reauthorization Legislation Enacted by Congress

by Ropes & Gray LLP on

On July 12, 2017, the House of Representatives passed H.R. 2430, the FDA Reauthorization Act of 2017 (FDARA), and on August 3, 2017, the Senate followed suit by passing FDARA without amendment by a vote of 94-1. The President...more

New Information on Photophobia following TBI

One of the most common symptoms following TBI is photophobia, an intense intolerance to light that can cause significant discomfort, interfere with activities of daily living, and contribute to post traumatic headaches. It...more

Pro Te: Solutio - Vol. 10 No. 2 – Spring 2017

by Butler Snow LLP on

It’s Spring! In this issue of Pro Te, we do a little a “spring cleaning” to brush the dust off some familiar topics that we consider in day-to-day pharmaceutical litigation. In The Forgotten Element? Warnings Proximate...more

Health Alert (Australia) 24 July 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 18 July 2017 - Ms Shahin Tavassoli v Bupa Aged Care Mosman [2017] FWC 3200 - Application for an unfair dismissal remedy. The...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

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