News & Analysis as of

Medical Research

Combining Ritalin and Cognitive Behavioral Rehabilitation Shows Promise Following TBI

by Downs Rachlin Martin PLLC on

A treatment protocol combining Ritalin, a stimulant commonly used for ADHD, and a form of Cognitive Behavioral Rehabilitation known as “Memory and Attention Adaptation Training” (MAAT) shows great promise for improving...more

What’s new with the Common Rule? Clinical research and Common Rule updates

by Bricker & Eckler LLP on

The updates to the Common Rule, effective January 19, 2018, make some significant changes of which those involved in government-funded clinical research involving human subjects should be aware. These changes include...more

HHS Office for Civil Rights Releases Research-Related HIPAA Guidance Required by 21st Century Cures Act

by Ropes & Gray LLP on

In December 2017, the U.S. Department of Health and Human Services Office for Civil Rights (“HHS OCR”) released two sets of guidance mandated by the 21st Century Cures Act, which was enacted in 2016 (the “Act”). The guidance...more

FDA Issues Draft Guidances on Targeted Therapies and the Use of Standards

by Goodwin on

The FDA published two draft guidances for comment this week: “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease” and “Standards Development and the Use of Standards in Regulatory Submissions...more

Italy approves new provisions on informed consent and advance decision of medical treatments – Why it matters for clinical trials...

by Hogan Lovells on

On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the...more

Health Alert (Australia) 11 December 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 1 December 2017 - Laerdal Medical Pty Ltd and Comptroller-General of Customs AATA 2427 - CUSTOMS – whether subject goods accessory –...more

Americans For Medical Progress Premieres An Extraordinary Video That Describes The Incredible Need For And Contribution Of Animals...

by Fox Rothschild LLP on

Americans for Medical Progress (AMP) “supports research involving animals when it is necessary to advance our understanding of biological processes.” and provides tools for “public outreach that builds understanding and...more

Important Opposition To The PUPPERS Act (H.R. 3197) Mounts.

by Fox Rothschild LLP on

The “PUPPERS” Act, H.R. 3197, a bill that would prohibit the use of canines in biomedical research at the Veterans Administration by eliminating required funding, is misguided and, if enacted, would be harmful to both humans...more

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

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