News & Analysis as of

Medical Devices › Pharmaceutical Industry › Cancer

Console and Associates, P.C.

Medical Device Manufacturer B. Braun at the Center of Cancer Lawsuit Stemming from Ethylene Oxide Exposure

Console and Associates, P.C. on

B. Braun, a Germany-based medical device manufacturer, is facing allegations that the company’s Allentown, PA facility exposed workers and nearby residents to dangerous levels of the chemical ethylene oxide. Ethylene oxide...more

Console and Associates, P.C.

Philips CPAP Recall Update: Shocking Revelation From FDA Investigations and More

Console and Associates, P.C. on

What is the latest with the CPAP lawsuits? As 2022 begins, the thoughts of sleep apnea patients and their families are, naturally, returning to the Philips CPAP machine recall 2021....more

Knobbe Martens

Alpha Tau Receives FDA Breakthrough Device Designation for Alpha DaRT Treatment of GBM

Knobbe Martens on

Alpha Tau Medical Ltd. (“Alpha Tau”) is a medical technology start-up focused on the research, development, and commercialization of its Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) treatment for solid cancerous...more

Shook, Hardy & Bacon L.L.P.

The FDA’s Latest Warning: A Good Reminder Regarding the Litigation Risks of Off-Label Use

Shook, Hardy & Bacon L.L.P. on

Last week, the FDA issued a warning against the use of robotic surgery for mastectomy and other cancer-related procedures. ...more

Wilson Sonsini Goodrich & Rosati

FDA Outlines Considerations for the Development and Labeling of Companion Diagnostics for Use with a Specific Group or Class of...

Wilson Sonsini Goodrich & Rosati on

Recently, the U.S. Food and Drug Administration, or FDA, issued a draft guidance (the guidance) outlining considerations for the development and labeling of in vitro companion diagnostics to support indicated uses for...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

Skadden, Arps, Slate, Meagher & Flom LLP on

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

Knobbe Martens

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

Knobbe Martens on

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

Mintz - Health Care Viewpoints

FDA Reorganization Takes on Cancer Moonshot and Other Initiatives

Mintz - Health Care Viewpoints on

On July 11, 1969, the United States accomplished the almost unthinkable –two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

9 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide