Science, Computers & Technology Health

Read Science, Computers & Technology updates, news, alerts, and legal analysis from leading lawyers and law firms:
News & Analysis as of

Merck Fails to Obtain Summary Judgment on Preemption Defense – Third Circuit Rules “Impossibility Preemption” Presents a Question...

In re: Fosamax (Alendronate Sodium) Products Liability Litigation, Nos. 14-1900 et al. (3d Cir. March 22, 2017). In a precedential decision issued on March 22, 2017, the United States Court of Appeals for the Third...more

340B Program Ceiling Price and CMP Final Rule Delayed Until May 22

On 20 March 2017, the Health Resources and Services Administration (HRSA) published an Interim Final Rule (IFR) delaying the effective date of the 340B Ceiling Price and Civil Monetary Penalties (CMP) Rule (the Final Rule)...more

Updates to the Common Rule for the Protection of Human Subjects Research

On Sept. 8, 2015, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making (NPRM) to seek input on changes to the Federal Policy for the Protection of Human Subjects, otherwise known as...more

Novartis Secures FDA Approval for Breast Cancer Drug Kisqali

On March 13, 2017, the use of Novartis cell cycle inhibitor Kisqali® (ribociclib, LEE011) in combination with an aromatase inhibitor was approved by the U.S. Food and Drug Administration as a first-line treatment for...more

Ingestible e-Pill Approved For Use in Hospitals

BodyCap, a France-based company said to be dedicated to the development of miniature wireless electronic sensors, recently announced that its e-Celsius® device has earned CE mark approval and is now commercially available for...more

Wyden’s C-THRU Act – Publicizing PBM Rebate Data

Last week, Senate Finance Committee Ranking Member Ron Wyden (D- Ore.) introduced the “Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017.” As its name suggests, it seeks to require parties (e.g., PBMs)...more

Health Care E-Note - March 2017

Like pain clinics and pharmacies, practitioners treating substance use disorder appear to be a target for federal enforcers. Under President Trump's administration and Alabama Attorney General Steve Marshall, law enforcement...more

DELAYED: The FDA’s Intended Use Rule

The effective date of FDA’s Intended Use Rule has been extended until March 19, 2018. The comment period will remain open until May 19, 2017....more

ANDA Update - March 2017 Volume 3, Number 1

Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more

President’s budget ax takes a big whack at medical, scientific funding

The Trump budget for the federal government would be a huge step back from investment in medical research with consequences for many years in progress on promoting health and fighting disease....more

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

Drug and Device Makers Suggest Anti-Kickback Safe Harbor Clarifications to Encourage Value-Based Health Care Arrangements

In response to the annual solicitation by the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) for developing new, and modifying existing, safe harbors to the anti-kickback...more

Positive Clinical Results for Using Myriad’s BRACAnalysis CDx® for Identifying Breast Cancer Patients for Treatment with Lynaparza

Myriad Genetics recently announced clinical results showing that its BRACAnalysis CDx® test was able to identify patients with HER2-negative metastatic breast cancer who had improved response with Lynparza (olaparib),...more

Chicago Proposes Pharma Rep Licensing Rules and Ethical Standards

The City of Chicago Commissioner of Public Health on Friday, March 17, published proposed Rules to implement the highly-publicized pharmaceutical representative licensing ordinance enacted in November 2016....more

What If We Win? Off-Label Promotion & Product Liability

Since the nomination of Dr. Scott Gottlieb to head the FDA, we’ve seen quite a few references to his opposition to the current FDA prohibition against off-label promotion – regardless of the truth of the promotion itself. We...more

Key Takeaways From FHA’s Health Law Summit

Foley recently co-hosted the Florida Hospital Association’s (FHA) 2017 Health Law Summit, which brought together more than 40 in-house attorneys and compliance officers from FHA member hospitals to discuss the current state...more

NC Legislative Update - March 2017 #2

This Week - Final arguments were heard Tuesday for litigation brought by Gov. Cooper (D) over the legality of legislation passed late last year creating the Bipartisan State Board of Elections & Ethics Enforcement...more

Another Court Tackles Prescription Drug Design Defect

If you have been following along for a while, then you have surely run across our posts making some combination of the following points: 1) design defect claims rarely make sense for a drug because changing the design in...more

DWT Releases Latest Health Care Breach Charts

Following the HITECH Act, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) issued regulations requiring HIPAA covered entities to provide certain notifications for breaches of unsecured...more

Cures Act Developments: FDA Proposes Class II Device Exemptions

Since the 21st Century Cures Act became law on December 13, 2016, we have been blogging on regulatory and clinical areas affected by its provisions. On March 14, 2017, FDA made further progress on its Cures Act obligations by...more

The Cross-Industry Promise of Blockchain

The blockchain protocol (a form of a ‘distributed ledger system’) was originally designed as a platform to process Bitcoin transactions. The protocol enables peer-to-peer transactions and eliminates the need for a trusted...more

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more

Cardiology Group Hard Drive Stolen

Denton Heart Group, located throughout Dallas, has notified 21,665 patients that their protected health information has been compromised as a result of the theft of a hard drive from a locked closet....more

Tennessee Rule Change: Prohibition on Prescription Transfer Incentives

Tennessee pharmacies can no longer offer patients financial rewards in exchange for the transfer of the patient's prescriptions. Effective February 20, 2017, the Tennessee Board of Pharmacy enacted a new rule providing that...more

Solicitor General Urges Supreme Court to Reverse California’s Ill-Conceived Version of “Specific Jurisdiction”

The Defendant/Petitioner has filed its merits brief in the U.S. Supreme Court in BMS v. Superior Court. This is the case where the California Supreme Court expanded specific personal jurisdiction beyond recognition by basing...more

5,327 Results
|
View per page
Page: of 214
Cybersecurity

Follow Science, Computers & Technology Updates on:

"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 to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×