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Science, Computers & Technology Antitrust & Trade Regulation Health

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Pharma Distributors Trade Association Sued for Conspiracy to Exclude Competition for its Track and Trace Software

On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software,...more

FDA Releases Biosimilars Educational Materials

by Goodwin on

On October 23, 2017, FDA announced the release of new educational materials to help health care professionals understand what biosimilars are and how they are approved. The materials include four fact sheets and graphics that...more

Health Update - October 2017

A New Look at Digital Health Business Models - Editor’s Note: The Commonwealth Fund is developing an innovative digital health advisor (DHA)—an integrated suite of digital services that would provide consumers with health...more

China FDA’s Pharmaceutical Regulations Ready for Public Comments

by Ropes & Gray LLP on

The China Food and Drug Administration (CFDA) published its proposed amendment of the Drug Administration Law (DAL) and the Drug Registration Rules (DRR) for public comments. This Alert summarizes the key changes....more

U.S. watchdogs tally $1.5 billion cost for one type of defective medical device

Big medical device makers, like Big Pharma, have complained Big medical device makers, like Big Pharma, have complained relentlessly that Uncle Sam hamstrings them with red tape and bureaucracy that slows or prevents...more

Shanghai Tightens Industry Interactions with HCPs

by Ropes & Gray LLP on

In August 2017, multiple departments of Shanghai government, led by Shanghai’s Health and Family Planning Commission (“Shanghai HFPC”), jointly issued a series of administrative rules (collectively, “Recent Shanghai Rules”)...more

Building a Health App? Part 4: Avoiding an FTC Enforcement Action

The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow. Last week, the U.S. Food and Drug Administration (“FDA”) approved a new smartphone-based “carbon...more

Federal Trade Commission Announces Workshop on Competition in the Prescription Drug Market

On November 8, 2017, the Federal Trade Commission (FTC) will hold a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” Acting FTC Chairman Maureen K. Ohlhausen and...more

THE LATEST: Integra Forced to Divest Neurosurgical Tools to Gain FTC Clearance

by McDermott Will & Emery on

WHAT HAPPENED - On February 14, 2017, Integra agreed to purchase Johnson & Johnson’s Codman neurosurgery business (excluding Codman’s neurovascular and drug deliver businesses) for $1.045 billion.... ...more

Pfizer and Flynn Pharma fined €101 million for charging the UK health service excessive prices for Phenytoin sodium capsules, an...

by Dechert LLP on

The UK Competition and Markets Authority (“CMA”) recently published its infringement decision of 7 December 2016 that imposed a fine on Pfizer and Flynn Pharma (“Flynn”) for abusing their respective dominant positions by...more

Coming soon from FDA? Streamlined safety information in prescription drug television ads

by DLA Piper on

Most people are by now familiar with prescription drug TV ads that provide lengthy (and often confusing) laundry-list descriptions of numerous potential safety risks (seemingly regardless of the severity or likelihood of the...more

Specialty Pharmacy's Antitrust Claim against Humana Fails

by Baker Ober Health Law on

On August 9, District Judge Susan Wigenton (D. NJ) issued a ruling in Prime Aid Pharmacy v. Humana, Civ. No. 16-2104, granting Humana's motion to dismiss the plaintiff's Second Amended Complaint, finding that the plaintiff...more

Excessive Pricing in Generic Drug Markets

by Ropes & Gray LLP on

EU and UK antitrust laws make it illegal for dominant firms to charge unfair or excessive prices. These laws have most often been applied in markets that feature high barriers to entry or expansion, which enable a dominant...more

Forging ahead: US M&A H1 2017: Healthcare deals flourish, but uncertainty looms large

by White & Case LLP on

Megadeals fuel pharma activity, while healthcare dealmakers face antitrust hurdles - Dealmaking in the pharmaceuticals and healthcare sector saw a rebound in H1 2017, with deal value increasing 51.8 percent compared to the...more

Health Update - July 2017

Contracting With Technology Vendors: Obligations and Compliance Strategies - Editor’s Note: In a recent webinar, Manatt Health examined how to protect privacy when communicating in the digital age. The session revealed how...more

Second Circuit Allows Class Action Suit Involving Diabetes Drug to Proceed

by McDermott Will & Emery on

Purchasers of Takeda Pharmaceuticals Company’s branded diabetes drug, ACTOS, filed an antitrust suit alleging that Takeda falsely described two patents to the US Food and Drug Association (FDA) and, as a result, delayed...more

The Effects of the Actavis Decision on Reverse Payment Settlement Agreements in ANDA cases -- Four Years After

In 2013, the U.S. Supreme Court rendered its decision in FTC v. Actavis, finding that although so-called reverse payment settlement agreements were not per se antitrust violations in cases brought against generic drug makers...more

FTC Votes to Close Investigation of Texas Medical Board’s Conduct

by King & Spalding on

On June 21, 2017, the Federal Trade Commission (Commission) voted to close its investigation into whether the Texas Medical Board (TMB) violated federal antitrust laws by adopting rules that restricted the practice of...more

Health Update - June 2017

HIPAA and Emerging Technologies - Editor’s Note: According to a HIMSS Mobile Technology Survey of healthcare provider employees, about 90% say they are using mobile devices to engage patients in their healthcare—and 36%...more

FDA Steps Up on Medical Device Innovation

by Mark Mansour on

At long last, FDA has the makings of a coherent and forward-thinking policy to address the widening gap between industry's ability to innovate and FDA's regulatory capacity. Consistent with the mandate of the 21st Century...more

As FDA Ramps Up Digital Health Program, BakerHostetler Hosts a Medical Device Connectivity Webinar Addressing Digital Technology...

by BakerHostetler on

Recent reports indicate that Food and Drug Administration (FDA) plans to build a digital health unit within and assign a number of digital scientists to the Center for Devices and Radiological Health. The digital health unit...more

Healthcare Law Update: June 2017

by Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

FDA Commissioner Hints at Drug Pricing-Related Initiatives

During his first appearance before Congress as FDA Commissioner on May 25, 2017, Scott Gottlieb reported that the Agency is preparing a “Drug Competition Action Plan” that it will unveil in upcoming weeks and months. This was...more

China Announces Amendments to Regulation on the Supervision and Administration of Medical Devices

by Ropes & Gray LLP on

On May 19, 2017, China’s State Council promulgated the amendments to the 2014 Regulation on the Supervision and Administration of Medical Devices (“the Amendments”), which became effective immediately. The Amendments clarify...more

Global Inquiries into Drug Price Increases

European competition authorities announced this week an investigation into Aspen Pharmacare’s recent price hikes of five cancer drugs. The European Commission said in a press release that it had “information indicating that...more

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