Pharmaceutical Industry Healthcare

News & Analysis as of

Health Law Pulse - October 2015

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014

The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...more

Why Industry Drug-Assistance Programs Are a Sham

You probably heard about the recent price hike for a drug critical to AIDS patients when the manufacturer sold it to an evil hedge fund manager who promptly marked it up 5,000%. This prompted Los Angeles Times columnist...more

Don’t Flush the Drugs! The EPA is Coming!

The Environmental Protection Agency (EPA) recently issued a pre-publication Proposed Rule (40 C.F.R. part 266, subpart P) regulating the management and disposal of drugs deemed “hazardous waste pharmaceuticals” by healthcare...more

EPA Proposes Hazardous Waste Rule for Pharmaceuticals

A pre-publication draft of a proposed rule by EPA may clarify hazardous waste requirements for obsolete or defective pharmaceuticals. EPA proposes a new Subpart P entitled “Hazardous Waste Pharmaceuticals” to 40 CFR Part 266...more

Health Alert (Australia) - September 21, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments Australian Capital Territory (ACT) 4 September 2015 - Hobbs v Tym & Anor [2015] ACTSC 276 The Supreme Court has...more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

EPA Proposes New Rules for Pharmaceutical Hazardous Waste Management and for Other Hazardous Waste Generators

The U.S. Environmental Protection Agency (EPA) has announced two new proposed hazardous waste rules that EPA believes would clarify and simplify requirements for health care facilities and retail pharmacies to manage their...more

HRSA Issues 340B Program Omnibus Guidance

On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

A summary and analysis of HRSA's proposed 340B program guidance

On August 28, 2015, the US Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) published its long-awaited, if still only proposed, 340B program guidance (Proposed Guidance). 80 Fed....more

Key Digital Health Investment Trends to Watch

Our fourth annual Digital Health Summit brought together a select group of investors active in the digital health, life sciences, medical device, and healthcare industries for a one-day meeting to discuss the future of...more

Health Alert (Australia) - August 31, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpts from Judgments New South Wales (NSW) 28 August 2015 - Smith v Pennington [2015] NSWSC 1168 The Supreme Court gave judgement for the...more

Breaking News: Proposed 340B Omnibus Guidance Released

The Health Resources and Services Administration (“HRSA”) released an advanced copy of its long-awaited proposed 340B Omnibus Guidance (“Guidance”) today. The document can be found here. Polsinelli is currently reviewing the...more

Health Alert (Australia) - August 24, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: Victoria 17 August 2015 - Bourke v Coroners Court [2015] VSC...more

China’s State Council Announces Reform on the Drug and Device Approval System

China will launch new reforms of its current review and approval system for drugs and medical devices, announced by China’s State Council, in its August 18, 2015, circular Opinions Concerning the Reform of the Review and...more

How Far Is Too Far? Court Rules for Amarin in Off-Label Marketing Fight against FDA

Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that...more

Identifying the likely beneficiaries of an emerging biosimilars market

Financial analysts have predicted that over the next five years, biosimilars will be a $10 billion market, so it is understandable why considerable attention and investment is being made in this space. However, while there is...more

Patients' Voices Carry: Drug Development Increasingly Driven by Patients' Needs and Concerns

With the recent announcement of Sarepta’s filing for approval of its drug, eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD), coming on the heels of BioMarin’s announcement a few months earlier of a similar...more

Shire Development, LLC v. Watson Pharms., Inc.

Case Name: Shire Development, LLC v. Watson Pharms., Inc., 787 F.3d 1359 (Fed. Cir. June 3, 2015) (Circuit Judges Prost, Chen, and Hughes presiding; Opinion by Hughes, J.) (Appeal from S.D. Fla., Middlebrooks, J.) - Drug...more

Federal Circuit Delays Sandoz Biosimilar Launch

In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz's...more

Georgia Senator Introduces The Combination Product Regulatory Fairness Act of 2015

On July 17, 2015, Georgia’s U.S. Senator Johnny Isakson (R-GA), along with co-sponsors, Robert Casey (D-PA), and Pat Roberts (R-KS), introduced a Senate bill entitled, “The Combination Product Regulatory Fairness Act of...more

OIG Report Raises Serious Medicare Part D Fraud, Waste and Abuse Concerns

Last month, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a comprehensive report and data brief detailing its concerns about the ability of Medicare Part D sponsors – as...more

FDA's Proposed Rules to Address Inaccurate Orange Book Use Codes May Shorten Approval Timelines for Select 505(b)(2) and Generic...

Drug Approval and Patent Listing Process - Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and...more

Health Alert (Australia) - July 13, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: United Kingdom (UK) 7 July 2015 - Ross v A [2015] EWCOP 46 The England and Wales Court of Protection has held that a...more

21st Century Cures Act Passes House: Could Usher In Broad Reforms to Drug Approval Process

On Friday, July 10th the U.S. House voted overwhelmingly to streamline the approval process of prescription drugs and medical devices by the FDA. If passed in the Senate and signed by President Obama, the “21st Century Cures...more

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