Pharmaceutical Industry

News & Analysis as of

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

Congressional Panels Examining Pharmaceutical Distribution Systems, FDA Drug User Fees

Two Congressional committees are holding hearings this week on FDA user fees: a March 21 Senate Health, Education, Labor, and Pensions Committee hearing and a March 22 Energy and Commerce Subcommittee on Health hearing....more

Regulation A+ Issuer Aims for NYSE MKT Listing

Myomo, Inc. has had an offering statement qualified by the SEC in which it discloses an intent to apply to list its common stock on the NYSE MKT LLC. The offering seeks to raise $15 million on a “best efforts” basis without...more

Delaware Chancery Court Focuses On Negotiation History In Denying Former Securityholders A Milestone Payment Based On The...

On March 15, 2017, Chancellor Andre G. Bouchard of the Delaware Court of Chancery decided, post-trial, that a biopharmaceutical company was not required to pay a $50 million “milestone payment” under the terms of a merger...more

Your Daily Dose of Financial News

White Collar Watch dates itself considerably with its Perry Mason allusion, but its bigger point is an interesting one–good luck finding a true “gotcha” moment when dealing with what are “quintessentially offenses of the...more

Your Daily Dose of Financial News

Following up on news last week that Bill Ackman was finally done with his grand Valeant experiment, the Times gives us a deeper look at what was really going on with the activist investor’s bet and ultimate $4 billion loss....more

EMA public consultation on revised policy on access to documents

The EMA has launched a public consultation on its draft new Policy/0043 on access to documents. The document describes the EMA’s approach in balancing public and private interests involved in requests for access to documents...more

EU - US mutual recognition of GMP inspections: agreement published

On 4 March 2017, the agreement between the EU and the US governing the reciprocal recognition of GMP inspections of manufacturing sites for medicinal products for human use was published in the Official Journal of the EU:...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

Infrastructure M&A: Journey to the non-core: Six steps to non-core infrastructure success

Infrastructure funds are increasing their capital allocations to non-core sectors, although in doing so they will need to take on increased risk and operate outside an established regulatory environment. There are six steps...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

Blog: FDA Delays “Intended Use” Final Rule until March 2018

Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use...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

AGG Food and Drug Newsletter - March 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...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

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

The Uncertain Future of the 340B Drug Discount Program

Here we are in March 2017 and no one is sure where things stand with the 340B Drug Discount Program. HRSA and its oversight of the 340B program are subject to the recent Executive Orders restricting issuance of federal...more

FDA Is Cold As Ice As It Steps Up Foreign Inspection Enforcement

So far, in 2017, the Food and Drug Administration’s Office of Manufacturing Quality in the Center for Drug Evaluation and Research has released fourteen Warning Letters. Of these, 100% involved manufacturing facilities...more

Congressional Hypocrisy — Taking away your rights

As a part of the recent speed racing bills through Congress, they have put up HR 1215. Quite erroneously, they have titled it: “Protecting Access to Care Act of 2017”. A read of the act’s text quickly tells any objective...more

2016 – a year at a glance

What is a human? When is your best method not good enough? When is an inventor not an inventor? What happens when your patent application fails to deliver on its promise? These are just a few of the questions that the...more

PTAB Life Sciences Report -- Part II - March 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents....more

Congress is About to Take Away Your Rights

The U.S. Congress is fighting hard to take away your rights and the power of individual states to protect those rights. The influence of BIG BUSINESS over your elected representatives is being used protect careless and...more

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