News & Analysis as of

Prescription Drugs

Melinta Therapeutics Receives FDA Approval for Baxdela in Skin Infections

by Knobbe Martens on

On June 19, 2017, the U.S. Food and Drug Administration approved the use of the fluoroquinolone antibiotic, Baxdela® (delafloxacin), for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Approval...more

OIG Report Details Decline in Healthcare Fraud Recoveries

by King & Spalding on

Last week OIG released its semiannual report to Congress, which details the results of OIG’s operations for the first half of the 2017 federal fiscal year. Healthcare fraud recoveries by OIG totaled $2.04 billion during the...more

Senate Releases Repeal and Replace Legislation on ACA: The Better Care Reconciliation Act of 2017

by Foley & Lardner LLP on

After weeks of secrecy, the Senate has released a discussion draft of legislation that is the counterpart of the American Health Care Act (AHCA) previously passed by the House. The Senate legislation, entitled the Better Care...more

Cipla Plans to Reduce Biosimilars Investment to Focus on Respitory Products

by Goodwin on

As reported by Money News, Cipla Ltd., India’s fifth-largest drugmaker by sales, plans to reduce investment in biosimilars to sharpen its focus on building a portfolio of high-margin respiratory products. Cipla’s original...more

Continuous Manufacturing of Pharmaceuticals: FDA Wants to Hear from Industry

by Hogan Lovells on

Continuous manufacturing has often been highlighted by FDA as an exciting technology in the area of pharmaceutical manufacturing, but one that the Agency is still wrapping its head around. Accordingly, on June 22, 2017, FDA...more

Congressional Committees Advance Bipartisan FDA User Fee Agreements

by Baker Donelson on

On May 11 and June 7, the Senate HELP Committee and House Energy and Commerce Committee, respectively, both advanced bipartisan legislation to reauthorize four different user fee agreements that account for over a quarter of...more

Indiana Reverses Course on Telemedicine Prescribing and Controlled Substances Laws

by Foley & Lardner LLP on

Indiana has taken another step towards expanding the meaningful use of telemedicine in connection with clinical services and prescribing. HB 1337, signed by Governor Eric Holcomb and effective July 1, 2017, will allow...more

New York Times Obtains Copy of Draft Executive Order on Drug Prices; FDA Blogs that it is Working to Lift Barriers to Generic Drug...

by Dorsey & Whitney LLP on

On June 20, 2017, the New York Times reported that it had obtained a draft proposal of President Trump’s Executive Order on drug prices. The draft Executive Order, which has not been published, has been characterized as...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

Tenth Circuit Finds Citizen Petition Denial to be "Clear Evidence" of Conflict Preemption

A U.S. Court of Appeals has held that a Food and Drug Administration (FDA) denial of a citizen petition can be “clear evidence” of conflict preemption under the test set forth by the Supreme Court in Wyeth v. Levine, 555 U.S....more

Drug Companies – Peddlers of opiates?

Opioids put nearly 1.3 million people in the hospital in one year. Yet another example of the devastating effects of Fentanyl and other opiate abuse in our country. We have had a front row seat to this epidemic in Palm...more

Cleveland Clinic Decision Highlights Catch-22 Of Personalized Medicine Patents

by Foley & Lardner LLP on

The Federal Circuit decision in Cleveland Clinic Foundation v. True Health Diagnostics LLC, strikes another blow against the patent eligibility of diagnostic methods and highlights the difficulty of enforcing personalized...more

Targeting Generic Drug Prices

by Blank Rome LLP on

For years, states and the federal government focused their drug pricing enforcement efforts on higher priced and more expensive branded drugs. Not surprisingly, private qui tam lawyers followed on the coattails of these...more

Blog: Nevada Enacts Transparency Bill Targeting Diabetes Drug Price Increases, Sales Representatives, PBMs, Nonprofit...

by Cooley LLP on

As we discussed last week, Nevada’s Governor has signed into law SB 539, which provides sweeping transparency legislation related to several aspects of the pharmaceutical industry. Nevada joins several other states in...more

European Commission Sets its Sights on Allegedly Excessive Drug Prices

by Jones Day on

In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more

Nebraska Enacts Law To Allow Automatic Substitution Of Interchangeable Biosimilars

by Goodwin on

As we previously reported, the Nebraska legislature had been considering a bill that would allow automatic substitution of “interchangeable” biosimilar products where a physician prescribes a biologic product. Last month, the...more

Health Alert (Australia) 19 June 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 9 June 2017 - Health Services Union v St John of God Health Care [2017] FWC 2981 - Alleged dispute arising under an enterprise...more

Blog: FDA Solicits Comments Regarding Two New Studies Related to Drug Promotion

by Cooley LLP on

The U.S. Food and Drug Administration (FDA) published two Federal Register notices today announcing its intent to study different aspects of drug promotion. In Docket No. FDA-2017-N-1315, the FDA solicited comments regarding...more

NJ Gov. Chris Christie Seeks to Ease HIPAA Restrictions in Cases of Opioid Overdose

Last week, New Jersey Governor Chris Christie told reporters that he is in talks with representatives from the U.S. Department of Health and Human Services and the U.S. Department of Justice about easing HIPAA restrictions in...more

AGG Food and Drug Newsletter - June 2017

by Arnall Golden Gregory LLP on

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

Expected Executive Order to take on High Drug Prices; Senate Committee Hears Recommendations on Drug Supply Chain from Experts

by Dorsey & Whitney LLP on

According to an article posted today on the BioCentury website, the Trump administration is drafting an executive order that will take on the high costs of pharmaceuticals by instructing “executive agencies to use value-based...more

China FDA Proposes Hatch-Waxman-Like Regulatory Framework Linking Drug Approval to Patent Rights

Recently, the China Food and Drug Administration (CFDA) issued a policy proposal linking drug approval to patent rights.1 The proposal is intended to promote innovation in the development of both drugs and medical devices and...more

Congressional Hearings, Markups Focus on Chronic Care, Drug Pricing, HHS Budget, Other Health Programs

by Reed Smith on

House and Senate committees have held a number of hearings recently to focus on health policy topics, including the following: - A Senate Health, Education, Labor & Pensions Committee hearing on “The Cost of Prescription...more

Adalimumab Biosimilar Demonstrates Non-Inferiority For Efficacy and Safety

by Goodwin on

At the EULAR Annual Congress this week, Rieke H.E. Alten, MD, working at the University of Berlin, presented data from a randomized, double-blind, Phase III study comparing adalimumab and FKB327, Fujifilm Kyowa Kirin...more

Spelling Counts (Among Other Things): FDA Issues Warning Letters for Mistakes in Drug Listing

by Arnall Golden Gregory LLP on

Recently, the Food and Drug Administration issued two Warning Letters to pharmaceutical companies for failing to fulfill product listing obligations for what appear to be oversights. In the first letter issued at the end of...more

1,732 Results
|
View per page
Page: of 70
Cybersecurity

"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 using*

Already signed up? Log in here

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