News & Analysis as of

Pharmaceutical Industry

Samsung Bioepis’s Etanercept Biosimilar Said to be Less Immunogenic than Enbrel

by Goodwin on

A research letter published by the British Journal of Dermatology from investigators in Samsung Bioepis’s biosimilar etanercept (SB4) clinical trials reports that, in addition to therapeutic equivalence between SB4 and...more

House Energy and Commerce Report Recommends Reform and Increased Oversight of the 340B Drug Pricing Program

by King & Spalding on

On January 10, 2018, the House Energy and Commerce (E&C) Committee released a report calling for major reforms to the 340B Drug Pricing Program (340B program). Administered by the Health Resources and Services Administration...more

New Jersey Bans and Caps Certain Manufacturer Gifts and Payments to Prescribers

by McDermott Will & Emery on

On January 16, 2018, New Jersey’s new regulations limiting gifts and payments from prescription drug and biologics manufacturers to prescribers were issued in the New Jersey Register and became effective. After receiving...more

Biosimilar Market Developments Continue Apace in 2018

It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products....more

FDA Accepts Sandoz aBLA for Adalimumab Biosimilar

by Goodwin on

Sandoz, a division of Novartis, announced on Tuesday that the FDA has accepted for review its BLA under the 351(k) pathway for a biosimilar candidate to AbbVie’s Humira (adalimumab). According to the press release, adalimumab...more

eCTD Format Required for all Mutual Recognition Procedure Submissions

by Hogan Lovells on

Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure (“MRP”) submissions should be made in electronic Common Technical Document format (“eCTD format”)....more

MHRA confirms UK stance in Brexit update to pharma industry

by Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published an update to pharmaceutical companies in the UK on the status of the Brexit negotiations and confirmed the UK's wish for there to be a transition...more

This Year May be a Game Changer for 340B Drug Discount Program, Take Two

I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed...more

OIG Issues Letter Declining to Impose Administrative Sanctions for Provision of Certain Free Drugs

by Holland & Knight LLP on

On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries. Specifically, the OIG stated that...more

Generic drugs taking hold in the Asian marketplace: STAT News interview

by Hogan Lovells on

Aging populations and rising healthcare costs across Asia — particularly in Japan — have created new market opportunities for generic drug makers operating in the region. For originator drug manufacturers, that means...more

Don’t Forget Your FDA Valentine

by Arnall Golden Gregory LLP on

In addition to reauthorizing various user fee programs, the FDA Reauthorization Act of 2017 (FDARA), which was enacted last summer, added a one-time marketing status reporting requirement for holders of new drug applications...more

Drug Pricing Continues to be a Hot Topic for State Legislatures

by Arnall Golden Gregory LLP on

Due to the recent significant increases in certain drug prices that have led to allegations of “price gouging” and antitrust violations, several state legislatures have enacted new laws aimed at controlling prescription drug...more

Trump Administration: 2017 Recap and 2018 Outlook

On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more

FDA Announces Release of 2018 Strategic Policy Roadmap

by Goodwin on

On January 11, FDA announced the release of its 2018 Strategic Policy Roadmap, which provides an overview of several policy areas that FDA intends to focus on in 2018. FDA noted that, among these policy areas, it planned to...more

The China Food and Drug Administration pushes forward on conditional approval and compassionate use of new drugs

by Hogan Lovells on

On December 20, 2017, the China Food and Drug Administration (“CFDA“) released two draft documents for public comment: (1) Conditional Approval for Urgently Needed Drugs Technical Guidance (the “Draft Conditional Approval...more

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns

by Hogan Lovells on

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more

Dr. Frederick Ch’en discusses generic drugs and the changing pharmaceutical landscape in Asia

by Hogan Lovells on

Dr. Frederick Ch’en, an IP partner in Hogan Lovells’ Tokyo office, explains the political and demographic changes fueling changes in Japan and throughout Asia, and the practical impact on pharmaceutical companies doing...more

Guest Post – No Way For Non-Resident Plaintiffs To “MacGyver” Their Way Into Illinois Court Due To Forum Non Conveniens

by Reed Smith on

Today’s post is another guest post from Kevin Hara, of Reed Smith, who is on his way to becoming a semi-regular blog contributor. This post is about forum non conveniens, which is more discretionary, and less enforceable...more

In Proposed Regulations CMS Requests Information on Changes to Part D Negotiated Prices

Today, January 16, 2018 is the deadline for interested parties to submit comments to CMS regarding the proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule focuses on many issues. In...more

PTAB Life Sciences Report - January 2018

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Micro Labs Ltd. v. Santen Pharmaceutical Co. - PTAB Petition: IPR2017-01434; filed May 12,...more

FDA Proposes to Delay Off-Label “Intended Use” Rule

by Reed Smith on

Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but it is also true for drug and device litigation regulation. Such drug and...more

France Aims for 80% Biosimilar Penetration by 2022

by Goodwin on

In its 2018-2022 National Health Strategy, France aims for 80% biosimilar penetration by 2022, an increase from last year’s 70% target. France’s support for biosimilars is not new. ...more

No Old Kentucky Home for Parallel FDCA-Based Tort Claims

by Reed Smith on

Several years ago, in a post entitled “Negligence Per Se Trivia,” we included the following: "In Kentucky, negligence per se has been codified, and claims based on federal (but not state) statutes or regulations (like the...more

FDA to step up enforcement of homeopathic medicine

by Thompson Coburn LLP on

Homeopathic medicine has long occupied a niche in American culture. Since 1988, with the issuance of the Compliance Policy Guide, § 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed,” the FDA has had a...more

2017 – It was biotech and pharma who kept the Australian legal system busy

by FPA Patent Attorneys on

2016 saw the Australian legal system deal with the questions that ranged from defining a human being to defining an inventor. 2017 proved to be just as interesting, and just as informative for patentees and applicants as to...more

4,239 Results
|
View per page
Page: of 170
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.