News & Analysis as of

Orphan Drugs

Capitol Hill Healthcare Update

by BakerHostetler on

The House last week voted to renew the Children’s Health Insurance Program (CHIP) through 2022, but disagreements over how to pay for the program are likely to delay consideration in the Senate beyond this month. On a...more

These Flakes Can’t Fake it – FDA Says They’re Not Medical Foods

by Arnall Golden Gregory LLP on

FDA recently issued a warning letter to a medical food manufacturer for several violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The violations were discovered during FDA’s inspection of the facility. FDA said...more

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

by Hogan Lovells on

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

FDA Approving Orphan Drugs At A Record Pace

by Fox Rothschild LLP on

It is only August, but the U.S. Food and Drug Administration (FDA) is on track to set a record for orphan drugs approved this year. At last count, 42 orphan drugs have been approved between January 1, 2017 and August 9, 2017....more

Witnesses at Congressional Hearing on 340B Urge Congress To Give HRSA Broader Regulatory Authority

On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Oversight since March 2015. A...more

AGG Food and Drug Newsletter - July 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

Rare but Not Forgotten: FDA Speeds Review of Orphan Drug Requests

Ever heard of Hailey-Hailey Disease? How about factor V deficiency or Hemimegalencephaly? These are a few examples of rare diseases, e.g., those afflicting fewer than 200,000 Americans. Rare diseases have long had trouble...more

House Bill Would Narrow Orphan Drug Exception

by Arnall Golden Gregory LLP on

A recent House bill, titled the "Closing Loopholes for Orphan Drugs Act," would narrow the exception for orphan drugs in the federal 340B Drug Pricing program. Representative Peter Welch (D-VT) introduced the bill on June 13,...more

Money for Nothin': FDA's PDUFA Fee Waivers and Exemptions

by Arnall Golden Gregory LLP on

Lately, we have received a number of client inquiries about prescription user fee waivers. The Prescription Drug User Fee Act (PDUFA), enacted in 1992, authorizes FDA to collect fees from companies that produce certain human...more

21st Century Cures: What's In the Box?

by Mark Mansour on

One of FDA’s most important tasks in the coming months will be the implementation of the 1,000 page long 21st Century Cures bill, enacted last year. We have assembled a quick, bullet-pointed summary of some of the major...more

Tesaro Receives Early FDA Approval for Ovarian Cancer Drug Zejula

by Knobbe Martens on

On March 27, 2017, the U.S. Food and Drug Administration approved the use of the poly ADP-ribose polymerase (PARP) inhibitor, Zejula (niraparib), for the maintenance treatment of recurrent ovarian, fallopian tube, or primary...more

Orphan Drug Designation

by Knobbe Martens on

“Orphan drug” is a designation given to certain pharmaceutical and biological products (drugs) that would likely not be developed due to a relatively small patient population and limited potential for profitability. In the...more

FDA User Fee Hearings Picking Up Steam on Capitol Hill

As we noted previously in our introductory blog post on the 2017 User Fee Act (UFA) reauthorization process, the first UFA hearing on Capitol Hill was convened on March 2, 2017 by the House Energy & Commerce Committee’s (E&C)...more

GAO, states jump into battles to rein in Big Pharma’s sky-high prices

Big Pharma’s skyrocketing prices are finally in for some real scrutiny by the U.S. Government Accountability Office (GAO), as well as new initiatives in the Maryland and New York statehouses....more

Big Pharma found to exploit ‘orphan’ drug law to jack up product prices

Big Pharma has ruthlessly exploited a well-intentioned measure that sought to provide medications to treat patients with rare diseases that might otherwise have been ignored. Drug companies, instead, have manipulated the 1983...more

Scottish government to reform approval process for new end-of-life and orphan medicines

by Hogan Lovells on

The Scottish government has announced plans to implement the 28 recommendations proposed in an independent review of access to new end-of-life, orphan and ultra-orphan medicines by patients in Scotland, published in a report...more

AGG Food and Drug Newsletter - December 2016

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

Thanks to 21st Century Cures, the Sun is Coming out Tomorrow for Orphan Drugs and Pediatric Priority Review Vouchers

by Arnall Golden Gregory LLP on

The 21st Century Cures Act, a bill that includes major Food and Drug Administration reform, was passed by the Senate last week and was signed by President Obama on Tuesday, December 13, 2016. While the new law addresses a...more

Spectrum Pharms., Inc. v. Burwell

by Robins Kaplan LLP on

Case Name: Spectrum Pharms., Inc. v. Burwell, No. 15-5166, 2016 U.S. App. LEXIS 10095 (D.C. Cir. June 3, 2016) (Circuit Judges Griffith, Cavanaugh, and Wilkins presiding; Opinion by Griffith) (Appeal from D.D.C., Lamberth,...more

FDA Adjustment to Orphan Drug Review May Indicate Increased Scrutiny of Designations

In recent years, applications for orphan drug designations have flooded into FDA at a rapid pace, and this year appears to be no exception. Orphan drug applications received by FDA rose by approximately 30% over the previous...more

Health Alert (Australia) June 6, 2016

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland 24 May 2016 - Zahedpur v Idameneo (No 123) Pty Ltd [2016] QCA 134 - Mr Zahedpur is a medical...more

FDA Finalizes Additional Guidance on Medical Foods; Continues to Take Narrow View of Category

by Kelley Drye & Warren LLP on

FDA has finalized its guidance document relating to medical foods, a special class of products defined under the Orphan Drug Act. Although most of the content of the final guidance mirrors the draft guidance released in...more

European Life Sciences Review: Issue 2

by Morgan Lewis on

Welcome to the second issue of our EU life sciences alerter that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

Pharmaceutical Life Cycle Management: Navigating the New IP, FDA and Antitrust Terrain

by BakerHostetler on

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of...more

Health Alert (Australia) - January 25, 2016

by DLA Piper on

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments Commonwealth. Fair Work Commission 15 January 2016 - Lawrence v Calvary Home Care Services Ltd [2016] FWC 175 This...more

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