News & Analysis as of

Orphan Drugs

China Drug Administration publishes a key Draft Guidance on data exclusivity

by Hogan Lovells on

This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more

BioArctic Announces Patent Allowance Entitled Spinal Cord Devices and Methods for Promoting Axonal Regeneration

by Knobbe Martens on

BioArctic AB, a public Swedish biopharma company, recently announced that they received allowance of a patent application directed to a method of promoting axonal regeneration using a biodegradable spinal cord device. The...more

When a 20 year patent term just isn't enough: Market and data exclusivity

by FPA Patent Attorneys on

In our first article in this series we considered patent term extension regimes in key jurisdictions as a means for extending the 20 year patent term. This next article considers market and data exclusivity provisions, which...more

As Congress Struggles With ACA Repeal, Trump Administration Moves Forward With Regulatory Reform

The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...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

The New Tax Reform Law: Highlights of Provisions Affecting Health Care and Nonprofits

by Epstein Becker & Green on

On December 22, 2017, President Trump signed into law tax reform legislation (the “Act”), which contains many substantial changes to the Internal Revenue Code (the “Code”). This Client Alert provides a brief description of...more

Tax Reform Changes to Healthcare

by Holland & Knight LLP on

Following a final vote in the U.S. House of Representatives on Wednesday morning, Dec. 20, 2017, Congress sent the Tax Cuts and Jobs Act (H.R. 1) to President Donald Trump's desk. In addition to extensive revisions to the tax...more

FDA Issues Draft Guidance on Orphan Drug Designation in Pediatric Subpopulations

by Latham & Watkins LLP on

New guidance intends to limit product sponsors’ exclusions from the requirement to study pharmaceuticals in pediatric patients. On December 20, 2017, the US Food and Drug Administration (FDA or Agency) issued draft...more

EMA released Practical Guidance for Brexit and Market Authorisation Holders

by Hogan Lovells on

The European Medicines Agency (“EMA”) has released a Practical Guidance concerning the steps that centralised Market Authorisation Holders (“MAH”) will be required to take should the United Kingdom (“UK”) become a third...more

Capitol Hill Healthcare Update

by BakerHostetler on

SHUTDOWN SHOWDOWN: CHIP, OTHER HEALTH PROVISIONS AT RISK AS DEADLINE NEARS - Renewal of the Children’s Health Insurance Program and a host of other healthcare provisions hang in the balance as congressional Republicans...more

FDA Approves Zelboraf for Treatment of a Rare Cancer

by Knobbe Martens on

On November 6th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester Disease (ECD). The FDA approved Zelboraf under Priority Review, Breakthrough...more

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

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

84 Results
|
View per page
Page: of 4
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.