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Prescription Drugs The United States Food and Drug Administration

Blog: User Fee Act Legislation Introduced Free of Controversial Issues…for the Time Being

by Cooley LLP on

Recently, the House Energy and Commerce Committee and Senate Health, Education, Labor and Pensions (HELP) Committee introduced a bipartisan discussion draft of legislation to reauthorize the Food and Drug Administration’s...more

Glenmark Pharmaceuticals Begins Clinical Investigation for Omalizumab Biosimilar

by Goodwin on

In a press release, Glenmark Pharmaceuticals announced today that the U.S. FDA has cleared Glenmark’s Investigational New Drug (IND) application of GBR 310, a proposed biosimilar of XOLAIR® (omalizumab), to initiate a...more

What Does the Cures Act Really Mean for Patients?

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

Appeal for Legislative Action to Address REMS Concerns

by Goodwin on

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision...more

New State Substitution Laws, and a Busy Spring for Biosimilars

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more

Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017

On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting, these two...more

First Circuit Affirms Dismissal Of Securities Fraud Claims For Failure To Adequately Plead Scienter

by Shearman & Sterling LLP on

On April 7, 2017, the United States Court of Appeals for the First Circuit affirmed the dismissal of a putative securities fraud class action against the biopharmaceutical developer Zafgen, Inc. (“Zafgen”) and its CEO. ...more

Cures Corner: FDA Launches Regenerative Medicine Advanced Therapy Designation Program

by Jones Day on

In late January 2017, FDA took the first steps to implement certain provisions of the 21st Century Cures Act ("Act"), signed into law on December 13, 2016, by launching a new designation program for regenerative medicine...more

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

by Jones Day on

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more

[Webinar] Investment Decisions for Investors and Entrepreneurs Considering 505(b)(2) Drug Applications: How to Make Sure Your...

by Robins Kaplan LLP on

Wednesday, April 19, 2017, 1:00 P.M. CST -- Are you an investor or entrepreneur considering 505(b)(2) drug applications? Join Jake Holdreith, Robins Kaplan, and Ken Phelps, Camargo Pharmaceutical Services for a complimentary...more

DEA awards Schedule II classification to synthetic THC drug

by Thompson Coburn LLP on

On March 23, 2017, the DEA announced it has scheduled the newly approved synthetic THC-containing drug, Syndros, as a Class II substance. This announcement comes as a surprise to some for a number of reasons, including that...more

Roche's Subcutaneous Rituximab Gets Unanimous Recommendation from FDA Advisory Committee

by Goodwin on

In a press release, Roche announced today that FDA’s Oncologic Drug Advisory Committee has voted unanimously in favor of a subcutaneous injection of rituximab for the treatment of certain blood cancers, including previously...more

Trump's Proposed 2018 Budget Will Double FDA User Fees

by Foley & Lardner LLP on

During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more

How Might the FDA's Proposed Patient Affairs Office Impact Patient Advocacy Efforts?

by Faegre Baker Daniels on

Earlier this month, the Food and Drug Administration (FDA) solicited public comments on the agency’s proposal to create a new Office of Patient Affairs. The agency said in its Federal Register notice that the concept was...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

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to...

by Hogan Lovells on

In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug...more

FDA Publishes Guidance on Off-Label Use Communications

by BakerHostetler on

The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents and a memorandum related to off-label communications and the FDA’s power to regulate such communications. The publications are the...more

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

by Reed Smith on

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

FDA Changes Warning For Fluoroquinolones

Fluoroquinolones is a drug used to treat respiratory and urinary infections. Fluoroquinolones include these drugs: - Avelox (moxifloxacin); - Cipro (ciprofloxacin); - Cipro extended-release (Cirpofloxacin...more

TrumpCare: The Pharmaceutical Industry and FDA

Hope in the Midst of Uncertainty - The New Year ushered a period of uncertainty for the pharmaceutical industry. We face the beginning of the Trump Administration and a Congress with both houses controlled by Republicans...more

FDA Request for Justification Found to Provide a Mere Research Suggestion—Not Conception of Claimed Formulation

In Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC, Nos. 16-1115, -1259 (Fed. Cir. Jan. 26, 2017), the Federal Circuit affirmed the lower court’s holding that a patent covering a chelating-agent-free drug...more

Endo Pharms. Inc. v. Amneal Pharms. LLC

by Robins Kaplan LLP on

Case Name: Endo Pharms. Inc. v. Amneal Pharms. LLC, Civ Nos. 14-1382-RGA, 14-1389-RGA, 2016 U.S. Dist. LEXIS 140112 (D. Del. Oct. 7, 2016) (Andrews, J.). Drug Product and Patent(s)-in-Suit: Opana® ER (oxymorphone...more

22 Novel Drugs Approved by FDA in 2016

Every year, the FDA’s Center for Drug Evaluation and Research (CDER) approves new medications. Some medications are variations of existing products, such as generic formulations or new dosage forms of previously-approved...more

Federal Circuit Finds Infringement Under Akamai Of Two-Step Method Of Treatment

by Foley & Lardner LLP on

In Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., the Federal Circuit affirmed the district court decision finding infringement under Akamai of a two-step method of treatment when the prescribing information for the...more

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