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Knobbe Martens

TELA Bio Launches OviTex Inguinal Reinforced Tissue Matrix in Europe

Knobbe Martens on

TELA Bio—which was founded in 2012 and is headquartered in Pennsylvania—is a medical device company that specializes in providing soft-tissue surgical products. According to TELA Bio, its soft-tissue reconstruction solutions...more

Gardner Law

The Importance of a Clinical Trial Strategy

Gardner Law on

Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

Benesch

Dialysis & Nephrology Digest - June 2025

Benesch on

Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more

Robins Kaplan LLP

Generic Launches - Winter 2024

Robins Kaplan LLP on

This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more

Goodwin

Recent Ustekinumab and Denosumab Biosimilars Deals

Goodwin on

On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia....more

Brownstein Hyatt Farber Schreck

A Look at RFK Jr.’s Take on FDA

Brownstein Hyatt Farber Schreck on

Robert F. Kennedy Jr., whom President-elect Trump has said will “go wild on health” in his administration, posted shortly before the election...more

Jones Day

California Supreme Court Will Review Novel Negligence Theory for Pharmaceutical Manufacturers

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The Situation: The California Supreme Court recently granted review of a California Court of Appeal decision, Gilead Life Sciences, Inc. v. The Superior Court of the City and County of San Francisco, that made waves in the...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Knobbe Martens

FDA Approves Neuralink to Begin Human Trials of Brain Implants

Knobbe Martens on

Neuralink, the biotechnology company founded by Elon Musk, has received approval from the U.S. Food and Drug Administration (FDA) to commence human trials of its implantable brain-computer interface device.  Recruitment for...more

Mintz - Health Care Viewpoints

Device Modernization Series: FDA’s Changes to the 510(k) Program

Mintz - Health Care Viewpoints on

In our “FDA 2018 Year in Review (and a Few Thoughts on 2019)” post and recent webinar, we observed that we may look back at 2018 as the beginning of the end for the 510(k) program as it has existed since the 1976 Medical...more

Hogan Lovells

FDA releases final guidance document on PMA manufacturing site change supplements

Hogan Lovells on

On 17 December 2018 the U.S. Food and Drug Administration (FDA) issued a final guidance document intended to help manufacturers determine the appropriate premarket approval (PMA) application supplement reporting pathway for...more

Hogan Lovells

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

Hogan Lovells on

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available for two decades, for the past 20...more

Robins Kaplan LLP

Challenging Drug Patents: Does AIDS Healthcare Raise an “Actual Controversy”?

Robins Kaplan LLP on

Manufacturers who want to introduce generic drugs face a special delay and enjoy a corresponding special right to challenge patents on branded drugs based on the great compromise in the Hatch-Waxman Act. ...more

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