Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Life Sciences, Biotechnology & Nanotechnology
Reed Smith
A couple of years ago we penned a paean to Indiana and its cultural and legal triumphs. Now that another chunk of our family has decided to relocate ...
Mintz
As our use of AI technology becomes more frequent, interconnected, and integral to daily life, the liability exposure to AI product designers and manufacturers continues to escalate
Reed Smith
When it comes to medical device preemption, having Pre-Market Approval ("PMA") is like being dealt pocket aces in Texas Hold'Em Poker. It's the strongest starting hand you can have; a 4:1 favorite
Reed Smith
We've blogged several times about the Biomaterials Access Assurance Act of 1998, 21 U.S.C. §§1601-06.
Morgan Lewis
Some states have recently enacted legislation regarding drug price transparency in an attempt to respond to the public and payor concerns regarding prescription drug cost and pricing,
Oblon, McClelland, Maier & Neustadt, L.L.P
On Friday, November 2, 2018, the USPTO released its interim procedure for patentees to request recalculation of the patent term adjustment with respect to information disclosure statements accompanied by ...
Arnold & Porter
As expected, Gavin Newsom was recently elected to be the next Governor of California.
Foley Hoag LLP
Schultz "Jason" Chan, former director of biostatistics at Akebia Therapeutics, Inc. (Nasdaq: AKBA), was sentenced to three years in prison following his conviction for insider trading.
Fenwick & West LLP
We analyzed the terms of 215 venture financings closed in the third quarter of 2018 by companies headquartered in Silicon Valley.
Reed Smith
The 21st Century Cures Act is noteworthy as the first legislative attempt at regulating artificial intelligence ("AI") in the medical field. The Act added this provision to the FDCA:
Reed Smith
The Centers for Medicare & Medicaid Services has confirmed that it expects to have a "temporary gap" in the DMEPOS competitive bidding program (CBP) during calendar years 2010-2020.
Arnold & Porter
Following historical trends, the first mid-term Congressional election in the Trump Administration has concluded with significant losses among the House GOP, resulting in a new Democratic majority.
Reed Smith
A federal judge in one of our non-drug or device cases recently informed the parties that he was so busy with his criminal docket that it might be better to let the magistrate judge take over our case, including trial.
Morrison & Foerster LLP
This month we highlight a new law requiring notification to the Federal Trade Commission and Department of Justice of biosimilar litigation settlements and perhaps the end of a long-running Mylan venue dispute in Delaware.
Shearman & Sterling LLP
The Company develops antibiotics to treat infectious diseases, and was working on developing and releasing solithromycin, a drug for community-acquired bacterial pneumonia.
Cooley LLP
Because this change applies to all data submitted on or after January 1, 2022, companies must begin collecting reportable data on January 1, 2021.
Foley & Lardner
This year marks the 15th anniversary of the completion of the Human Genome Project.
McDermott Will & Emery
The PTAB determined, and the Federal Circuit agreed, that both claimed inventions were separately patentable and did not interfere with each other.
Jones Day
Jones Day partner Ann Hollenbeck shares an informative conversation with associate Ian Pearson, who was a lead in the area of digital health at the U.S. Food and Drug Administration.
Arnold & Porter
On 25 October 2018, the Court of Justice of the EU (CJEU) held in Case C-527/17 Boston Scientific that, where a medical device incorporates an ancillary drug substance, that substance will not be entitled to supplementary protection certificate (SPC) protection.
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Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
If you read part one of this series, you appreciate that it is imperative that all individuals involved in drug development — including scientific, regulatory, marketing, and financial personnel...
Patterson Belknap Webb & Tyler LLP
The Food and Drug Administration is stepping up its game with respect to the cybersecurity of medical devices.
Morrison & Foerster LLP
This month we highlight the possibility that the Supreme Court will consider the standard for adequacy of written description and a Federal Circuit exposition on the relationship between "blocking patents" and objective indicia of nonobviousness.
Duff and Phelps
The market is experiencing tremendous growth due to the reduction in overall cost and decrease in time required to bring a product to market.
Arnold & Porter
Following historical trends, the first mid-term Congressional election in the Trump Administration has concluded with significant losses among the House GOP, resulting in a new Democratic majority.
Holland & Knight
Masked by the recent high-profile drug pricing debate has been the Trump Administration's discussions about the development, approval and reimbursement of medical devices
Jones Day
The Department of Justice ("DOJ") recently announced that it agreed with AmerisourceBergen Corporation ("ABC") and several of its subsidiaries to resolve a False Claims Act ("FCA") case for $625 million.
Reed Smith
Private plaintiffs love to scream "fraud on the FDA"! Agency fraud is their magic potion for dissolving any FDA action that they don't like.
Reed Smith
Pennsylvania Fire cannot be divorced from the outdated jurisprudential assumptions of its era.
Jones Day
Jones Day partner Ann Hollenbeck shares an informative conversation with associate Ian Pearson, who was a lead in the area of digital health at the U.S. Food and Drug Administration.
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