Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Mayer Brown ordered by Published Date Descending.
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Chris Mikson: Practicing At The Intersection Of Law And Medicine
Perspectives spoke with Litigation & Dispute Resolution partner Chris Mikson (DC), whose training as a physician, registered patent attorney and trial lawyer has opened doors to a colorful and fulfilling career.
United States
16 Jan 2019
Federal District Court Reduces Punitive Damages To Amount Of Compensatory Damages—But That's Still Not Enough
Usually, when a defendant gets a punitive award reduced to the same amount as the compensatory damages, it considers that a victory.
United States
23 Nov 2018
European Commission's Update Of Guideline On Duplicate Marketing Authorizations To Cover Biosimilars
On May 18, 2018, the European Commission ("Commission") launched a public consultation on "Duplicate Marketing Authorisation for Biological Medicinal Products" ("Consultation") in relation to updating ...
European Union
31 May 2018
Biotech Start-up Funding: An Ounce Of Prevention Is Worth A Pound Of Cure
Subject to certain limitations, investors can choose between providing debt and equity funding to a start-up company
United States
12 Oct 2017
Supreme Court Decision Alert - June 12, 2017
Today, the Supreme Court issued three decisions, described below, of interest to the business community: Class Actions—Appellate Jurisdiction; Biologics Price Competition and Innovation Notice Requirement...
United States
13 Jun 2017
Supreme Court Docket Report - January 13, 2017
Today, the Supreme Court granted certiorari in the following cases of interest to the business community: Clean Water Act—Judicial Review; Biologics Price Competition and Innovation Act—Notice Requirement; National Labor Relations Act—Enforceability of Arbitration Clauses; Fair Debt Collection Practices Act—Debt Collectors; Statutes of Repose—Availiability of American Pipe Tolling; Personal Jurisdiction—Constitutional Limits of General Jurisdiction
United States
13 Jan 2017
FDA Seeks Comment On Draft Guidance For Manufacture Of Interoperable Medical Devices
On January 26, 2016, the US Food and Drug Administration (FDA) issued draft guidance entitled Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.
United States
8 Feb 2016
US FDA Issues Warning Letter To Stem Cell Treatment Centers
The US Food and Drug Administration ("FDA") has sent a Warning Letter covering three physician-operated stem cell treatment centers in California, Florida and New York asserting that the centers have unlawfully recovered and processed adipose (fat) tissue to perform stem cell therapy and deviated from current good manufacturing practice ("CGMP") and current good tissue practice ("CGTP") in doing so.
United States
21 Jan 2016
Has the New Patent Act Created a Mechanism for Investment Firms to Dramatically Alter the Value of Their Investments?
The America Invents Act of 2011 (AIA) created procedural vehicles for new market participants, such as investment firms, to challenge patents.
United States
25 Mar 2015
Life Sciences: 2013 Legal Developments You Need To Know About - Summer 2013
This is a short guide outlining some of the key legal developments in the life sciences sector in 2013.
29 Jul 2013
Supreme Court Decision Alert - June 13, 2013
On June 13, 2013 the Supreme Court issued three decisions, described below, of interest to the business community
United States
14 Jun 2013
Federal Communications Commission Action On Radio Frequency Exposure Limits
The US Federal Communications Commission recently released an Order, Further Notice of Rulemaking and Notice of Inquiry on radio frequency exposure limits and policies.
United States
16 Apr 2013
Life Sciences: 2013 Legal Developments You Need To Know About
The developments include a proposed modification to the HSR Form that would impact reporting requirements, AIA’s First-Inventor-to-File provisions, Federal Circuit cases to watch, Reverse-Payment legislation, proposed State legislation concerning the substitution of biosimilar products, the US Federal Excise Tax on medical devices sales and the FDA’s draft guidance for the evaluation and labeling of abuse-deterrent opioids.
United States
18 Feb 2013
US Department Of Health And Human Services Issues Final "Sunshine" Rule Imposing Reporting Requirements On Payments To Physicians And Teaching Hospitals
The Centers for Medicare & Medicaid Services (CMS) has announced a final rule that will implement section 1128G of the Social Security Act, as added by section 6002 of the Affordable Care Act.
United States
14 Feb 2013
Recent Updates To AIA And PTO Fee Rules Mark Significant Changes For Post-Grant Framework
Recent legislative and administrative activities have further changed, and improved on, the implementation of the patent laws under the Leahy-Smith America Invents Act (AIA).
United States
29 Jan 2013
FDA Issues Highly Anticipated Draft Guidance On Biosimilars
On February 9, 2012, the US Food and Drug Administration (FDA) issued three draft guidance documents regarding biosimilars (a/k/a follow-on biologics).
United States
14 Feb 2012
Fourth Circuit Rules That Federal Law Preempts State-Law Claims Arising From Alleged Malfunction Of Medical Device That Complied With FDA Requirements
In Walker v. Medtronic, Inc., No. 10-2219, ___F.3d___ (January 25, 2012), the US Court of Appeals for the Fourth Circuit held that the Medical Device Amendments to the Food, Drug, and Cosmetic Act preempt state-law claims arising from the alleged malfunction of a Class-III medical device that had received premarket approval from the Food and Drug Administration and had complied with all requirements imposed by the agency.
United States
7 Feb 2012
US Supreme Court Grants Certiorari in Matrixx Initiatives, Inc. v. Siracusano
Section 10(b) of the Securities Exchange Act of 1934 and SEC Rule 10b-5 provide that a business may be held liable for failure to disclose any material fact in connection with the purchase or sale of its securities.
United States
17 Jun 2010
Supreme Court Grants Certiorari in National Childhood Vaccine Injury Act Case
The National Childhood Vaccine Injury Act of 1986 ("Vaccine Act") , 42 U.S.C. §§ 300aa-1 "et seq.", expressly preempts state-law claims against vaccine manufacturers if the injury or death giving rise to such a claim "resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warning."
United States
18 Mar 2010
Impact of the New Rules for Technology Licences in Europe
The European Commission has adopted a new Technology Transfer Block Exemption Regulation, which came into effect on 1 May 2004. The Regulation provides a "safe harbour" from the effects of EU competition rules for certain types of technology licence agreements.
20 Sep 2004
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