Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Antoinette Konski ordered by Published Date Descending.
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Personalized Therapy Patent Falls As Patent-Ineligible
In a non-precedential opinion, the Federal Circuit held as patent-ineligible patent claims to personalized therapy to treat patients who would benefit from inhaled nitric oxide treatment
United States
12 Sep 2019
Federal Circuit Invalidates Patented Cancer Therapy
In BTG International Limited v. Amneal Pharmaceuticals LLC, (Fed. Cir. Slip Op. 2019-1147, May 14, 2019), the Federal Circuit held that U.S. Patent No. 8,822,438 ("the ‘438 Patent") was invalid as obvious over the prior art.
United States
30 May 2019
PMC Releases "A Consumers Guide To Genetic Health Testing"
The Personalized Medicine Coalition, or the "PMC" is an organization of over 250 members that seeks to promote the understanding and adoption of personalized or precision medicine concepts, services,
United States
21 May 2019
The Business Of Personalized Medicine
This year marks the 15th anniversary of the completion of the Human Genome Project.
United States
9 Nov 2018
Over 30% Of New Drug Approvals In 2017 Were Personalized Medicines
The Personalized Medicine Coalition (PMC) recently published its "Personalized Medicine at FDA: 2017 Progress Report" (Report) that highlights drug approval developments and milestones achieved in 2017.
United States
21 Feb 2018
FDA Hits "Pause" On Regulation Of LDTs
On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (LDTs) (Discussion Paper).
United States
17 Feb 2017
New Report Outlines 5 Year Plan To Achieve Cancer Moonshot
Five goals emerged, each of which is noted to be critical to the overall mission, but also intended to build on and augment the success of the other goals.
United States
19 Oct 2016
Three Dozen States Sue Makers Of Opioid Addiction Treatment Medications For Antitrust
In addition to alleged "product hopping," Reckitt also is accused of manipulating the Risk Evaluation and Mitigation Strategy ("REMS") program for Suboxone.
United States
17 Oct 2016
Inherent Disclosure Satisfied Written Description
The Federal Circuit held that a claim to an isolated protein described by its partial amino acid sequence satisfies 35 U.S.C. § 112 when the partial sequence is combined with other identifying characteristics of the protein.
United States
23 Sep 2016
FDA Issues Draft Guidance To Streamline Regulatory Oversight Of NGS-Based Tests For Diagnosing Germline Diseases
Personalized or Precision Medicine needs reliable and accurate diagnostic tests to guide clinical intervention and treatment decisions.
United States
3 Aug 2016
Federal Circuit's Recent Primer On Patent-Eligibility
A method of producing a desired population of multi-cryopreserved hepatocytes was held to be patent-eligible because the challenged claims did not recite a judicial exception.
United States
8 Jul 2016
Supreme Court Declines Sequenom Review
The '540 Patent was awarded to inventors Yuk-Ming Dennis Lo and James Stephen Wainscot for "Non-invasive prenatal diagnosis."
United States
7 Jul 2016
Will The Supreme Court Clarify Patent-Eligibility?
There is no doubt that the courts and the USPTO, at least initially, have broadly applied Alice and Mayo to diagnostic method patents and inventions in the personalized medicine space.
United States
29 Jun 2016
EMA's New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine
The Guidance notes that these recommendations apply to Marketing Authorization Applications for medicines for human use and they should be read in conjunction with other relevant EU and ICH guidelines and reflection papers.
European Union
21 Jun 2016
Capitalizing On Collaboration – The President's Precision Medicine Initiative
President Obama marked the one year anniversary of his Precision Medicine Initiative by holding a web-accessible panel discussion where he and interested stakeholders discussed his PMI initiative, its progress and future direction.
United States
8 Mar 2016
Patent Subject Matter Eligibility – Impact On Litigation And Prosecution
Personalized medicine relies on diagnostic technologies to accurately evaluate a patient's clinical or genetic signature to guide treatment decisions.
United States
22 Sep 2015
Nautilus Standard Sinks Dow Patents
Dow sued NOVA alleging infringement of U.S. Patent Nos. 5,847,053 (the '053 Patent) and 6,111,023 (the '023 Patent).
United States
2 Sep 2015
Federal Circuit Invalidates Another Diagnostic Patent
The '540 Patent was awarded to inventors Yuk-Ming Dennis Lo and James Stephen Wainscot for "Non-invasive prenatal diagnosis."
United States
30 Jun 2015
California’s Bet On Precision Medicine
California sees opportunities in personalized medicine. Earlier this month, Governor Brown announced the creation of a two year initiative – California Initiative to Advance Precision Medicine.
United States
27 Apr 2015
Direct-To-Consumer Genetic Test Authorized By FDA
Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order fashion.
United States
24 Feb 2015
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