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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Jones Day ordered by Published Date Descending.
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1
Jones Day Talks Intellectual Property: Section 101, Life Sciences, And The Alice Two-Step
Section 101 of the U.S. Patent Act─which identifies four categories of inventions or discoveries that are eligible for patent protection─presents a number of challenges to companies working on innovations in the life sciences space.
United States
21 Jan 2019
2
PTAB Denies Institution of IPR Proceedings Against Bayer's Patent Covering STIVARGA®
On February 8, 2017, the PTAB denied Fustibal LLC's ("Fustibal") petition to institute inter partes review of U.S. Patent 8,637,553 B2 ("the '553 patent") owned by Bayer HealthCare LLC ("Bayer") (IPR2016-01490).
United States
14 Mar 2017
3
Deal On IP Rights For Biologic Drugs Under TPP Close
According to industry and congressional sources, a deal on intellectual property rights for biologic drugs under the TPP may be in the near future.
United States
14 Nov 2016
4
European Commission Authorizes GMOs For Food And Feed Uses
The European Commission authorized the sale of products containing, consisting of, or produced from four related GM maizes combining three different single GM events, and six related GM maizes combining two different single GM events.
European Union
12 Oct 2016
5
EFSA To Present Draft GM Plant Allergenicity Guidance To Stakeholders
On November 23, 2016, EFSA will present its draft guidance document on allergenicity of genetically modified ("GM") plants at a meeting in Parma, Italy.
European Union
12 Oct 2016
6
French Publish Study On Safety Of Medical Devices Software
On July 13, 2016, the French national Agency for Medicines and Health Products Safety published a study on the safety of medical devices software.
European Union
12 Aug 2016
7
EMA Completes Zydelig Review
The PRAC's recommendations will now be passed to EMA's Committee for Medicinal Products for Human Use, or CHMP, for adoption of the Agency's final position.
European Union
12 Aug 2016
8
MHRA Publishes New Guidance On Remanufacturing Of Single-Use Devices
On July 5, 2016, the MHRA published new guidance on the remanufacturing of single-use devices ("SUDs") and expectations for their use.
United States
11 Aug 2016
9
FDA Announces Public Workshop On ICH Guideline Q3D Regarding Elemental Impurities
In the July 8, 2016, Federal Register, FDA announced a public workshop titled "Regional Public Workshop on ICH Q3D Implementation of Guideline for Elemental Impurities."
United States
10 Aug 2016
10
FDA Proposes Regulatory Framework For Next Generation Sequencing-Based Tests
FDA also suggests that its analytical validity-related recommendations could also form the basis for special controls or conditions for 510(k) exemption in the future.
United States
9 Aug 2016
11
FDA Continues To Refine Regulatory Approach For Compounding Pharmacies: "Essentially A Copy" Provisions And Inspection Protocol For Non-Outsourcing Facilities
FDA released two draft guidance documents setting forth the Agency's policies for applying the "essentially a copy" provisions of Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
United States
9 Aug 2016
12
First Medicines Approved Under EU's Priority Medicines Scheme
On June 1, 2016, EMA announced the outcome of the assessment of the first batch of applications received from medicine developers for its PRIME (PRIority MEdicines) scheme...
European Union
21 Jul 2016
13
EU Launches Four Clinical Trial Public Consultations
On June 1, 2016, the European Commission launched four public consultations in the field of clinical trials.
European Union
21 Jul 2016
14
New EU Rules On Medical Devices
On May 25, 2016, the EU agreed on new rules on medical devices and in vitro diagnostic medical devices—almost four years since the European Commission first published its proposal.
European Union
20 Jul 2016
15
EMA Reflects On First-In-Human Clinical Trials Following Fatal Rennes Trial
The aim of EMA's work is to agree on a concept paper by July 2016 identifying areas for change and proposals to further minimize the risk of similar accidents.
European Union
20 Jul 2016
16
FDA Issues Final Rule On Symbols In Labeling
In the June 15, 2016, Federal Register, FDA issued a final rule revising the Agency's medical device and certain biological product labeling regulations.
United States
19 Jul 2016
17
FDA Modifies List Of Recognized Consensus Standards
In the June 15, 2016, Federal Register, and June 27, 2016, Federal Register, FDA published modifications to the list of standards FDA recognizes for use in premarket reviews.
United States
19 Jul 2016
18
FDA Issues Final Rule Amending Regulations Relating To Embryos Donated For Reproductive Use
In the June 22, 2016, Federal Register, FDA issued a final rule amending certain donor eligibility regulations to increase access to embryos donated for reproductive use.
United States
19 Jul 2016
19
FDA Announces Public Workshop On Sequencing Quality Control 2
In the May 31, 2016, Federal Register, FDA announced an upcoming public workshop called "Sequencing Quality Control II."
United States
18 Jul 2016
20
FDA Announces Public Workshop On Antibacterial Drug Development
In the May 31, 2016, Federal Register, FDA announced an upcoming public workshop regarding antibacterial drug development for patients with unmet need and developing antibacterial drugs that target a single species.
United States
18 Jul 2016
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