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HTMLFDA Proposes a New Layer of Regulation for Laboratory Developed Tests
Caroline M. Tinsley; Baker Sterchi Cowden & Rice, L.L.C.;
Legal Alert/Article
September 2, 2014, previously published on August 21, 2014
The Food and Drug Administration (FDA) announced its intention to expand the regulation of laboratory developed tests (LDTs). LDTs identify patients’ individual reactions to pharmaceutical treatments, so medical providers can prescribe the best treatment for the particular patient. Unlike...

 

HTMLFDA Notifies Congress of Framework for Long-Awaited Guidance on Laboratory Developed Tests and Issues Final Guidance on Companion Diagnostics
Linda D. Bentley; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
September 1, 2014, previously published on August 25, 2014
After many years of promising that it would be providing guidance on the regulation of laboratory developed tests (LDTs), the Food and Drug Administration (FDA) provided notice to Congress on July 31, 2014 that it intends to issue a draft guidance document entitled, “Framework for Regulatory...

 

HTMLFederal Circuit Upholds Validity of Lysteda Patents
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
August 29, 2014, previously published on August 28, 2014
In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either Apotex’s or Watson’s Abbreviated New Drug Applications...

 

HTMLWill the USPTO Respond to Public Feedback of Its Eligibility Guidance?
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
August 28, 2014, previously published on August 25, 2014
Periodically, the USPTO holds open meetings with the public to discuss its thinking on current topics relating to the patent procurement process. Late last week, the Biotechnology, Chemical and Pharmaceutical Customer Partnership of the USPTO announced the first bi-coastal meeting to be held via...

 

HTMLAiring the USPTO's Naturally Occurring Dirty Laundry — the Subject Matter Eligibility Stain
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
August 27, 2014, previously published on August 21, 2014
It has been five months since the USPTO issued its Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products to aid examiners in applying the principles of Myriad and Prometheus to any claim “reciting or...

 

HTMLYamanaka iPSC Patent Challenged
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
August 27, 2014, previously published on August 21, 2014
Dr. Shinya Yamanaka of Kyoto University shared the 2012 Nobel Prize in Physiology or Medicine with Dr. John B. Gurdon for their respective discoveries that mature, specialized cells can be reprogrammed to become immature cells capable of developing into all tissues of the body. In the 2012 Nobel...

 

HTMLFDA Issues Draft Guidance on Determination of Reference Product Exclusivity for Biologics
Colleen Heisey, Mark Mansour, Christopher M. Mikson; Jones Day;
Legal Alert/Article
August 12, 2014, previously published on August 2014
On August 4, the U.S. Food & Drug Administration ("FDA") issued a draft guidance titled "Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act." The draft guidance is intended to assist biological product sponsors and applicants in...

 

HTMLJ&J Withdraws Morcellators From Market Due to Cancer Risk
Annika K. Martin; Lieff, Cabraser, Heimann & Bernstein, LLP;
Legal Alert/Article
August 11, 2014, previously published on August 1, 2014
Johnson & Johnson ("J&J") is asking doctors to return its laparoscopic power morcellators, controversial surgical devices that may inadvertently spread cancer in women being treated for uterine growths called fibroids. The company's Ethicon unit in April suspended sales and...

 

HTMLFDA Accepts First Application for Biosimilar Product
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
August 5, 2014, previously published on July 2014
In a significant step for generic biologic products, FDA accepted for review the first application for a biosimilar product. If approved, it could be the first biosimilar product to enter the U.S. market under the nearly five-year-old Biologics Price Competition and Innovation Act...

 

HTMLComments on Patent Subject Matter Eligibility Guidance Due by July 31
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
August 2, 2014, previously published on July 28, 2014
This week brings the July 31, 2014 deadline for submitting written comments on two USPTO patent subject matter eligibility guidance documents: The “Myriad-Mayo” Guidance issued March 4, 2014 (for claims involving laws of nature, natural phenomena, and natural products) and the...

 


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