March 29, 2015

Biotechnology, Food & Drug Administration FDA News

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The National Law Review includes articles impacting the biotech and cleantech fields addressing: licensing and patent issues, intellectual property due diligence, litigation and tax. Content is also included addressing: greenhouse gas (GHG) regulation; mandated emissions reduction legislation; NEPA and CEQA claims, common law nuisance litigation; acquiring and selling emission offset and emission reduction credits and acid rain allowances under the United States Clean Air Act, SCAQMD RECLAIM and other air credit programs.

Date Title Organization
28
Mar
Threshold Issues: IPR Not Derailed by Unidentified D/B/A Name or Prior ANDA Certification McDermott Will & Emery
28
Mar
TMI: When Does Fitness Data Become Too Much of a Good Thing? Greenberg Traurig, LLP
28
Mar
PhRMA's Objections to HSR Rule on Exclusive Licenses Face Skeptical Appellate Judges Schiff Hardin LLP
27
Mar
Strike Two – FDA Rejects Amgen’s Certification Petition for Biosimilar Applicants Sterne, Kessler, Goldstein & Fox P.L.L.C.
27
Mar
Fourth Circuit Sustains Securities Fraud Claim Against Drug Manufacturer Katten Muchin Rosenman LLP
26
Mar
European Food Safety Authority (EFSA) Grants Public Access to Data through Scientific “Data Warehouse” Covington & Burling LLP
26
Mar
FDA Issues Draft Guidance on Use of Electronic Informed Consent in Clinical Trials McDermott Will & Emery
26
Mar
Patent Term Adjustment In The Post-RCE Period -- Request for Continued Examination Foley & Lardner LLP
25
Mar
Failure to Warn About Dangers of Off-Label Use of Medical Device Preempted Under Federal Law Varnum LLP
25
Mar
Teva Pharmaceuticals: Is It Time to Rethink How You Will Argue Claim Construction? Dickinson Wright PLLC
25
Mar
Increased FTC Enforcement as FDA Deregulates Low-Rish Health IT Devices Morgan, Lewis & Bockius LLP
25
Mar
Northern District of California Judge Seeborg Opens the Door to Alternative Route to Challenge Patents on Biologics Schiff Hardin LLP
25
Mar
When on Antibiotics in Nursing Home or Hospital Watch for Diarrhea – It Could Be C-Diff Stark & Stark
24
Mar
While FDA’s Proposed e-Cigarette Rule is Pending, FTC Mulls Enforcement Action Morgan, Lewis & Bockius LLP
24
Mar
USPTO Myriad-Mayo Guidance Still Not At An Alpha Standard Schwegman, Lundberg & Woessner, P.A.
23
Mar
FDA is Examining Device Risk Assessments in Postmarket Settings Covington & Burling LLP
23
Mar
One More Hurdle Cleared – Amgen’s Preliminary Injunction Motion for Filgrastim is Denied Sterne, Kessler, Goldstein & Fox P.L.L.C.
23
Mar
California Federal Judge Finds Biosimilar Patent Procedures Optional Foley & Lardner LLP
21
Mar
District Court Rules Against Amgen’s Motion for Preliminary Injunction to Prevent Marketing of Sandoz’s Biosimilar Zarxio Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
19
Mar
FDA Issues Revised Draft Guidance on Disclosures of Risk Information in Consumer-Friendly Print Advertisements and Promotional Labeling McDermott Will & Emery

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