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HTMLFDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers
Duane Morris LLP;
Legal Alert/Article
July 8, 2014, previously published on June 20, 2014
The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, which provides answers to questions from public comments received on the draft Guidance for Industry on ANDAs:...


HTMLFDA Issues Draft Guidance for Identification and Notification of Suspect Products
Duane Morris LLP;
Legal Alert/Article
July 8, 2014, previously published on June 24, 2014
As discussed in our April 11, 2014 Alert, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." Recently, the U.S. Food and Drug...


HTMLHow the Supreme Court Decision in Alice Corp. v. CLS Bank Undermines the USPTO Subject Matter Eligibility Guidance
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
June 30, 2014, previously published on June 24, 2014
On June 19, 2014, the Supreme Court issued its decision in Alice Corp. v. CLS Bank International, finding that patents directed to “a computer-implemented scheme for mitigating ‘settlement risk’” were invalid as being drawn to a patent-ineligible abstract idea. Although the...


HTMLUPDATE: The Hare Loses Steam - Patent Litigation Reform Law Unlikely This Year
Ann G. Fort; Sutherland Asbill & Brennan LLP;
Legal Alert/Article
May 27, 2014, previously published on May 23, 2014
Efforts by the U.S. Senate to pass an alternative to the Innovation Act, which aims to reform abusive patent litigation, have stalled. Sen. Patrick Leahy, who is leading the effort, has announced that his committee is tabling that work until the interested parties reach a bipartisan compromise....


HTMLFederal Jury Awards Punitive Damages In Actos Bladder Cancer Trial
Stephen H. Cassidy; Lieff, Cabraser, Heimann & Bernstein, LLP;
Legal Alert/Article
April 22, 2014, previously published on April 8, 2014
A federal jury in Louisiana yesterday ordered Takeda Pharmaceutical Company and Eli Lilly & Company to pay $1,475,000 in compensatory damages, finding that they failed to adequately warn about bladder-cancer risks of their diabetes medicine Actos. Jurors also found that Takeda and Lilly...


HTMLActos Decision Statement: $9 Billion Decision on Eli Lilly and Takeda Pharmaceuticals
Motley Rice;
Legal Alert/Article
April 11, 2014, previously published on April 8, 2014
On Monday, April 7, a federal court jury in Louisiana decided that Takeda Pharmaceuticals and Eli Lilly hid the risks of bladder cancer from the diabetes drug, Actos. Takeda was ordered to pay $6 billion and Eli Lilly was ordered to pay $3 billion.


HTMLDrager v. PLIVA USA, Inc.: Fourth Circuit Explicitly Rejects Stop Selling Attempt to Avoid Generic Preemption
Angela M. Higgins; Baker Sterchi Cowden & Rice, L.L.C.;
Legal Alert/Article
March 24, 2014, previously published on February 19, 2014
The Fourth Circuit has recently weighed in on a generic drug maker’s duties in a post-Bartlett and PLIVA v. Mensing world. In Drager v. PLIVA USA, Inc., 2014 U.S. App. LEXIS 1696, 2014 WL 292700 (4th Cir. Jan. 28, 2014), plaintiff conceded that his failure to warn claims against the generic...


HTMLGeneric Drug Labeling Preemption: The Flavor of the Day
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
March 12, 2014, previously published on March 10, 2014
It was only about a year ago when the topic du jour was generic drug labeling and whether federal law - the FDC Act and FDA’s implementing regulations - preempts state-law product liability claims (failure-to-warn, design defect, failure-to-conform/update, etc.) against generic drug...


HTMLPennsylvania Supreme Court Rules on Whether Drug Company Has Expanded Duties
Henry F. Canelo, Kathleen D. Wilkinson; Wilson Elser Moskowitz Edelman & Dicker LLP;
Legal Alert/Article
February 19, 2014, previously published on February 10, 2014
On January 21, 2014, the Pennsylvania Supreme Court held in a 4-2 vote in Lance v. Wyeth, 2014 PA. 17 EAP 2011 (PA Supreme Court 2014), that a pharmaceutical company for the first time under Pennsylvania law may face negligence claims where the drug manufacturer introduced a drug into the...


HTMLLawmakers Express “Grave Concerns” with Generic Drug Labeling Proposal; Demand Answers from FDA
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
January 28, 2014, previously published on January 22, 2014
In a Januarry 22, 2014 letter to FDA Commissioner Margaret Hamburg, M.D. signed by 28 members of Congress, lawmakers express “grave concerns” about FDA’s November 2013 proposed rule to allow generic drug manufacturers to independently update product labeling (with respect to...


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