Intellectual Property Law

Biosimilars and Biobetters Conference
The SMi Group will be holding its 2nd conference on Biosimilars and Biobetters from September 26-27, 2011 in London, UK. The conference will offer presentations on the following topics: ? The market for biosimilars: Unraveling the mystery; ? The EMA scientific advice compared with EMA guidelines; ? Industry interpretation the new guideline on biosimilar mAbs; ? Next generation monoclonal antibody development and clinical challenges with biosimilar drug development; ? EU litigation considerations and update; ? The ins and outs of the biosimilar regulatory pathway; ? The developing biosimilars regulatory framework in the U...

CEQ Issues Draft Guidance on Considering GHG Under NEPA Review
Last week, the U.S. Council on Environmental Quality (CEQ) released for comment draft guidance on the consideration of greenhouse gases under the National Environmental Policy Act.  The public comment period is 90 days...

Biosimilars Conference
Visiongain will be holding its 4th Biosimilars conference on November 11-13, 2008 in Philadelphia, PA. The conference is intended to help attendees: ? Identify the trends that will shape future market development of follow-on biologics;? Explore the current market and regulatory environment for biosimilars in Europe and the relevance to U...

IIR 10th Annual Generic Drugs Summit
The Institute for International Research (IIR) will be holding its 10th Annual Generic Drugs Summit entitled "Business of Biosimilars: Innovative Tools and Strategies to Compete in the Evolving Biosimilars Market" on September 23-25, 2009 in Boston, MA...

FDA Issues Draft Guidance on the Judicious Use of Medically Important Antimicrobials in Food-Producing Animals
News release: "The U.S. Food and Drug Administration today issued draft guidance intended to help reduce the development of resistance...

Business of Biosimilars Conference
The Institute for International Research (IIR) will be holding its 2nd Annual Business of Biosimilars conference from September 20-22, 2010 in Boston, MA. The conference will allow attendees to: ? Navigate worldwide regulatory and legislative issues; ? Build strategic partnerships with emerging markets; ? Adopt effective IP and patent protection strategies for biosimilars; ? Evaluate scientific implications of biosimilars to ensure safety, quality, and efficacy; ? Manage risk and make investment decisions to ensure ROI; ? Obtain branding strategies to differentiate a product on the market; ? Negotiate pricing and reimbursement strategies with government and payers; ? Profit from practical...

FDA Issues Safety Warning About Valproic Acid and Divalproex Sodium
Valproic Acid and Divalproex Sodium FDA Issues Safety Warning About Risk for Birth Defects

FDA Issues Warning Regarding Topical Ibuprofen Drug Products
Topical Ibuprofen Drug Products FDA Issues Warning Letters

FDA Issues Update on Safety Review Orlistat
Orlistat FDA Issues Update on Safety Review

FDA Issues Warning about Promethazine Hydrochloride Injection
Promethazine Hydrochloride Injection FDA issues warning

Honda Issues Massive Recalls in US and Canada
Honda Issues Massive Recalls in US and Canada

FDA Issues Early Safety Communication About Meridia Diet Pill
Meridia Diet Pill FDA Issues Early Safety Communication