Gerson Lehrman Group - Intelligently Connecting Institutions and Expertise.

All GLG News Analyses Filed Under: Legal Issues

Analyses are solely the work of the authors and have not been edited or endorsed by GLG.

Jeff Stier, Associate Director

Jeff StierAssociate DirectorAmerican Council on Science and Health What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Don't Assume We Can Predict What Will Happen In Post-Engle Cases

March 27, 2009

 Third Time's the Charm for Defense in Fla. Smoker Suits | www.law.com

We just don't know whether tobacco companies are going to be hit hard by the post-Engle cases. They might. They might not. Or "post-Engle" may not mean what we think it means.

Comments on the Viropharma Response to FDA Guideline on Generic Vancocin

March 26, 2009

GLG Expert Contributor

 ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance | phx.corporate-ir.net

This is an important response to the FDA proposed guideline on generic Vancocin.  The arguments put forward by Viropharma are not new, but are nevertheless well reasoned. It will be interesting to see the extent to which these arguments are successful in changing the proposed policy. The FDA has...

Patrick Joseph Igoe, Life Sciences Patent Attorney

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

CUBICIN (daptomycin for inection) Patent Litigation Starts As Cubist (NasdaqGS:CBST) Sues Teva (NasdaqGS:TEVA)

March 25, 2009

 Cubist Pharmaceuticals Files Patent Infringement Lawsuit Against Teva Parenteral Medicines, Inc. | www.cubist.com

As noted in the Mon 23 Mar 2009 press release, Cubist has sued Teva in response to Teva's Abbreviated New Drug Application (ANDA) seeking FDA approval of a generic version of CUBICIN.  This patent dispute is critical because, as noted in recent SEC filings, CUBICIN sales account for substantially...

Martin Alpert, Vice President, Environmental Claims

Martin AlpertVice President, Environmental ClaimsHINZ CLAIM MANAGEMENT INC What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

WR Grace: Will Ex-employees bring Company Down!

March 24, 2009

 Ex-employee says he warned of asbestos risk in '76 | www.seattlepi.com

Is the testimony of ex-employees tainted or the downfall of a company? What is the punishment for willful disregard for the safety of others?

Patrick Joseph Igoe, Life Sciences Patent Attorney

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

MULTAQ (dronderone hydrochloride) NDA - Sanofi-Aventis Awaits FDA Final Decision

March 23, 2009

 Heart-Drug Review Gives Sanofi Shot at $1.9 Billion (Update2) | www.bloomberg.com

As indicated in the Tue 17 Mar 2009 Bloomberg article, the FDA has provided Sanofi-Aventis SA (NYSE:SNY) with a positive viewpoint for current NDA No. 22-425 [submission date: 31 Jul 2008], the New Drug Application for MULTAQ (dronderone hydrochloride).  However, this positive viewpoint is not...

Patrick Joseph Igoe, Life Sciences Patent Attorney

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

TARCEVA Patent Infingement Battle Begins As OSI Pharmaceuticals Sues Teva And Mylan

March 20, 2009

 OSI Pharmaceuticals Files Patent Infringement Lawsuits Against Teva Pharmaceuticals USA and Mylan Pharmaceuticals | phx.corporate-ir.net

As stated in a Thu 19 Mar 2009 press release, OSI Pharmaceuticals (OSIP), in protection of its TARCEVA cancer drug, has filed separate lawsuits against each of Teva and Mylan.  As the innovator company for TARCEVA [a FDA Orange Book Prescription (Rx) Referencle Listed Drug (RLD) Product with 3...

Martin Alpert, Vice President, Environmental Claims

Martin AlpertVice President, Environmental ClaimsHINZ CLAIM MANAGEMENT INC What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

AIG; Throwing Good Money after Bad?

March 19, 2009

 What Does AIG's Future Hold? | biz.yahoo.com

Will all this help really help? Is the handwriting already on the wall & we are simply delaying the inevitable?

Patrick Joseph Igoe, Life Sciences Patent Attorney

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

VANCOCIN - ViroPharma Fights FDA's Possible Decision Allowing ANDA Filers To Establish Bioequivalence With In-Vitro Dissolution Testing

March 19, 2009

 ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance | phx.corporate-ir.net

In reaction to the December 2008 FDA release of its Draft Guidance on Vancomycin Hydrochloride, ViroPharma announced Wed 18 Mar 2009 its submission of comments to the FDA.  As the innovator company for VANCOCIN, a FDA Orange Book Rx Reference Listed Drug without any listed patents nor any listed...

Patrick Joseph Igoe, Life Sciences Patent Attorney

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

SOLODYN/FDA Denies Medicis Citizen Petition Seeking 30-Month Stay Against ANDA Filers

March 19, 2009

 SOLODYN/Medicis SEC Filing, 18 Mar 2009, Form 8-K Current Report | idea.sec.gov

The FDA, acting with surprising speed, recently denied a Citizen Petition (CP) filed 13 Feb 2009 by Medicis (NYSE: MRX) in support of SOLODYN.  If FDA's denial of this CP is not reversed, then the current 3 ANDA filers [Mylan (NasdaqGS: MYL);  Barr/Teva (NasdaqGS: TEVA); and Sandoz/Novartis...

Martin Alpert, Vice President, Environmental Claims

Martin AlpertVice President, Environmental ClaimsHINZ CLAIM MANAGEMENT INC What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Federal Preemption: Trend a Complete 180!

March 18, 2009

 Pre-emption opponents work to overturn ruling | www.businessinsurance.com

undefined Wyeth seems to give support for the Medical Device Act of 2009? undefined

Previous Page : 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Next51 to 60 of 428

Request a News Analysis

Subscribe to Updates

RSS By RSS

Add to Google Reader or Homepage

Subscribe in Bloglines

Leading institutions connect with members of the Legal, Economic & Regulatory Affairs councils through GLG

Get Intelligently Connected
with the world's leading experts

GLG's 850+ Clients Include:

More than 70% of the world's leading
mutual funds
15 of the leading 20
global banks
7 of the leading 10
global private equity firms
5 of the leading 10
AmLaw firms
Fortune 500® Companies
in nearly every industry sector, including pharmaceuticals, insurance, chemicals, energy and computer software

Most Popular Legal, Economic & Regulatory Affairs News