Pharmaceutical, FDA | JD Supra Law News

Pro Te Solutio - Vol. 6 No. 1 February 2013

by Hemant Gupta, Keishunna Randall, Travis Swearingen | Butler, Snow, O'Mara, Stevens and Cannada,... on 5/22/2013

In This Issue: - Can Experts Testify as to the Ethics or State of Mind of Corporate Defendants? - Patent Reform for Biotech Companies - United States v. Caronia and its Implications for Off-Label...more

Are Your Prescription Drugs Safe?

by Thorsnes Bartolotta McGuire LLP on 5/21/2013

Millions of people rely on daily medication — from over-the-counter medications to treat minor sickness to sophisticated prescription drugs and vaccines to prevent or cure illness. We depend on drugs to treat pain, relieve...more

Jury Buys Plaintiff’s Argument That Drug Manufacturer Should Have Distributed Dear Doctor Letter Sooner, Without Prior FDA...

by Ellen Adler, James W. Huston, Joanna Simon | Morrison & Foerster LLP on 5/16/2013

Dear Doctor letters were front and center in the just-tried case of Tietz v. Abbott Laboratories, Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the...more

Capital Infusion - May 2013: Dealmaker’s Corner

by Adam Connatser, Jon Finger, Rani Hauth Guerra, J. Atwood Jeter, David McLean | Patton Boggs LLP on 5/16/2013

In this issue’s installment of “Dealmaker’s Corner,” Jon Finger, a partner in our private equity group, had the opportunity to visit with Kyle Bradford, Managing Director with American Capital, Ltd., concerning the...more

China Life Sciences Health Industry Client Briefing – April 2013 (May 15, 2013)

by Vicki Lung, Gordon B. Schatz, Katherine Yang, Amy Yin | Reed Smith on 5/15/2013

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Drugs - Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23): Given the...more

Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

by Michael Greenfield | McDonnell Boehnen Hulbert & Berghoff LLP on 4/25/2013

Contraceptives were the subject of the Federal Circuit's recent decision in Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. But, unfortunately, it's a rather fact-specific case with nothing of prurient...more

Lawsuits Claim SSRIs Can Cause Severe Birth Defects [Video]

by Lawyers.com on 4/22/2013

Millions of patients take selective serotonin reuptake inhibitors (SSRIs) for depression, anxiety and other disorders. One out of 10 people in the United States use antidepressants, making them one of the most widely...more

FDA Grapples with Social Media

by Audet & Partners, LLP on 4/18/2013

As businesses continue to capitalize on social media as an inexpensive and effective advertising tool, pharmaceutical companies are struggling to find ways to embrace this trend while abiding by FDA regulations, “…fear of...more

Business Litigation Report -- April 2013

by Quinn Emanuel Urquhart & Sullivan, LLP on 4/15/2013

In This Issue: - Firm News: DoJ Star Healthcare Fraud Prosecutor Joins Washington, D.C. Office; and Quinn Emanuel Wins Top Honors at the Inaugural U.S. Benchmark Annual Awards - Main...more

Federal Court Orders FDA to Approve OTC Sales of “Morning-After Pill,” Finds Current Age and Point-of-Sale Restrictions to be...

by Fuerst Ittleman David & Joseph, PL on 4/11/2013

On April 5, 2013, Judge Edward R. Korman of the United States District Court for the Eastern District of New York found that the Secretary of Health and Human Service’s (“HHS”) decision to limit over-the-counter (“OTC”)...more

The First Amendment and Off-Label Promotion: United States v. Caronia

by Quinn Emanuel Urquhart & Sullivan, LLP on 4/11/2013

For years, the U.S. Department of Justice has aggressively pursued and brought charges over “off-label promotions”—the promotion of drugs for uses that have not received FDA approval—by pharmaceutical manufacturers and their...more

Thoughts on Regulatory Constraints of Business Models

by Seth Mailhot | Sheppard Mullin Richter & Hampton LLP on 4/8/2013

I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more

Litigation Alert: U.S. Supreme Court to Weigh In on Reverse Payment Deals

by Melanie Mayer, David Tellekson | Fenwick & West LLP on 4/3/2013

On March 25, 2013, the U.S. Supreme Court heard oral argument in FTC v. Actavis, Inc.,1 which is on appeal from the U.S. Court of Appeals for the Eleventh Circuit. This case addresses a type of patent litigation settlement...more

Supreme Court Oral Argument in FTC v. Actavis

by Kevin E. Noonan | McDonnell Boehnen Hulbert & Berghoff LLP on 4/2/2013

The Supreme Court heard oral argument in Federal Trade Commission v. Actavis (the caption for what was Federal Trade Commission v. Watson Pharmaceuticals, Inc. in the 11th Circuit opinion below) last Monday, with Deputy...more

Beware Of Topamax — It Can Be A Dangerous Drug

by Tate Law Group, LLC on 4/2/2013

Topamax (topiramate) was first approved by the United States Food and Drug Administration (FDA) in 1996 as an anti-convulsant for the treatment of seizures. Topamax was widely used to treat epilepsy in children and adults....more

Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

by Vincent Capuano, L. . Norwood Jameson, Alan Klein, Vicki Norton, Siegfried Ruppert | Duane Morris LLP on 3/28/2013

On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug. ...more

Can Big Pharma Pay To Keep Generics Off the Market?

by Aaron Kase | Lawyers.com on 3/26/2013

The U.S. Supreme Court today heard arguments over whether big pharmaceutical companies can pay generic drug manufacturers to delay their entry into the marketplace....more

Case Brief: Federal Trade Commission v. Watson Pharmaceuticals

by Kwame Mensah | McDonnell Boehnen Hulbert & Berghoff LLP on 3/26/2013

[Ed. The Supreme Court heard oral argument today in Federal Trade Commission v. Watson Pharmaceuticals. While Patent Docs will provide analysis regarding the oral argument in a subsequent post, we provide the following...more

Virginia Enacts Nation’s First Biosimilar Substitution Law

by Joy Liu | Ropes & Gray LLP on 3/26/2013

On March 21, 2013, Virginia governor Bob McDonnell signed into law the nation’s first state law concerning substitution of biosimilars. The law’s requirements that pharmacists keep records of substitutions, give notice of...more

Dechert Survey of Securities Fraud Class Actions Brought Against U.S. Life Sciences Companies

by David Kotler | Dechert LLP on 3/20/2013

Publicly Traded Life Sciences Companies in the United States Remain an Increasingly Popular Target of Securities Fraud Class Action Lawsuits: The past year was particularly noteworthy with respect to the absolute and...more

"Complex Mass Tort Product Liability Alert: Supreme Court Hears Oral Argument Regarding Scope of Generic Drug Preemption"

by John Beisner, Sheila Birnbaum, Mark Cheffo, Steven Napolitano | Skadden, Arps, Slate, Meagher & Flom LLP on 3/19/2013

Today, the Supreme Court of the United States held oral argument in Mutual Pharmaceutical Co. v. Bartlett, a follow-up to its landmark ruling in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which addressed federal...more

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Pharmaceutical › The United States Food and Drug Administration

Pro Te Solutio - Vol. 6 No. 1 February 2013

Are Your Prescription Drugs Safe?

Jury Buys Plaintiff’s Argument That Drug Manufacturer Should Have Distributed Dear Doctor Letter Sooner, Without Prior FDA...

Capital Infusion - May 2013: Dealmaker’s Corner

China Life Sciences Health Industry Client Briefing – April 2013 (May 15, 2013)

Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

Lawsuits Claim SSRIs Can Cause Severe Birth Defects [Video]

FDA Grapples with Social Media

Business Litigation Report -- April 2013

Federal Court Orders FDA to Approve OTC Sales of “Morning-After Pill,” Finds Current Age and Point-of-Sale Restrictions to be...

The First Amendment and Off-Label Promotion: United States v. Caronia

Thoughts on Regulatory Constraints of Business Models

Litigation Alert: U.S. Supreme Court to Weigh In on Reverse Payment Deals

Supreme Court Oral Argument in FTC v. Actavis

Beware Of Topamax — It Can Be A Dangerous Drug

Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

Can Big Pharma Pay To Keep Generics Off the Market?

Case Brief: Federal Trade Commission v. Watson Pharmaceuticals

Virginia Enacts Nation’s First Biosimilar Substitution Law

Dechert Survey of Securities Fraud Class Actions Brought Against U.S. Life Sciences Companies

"Complex Mass Tort Product Liability Alert: Supreme Court Hears Oral Argument Regarding Scope of Generic Drug Preemption"

Levick Weekly - March 15, 2013: Miracle Workers - How Utilities Can Generate More Goodwill

Z-Pack: Pfizer Can’t Assume That Science Will Trump A Scare Story

Two New Developments in First Amendment Challenges to Off-Label Promotion: What's Next?

A Cure For Antitrust Standing?

Lawsuits Claim SSRIs Can Cause Severe Birth Defects [Video]

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