Bleeding Deaths Linked to Pradaxa
Lawsuits Claim SSRIs Can Cause Severe Birth Defects
Insurance Dispute Freezes Avandia Victims’ Fund
On May 14, 2013, the French Autorité de la Concurrence (Autorité) issued a decision imposing a fine of €40.6 million on French company Sanofi-Aventis France (Sanofi) for an abuse of dominance in the market for the...more
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
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
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
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
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
Lawyers.com videojournalist Matt H. Mayes from Los Angeles reports that a big pharma and insurance legal dispute was allowed to deprive innocent victims of money that they were entitled to and often desperately needed. ...more
On April 16, 2013, in Bayer Schering Pharma AG v. Watson Pharm., Inc., the U.S. Court of Appeals for the Federal Circuit (Lourie,* Schall, Prost) reversed the district court's summary judgment that U.S. Reissue Patent No....more
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
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
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
In This Issue: Novartis Pharmaceuticals Corp. et al. v. Noven Pharmaceuticals Inc. et al.; Purdue Pharmaceutical Products L.P. et al. v. Dr. Reddy's Laboratories, Inc. et al.; Taro Pharmaceuticals North America, Inc....more
In a March 2013 article, I wrote about members of Congress calling for increased oversight of the 340B drug discount program and, in particular, hospital use of 340B drugs. This week, Senator Charles Grassley of Iowa...more
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
Originally published in WP Thompson & Co. on April 1, 2013. The "Obvious to Try" Test Is Overused in Assessing Obviousness - The UK Court of Appeal Decision in Novartis AG vs Generics (UK) Ltd (trading as United...more
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
Following the recent release of new Program Notices regarding the Group Purchase Organization (GPO) prohibition and Medicaid Exclusion File, 340B participating entities should review their 340B program policies and procedures...more
Big Pharma and academia cement big deals in the quest for bigger prizes - With the patents of many highly profitable blockbuster drugs expiring over the course of a few years, the search is on for new drugs to fill...more
“Wait a minute, Occifer, I have a subscription for that drug” These days it seems like everyone takes a pill for something. Just go to a doctor with an ache or a pain, and walk away with a little pill to cure what...more
Originally Published in BNA Bloomberg, Medical Devices Law & Industry Report on March 20, 2013. On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations for...more
China’s Ministry of Health released the new essential drug list (the “2012 EDL”) on March 15, 2013, effective as of May 1, 2013. Essential drugs are those which meet basic health care demands in suitable dosage forms with...more
Earlier this month, Genetic Engineering & Biotechnology News published its list of the top 20 best-selling prescription drugs worldwide for 2012 (see "GEN Compiles List of Top Selling Drugs for 2012"). The biotech...more
This week, the U.S. Food and Drug Administration (FDA) issued a warning that Pfizer’s popular Z-pack antibiotic (also known as Zithromax or Zmax) may cause sudden death in some patients with preexisting heart conditions....more
Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more
A three-judge panel of the U.S. Court of Appeals for the Ninth Circuit, in a recent unpublished opinion, upheld the conviction and sentencing of former InterMune, Inc. executive Scott Harkonen for wire fraud. In 2009, a jury...more
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