Wall Street Journal Morning Pharmaceutical Newsletter

Posted on May 29, 2015 09:10 am CDT

Wall Street Journal

Ed Silverman

Good morning, everyone, and how are you today? The sun is trying to peek through a muggy haze descending this morning on the Pharmalot campus, where our official mascots are lounging about and assorted birds and bugs can be heard in the distance. As for us, we are immersed in our usual routine of foraging for interesting items and brewing cups of stimulation. It is, after all, another busy day. No doubt, it is the same for you. So here are some tidbits to help you along. Hope today proves successful and keep in touch…

The FBI is investigating a surgical device that was found to spread cancer in women, including what Johnson & Johnson JNJ +0.37% knew about its hazards before pulling it off the market last year, according to The Wall Street Journal. Over the past several months, FBI agents interviewed a retired pathologist who alerted J&J about potential problems with morcellators in 2006, a doctor who went public after her own cancer was worsened by the tool in 2013, and a California woman who has collected names of close to 400 patients and relatives who may have been harmed by the tool.

People with HIV should be put on antiretroviral drugs as soon as they learn they are infected, federal health officials said in announcing they were halting the largest ever clinical trial of early treatment because its benefits were already so clear, The New York Times tells us. The study was stopped more than a year early because preliminary data already showed that those who got treatment immediately were 53% less likely to die during the trial or develop AIDS or a serious illness than those who waited.

A St. Louis jury awarded a Minnesota girl $23 million in punitive damages after deciding that Abbott Laboratories ABT +0.19%’ anti-epileptic drug Depakote was to blame for her birth defects, The St. Louis Post-Dispatch writes. The verdict follows the same jury’s decision to award the 12-year-old plaintiff, Maddison Schmidt, $15 million in compensatory damages. In total, the jury awarded $38 million to Schmidt, after finding that her birth defects, including spina bifida, were the result of her mother taking Depakote while pregnant. AbbVie ABBV +1.50%, however, is financially responsible.

New data to be released this weekend should help deepen the understanding of how broadly new drugs that unleash the body’s immune system to fight cancer can be used, Reuters reports. Results from key clinical trials will be presented at the annual meeting of the American Society of Clinical Oncology and will include studies aimed at defining ahead of time which patients are likely to benefit.  At the forefront will be rival drugs from Bristol-Myers Squibb BMY +0.50% and Merck designed to block a protein known as PD-1 that tumors use to evade the body’s immune system.

Teva Pharmaceutical is close to a settlement valued around $1 billion to resolve government allegations its Cephalon subsidiary paid generic drug makers to delay competing versions of the sleep-disorder drug Provigil, according to The Wall Street Journal. The settlement with the  U.S. Federal Trade Commission, which could be announced soon, comes ahead of trial proceedings scheduled to begin June 1 in a Philadelphia federal court. The agreement will be a milestone in the FTC’s long-running campaign to stop pay-to-delay settlements.

A lawyer seeking to free two chimpanzees from a state university told a judge Wednesday that their confinement for research purposes is akin to slavery, the involuntary detention of mentally ill people and imprisonment, the Associated Press says. Steven Wise, an attorney with the Nonhuman Rights Project, argued Hercules and Leo are “autonomous and self-determining beings” who should be granted a writ of habeas corpus and be moved from Stony Brook University on Long Island to a sanctuary in Florida.

Teva Pharmaceutical TEVA -0.42% bought 1.35% of Mylan Laboratories MYL -1.15%stock on the open market, putting pressure on its rival to accept a takeover offer, Bloomberg News reports.

The FDA approved new irritable bowel syndrome drugs from Actavis and Valeant Pharmaceuticals VRX.T +0.66%, validating big investments both companies made to acquire the products, according to Reuters.

Rep. Billy Long (R-Mo.) introduced a bill that would require the FDA to update social media regulations and let drug makers add prescribing information via hyperlinks, Medical Marketing Media says.

Gilead Sciences GILD -0.16% plans to invest another $100 million to add a manufacturing facility to its campus in Edmonton, where about 300 people are employed, The Edmonton Journal writes.

Retrophin agRTRX +2.99%reed to sell a rare pediatric priority review voucher meant to speed drug approval to Sanofi SAN.FR -0.84% for $245 million in cash, just three months after acquiring the voucher as part of a deal to buy Asklepion Pharmaceuticals, says Xconomy.

GlobeImmune GBIM -1.33% and Gilead Sciences suffered a setback after their new hepatitis B vaccine missed its mid-stage trial target, according to Pharma Times.

GlaxoSmithKline GSK.LN -0.02% and the plaintiffs firm leading dozens of thalidomide-injury suits against the drug maker are squabbling over an attorney-client privilege issue before a federal appeals court, The Legal Intelligencer reports.

Novartis NOVN.VX -0.11% is eliminating up to 100 positions from various locations around the U.S. through a voluntary retirement program, a spokeswoman confirms.

Zogenix saZGNX -2.16%ys that fenfluramine, which was once used to fight obesity before it was taken off the market, may help treat a rare disease that causes severe seizures in young children, Reuters reports.

 

 

 

 

 

 

 

 

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