Most Clicked FDLI SmartBrief Stories


1. Jury orders $15M payment in birth defect case

FDLI SmartBrief | May 27, 2015

A jury in St. Louis ruled against Abbott in a lawsuit related to the anti-epileptic medication Depakote, ordering that $15 million be paid to a girl born with birth defects. The panel on Tuesday was considering the possibility of awarding punitive damages. AbbVie, which was spun off from Abbott in 2013, bears financial responsibility for the verdict. St. Louis Post-Dispatch (05/26)


2. CDC issues report on salmonella outbreak affecting 9 states

FDLI SmartBrief | May 22, 2015

The CDC released a report warning the public about a salmonella outbreak that occurred from March 5 to May 1 that may have been caused by the use of raw tuna in sushi. The agency said the paratyphi B strain sickened at least 53 people in nine states, affecting Southern California the most. The FDA is still working to trace the source of the outbreak. The Washington Post (tiered subscription model) (05/22)


3. House panel OKs 21st Century Cures measure

FDLI SmartBrief | May 22, 2015

The 21st Century Cures bill passed the House Energy and Commerce Committee in a 51-0 vote Thursday. The bill would speed up drug approval by requiring the FDA to improve its drug review process, look at adaptable forms of clinical studies and include patient experience in the decision-making process. The full House is expected to vote on the measure in June. The Hill (05/21) Reuters (05/21)


4. Bill introduced to address rising generic-drug costs

FDLI SmartBrief | May 27, 2015

Sen. Bernie Sanders, I-Vt., and Rep. Elijah Cummings, D-Md., have introduced legislation to address the rising costs of generic drugs. If approved, the Medicaid Generic Drug Price Fairness Act of 2015 would require manufacturers of generic drugs to pay state Medicaid rebates if generic-drug price growth outpaces inflation. Makers of brand-name drugs are already subject to inflationary rebates, while makers of generics pay a flat rate of 13%. The change could save the federal government $1 billion and state programs $750 million over a decade, said a Sanders aide. FDAnews (05/27)


5. Appeals court rules against Actavis in antitrust case

FDLI SmartBrief | May 26, 2015

The 2nd U.S. Circuit Court of Appeals, based in New York, has ruled against Actavis in an antitrust case filed by New York Attorney General Eric Schneiderman. According to the court, the company can't stop selling the Alzheimer's disease drug Namenda IR, which is taken twice per day, in favor of Namenda XR, a once-daily version. Actavis has been accused of trying to establish a base of prescriptions for the new version of the Alzheimer's drug before generic rivals of Namenda IR become available in July. The Wall Street Journal (tiered subscription model) (05/22)


6. Appeals court: Tobacco companies don't have to admit they lied about cigarettes' health risks

FDLI SmartBrief | May 26, 2015

The U.S. Court of Appeals for the District of Columbia Circuit upheld some of the decisions of a lower court in a racketeering lawsuit filed by the U.S. government against tobacco firms including Reynolds American and Lorillard. The appeals court judge upheld the lower court's requirement that tobacco firms release corrective statements saying they "intentionally designed cigarettes to ensure addiction" and said the companies had no grounds to object. However, the appeals court gave tobacco companies a partial victory when it found that federal racketeering law does not require them to announce they lied to the public about the health risks of cigarettes. Reuters (05/22)


7. FDA committee might restrict compounding of 4 drugs

FDLI SmartBrief | May 22, 2015

The FDA's Pharmacy Compounding Advisory Committee will be asked by the agency to decide on whether to include acetaminophen, bromocriptine mesylate, ondansetron hydrochloride and aprotinin on the list of "difficult to compound" drugs that cannot be compounded by outsourcing pharmacies. The committee is set to discuss the issue on June 17. The committee will also consider whether to recommend adding the drug substances oxitriptan, n-acetyl-d-glucosamine, tranilast and Brilliant Blue G to an FDA list of banned substances. Regulatory Focus (05/21)


8. Chemotherapy drug receives FDA OK for treating radiation exposure

FDLI SmartBrief | May 26, 2015

The FDA has approved Amgen's Neupogen to treat people who have been exposed to radiation caused by a nuclear disaster. The decision was based on a study conducted by researchers from the University of Maryland School of Medicine, which found the medication to be effective in protecting blood cells from severe radiation poisoning. eMaxHealth.com (05/25)


9. Irritable bowel syndrome drugs from Actavis, Valeant receive FDA approval

FDLI SmartBrief | May 28, 2015

The FDA has granted approval to two drugs for the treatment of diarrhea-predominant irritable bowel syndrome in adults. Actavis' eluxadoline, or Viberzi, reduces bowel contractions and constipation risk, while Valeant Pharmaceuticals' rifaximin, or Xifaxan, was previously approved as a treatment for traveler's diarrhea. The approvals were backed by trial data showing the drugs improved IBS-D symptoms more effectively than placebo. Medscape (free registration) (05/27) Reuters (05/27)


10. Study shows FDA ban cut ephedra-related poisonings

FDLI SmartBrief | May 28, 2015

A study in the New England Journal of Medicine showed that ephedra-related poisonings and deaths have declined since the FDA outlawed the sale of weight-loss supplements including the herb in 2004. Ephedra was proven to be dangerous, especially when used with caffeine, and was linked to health problems such as heart attack, seizure and stroke. The study found a drop in ephedra poisoning cases of over 98% since 2002. Reuters (05/27)




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