Most Clicked FDLI SmartBrief Stories


1. Federal officials propose life sentence for former Peanut Corp. of America owner

FDLI SmartBrief | Jul 24, 2015

A life sentence has been recommended by federal officials for Stewart Parnell, the former owner of Peanut Corp. of America who was found guilty of covering up the Salmonella contamination in his company's products that caused an outbreak in 2008 to 2009. According to a brief submitted by prosecutors to the U.S. District Court in Albany, Ga., the U.S. Probation Office confirmed that the offenses committed by Parnell fall within the life sentence guidelines. If the judge agrees with the proposal, the sentence would be the most severe sentence ever given in a U.S. food-illness case, according to experts. The Wall Street Journal (tiered subscription model) (07/23)


2. FDA to study patient perceptions on effectiveness claims in drug advertisements

FDLI SmartBrief | Jul 23, 2015

The FDA will conduct two studies to examine how effectiveness claims in direct-to-consumer prescription drug advertisements affect consumer beliefs about the quality of the treatment. The studies will show different print ads to patients with diabetes to measure what they remember about the ads, how the ads affect their understanding of risks and benefits, how skeptical they are about ad claims, and how their perceptions of the drugs are affected by the advertisements. The Wall Street Journal (tiered subscription model) (07/22)


3. Oncologists seek regulations to control rising cancer drug prices

FDLI SmartBrief | Jul 23, 2015

Around 118 oncologists from leading cancer care facilities across the country added their names to a Mayo Clinic journal editorial expressing opposition to the rising prices of cancer drugs in the U.S. The oncologists called for Congress to allow Medicare to bargain directly with pharmaceutical companies, for patients to be able to legally obtain cancer drugs from other countries, and for tighter control of patents and better oversight to prevent efforts that would delay the launch of generic drugs on the market. The pharma industry cautions that the value of these new drugs should not be overlooked. The Wall Street Journal (tiered subscription model) (07/23)


4. Cholesterol drug from Regeneron, Sanofi wins FDA approval

FDLI SmartBrief | Jul 27, 2015

Regeneron Pharmaceuticals' and Sanofi's cholesterol-lowering Praluent, or alirocumab, has been approved by the FDA for use in patients with clinical atherosclerotic cardiovascular disease and heterozygous familial hypercholesterolemia. The drug was also recommended by European regulators as a treatment for patients with high cholesterol who respond inadequately to statins. The approval from the European Commission is expected in September. Reuters (07/24)


5. Appeals court rules in favor of Novartis in Neupogen patent infringement case

FDLI SmartBrief | Jul 22, 2015

The U.S. Court of Appeals for the Federal Circuit ruled Tuesday to allow Novartis to market Zarxio, a biosimilar version of Amgen's anti-infection drug Neupogen, starting Sept. 2. The decision stemmed from a case filed by Amgen claiming that Sandoz, the generic drug unit of Novartis, infringed on the patent Amgen holds for the treatment. Novartis obtained FDA approval to sell the biosimilar in the U.S. in March. Reuters (07/21)


6. Bristol-Myers' lung cancer drug gains EU approval

FDLI SmartBrief | Jul 21, 2015

Bristol-Myers Squibb's nivolumab was approved by the European Commission as a treatment for patients with locally advanced or metastatic squamous non–small cell lung cancer who have received chemotherapy. The decision was backed by trial data showing the drug yielded overall survival rates of 42% at one year, compared with 24% for docetaxel. PharmaTimes (U.K.) (07/21) Medscape (free registration) (07/20)


7. Voluntary biotech food labeling bill clears the House

FDLI SmartBrief | Jul 24, 2015

The Safe and Accurate Food Labeling Act, which would prohibit the mandatory labeling of biotech foods, was approved by the House of Representatives in a 275-150 vote on Thursday. "... It is not the place of government, government at any level, to arbitrarily step in and mandate that one plant product should be labeled based solely on how it was bred, while another identical product is free of government warning labels because the producer chose a different breeding technology," said Rep. Mike Pompeo, R-Kan., sponsor of the bill. The Huffington Post (07/23)


8. FDA proposes rule on mandated sugar labeling

FDLI SmartBrief | Jul 27, 2015

The FDA on Friday issued a proposed rule that would require food and beverage companies to list amounts of added sugar and recommended consumption levels on the nutrition labels of packaged food and drinks. The proposed rule sets the recommended intake of added sugar at no more than 200 calories a day, equal to about 13 teaspoons and 10% of the standard 2,000-calorie diet used for nutrition guidance. The Wall Street Journal (tiered subscription model) (07/24)


9. EU approves Amgen's cholesterol drug

FDLI SmartBrief | Jul 22, 2015

The European Commission has granted approval to Amgen's Repatha, or evolocumab, as a treatment for patients with genetic predisposition to high cholesterol and those who are intolerant or insufficiently responsive to statins. The approval was based on trial data showing the drug yielded about a 55% to 75% reduction in LDL cholesterol in patients with primary hyperlipidemia and mixed dyslipidemia, and about a 15% to 30% reduction in patients with high-risk homozygous familial hypercholesterolemia, compared with placebo. PharmaTimes (U.K.) (07/21) Reuters (07/21)


10. FDA clears device for underarm hair removal from Miramar

FDLI SmartBrief | Jul 27, 2015

The miraDry system, a device developed by Santa Clara, Calif., medtech firm Miramar Labs for underarm sweat reduction, has received expanded 510(k) clearance from the FDA for removal of underarm hair. The product, which relies on microwave energy, will be available next month. FDAnews (07/27)




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