Most Clicked FDLI SmartBrief Stories


1. FDA holds hearings to consider regulation of homeopathic therapies

FDLI SmartBrief | Apr 23, 2015

The FDA may consider tighter regulatory control of homeopathic treatments following two days of public hearings on the issue held this week. Cynthia Schnedar of the FDA's Center for Drug Evaluation and Research said there has been a significant increase in the popularity of homeopathic products, along with safety concerns that have led to almost 40 warning letters to manufacturers since 2009. Some critics say the remedies could pose a danger and there is no evidence that they work. Modern Healthcare (tiered subscription model) (04/22) HealthDay News (04/22)


2. Malignant glioma treatment from Oncolytics Biotech receives orphan-drug designation

FDLI SmartBrief | Apr 20, 2015

Oncolytics Biotech's Reolysin, or pelareorep, secured orphan-drug status from the FDA as a treatment for malignant gliomas. The designation was granted based on favorable data from three studies of brain cancer patients. Healio (free registration) (04/17)


3. Vt. enacts biotech food-labeling law

FDLI SmartBrief | Apr 21, 2015

Vermont Attorney General Bill Sorrell has formally filed a state law that requires the mandatory labeling of biotech foods. The law will be implemented July 1, 2016. Burlington Free Press (Vt.) (tiered subscription model), The (04/21)


4. 5 supplement makers warned by FDA to stop selling unapproved stimulant

FDLI SmartBrief | Apr 24, 2015

Human Evolution Supplements, Better Body Sports, Train Naked Labs, Tribravus Enterprises and Hi-Tech Pharmaceuticals received warning letters Thursday from the FDA asking them to discontinue sales of diet supplements with beta-methylphenylethylamine, an unapproved stimulant considered by the World Anti-Doping Agency to be a doping agent. The FDA cited the companies for product misbranding because BMPEA does not qualify as a dietary ingredient, and the ingredient with which it is associated, Acacia rigidula, does not contain BMPEA. The products affected include Phoenix Extreme, Core Burner, Sudden Impact, Lipodrene and Fastin-XR. Reuters (04/23)


5. FDA grants breakthrough status to Pfizer cancer drug

FDLI SmartBrief | Apr 22, 2015

The FDA has granted breakthrough therapy designation to Pfizer's Xalkori, or crizotinib, for use in patients with ROS1-positive non-small cell lung cancer. The drug has already received approval as a treatment for metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer. PharmaTimes (U.K.) (04/21)


6. FDA to use EHRs to evaluate drugs' postmarket safety

FDLI SmartBrief | Apr 22, 2015

A $1 million grant will be offered by the FDA to use EHR data to assess drugs' postmarket effectiveness and safety. Applications for the grant are open to the participants of the Reagan-Udall Foundation's Innovations in Medical Evidence Development and Surveillance-Methods program and will be accepted until June 15. FDAnews (04/21)


7. Merck submits application to market Keytruda for lung cancer

FDLI SmartBrief | Apr 20, 2015

An application to market PD-1 inhibitor Keytruda, or pembrolizumab, to treat advanced non-small cell lung cancer patients was filed in the U.S. by Merck. The application was based on clinical data that showed a 45.2% overall response rate among patients treated with the drug. PharmaTimes (U.K.) (04/19)


8. Ovarian cancer drug from CanTx gains orphan status

FDLI SmartBrief | Apr 23, 2015

CanTx's TRXE-002, or Cantrixil, has received orphan drug status from the FDA as a treatment for ovarian cancer. The designation was supported by study data that showed the drug was linked to a more than 95% reduction of tumors among models representing late-stage ovarian cancer that failed to respond to chemotherapy. Healio (free registration) (04/22)


9. HHS aims to complete e-cigarette rules this summer

FDLI SmartBrief | Apr 24, 2015

HHS plans to have rules to regulate e-cigarettes ready by this summer, Secretary Sylvia Mathews Burwell told Congress on Thursday. According to the CDC, the percentage of high-school students who used e-cigarettes at least once in a 30-day period in 2014 climbed to 13.4% from 4.5% in 2013. The use of e-cigarettes among middle-school students also increased to 3.9% in 2014 from 1.1% a year earlier. Washington Times, The (04/23)


10. AstraZeneca's uveal melanoma drug receives orphan status

FDLI SmartBrief | Apr 21, 2015

AstraZeneca's experimental MEK inhibitor selumetinib has received orphan drug status from the FDA for use as a treatment for uveal melanoma. A late-stage trial is being conducted to assess the drug in combination with chemotherapy. Pharmaceutical Business Review Online (04/20)




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