Valsartan prices double after recall | Keytruda, Inlyta combo shows benefits for kidney cancer patients | FDA grants tentative approval to Teva's generic mifepristone
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October 19, 2018
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Drugs & Biologics
Valsartan prices double after recall
Valsartan prices double after recall
(Pixabay)
The cost of two valsartan dosages, used to treat high blood pressure, increased more than any other drug in the US last month after pharmaceutical ingredient manufacturer Zhejiang Huahai Pharmaceuticals pulled valsartan the US market following discovery of a probable carcinogen. Prices more than doubled over August rates.
Reuters (10/16) 
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Keytruda, Inlyta combo shows benefits for kidney cancer patients
Statistically meaningful improvements in overall survival and disease progression were seen in patients with kidney cancer treated with a combination of Merck's Keytruda, or pembrolizumab, and Pfizer's Inlyta, or axitinib. The combination treatment met the main goals of the late-stage trial as compared with kidney cancer drug Sutent, or sunitinib malate, also from Pfizer.
Specialty Pharmacy Times (10/18) 
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FDA grants tentative approval to Teva's generic mifepristone
Teva Pharmaceutical Industries' generic version of mifepristone was granted tentative approval from the FDA. The drug is the active ingredient in Corcept Therapeutics's Korlym.
Seeking Alpha (10/18) 
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Medical Devices
Beddr debuts sleep monitoring wearable
Mountain View, Calif.-based Beddr has announced the release of its FDA-registered consumer wearable, SleepTuner, which monitors a user's blood oxygen, heart rate, stopped breathing events, position, movement and awakenings during sleep using optical sensors and a three-axis accelerometer. The Bluetooth-enabled device, which is designed to be worn on the forehead, provides insights on how sleep quality can be improved and stores data in the Beddr Cloud until it syncs with the Beddr iOS mobile app.
VentureBeat (10/18),  MobiHealthNews (10/18) 
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Final orders on 6 down-classifications issued by CDRH
The FDA's Center for Devices and Radiological Health has released final orders down-classifying six new device types, including putting wound autofluorescence imaging devices in class I. The orders down-classify five device types into class II (special controls): the intranasal electrostimulation device for dry-eye symptoms, hemostatic device for intraluminal gastrointestinal use, the positive airway pressure delivery system, the thermal vestibular for headache and the light-based energy source device for topical application.
Regulatory Focus (10/18) 
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Food & Dietary Supplements
Omega-3 fatty acid consumption tied to healthy aging, research shows
Omega-3 fatty acid consumption tied to healthy aging, research shows
(Pixabay)
A study in The BMJ found that individuals who consumed the highest levels of seafood-derived docosapentaenoic acid had a 24% reduced risk of aging unhealthily, compared with those with the least consumption. Based on 2,622 adults from the Cardiovascular Health Study with an average age of 74, those in the top three DPA-consuming quintiles reduced their risk of experiencing unhealthy aging by up to 21%.
Medical News Today (10/18) 
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Global Focus
Allergan to seek US approval for migraine drug
Dublin, Ireland-based Allergan plans to submit a marketing application for its migraine therapy ubrogepant to the US early next year. Allergan recently finished two safety studies in which more patients treated with 50-mg and 100-mg doses of the drug experienced relief from pain and bothersome migraine-associated symptoms two hours after the initial dose, compared with those receiving placebo.
PharmaTimes online (UK) (10/18) 
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Chinese biopharma initiates Phase I study for AML candidate
An early-stage study was launched in China by Hutchison China MediTech, or Chi-Med, to assess the preliminary efficacy, safety and pharmacokinetics of its experimental drug HMPL-523, combined with azacitidine, as a treatment for elderly acute myeloid leukemia patients who have not been previously treated or who are ineligible to undergo standard induction therapy. The study's primary endpoint includes overall response rate as well as adverse events.
Seeking Alpha (10/18) 
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Food and Drug Law Institute (FDLI) Highlights
FDLJ Symposium: What Is the Path Forward for Federal Regulation of Cannabis? | November 2, Washington, DC
FDLJ Symposium: What Is the Path Forward for Federal Regulation of Cannabis? | November 2, Washington, DC
Complimentary for Members
Join scholars and practitioners to discuss the evolution of the cannabis industry from past to present and future, including the current state of the federal regulation of cannabis, and its legal and practical implications moving forward. The Symposium focuses on FDA but will also examine other federal agencies. Register Now
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Update Magazine Feature: Future Developments in the Regulation of Electronic Nicotine Delivery Systems: Potential Over-the-Counter Pathway
Update Magazine Feature: Future Developments in the Regulation of Electronic Nicotine Delivery Systems: Potential Over-the-Counter Pathway
Azim Chowdhury and Samuel Jockel (Keller and Heckman LLP) analyze the legal framework and business potential for electronic nicotine delivery systems (ENDS) to be regulated as over-the-counter (OTC) nonprescription drugs. Recent FDA statements indicate that the agency is considering an OTC pathway for ENDS. Read More
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