Celgene discontinues late-stage study of Crohn's disease drug | FDA gives orphan status to Pluristem's acute radiation syndrome drug | Spectrum reports positive results from midstage study of NSCLC drug
October 20, 2017
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Celgene discontinues late-stage study of Crohn's disease drug
A Phase III trial of mongersen, or GED-0301, for the treatment of Crohn's disease was suspended by Celgene after an independent committee conducted an interim futility analysis and benefit-risk assessment of the drug. Celgene said it will decide what is next for the drug candidate after data from a midstage trial evaluating it for an ulcerative colitis indication is available.
BioCentury (10/19),  STAT (tiered subscription model) (10/19) 
FDA gives orphan status to Pluristem's acute radiation syndrome drug
Pluristem Therapeutics' PLX-R18, which is being developed as a treatment for patients with acute radiation syndrome, was granted orphan drug designation by the FDA. An early-stage trial is underway in patients with incomplete bone marrow recovery who had hematopoietic cell transplant.
Seeking Alpha (free registration) (10/19) 
Spectrum reports positive results from midstage study of NSCLC drug
Spectrum Pharmaceuticals' poziotinib, or HM781-36B, achieved an objective response rate of 73% in a midstage study for non-small cell lung cancer with EGFR exon 20 insertion mutations.
BioCentury (10/18) 
Study of hemophilia B gene treatment to be launched by uniQure
UniQure intends to launch a pivotal study next year that will evaluate AMT-061 in patients with severe and moderately severe hemophilia B in which the primary endpoint will be the prevention of bleeds in patients. The drug candidate has been included by the FDA in the breakthrough therapy status and investigational new drug designation for the structurally identical AMT-060, while the European Medicines Agency will include AMT-061 under its PRIME status.
Seeking Alpha (free registration) (10/19) 
7 keys: Put real-world evidence into action
Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
Global Focus
Dr. Reddy's Famotidine tablets recalled in US
A recall was issued by India-based Dr Reddy's Laboratories in the US for over half a million bottles of over-the-counter Famotidine tablets, 10 mg, indicated for the treatment and prevention of ulcers in the stomach and intestines after the drug failed an FDA test of impurities/degradation specifications. The FDA classified the recall as Class III.
Business Standard (India) (tiered subscription model) (10/20) 
Food & Dietary Supplements
Listeria risk triggers US, Canadian recall of fresh-cut veggies
Mann Packing issued nationwide recalls in both the US and Canada for 11 brands of fresh-cut vegetable products because the Canadian Food Inspection Agency discovered listeria contamination during a random test in one of the products. The recalled products have "best if used by" dates ranging from Oct. 11 to Oct. 20, and brands being recalled include Trader Joe's, Wal-Mart and Archer Farms.
Food Safety News (10/20) 
Medical Devices
France OKs trial of Pixium Vision's next-gen subretinal implant
France's regulatory agency granted Pixium Vision approval to conduct a five-patient feasibility clinical study of the Prima system, a next-generation subretinal wireless implant system intended for the treatment of retinal dystrophies with a focus on advanced atrophic dry age-related macular degeneration. The study will assess the system's tolerance, as well as evoked central visual perception, among patients who lost their sight because of dry AMD, with evaluations at six months and 36 months.
MassDevice (Boston) (10/19) 
Varian announces EU launch of radiotherapy cancer treatment system
The Halcyon image-guided volumetric intensity modulated radiotherapy cancer treatment system was launched by Varian Medical in the European Union, with the first procedure using the product recorded in Belgium. The system comes with enhancements that improve patient comfort and streamline workflow of the operator, reducing the steps from start to treatment from 30 in legacy machines to nine in the Halycyon system.
MassDevice (Boston) (10/19) 
EU approves Implanet's Jazz Platform
European regulators gave Implanet CE mark approval for Jazz Passer, a system intended for use in posterior fixation during spine surgery for treating degenerative scoliosis deformities and trauma pathologies. The system comes with new instruments, including a variation of the company's Jazz Band braid and is compatible with the whole Jazz Platform.
Becker's Spine Review (10/19) 
FDA considers banning flavors in cigarettes, e-cigarettes
FDA considers banning flavors in cigarettes, e-cigarettes
(Joe Raedle/Getty Images)
The FDA is reviewing the possibility of banning flavors such as menthol in e-cigarettes and cigarettes as part of a larger overhaul of tobacco regulation in which it seeks to reduce nicotine in tobacco products to a level that they are no longer addictive and encourage smokers to switch to less-harmful products. FDA Commissioner Scott Gottlieb said the agency wants to evaluate if flavors attract more young people to smoking or if, on the other hand, flavors could make it easier for smokers to switch to less-harmful tobacco products, such as e-cigarettes.
The Wall Street Journal (tiered subscription model) (10/19) 
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