Shire's Crohn's, HAE candidates granted special development designations | Cellectis gains 2 CRISPR T-cell patents | Pain's NDA for chronic pain drug refiled to FDA
February 14, 2018
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Shire's Crohn's, HAE candidates granted special development designations
A priority review status was given by Health Canada to Shire's marketing application for SHP643, or lanadelumab, which is being developed to prevent angioedema attacks in patients ages 12 and older with hereditary angioedema. An FDA orphan status was also granted to the company's SHP647, which is being developed to treat moderately to severely active Crohn's disease in pediatric patients.
Seeking Alpha (free registration) (2/13) 
Cellectis gains 2 CRISPR T-cell patents
Two US patents were granted to Cellectis related to the invention of specific uses for RNA-guided endonucleases for T-cell gene editing, such as Cas9 or Cpf1.
Seeking Alpha (free registration) (2/13) 
Pain's NDA for chronic pain drug refiled to FDA
A new-drug application was resubmitted by Pain Therapeutics to the FDA for Remoxy ER, a treatment for patients with chronic pain.
Reuters (2/13) 
Dosing of first patient completed for midstage trial of Imara's sickle cell drug
The first adult patient with sickle cell disease was dosed with Imara's lead candidate, IMR-687, which was granted rare pediatric disease designation by the FDA in last May. The midstage trial will assess IMR-687's safety, pharmacokinetics and pharmacodynamics through administration of escalated doses in patients with SCD.
Rare Disease Report (2/13) 
Global Focus
Diurnal's insufficient adrenal therapy gets EU nod
The European Commission approved Diurnal Group's Alkindi, or infacort, as a replacement therapy for patients under the age of 18 with adrenal insufficiency. The company intends to launch the drug next quarter.
BioCentury (2/13) 
Counterfeit drugs for rare blood disorders, HIV discovered in Argentina
Several batches of different counterfeit drugs were found this month in Argentina, according to the country's national food, drug and medical technology administration, or ANMAT. Among the fake drugs discovered were batches of Alexion's Soliris, or eculizumab, an FDA-approved treatment for rare blood disorders such as paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome; batches of Novartis' chronic myeloid leukemia drug Tasigna, or nilotinib; as well as treatments for HIV, multiple sclerosis and several others.
Securing Industry (2/13) 
Food & Dietary Supplements
Wash., FDA probe contamination in Darwin's pet foods
Wash., FDA probe contamination in Darwin's pet foods
The FDA and the Washington State Department of Agriculture are investigating a pattern of listeria and salmonella contamination in raw pet foods made by Arrow Reliance, which includes Darwin's Natural Pet Products and ZooLogics Pet Food -- recalled by the company through emails sent only to customers who purchased the products. As of this month, the agency received six complaints of illnesses in animals, including the death of a kitten, that had eaten the recalled foods.
Food Safety News (2/14) 
Medical Devices
Orthofix starts enrollment for rotator cuff repair study
Orthofix has begun enrollment for a study of its RCStim device as an adjunctive treatment to full-thickness rotator cuff tear surgical repair. The study, which will enroll 538 patients ages 21 to 80 across up to 30 US sites, will evaluate the ability of pulsed electromagnetic field technology to lower the rate of subsequent tears in repaired tendons, as well as if the treatment procedure correlates with range of motion, enhanced muscle strength and decreased pain scores.
Becker's Spine Review (2/13) 
DarioHealth brings blood glucose monitoring tech to Pa. diabetes clinic
A partnership was reached by DarioHealth with the Diabetes and Endocrinology Consultants of Pennsylvania to provide the 5,000-patient facility with access to its Dario blood glucose monitoring system, which synchronizes with the company's diabetes management app. The blood glucose monitor is expected to enable the facility "to actively identify and manage those patients with diabetes that need our guidance in a timely manner," said Dr. Arvind Cavale, one of the owners of the clinic.
Drug Delivery Business News (2/13) 
FDA expands premarket approval for Abiomed's heart pumps
Abiomed said its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps were granted expanded premarket approval by the FDA for use in treating heart failure linked to cardiomyopathy leading to cardiogenic shock, in addition to its use for treating acute myocardial infarction cardiogenic shock and postcardiotomy cardiogenic shock. The company also initiated the Women's Initiative, which will concentrate on heart recovery awareness and education.
MassDevice (Boston) (2/13) 
Food and Drug Law Institute Highlights
Introduction to US Drug Law and Regulation
Introduction to US Drug Law and Regulation
April 12-13 | Washington, D.C.
Expand your knowledge of drug law and regulation essentials like Rx to OTC switches, the new drug application process and Good Manufacturing Practices. Register by March 8 and save. View the agenda.
Now shipping: FDCA Statutory Supplement, 2018
Now shipping: FDCA Statutory Supplement, 2018
FDLI's new FDCA Statutory Supplement, 2018, is updated to incorporate the FDA Reauthorization Act of 2017 (FDARA) and provides cross-referencing of the numerous legislative amendments with the original statute. Order your copy.
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