Eagle wins orphan status exclusivity in court for blood cancer drug | AbbVie, Genentech's CLL, SLL therapy wins FDA full approval | FDA approves Alembic's major depressive disorder tablets
June 11, 2018
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Eagle wins orphan status exclusivity in court for blood cancer drug
Eagle wins orphan status exclusivity in court for blood cancer drug
(Joe Raedle/Getty Images)
A court awarded seven-year orphan drug status exclusivity to Eagle Pharmaceuticals' blood cancer drug Bendeka, or bendamustine hydrochloride. The FDA was sued by Eagle after the agency said there was no evidence of clinical superiority of the drug and did not give it orphan drug-related exclusivity.
Seeking Alpha (6/8) 
AbbVie, Genentech's CLL, SLL therapy wins FDA full approval
AbbVie and development partner Roche Holding unit Genentech's venetoclax was granted full approval by the FDA as a treatment for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with or without 17p deletion who had at least one prior line of treatment.
Seeking Alpha (6/8) 
FDA approves Alembic's major depressive disorder tablets
The FDA has approved Indian drugmaker Alembic Pharmaceuticals' abbreviated new drug application for major depressive disorder drug bupropion hydrochloride tablets USP, 75 mg and 100 mg. The drug is therapeutically equivalent to GlaxoSmithKline's Wellbutrin, its reference drug.
PharmaBiz (India) (6/11) 
CytoDyn reports on data for PRO 140 to treat multidrug-resistant HIV-1
PRO 140, the investigational humanized monoclonal antibody developed by CytoDyn, attained its primary endpoint in a pivotal trial that tested the candidate on 50 patients with multidrug-resistant HIV-1 in combination with antiretroviral treatment, with participants achieving a 97% mean viral load reduction from baseline one week after receiving a single injection, according to a presentation made at the conference of the American Society for Microbiology. Based on the favorable results, CytoDyn plans to file for a biological license application for PRO 140 in a combination therapy indication.
Healio (free registration)/Infectious Disease News (6/9) 
Manage Data Integrity When Using Foreign CMOs
Sponsors headquartered in the US or Europe who have foreign contract manufacturing organizations (CMO), may not be aware of or compliant with the quality manufacturing requirements for products destined for the US or Europe. Learn how to manage your CMO to safeguard data integrity. Read more.
Global Focus
AZ's Tagrisso gets EU nod as first-line NSCLC therapy
The European Commission has approved AstraZeneca's Tagrisso, or osimertinib, as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer that expresses EGFR mutations. The decision was supported with data from a late-stage FLAURA study, in which the drug achieved the primary endpoint of improving progression-free survival as compared to standard of care in the first-line setting.
BioCentury (6/8) 
Food & Dietary Supplements
Caito melon products linked to multistate salmonella outbreak
Caito melon products linked to multistate salmonella outbreak
(Joe Raedle/Getty Images)
Precut melon produced at the Indianapolis facility of Caito Foods has been linked to a salmonella outbreak in eight states that sickened 60 people and caused 31 to be hospitalized. Caito has recalled its fresh-cut cantaloupe, honeydew melon, watermelon and mixed fruit products that could contain the tainted melon and were shipped to stores including Walmart, Costco, Kroger, Trader Joe's and Whole Foods in Illinois, Indiana, Georgia, Michigan, Missouri, Kentucky, North Carolina and Ohio.
Reuters (6/10) 
Study shows health benefits of omega-3 supplementation to babies
Australian researchers found that infant boys who received a daily supplement of omega-3 long-chain polyunsaturated fatty acid from birth to six months had a 22% reduction in insulin resistance and a 21% reduction in insulin concentrations, compared with those who received olive oil. The findings in the journal Pediatrics, based on 420 infants, showed those who received n-3 LCPUFA supplementation also had a smaller waist circumference at five years than the control group.
Physician's Briefing/HealthDay News (6/8) 
Medical Devices
Cost-effectiveness demonstrated in UK study of Teleflex unit's UroLift
An Imperial College Partners study showed the use of Teleflex unit NeoTract's UroLift System as an alternative for transurethral resection of the prostate, the standard-of-care intervention for benign prostate hyperplasia, would result in about $36 million in post-surgical complication-related cost savings for the UK's National Health Service. The system, designed to be implanted via a minimally invasive procedure in the physician's office, also demonstrated better quality-of-life scores.
Seeking Alpha (6/8) 
Japan clears Corindus Vascular's robotic surgical platform
Japan's Pharmaceuticals and Medical Devices Agency has granted Corindus Vascular Robotics clearance to market its CorPath GRX robotic surgical device, a platform intended to facilitate percutaneous coronary intervention procedures. The company said it plans to conduct a post-market study for the platform and is working on obtaining reimbursement coverage for robotic percutaneous coronary intervention procedures in the country.
The Robot Report (6/8) 
Hot Topics
Food and Drug Law Institute Highlights
New webinar this Thursday: USDA's Proposed Bioengineered Food Disclosure Standard - Key Issues and Next Steps
New webinar this Thursday: USDA's Proposed Bioengineered Food Disclosure Standard - Key Issues and Next Steps
June 14 | 2:00 - 3:30 PM ET
Following the recent release of the National Bioengineered Food Disclosure Standard proposed rule, this webinar will highlight different types of genetic modifications and decipher which methods of bioengineering may be required to provide a disclosure under the final rule. Register now.
Update Magazine feature -- China: Breaking Down the "Great Wall"?
Update Magazine feature -- China: Breaking Down the "Great Wall"?
Xin Tao of Hogan Lovells reports for FDLI's Update Magazine on recent changes to the Chinese regulatory scheme aimed at facilitating market entry for pharmaceuticals. Developments to watch include changes in the approval process, patent rights and overseas inspections. Read more.
Learn more about FDLI:
About | Programs | Resources | Engage | Career
powered by
Pharmaceutical Compliance Attorney
Director, Office of Surveillance and Compliance
Junior/Mid-Level Associate
Food and Drug Associate
I started life with two great advantages: no money, and good parents.
Margaret Thatcher,
prime minister
Sign Up
SmartBrief offers 200+ newsletters
Learn more about the SmartBrief audience
Subscriber Tools:
Contact Us:
Jobs Contact  -  jobhelp@smartbrief.com
Advertising  -  Sarah Hostetler
Editor  -  Lisa Gough
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004
© 1999-2018 SmartBrief, Inc.®
Privacy Policy (updated May 25, 2018) |  Legal Information