Lilly receives complete response letter for liprotamase
INDIANAPOLIS — The Food and Drug Administration declined to approve a drug made by Eli Lilly for treating a disease of the pancreas that often occurs in patients with cystic fibrosis, Lilly said.
The FDA issued a complete response letter to Lilly related to its application for liprotamase, a pancreatic enzyme replacement therapy for exocrine pancreatic insufficiency, requesting that the drug maker conduct an additional clinical trial before resubmitting its application. The FDA issues a complete response letter when it has finished reviewing the application for a drug, but issues remain that preclude final approval.
“Lilly is looking forward to further discussion with the FDA to address the items outlined in the letter and provide the requested information as quickly as possible,” Lilly VP autoimmune, bone-muscle-joint and liprotamase product development Eiry Roberts said. “We are committed to working with the agency and the cystic fibrosis community to make this important treatment available to patients.”
Albertson’s LLC announces participation in Diabetes Prevention and Control Alliance
BOISE, Idaho — Albertson’s LLC, which operates more than 200 stores across seven states under the Albertsons banner, announced it has joined the Diabetes Prevention and Control Alliance.
The retail grocery chain joins such companies as UnitedHealth Group, YMCA, Walgreens and Novo Nordisk as a DPCA partner. Albertson’s LLC will participate in the DCPA’s Diabetes Control Program, offering its customers community-based programs that help prevent and control diabetes.
In-store pharmacists in select Albertson’s LLC locations will conduct blood-glucose, cholesterol and blood-pressure testing services for program participants. Additionally, the in-store pharmacists will provide the participants with on-the-spot results, enabling patients to get immediate feedback on their status or progress in managing their diabetes.
The company now is offering the program at stores in Phoenix and Tucson, and will offer the program throughout other stores later this year.
“Diabetes is becoming increasingly pervasive in the United States and in the communities we serve,” said Raymond McCall, VP pharmacy operations for Albertson’s LLC. “By participating in the Diabetes Prevention and Control Alliance, we are able to offer more specific disease management to participating patients that will help them control their diabetes and maintain a healthy lifestyle.”
NCPA, Purdue kick off ‘Protect Your Pharmacy Week’
ALEXANDRIA, Va. — The National Community Pharmacists Association and Purdue Pharma announced the start of “Protect Your Pharmacy Week” — a reflection of the Protect Your Pharmacy Now! initiative that began in 2008 to encourage pharmacists to protect their stores, staff and patients against pharmacy crimes, including prescription drug robbery and thefts.
This year, NCPA and Purdue introduced a new theme encouraging pharmacists to make a plan to REACT. The acronym REACT — remain calm, eye witness, activate alarm, call police and take charge — represents some highly recommended tips for community pharmacists to remember in the case of a crime against a pharmacy.
“NCPA and its partners developed the Protect Your Pharmacy Now! initiative in 2008 to help pharmacy owners proactively prepare to keep pharmacies a place of safe and effective health care,” stated Robert Greenwood, NCPA president. “We are proud to continue the program with additional tools and resources to help pharmacists effectively REACT in the case of a crime against their stores.”
As part of the program this year, new benefits to NCPA members include:
New security height decals for the pharmacy doorway featuring a REACT reminder above to help pharmacists, staff and patients be better witnesses;
Discounts and free shipping on the line of narcotics dispensers, safes and cabinets from Pharmasafe; and
A volunteer opportunity to be featured in the 2012 Protect Your Pharmacy Now! "RxPatrol Pharmacy Safety and Security" video to highlight real-life examples, tips and suggestions to help pharmacy owners prepare to improve the safety and security of their stores.
In addition, NCPA members can receive free ceiling mobiles to draw attention to security cameras in their stores, links to RxPatrol training videos on pharmacy crime, discounts on closed-circuit TV cameras, recorders and surveillance equipment, and safety and security tips from law enforcement professionals.
Purdue Pharma created RxPatrol, a national database that tracks, analyzes and provides information on pharmacy crime to law enforcement and pharmacies. Purdue is partnering with Crime Stoppers and other community anti-crime programs to offer rewards for information leading to arrests for pharmacy crime. Tips can be made anonymously and have led to more than 100 arrests since the program’s inception. More information about the program can be found at RxPatrol.org.