Tag Archives: biological drugs

FDA approves drug to treat Parkinson’s Disease

Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting.  Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both  clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients. 

The focus of our post this week is Parkinson’s Disease and treatment.  Therefore, we are sharing this article from the FDA concerning its new drug approval of Xadago.

The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremors and difficulty walking.

“Parkinson’s is a relentless disease without a cure,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We are committed to helping make additional treatments for Parkinson’s disease available to patients.”

An estimated 50,000 Americans are diagnosed with Parkinson’s disease each year, according to the National Institutes of Health, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, though it can occur earlier, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement – such as eating, writing, and shaving. Early symptoms of the disease are subtle and occur gradually. In some people, Parkinson’s disease progresses more quickly than in others.

The efficacy of Xadago in treating Parkinson’s disease was shown in a clinical trial of 645 participants who were also taking levodopa and were experiencing “off” time. Those receiving Xadago experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo. The increase in “on” time was accompanied by a reduction in “off” time and better scores on a measure of motor function assessed during “on” time than before treatment.

In another clinical trial of 549 participants, the participants adding Xadago to their levodopa treatment had more “on” time without troublesome uncontrolled involuntary movement compared to those taking a placebo, and also had better scores on a measure of motor function assessed during “on” time than before treatment.

Certain patients should not take Xadago. These include patients who have severe liver problems, or who take a medicine used to treat a cough or cold called dextromethorphan. It also should not be taken by patients who take another medicine called a monoamine oxidase inhibitor (MAOI) because it may cause a sudden severe increase in blood pressure, or by those who take an opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.

The most common adverse reactions observed in patients taking Xadago were uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia).

Serious, but less common, risks include the following: exacerbated high blood pressure (hypertension); serotonin syndrome when used with MAOIs, antidepressants, or opioid drugs; falling asleep during activities of daily living; hallucinations and psychotic behavior; problems with impulse control/compulsive behaviors; withdrawal-emergent hyperpyrexia (fever) and confusion; and retinal pathology.

The FDA granted approval of Xadago to Newron Pharmaceuticals.

Sentry BioPharma Services offers temperature sensitive biological product management to pharmaceutical companies, hospitals and organizations with need for validated  GMP storage, labeling, kitting and temperature-sensitive drug distribution services.  For more information about how Sentry’s GMP services can help protect the integrity and delivery of your biological products to patients, contact Sentry via email or by phone at 1-866-757-7400.

DoD | Human Trials Begin for Army-Developed Zika Vaccine

By Cheryl Pellerin, DoD News, Defense Media Activity / Published Nov. 8, 2016

A clinical trial began yesterday at the Walter Reed Army Institute of Research, where 75 participating healthy adults were vaccinated with a Zika virus vaccine that the institute’s scientists developed earlier this year, Walter Reed officials announced today.zika

Laboratory-confirmed Zika virus disease cases reported to ArboNET by state or territory as of Nov. 2, 2016. ArboNET is a national surveillance system for arthropod-borne virus diseases in the United States, such as those from ticks and mosquitoes.

The Phase 1 trial will test the safety and immunogenicity — the ability of the vaccine to trigger an immune response in the body — of the purified, inactivated Zika virus vaccine called ZPIV. The vaccine is being tested at WRAIR’s Clinical Trial Center in Silver Spring, Maryland.

“The Army has moved efficiently from recognizing Zika virus as a threat, producing ZPIV for use in animals and demonstrating its effectiveness in mice and monkeys, producing ZPIV for human testing, and now initiating clinical trials to establish its safety and build the case for subsequent efficacy trials,” Army Col. (Dr.) Nelson Michael, director of WRAIR’s Military HIV Research Program, or MHRP, and Zika program co-lead, said in a statement.

Efficacy refers to the vaccine’s ability to demonstrate a health effect when tested in a clinical trial.  “All of this,” he added, “was done in 10 months.”

Dr. Kayvon Modjarrad, Zika program co-lead and associate director for emerging infectious disease threats at WRAIR’s MHRP, said the Army was able to move so quickly in developing, manufacturing and testing a Zika vaccine “because of its extensive experience with this vaccine platform and longstanding investments in the understanding and mitigation of flaviviruses like yellow fever, dating back to the founding of WRAIR.”

DoD Zika Response

WRAIR officials say this study is part of the Defense Department response to the ongoing Zika outbreak in North and South America and Southeast Asia.

For service members, there are concerns about infection during deployment and travel, but also in the continental United States, where most military installations are concentrated in southern states. There, climate conditions and mosquito populations favor Zika transmission, WRAIR officials say.mosquito

Zika virus is transmitted to people primarily through the bite of an infected Aedes species mosquito — Aedes aegypti, shown here, and Aedes albopictus. The same mosquitoes spread dengue and chikungunya viruses. The mosquitoes typically lay eggs in and near standing water in things like buckets, bowls, animal dishes, flower pots and vases. They prefer to bite people and live indoors and outdoors near people. Mosquitoes that spread chikungunya, dengue, and Zika are aggressive daytime biters, but they can also bite at night. Mosquitoes become infected when they feed on a person already infected with the virus. Infected mosquitoes can then spread the virus to other people through bites. CDC photo by James Gathany

As of Nov. 2, according to the Centers for Disease Control and Prevention, 149 cases of Zika infection were confirmed in the military health system, including four pregnant service members and one pregnant family member.

Zika infection during pregnancy, CDC says, can cause a birth defect of the brain called microcephaly and other severe fetal brain defects.

Other problems have been detected among fetuses and infants infected with Zika virus before birth, such as defects of the eye, hearing deficits and impaired growth. And reports have increased about Guillain-Barré syndrome, an uncommon sickness of the nervous system, in areas affected by Zika, CDC says.

But even Zika infections without symptoms “can lead to severe birth defects and neurological complications,” Zika study principal investigator Army Maj. (Dr.) Leyi Lin said, adding, “A safe and effective Zika vaccine that prevents infection in those at risk is a global public-health priority.”

Zika and Other Flaviviruses

Flaviviruses like Zika are found mainly in mosquitoes and ticks and cause widespread morbidity and mortality worldwide. Other mosquito-transmitted viruses that are members of the flavivirus genus include yellow fever, or YF, dengue fever, Japanese encephalitis, or JE, and West Nile viruses, according to the CDC web page.

“We want to assess the safety and immune response of the ZPIV vaccine in JE and yellow fever YF vaccine recipients because these vaccines may alter the response to the ZPIV vaccine,” Lin said.

“Uniquely,” he added, “illness as a result of natural infection from JE, YF or Zika could be more severe when prior flavivirus infection or vaccination exists. Our study assesses co-vaccination to learn how to reduce risk when protecting against circulating flaviviruses.”

This is important for service members who are vaccinated against other flaviviruses and then stationed in or deployed to areas where Zika is becoming endemic, WRAIR scientists say.

Zika Vaccine Platform

WRAIR’s inactivated flavivirus vaccine platform was the same technology the institute used to create its Japanese encephalitis vaccine, licensed in 2009.

An earlier preclinical study found that rhesus monkeys vaccinated with ZPIV developed a strong immune response and were protected against two strains of Zika virus.

The National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health, helped identify the viral strain used in the ZPIV vaccine, supported the preclinical safety testing and is sponsoring the conduct of this trial.

WRAIR, NIAID and the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, or BARDA, have established a joint research collaboration agreement to support the vaccine’s development.

The Pilot Bioproduction Facility at WRAIR manufactured the ZPIV vaccine being used in Phase 1 clinical studies, and the Army recently signed a cooperative research and development agreement to transfer the ZPIV technology to Sanofi Pasteur to explore larger-scale manufacturing and advanced development. BARDA recently awarded a six-year contract to Sanofi Pasteur to further develop this vaccine to licensure, according to the WRAIR release.

Other ZPIV Trials

WRAIR’s ZPIV candidate also will soon be part of an NIH trial that began in August. The NIH vaccine contains DNA that instructs volunteers’ cells to make certain Zika proteins that then illicit an immune response. As part of that study, WRAIR’s ZPIV vaccine will be given to volunteers as a booster after they receive the NIH DNA vaccine, WRAIR officials say.

Three more Phase 1 trials using ZPIV are scheduled to begin this year, the WRAIR release noted:

— St. Louis University researchers, through the NIAID-funded Vaccine and Treatment Evaluation Units network, will examine the optimal dose of the vaccine to be used in larger studies.

— Beth Israel Deaconess Medical Center and Harvard Medical School researchers will evaluate the safety and immune response from a compressed vaccine schedule.

— The Ambulatory Center for Medical Research, part of Ponce Health Sciences University in Puerto Rico, will examine the vaccine’s safety and immune response in participants who have already been naturally exposed to Zika or dengue viruses.

The WRAIR trial that began yesterday is sponsored by NIAID and funded by the Army and the Defense Department.

For more information about how Sentry’s proven vaccine management system can protect your vaccine throughout the global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

For more information: http://www.defense.gov/DesktopModules/ArticleCS/Print.aspx?PortalId=1&ModuleId=753&Article=999584

Sentry’s New Vaccine Storage Campaign

Sentry BioPharma Services is proud to announce its new vaccine storage and distribution services campaign. Sentry’s decade long commitment to protect product integrity  married with its state-of-the-art facility provides the life sciences industry with a unique level of quality, regulatory and operational advantages that strengthen the vaccine supply chain. Sentry’s vaccine program advantages include:

Proven Track Record of Compliant Vaccine Storage, Rotation And Vaccine Drug Distribution

vaccinecampaignSentry’s long and unblemished regulatory inspection history is a reflection of its superior approach to standard operating procedures and temperature sensitive product management.

Large Scale Repository and Tracking Capabilities Through Advanced Inventory Management Systems

Live 24/7 real-time inventory tracking ensures full visibility of inventory throughout an organization and accurate tracking compliant with GMP storage regulations 21 CFR Parts 210 and 211. High-touch communication with the Sentry Operations and Quality Teams provides proper distribution of vaccines for routine fulfillment or pandemic response.

Advanced Building Management Systems That Monitor And Control Temperature Of Storage Environments

Sentry’s validated cold chain storage environments minimize time-out-of-refrigeration (TOR) risks, helping to reduce or eliminate waste attributable to deficient storage methods. The facility’s multi-tiered security structure and flexible storage options help fulfill requirements for specific seasonal or stockpile campaigns.

Trusted By Hospitals, Government Healthcare Agencies, And Manufacturers To Protect Vaccine Products And Stockpile

Over its ten years as a contract service organization, Sentry has been a trusted partner to hospitals, vaccine manufacturers and government healthcare organizations concerned with drug product integrity, vaccine storage security, risk management and timely vaccine distribution.

For more information about how Sentry’s temperature sensitive product management expertise can help you optimize your seasonal vaccine stockpile requirements, contact Sentry via email or by phone at 1-866-757-7400.

FDA Announces Meeting on Implementing DSCSA’s Product Identification Requirements

Sentry BioPharma Services continues to strengthen its leadership position in providing high quality and secure pharmaceutical supply chain services to pharmaceutical clients and companies utilizing biotechnology to manufacture biological products and vaccines.  Therefore, we would like to draw attention to an upcoming public meeting concerning the Drug Supply Chain Security Act (DSCSA) hosted by the FDA.

fda-dscsaThe Food & Drug Administration (FDA) will be holding a public meeting to provide members of the pharmaceutical distribution supply chain and interested stakeholders an opportunity to discuss with FDA the implementation of the Drug Supply Chain Security Act’s (DSCSA’s) product identification requirements. To be held on October 14, 2016, from 9:00 a.m. to 4:00 p.m. at FDA’s White Oak Campus in Silver Spring, MD, the meeting, “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act,” will include presentations from the public and follow-up questions from an FDA panel. The objective of the meeting is to discuss the pharmaceutical supply chain’s progress toward implementing the DSCSA’s product identification requirements, including best practices in each sector of the pharmaceutical distribution supply chain to conduct product tracing, verification, and identification.

More Background on the Drug Supply Chain Security Act (DSCSA)

Title II of the Drug Quality and Security Act of 2013

The Drug Quality and Security Act (DQSA), was signed into law by President Obama on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act, outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.

Ten years after enactment, the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain. The new system will:

  • enable verification of the legitimacy of the drug product identifier down to the package level;
  • enhance detection and notification of illegitimate products in the drug supply chain; and
  • facilitate more efficient recalls of drug products.

Drug manufacturers, wholesale drug distributors, repackagers, and many dispensers (primarily pharmacies) will be called on to work in cooperation with FDA to develop the new system over the next 10 years.

Among key provisions implemented over the next 10 years are requirements for:

  • Product identification: Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically.
  • Product tracing: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) in the drug supply chain to provide information about a drug and who handled it each time it is sold in the U.S. market.
  • Product verification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to be able to verify the product identifier on certain prescription drug packages.
  • Detection and response: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous.
  • Notification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found.
  • Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to FDA. This information will then be made available in a public database.
  • Third-party logistics provider licensing: Third-party logistic providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license.

The law requires FDA to develop standards, guidance documents, and pilot programs and to conduct public meetings, in addition to other efforts necessary to support efficient and effective implementation. FDA is developing a schedule for implementing the law’s requirements.

This system will enhance the U.S. Food and Drug Administration’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers. Failure to comply with the requirements of the law can result in penalties.

The development of the system will be phased in with new requirements over a 10-year period. These requirements will include providing product and transaction information at each sale with lot level information, in paper or electronic format, and placing unique product identifiers on individual drug packages.

The FDA is soliciting either electronic or written comments related to this public meeting by November 14, 2016. To register or request to make a presentation, visit the public meeting web page.

For more information about how Sentry’s secure drug supply chain management programs can ensure drug product integrity in every phase of the pharmaceutical supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Bring Your Brave: Breast Cancer Awareness Month Begins Today!

braveDid you know that one in eight women in the U.S. will be diagnosed with breast cancer in her lifetime?  At that current rate, that means 13 million breast cancer deaths around the world will occur in the next 25 years.

The most significant risk factors for breast cancer are gender (being female) and age (growing older).  Other factors can be changed by making choices. By choosing the healthiest lifestyle options possible, you can empower yourself and make sure your breast cancer risk is as low as possible.

Reduce Risk Factors:

  • Do not smoke
  • Drink alcohol in moderation
  • Exercise at least three hours per week or about 30 minutes a day
  • Eat a nutritious, low-fat diet (30 grams or less) with plenty of fruits and green and orange vegetables

The National Breast Cancer Foundation launches the annual campaign by raising awareness during the month of October.  The endeavor begins today, October 1, 2016 and lasts through the end of the month.  Getting a high-quality screening mammogram and having a clinical breast exam on a regular basis are the most effective ways to detect breast cancer early.

Early Detection Strategies:

  1. Recognize signs & symptoms
  2. Perform a monthly breast self-exam (BSE)
  3. Have an annual clinical breast exam
  4. Screen for abnormalities with a mammogram

The American College of Radiology (ACR) has established a uniform way for radiologists to describe mammogram findings. The system, called BI-RADS, includes seven standardized categories, or levels. Each BI-RADS category has a follow-up plan associated with it to help radiologists and other physicians appropriately manage a patient’s care.

bi-rads

Some state and local health programs and employers provide mammograms free or at low cost. For example, the Centers for Disease Control and Prevention (CDC) coordinates the National Breast and Cervical Cancer Early Detection Program. This program provides screening services, including clinical breast exams and mammograms, to low-income, uninsured women throughout the United States and in several U.S. territories. Contact information for local programs is available on the CDC website or by calling 1–800–CDC–INFO (1–800–232–4636).

Information about free or low-cost mammography screening programs is also available from the National Cancer Institute’s (NCI’s) Cancer Information Service at 1–800–4–CANCER (1–800–422–6237) and from local hospitals, health departments, women’s centers, or other community groups.

For more information:

Sentry’s Controlled Substance Program Strengthens the Reliable and Secure Pharmaceutical Drug Supply Chain

Regulatory oversight shapes every dimension of controlled substances: licensing, registration, storage, security, use, inventory and controlled drug disposal. Finding a Drug Enforcement Administration (DEA) licensed partner to store, distribute and manage returns and destruction of Schedule III-V controlled substances while maintaining regulatory and quality standards required for a secure pharmaceutical supply chain can be a challenge. Sentry BioPharma Services provides seamless product management required to safeguard controlled substances which are brought into Sentry’s custody and care.

pills2

Features & Benefits of Sentry’s Controlled Substance Program

DEA Regulation Secure Storage – Inspected and approved by the Drug Enforcement Administration  in 2014, Sentry’s state-of-the-art controlled substance capacity provides secure and reliable storage to support your pharmaceutical supply chain needs.

Controlled Substance Importation/Exportation – Sentry’s controlled substance importation and controlled substance exportation capabilities provide pharmaceutical organizations unique flexibility in the drug supply chain. This coupled with Sentry’s high quality standards affords pharmaceutical companies a competitive advantage throughout the drug development process.

Redundant Systems and Extensive Security Measures Product safety, identity, strength, purity and quality (SISPQ) remain intact.  Sentry features which support this agenda include:

  • Auxiliary power feeds and back-up systems
  • Continuous (24/7) security monitoring
  • Foreign Trade Zone (FTZ) status which allows controlled substances to be internationally shipped directly to Sentry where DEA, Customs & Border Patrol (CBP) and FDA clearances can be obtained within the security provided by Sentry’s GMP facility
  • Physical plant security
  • Redundant HVAC systems
  • Secure data and document programs

Pharmaceutical Labeling and Packaging – Sentry’s light pharmaceutical manufacturing capabilities help streamline clinical trial distribution and commercial drug distribution with one stop shop GMP labeling and GMP secondary packaging.

Drug Product Return and Drug Disposal Services – Sentry completes the controlled substance supply chain with a full-service approach to product guardianship.  Our drug product return and drug destruction program ensures project integrity, reliable inventory tracking and public safety from development to launch.

For more information about how Sentry can provide controlled substance supply chain solutions for your project, contact Sentry via email or by phone at 1-866-757-7400.

Sentry Raises Public Awareness for DEA’s National Prescription Drug Take-Back Day Initiative

As part of the U.S. Drug Enforcement Administration’s (DEA’s) National Prescription Drug Take-Back Day Initiative (NTBI), people will be able to dispose of expired, unwanted or unused prescription drugs on Saturday, October 22, 2016 from 10:00 a.m. to 2:00 p.m. at numerous collection sites around the U.S.

The DEA collected a record amount of meds during the 11th annual National Prescription Drug Take-Back Day on April 30, 2016.  According to the DEA’s May 6, 2016 press release, the DEA and over 4,200 of its state, local, and tribal law enforcement partners collected 893,498 pounds of unwanted medicines—about 447 tons—at almost 5,400 sites spread through all 50 states, beating its previous high of 390 tons in the spring of 2014 by 57 tons, or more than 114,000 pounds.

dea-take-back-day

The top five states with the largest collections, in order, were:

  1. Texas (almost 40 tons)
  2. California (32 tons)
  3. Wisconsin (31 tons)
  4. Illinois (24 tons)
  5. Massachusetts (24 tons)

“I am very proud of our state officials and residents,” said Ms. Jennifer Marcum, Sentry BioPharma Services’ chief executive officer.  Ms. Marcum continued, “Indiana’s authorities collected 29,125 pounds (14.6 tons).  That’s an enormous amount of unwanted prescription drugs and controlled substances to be safely removed from the pharmaceutical supply chain.  The statistics best illustrate how much the people of Indiana care about this important matter; no question about it.”

Marcum continued, “During the event, people can anonymously bring unwanted prescription pharmaceuticals and over-the-counter (OTC) medications to a participating drop-off site for proper drug disposal by law enforcement authorities with no questions asked.  The service is free and an ideal way to preserve the environment from pharmaceutical contamination.  This is a terrific opportunity to safely dispose of accumulated prescription drugs and medications that may have expired or are simply unwanted.”

The FDA’s Ilisa Bernstein, Pharm.D., J.D., offers a few more helpful tips when discarding drugs:

  1. Scratch out all identifying information on the prescription label to make it unreadable. This will help protect your identity and the privacy of your personal health information.
  2. Do not give your medicine to friends. Doctors prescribe medicines based on your specific symptoms and medical history. Something that works for you could harm another person.
  3. When in doubt about proper drug disposal, ask your pharmacist.

For more information about the DEA’s National Prescription Drug Take-Back Day Initiative, general public inquiries can be made by calling the DEA toll free at: 1-800-882-9539.

If you would like to learn more about Sentry’s pharmaceutical drug destruction services, please contact Sentry via email or by phone at 1-866-757-7400.

Features & Benefits of a Pharmaceutical Foreign Trade Zone

What is a Foreign Trade Zone?

The U.S. Foreign Trade Zone program was established by the Foreign Trade Zone Act of 1934 to “expedite and encourage foreign commerce” in the United States. Certain geographical areas, in or adjacent to Customs Ports of Entry, can obtain foreign-trade zone (FTZ) status and receive commercial merchandise under the same Customs standards as if it were outside the commerce of the United States. Any merchandise, including pharmaceutical products, admitted and held in a foreign trade zone can be exempt of any Customs duties, tariffs and other ad valorem taxes. No duty or back taxes are charged on “value-added,” or foreign-sourced parts or materials incorporated into a finished product using U.S. parts and labor until the product is officially imported into the U.S. Commerce. This tariff and tax relief lowers the costs of U.S.-based organizations engaged in international trade while creating and retaining employment and capital investment opportunities that result from those operations.

Benefits to the Biopharmaceutical Industryshutterstock_367703690

Pharmaceutical and biopharmaceutical companies can take advantage of Sentry’s GMP temperature-sensitive pharmaceutical storage and light manufacturing facility, which  resides in a foreign trade zone.  Sentry’s zone allows drug product to reside within the product’s designated temperature range, (such as API, biologics, controlled substances, etc.), while awaiting clearance for importation by the CBP and approved for distribution by the Food & Drug Administration (FDA).

During its stay in the FTZ, the biopharmaceutical  product can be further labeled and secondarily packaged  while greatly mitigating the numerous logistic and economic challenges encountered throughout the  drug importation and development process.

Logistic Benefits 

Unlimited Storage Terms Term of pharmaceutical material storage in an FTZ is indefinite.
Eliminated U.S. Quota Restrictions Product previously subject to quota limitations is now exempt from such restrictions.
Strengthened Foreign Pharmaceutical Supply Chain Eliminate administrative and importation hold-ups at Customs and ports of entry by bringing product straight to our GMP pharmaceutical storage environments ensuring product integrity: safety, identity, strength, purity and quality (SISPQ) along the drug supply chain.
Uninterrupted Local Manufacture Prior to Importation Product can be labelled, kitted and packaged and stored in the United States until need for importation into U.S. Commerce and Customs Clearance.
Expedited Release to Market Product can be held in an FTZ until FDA approval, greatly reducing time and logistic hassle from manufacturer to end-user.

Economic Benefits 

Duty Deferral or Duty Aversion  Import, admit and hold product without paying U.S. Customs duties.
Zero Inventory Taxes All materials held in an FTZ are exempt from state, county and local ad valorem taxes.
Country of Origin Marking and Labeling Country-of-origin labels are non-required on product admitted to an FTZ freeing companies from this expense.

Sentry BioPharma Services’ pharmaceutical supply chain management expertise and FTZ status across all storage environments ensures product integrity and project management flexibility.

For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import/export process, contact Sentry via email or by phone at 1-866-757-7400.

Read more about the Greater Indianapolis Foreign Trade Zone: inzone.org

FDA Releases Flu Vaccine Lots for the 2016-2017 Season

Cumulative 2016/2017 Season Lot Release Status (Updated 8/3/2016)

Flu vaccine lots that have been released by the U.S. Food & Drug Administration (FDA) and are available for national distribution by the vaccine manufacturers.

Manufacturer Total Number of Lots Released by FDA
Afluria – Seqirus Pty. Ltd. 19
Fluad – Seqirus, Inc. 0
Fluarix Quadrivalent – GlaxoSmithKline Biologicals 23
Flublok – Protein Sciences Corporation 0
Flucelvax Quadrivalent – Seqirus, Inc. 0
FluLaval Quadrivalent – ID Biomedical Corporation of Quebec 3
FluMist Quadrivalent – MedImmune, LLC 3
Fluvirin – Seqirus Vaccines Limited 9
Fluzone High Dose – Sanofi Pasteur, Inc. 2
Fluzone Quadrivalent – Sanofi Pasteur, Inc. 14

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Silver vials_v1Spring, Maryland, on March 4, 2016, to select the influenza viruses for the composition of the influenza vaccine for the 2016-2017 U.S. influenza season. During this meeting, the advisory committee reviewed and evaluated the surveillance data related to epidemiology and antigenic characteristics of recent influenza isolates, serological responses to 2015-2016 vaccines, and the availability of candidate strains and reagents.

The committee recommended that the trivalent formulation influenza vaccines for the U.S. 2016-2017 influenza season contain the following:

  • an A/California/7/2009 (H1N1)-like virus;
  • an A/Hong Kong /4801/2014 (H3N2)-like virus
  • a B/Brisbane/60/2008-like virus (B/Victoria lineage).

The committee also recommended that quadrivalent influenza vaccines contain the above three strains and the following additional B strain:

  • a B/Phuket/3073/2013-like virus (B/Yamagata lineage)

Secure GMP storage and flu vaccine distribution services protect your refrigerated inventory throughout the temperature-controlled supply chain.  For more information about how Sentry’s vaccine storage and proven vaccine management system can protect your vaccine throughout the global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

For information on seasonal flu vaccine distribution schedules, please contact the manufacturers listed in the table above directly.

The CDC & Sentry Gear Up for the 2016 Flu Season

Even though nearly half of the United States (U.S.) population gets a flu vaccine annually, the impact of influenza remains high. According to the Centers for Disease Control & Prevention (CDC), the flu costs the U.S. more than $87 billion annually and is responsible for the loss of close to 17 million workdays each flu season. Tens of thousands of people are hospitalized and thousands die from flu-related illnesses each year in the U.S.

Sentry BioPharma Services gears up for the 2016 flu season by promoting three strategies to combat illness:

  1. Get the 2016 flu vaccine.
  2. Exercise good health habits.
  3. See your doctor for an antiviral medication to treat the flu if you get sick.

August 29, 2013, Atlanta, GA - Chris Summerrow (left), Director of Business and Continuity Management, UPS, speaks with Dr. Ali Khan, Director, Office of Public Health Preparedness and Response, in the Emergency Operations Center at the CDC.

Flu Vaccine Facts

The seasonal flu vaccine protects against the influenza viruses that research indicates will be most common during the upcoming season. Trivalent vaccines are made to protect against three flu viruses; an influenza A (H1N1) virus, an influenza A (H3N2) virus, and an influenza B virus. Quadrivalent vaccines protect against four viruses; the same viruses as the trivalent vaccine as well as an additional B virus.

Flu vaccines CANNOT cause the flu. Flu vaccines are made with either killed or weakened viruses.

Flu vaccines are safe. Serious problems from the flu vaccine are very rare. The most common side effect that a person is likely to experience is either soreness at the injection site, or runny nose in the case of nasal spray. These side effects are generally mild and usually go away after a day or two. Visit Influenza Vaccine Safety for more information.

Can the flu be treated?

Yes. There are prescription medications called “antiviral drugs” that can be used to treat influenza illness.

What are antiviral drugs?

Antiviral drugs are prescription medicines (pills, liquid, an inhaled powder, or an intravenous solution) that fight against the flu in your body. Antiviral drugs are not sold over-the-counter. You can only get them if you have a prescription from your doctor or health care provider. Antiviral drugs are different from antibiotics, which fight against bacterial infections.

What should I do if I think I have the flu?

If you get the flu, antiviral drugs are a treatment option. Check with your doctor promptly if you have a high risk condition and you get flu symptoms. Flu symptoms can include fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills and fatigue. Your doctor may prescribe antiviral drugs to treat your flu illness.

Should I still get a flu vaccine?

Yes. Antiviral drugs are a second line of defense to treat the flu if you get sick. A flu vaccine is still the first and best way to prevent influenza.

What are the benefits of antiviral drugs?

When used for treatment, antiviral drugs can lessen symptoms and shorten the time you are sick by 1 or 2 days. They also can prevent serious flu complications, like pneumonia. For people with a high risk medical condition, treatment with an antiviral drug can mean the difference between having milder illness instead of very serious illness that could result in a hospital stay.

What are the possible side effects of antiviral drugs?

Some side effects have been associated with the use of flu antiviral drugs, including nausea, vomiting, dizziness, runny or stuffy nose, cough, diarrhea, headache and some behavioral side effects. These are uncommon. Your doctor can give you more information about these drugs or you can check the CDC or the Food and Drug Administration (FDA) websites.

When should antiviral drugs be taken for treatment?

Studies show that flu antiviral drugs work best for treatment when they are started within 2 days of getting sick. However, starting them later can still be helpful, especially if the sick person has a high risk health condition or is very sick from the flu. Follow instructions for taking these drugs.

What antiviral drugs are recommended this flu season?

There are three FDA-approved influenza antiviral drugs recommended by CDC this season to treat influenza. The brand names for these are Tamiflu® (generic name oseltamivir), Relenza® (generic name zanamivir), and Rapivab® (generic name peramivir). Tamiflu® is available as a pill or liquid and Relenza® is a powder that is inhaled. (Relenza® is not for people with breathing problems like asthma or COPD, for example.) Rapivab® is administered intravenously by a health care provider.

How long should antiviral drugs be taken?

To treat the flu, Tamiflu® and Relenza® are usually prescribed for 5 days, although people hospitalized with the flu may need the medicine for longer than 5 days. Rapivab® is administered intravenously for 15 to 30 minutes.

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