Students across the country are heading back to school and AstraZeneca and its employees joined together to help children in need get the necessary supplies to be prepared for a successful year.
AstraZeneca employees organized grassroots efforts, utilizing employee and corporate funding, to deliver over 370 backpacks filled with school supplies to children in Delaware and California. This is almost a five-fold increase of last year’s local back to school efforts by employees, which began in Delaware. In addition to these backpacks, 300 books were collected and $850 donated by employees went directly to supplementary supplies and school uniforms.
Employees across the business delivered the backpacks to Las Américas ASPIRA Academy, a bilingual charter school in Wilmington, Delaware; Adopt-A-Student, a program that aids families in crisis throughout Delaware; and the Boys and Girls Club, in Santa Ana, California. The AstraZeneca volunteers in California also had the opportunity to mentor the children during their Arts and Crafts and Physical Education sessions.
In addition to partnering with these organizations, AstraZeneca continues to invest time, energy and funds to support educational efforts across the United States, including those that build enthusiasm for and skills in science, technology, engineering and math (STEM).
With 3D printers that create human body parts to wearable technologies that transmit patients’ vitals in real-time to physicians, the paradigm of drug development is changing more rapidly than ever before. While the opportunities for innovation are boundless, recent figures from FasterCures, a center of the Milken Institute, suggest that there are still only 500 treatments available for an estimated 7,000 known diseases.
At AstraZeneca, we’re committed to pushing the boundaries of drug development to get our medicines in the hands of those who need them most. This isn’t easy. For example, according to PhRMA, it takes drug companies 10-15 years to develop a new medicine, and costs $1 billion on average. For good reason, there are many laws and regulations that govern every step of the development process, but we need to ensure these laws do not unnecessarily hinder innovation.
That’s why we’re excited to see the Committee on Energy and Commerce, part of the U.S. House of Representatives, taking a comprehensive look for the first time at how they can help pave the way for new cures and treatments for patients through the 21st Century Cures Initiative. The Committee on Energy and Commerce has responsibility for a number of the nation’s key priorities, including food and drug safety, and oversight of multiple agencies like the Food and Drug Administration. Over the next several months, the Committee will continue to focus its efforts on finding ways to expedite the discovery, development and delivery of innovative treatments to patients. Representatives will examine how we conduct research, looking at newly available technologies and assessing the need to break down outdated administrative and procedural hurdles, to ensure the U.S. remains a leader in biomedical innovation. And they’re asking for input.
Many key industry stakeholders have submitted recommendations to benefit the healthcare industry and patients around the world. On August 12, the President of AstraZeneca U.S., Paul Hudson, and Chief Medical Officer, Briggs Morrison, pledged our support for the initiative and submitted our recommendations, which:
- ask the Committee to support translational research (research that turns basic discoveries into applicable outcomes);
- encourage the modernization of the clinical trial ecosystem;
- promote the regulatory acceptance of modern clinical trial designs, tools and methodologies; and
- suggest that the Committee ensure that payers and formularly committees have relevant information about medicines from manufacturers to speed patient access to newly developed medicines.
It is our hope that these recommendations, taken together, can help to transform the healthcare industry, improve the lives of patients and dramatically enhance the current standard of care. We’ve already had several discussions with the Energy and Commerce Committee, and we applaud their efforts to look at how the Congress can play a role in accelerating progress in advancing medicine. We look forward to continuing this dialogue as part of our efforts to deliver on our ambition to achieve scientific leadership.
AstraZeneca today announced that it has received confirmation from the United States Department of Justice that it is closing its investigation into PLATO, a clinical trial with BRILINTA® (ticagrelor) tablets. The government is not planning any further action following the Civil Investigative Demand (CID) that AstraZeneca received in October 2013.
“We welcome the Department of Justice’s decision not to pursue further action. We have always had absolute confidence in the integrity of the PLATO trial and we are proud of the important benefit BRILINTA offers to patients around the world suffering from acute coronary syndrome. As one of AstraZeneca’s growth platforms, we remain committed to delivering the full potential of this important medicine,” said Pascal Soriot, Chief Executive Officer, AstraZeneca.
To learn more about this news, click here to read our company’s press release.
Now hear from Paul Hudson, President, AstraZeneca US, as he takes a moment to reflect on what this announcement means for the US market, healthcare providers and, most importantly, patients.
In 2011 the US Food and Drug Administration approved BRILINTA in the treatment of patients with acute coronary syndrome (ACS). BRILINTA has been approved by regulatory authorities in over 100 countries and is included in 11 major ACS management guidelines globally, including six established US guidelines. The trial manuscript from the PLATO Executive Committee was first published in the New England Journal of Medicine. Following additional rigorous peer-review, over 30 PLATO sub-analyses articles have subsequently been published. The combination of these global reviews makes the PLATO data set one of the most widely analyzed clinical trials.
BRILINTA is the first and only oral antiplatelet (OAP) U.S. Food and Drug Administration (FDA)-approved to demonstrate superior reductions in cardiovascular (CV) death vs clopidogrel in patients with ACS. BRILINTA is indicated to reduce the rate of thrombotic CV events in patients with ACS (unstable angina [UA], non–ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). In PLATO, BRILINTA has been shown to reduce the rate of a combined end point of CV death, MI, or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with an artery-opening procedure known as percutaneous coronary intervention (PCI), BRILINTA reduces the rate of stent thrombosis.
BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin above 100 mg daily.
IMPORTANT SAFETY INFORMATION ABOUT BRILINTA
WARNING: (A) BLEEDING RISK, (B) ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
A. BLEEDING RISK
- BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal, bleeding
- Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage
- Do not start BRILINTA in patients planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue BRILINTA at least 5 days prior to any surgery
- Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of BRILINTA
- If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events
B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
- Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided. After any initial dose, use with aspirin 75 mg – 100 mg per day
- BRILINTA is contraindicated in patients with a history of intracranial hemorrhage and active pathological bleeding such as peptic ulcer or intracranial hemorrhage. BRILINTA is contraindicated in patients with severe hepatic impairment because of a probable increase in exposure; it has not been studied in these patients. Severe hepatic impairment increases the risk of bleeding because of reduced synthesis of coagulation proteins. BRILINTA is also contraindicated in patients with hypersensitivity (e.g., angioedema) to ticagrelor or any component of the product
WARNINGS AND PRECAUTIONS
- Moderate Hepatic Impairment: Consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor
- Premature discontinuation increases the risk of MI, stent thrombosis, and death
- Dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients taking clopidogrel. Dyspnea resulting from BRILINTA is self-limiting. Rule out other causes
- BRILINTA is metabolized by CYP3A4/5. Avoid use with strong CYP3A inhibitors and potent CYP3A inducers. Avoid simvastatin and lovastatin doses >40 mg
- Monitor digoxin levels with initiation of, or any change in, BRILINTA therapy
- The most commonly observed adverse reactions associated with the use of BRILINTA vs clopidogrel were Total Major Bleeding (11.6% vs 11.2%) and dyspnea (14% vs 8%)
- In clinical studies, BRILINTA has been shown to increase the occurrence of Holter-detected bradyarrhythmias. PLATO excluded patients at increased risk of bradycardic events. Consider the risks and benefits of treatment
Please read full Prescribing Information, including Boxed WARNINGS, and Medication Guide. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.
Patients can find out more information about BRILINTA at www.BRILINTA.com or by calling 1-888-412-7454.
AstraZeneca offers the AZ&MeTM Prescription Savings Program. To determine eligibility, patients can visit www.AZandMe.com or call 1-800-AZandMe (292-6363).
2986102 Last Updated 8/14
By Dr Michael DePietro, Medical Director, Respiratory
As the summer comes to a close and the new school year approaches, parents of children with asthma have unique concerns. It’s an important time to have your own “Asthma: 101” and help your child manage asthma throughout the school year.
- Learn About Asthma
Asthma is a chronic disease that affects the airways in the lungs. When your child has an asthma attack, the airways become irritated and inflamed, making it more difficult for your child to breathe. Over 7 million children—or 1 out of 11 kids—suffer from asthma, and it can be a serious health concern that can impact daily life.
It can be easy to confuse asthma with a cold or flu, so it’s important to learn how to recognize the most common symptoms of asthma, such as coughing, wheezing, or tightness in the chest.
- Identify And Reduce Exposure To Your Child’s Triggers
Asthma attacks can be triggered by daily events and routines. Some common triggers include dust in the home, cigarette smoke, exercise, mold, and grass/tree/weed pollens. One particularly important group of triggers for worsening asthma symptoms are viral respiratory tract infections, such as the flu. It is recommended that most children with asthma receive a flu vaccination every year. This should be discussed with your child’s doctor. By identifying and eliminating triggers, you are taking an important step toward managing your child’s asthma.
- Talk to a Doctor
Because children can’t always express their symptoms, your child’s doctor may rely on you to report symptoms in order to make an accurate diagnosis and proper treatment recommendations.
One example of potential treatment is PULMICORT RESPULES® (budesonide inhalation suspension). PULMICORT RESPULES is an FDA-approved asthma maintenance medication created just for kids ages 12 months to 8 years to control and prevent asthma symptoms. PULMICORT RESPULES helps reduce swelling and inflammation in the lungs, and helps keep the airways open to reduce asthma symptoms. By breathing through a jet nebulizer connected to an air compressor with an adequate air flow, your child receives the medicine in his or her lungs. PULMICORT RESPULES is available in a once or twice-daily dosing option. It is available in 3 strengths: 0.25 mg/2 mL, 0.5 mg/2 mL, or 1 mg/2 mL.
Important Safety Information
PULMICORT RESPULES is not a bronchodilator and should NOT be used to treat an acute asthma attack. If your child is switching to PULMICORT RESPULES from an oral corticosteroid, follow the doctor’s instructions to avoid serious health risks when your child stops using oral corticosteroids.
Only use PULMICORT RESPULES with a jet nebulizer machine that is connected to an air compressor. Do not use an ultrasonic nebulizer.
Thrush infection of the mouth and throat may occur with PULMICORT RESPULES.
Avoid exposure of your child to infections such as chicken pox and measles. Tell your doctor immediately if your child is exposed.
Inhaled corticosteroids may cause a reduction in growth rate. The long-term effect on final adult height is unknown.
PULMICORT RESPULES should not be used if your child is allergic to budesonide or any of the ingredients.
Be sure to tell the healthcare provider about all your child’s health conditions and all medicines he or she may be taking.
As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If bronchospasm occurs following dosing with PULMICORT RESPULES, it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with PULMICORT RESPULES should be stopped and your physician consulted.
The most common side effects include respiratory infection, runny nose, coughing, ear infection, viral infection, thrush in the mouth and throat, inflammation of the stomach including vomiting, diarrhea, abdominal pain and loss of appetite, nose bleed, pink eye, and rash.
For Full Prescribing Information or more information about PULMICORT RESPULES, visit http://www.pulmicortrespules.com or call 1-800-236-9933 (Monday – Friday 8 AM – 6 PM ET, excluding holidays) to speak directly with a nurse, who will answer any questions that you may have.
- Work With Your Child’s School
After talking with your child’s doctor to establish a treatment plan, it’s important to work with school officials to ensure your child’s health and comfort when away from home. Before the school year starts, schedule an appointment with the school nurse or school representative to discuss your child’s needs, how the school can help minimize your child’s triggers, and find out what paperwork you may need to complete in order for your child to have his medication at school. If you need to sign any waivers for medication administration, make sure other adults, such as sports coaches, bus drivers, or after-school aides also have the forms they need.
By taking the time to talk with your healthcare provider and school nurse, you can help your child have a safe and healthy school year.
PULMICORT RESPULES® (budesonide inhalation suspension) is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.
Please click here for full Prescribing Information for PULMICORT RESPULES.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
This product information is intended for US consumers only.
PULMICORT RESPULES is a registered trademark of the AstraZeneca group of companies.
©2014 AstraZeneca. All rights reserved. 3028702 Last Updated 8/14
By Paul Hudson, President, AstraZeneca US and Executive Vice President, North America
As parents, we do everything we can to protect our children from harm. We fasten seat belts, insist on bike helmets, and visit the pediatrician for a seasonal flu vaccination. But what if a decision about helping to protect your high-risk child from an infectious disease was made for you – not by your child’s doctor, but by a committee of doctors whose ruling would replace what is already an accepted standard of care?
That’s the reality for many parents when it comes to protecting their children at high risk of severe respiratory syncytial virus (RSV) disease. RSV is a seasonal virus that affects nearly all babies by age 2. In most cases, it causes only mild-to-moderate cold-like symptoms. But for some babies – particularly those born prematurely and those with certain types of heart or lung disease – RSV can lead to serious lung disease. In fact, severe RSV disease causes approximately 125,000 infant hospitalizations each year in the United States.
A high-risk infant’s risk of hospitalization due to severe RSV disease can be significantly reduced with monthly injections of an FDA-approved therapy that my company has been making since 1998. Pediatricians, neonatologists, pediatric cardiologists, and pediatric pulmonologists around the country count on this medicine to help protect their tiny patients.
But every few years, a committee within the American Academy of Pediatrics (AAP) issues recommendations that progressively narrow the population of babies they believe should qualify for this medicine, despite the fact that the clinical benefit of this therapy has not changed. On July 28, they did it again – this time endorsing drastic reductions in babies who will be eligible.
This is ironic, given that the AAP is the same organization that issues recommendations – on topics from hand washing to toy safety – that are designed to protect children.
While the AAP will say that its recommendations have no binding or legal authority, many insurance companies and public payers have used them each time they are updated to deny coverage to families whose children fall outside of the AAP committee’s suggested eligibility parameters.
I have heard many stories from physicians who are trying to help protect their young patients from severe RSV disease, only to spend hours on the phone fighting with insurers to try to overturn their denial of coverage. And I have heard similar stories of parents, who feel helpless after spending months on the phone fighting to reverse denials, knowing that when they finally give up, their babies will be left without the protection their doctors prescribed.
Do these restrictive recommendations have a financial impact on my company? Of course. But this is about much more than the bottom line. It’s an issue of access to care for vulnerable children – and an issue of making critical medical decisions for the right reasons, based on the right information. More importantly, it’s about giving vulnerable babies the best possible chance at a healthy start to life.
There are real-life consequences from the AAP’s continued restrictions. For example, Vanessa Moore’s daughter, Sydney, was born at 34 weeks gestational age during the peak of RSV season. Despite being born 6 weeks before term, Sydney’s doctors deemed her healthy and didn’t discuss the option of preventive treatment for RSV. Vanessa took every precaution to keep her daughter safe during the same RSV season – constantly sanitizing hands and toys, avoiding crowds and even skipping family gatherings – but Sydney still contracted the highly contagious virus and was hospitalized for nearly a week.
After it became clear that Sydney would benefit from added protection, her doctors prescribed the preventive therapy but she was quickly denied coverage. Over the course of several months, Vanessa and Sydney’s doctors pleaded with their insurance company to obtain coverage, but they were denied time and time again. Meanwhile, Sydney had three more RSV-related hospitalizations that year.
So much for saving money – not to mention the emotional and physical toll it took on the family.
I wonder how many more preemies like Sydney will suffer a similar impact when the new, more restrictive recommendations take effect?
While the AAP asserts that its recommendations are based on research, it has chosen only certain studies on which to base its guidance. A more balanced approach would be to systematically review all of the existing data before reaching a conclusion. This is what has been outlined in the Institute of Medicine’s Standards for Developing Trustworthy Clinical Practice Guidelines.
I’m not the only one who disagrees with the AAP’s recommended approach. Several professional organizations and individual clinicians have expressed concerns that the new recommendations are inconsistent with current evidence.
As a father of three, I know there is no greater fear than your child becoming gravely ill. And there is no excuse that makes it OK to deny a proven method of prevention to a baby for whom it was prescribed.
Visit www.RSVfacts.com to take action to help protect our most vulnerable babies.
AstraZeneca continuously seeks opportunities to improve health in our local communities, including through its support of partners and programs that make a difference in the lives of patients and their families. On Tuesday, July 22, Christiana Care Health System dedicated its new atrium at Wilmington Hospital to AstraZeneca during a special ribbon-cutting ceremony, in a show of appreciation for the company’s $1 million contribution to support the Wilmington Hospital Transformation Project, designed to advance patient and family centered care.
At the event, Christiana Care Health System unveiled a plaque, which will be displayed in the atrium and serves to commemorate AstraZeneca and Christiana Care’s shared commitment to improving patient health. Joining in the celebration with Christiana Care and AstraZeneca executives and employees were government officials, including Delaware Governor Jack Markell, and other community and business leaders.
“AstraZeneca is dedicated to building strong, healthy communities across the state of Delaware and nationwide,” said Paul Hudson, president, AstraZeneca U.S. and executive vice president, North America. “Christiana Care shares in this commitment, and we’re pleased to support the expansion of its outstanding hospital system, which supports a patient-centered culture and delivers critical health resources to our community every day.”
The skylit atrium, complete with a waterfall fountain set amid lush indoor garden beds, serves as a new main entryway for Christiana Care patients, family and employees. It provides patients and their families with easy access to the new Wilmington Hospital Health Center, a full-service health care provider offering wellness and preventive health care visits for patients of all ages, as well as the Gateway Building, a 51,000-square-foot medical office building that allows doctors to practice onsite. Both the Wilmington Hospital Health Center and the Gateway Building will open this fall. The atrium also connects to Wilmington Hospital’s new outdoor Healing Garden and the First State School, one of only three hospital-based schools in the nation for students with serious illnesses.
The Wilmington Hospital Transformation Project, which includes a number of other improvements – from a new main lobby and intensive care unit, to an expanded emergency department and more – is expected to be completed in the spring of 2015.
“We are thankful to philanthropic partners like AstraZeneca for helping us transform the Wilmington Hospital campus so we can serve our neighbors in Wilmington and the surrounding region,” said Robert J. Laskowski, M.D., MBA, president and CEO, Christiana Care. “AstraZeneca’s generous investment enables us to provide more access to care and greater value for our patients.”
How is value defined by healthcare’s many stakeholders? How can the priorities of these stakeholders be pursued to get the best result for patients? How can the U.S. healthcare system improve patient health, while lowering the cost of care?
These questions and others were explored on Monday, July 14, as AstraZeneca executives – including Paul Spittle, Vice President of Growth and Marketing; Diane Sullivan, Vice President of Market Access & Patient Strategies; and Rich Buckley, Vice President of North America Corporate Affairs – hosted a group of industry experts in Washington, D.C. for a dinner discussion about the concept of value in today’s evolving healthcare environment.
Participants represented a broad range of stakeholders, from insurance and hospital executives, to nonprofit groups, policy experts and media. Julie Rovner, Robin Toner Distinguished Fellow and Senior Correspondent for Kaiser Health News, served as moderator for the discussion.
Participants discussed how the definitions and perceptions of value are wide-ranging and constantly evolving (over time and through changing circumstances), making it difficult to identify effective and sustainable solutions to improve healthcare. Despite these challenges, the group explored a number of actions that can be taken to help strengthen and preserve the quality of healthcare for patients while controlling costs — from better harnessing the power of available data and technology, to offering wellness and preventable care programs, to engaging patients in the health value discussion in a truly meaningful way.
The dinner was part of a series of events coordinated by National Journal LIVE, a premier events business that convenes top leaders in the Washington, D.C. area to discuss possible solutions to the country’s biggest challenges.
On Monday, July 14, Senator Barbara A. Mikulski, a senior member of the Senate Health, Education, Labor and Pensions (HELP) Committee, visited AstraZeneca’s Frederick Manufacturing Center in Maryland to learn more about the complex process of biologics manufacturing and the role of the facility in producing medicines used by millions of patients worldwide.
During the visit, the Senator joined AstraZeneca executives in a discussion about the importance of innovation in biotechnology, and how the company and the industry are working to make a positive impact on community health and the local economy. AstraZeneca also provided the Senator an overview of its Frederick manufacturing operations situated on a 33 acre campus and consisting of three buildings, where the company manufactures both commercial and clinical biologics. Afterward, the Senator met and mingled with employees over lunch.
“In Maryland, life sciences are the life blood of our economy. Here at AstraZeneca, I heard first-hand the importance of biotech in promoting community health and supporting research, innovation and manufacturing jobs here in Frederick,” said Senator Mikulski.
“I’m proud to support research and innovation jobs in Maryland’s biotech industry, keeping our state competitive in the global economy. By working to develop safe and effective treatments, we can help ensure that our nation’s health care providers have the tools they need to keep families healthy.”
AstraZeneca’s Frederick Manufacturing Center is an FDA licensed, large-scale cell culture production facility, with hundreds of thousands of square feet of administrative, production, warehouse, laboratory and utility space. The center is the largest biologics manufacturing facility within AstraZeneca’s global network and portfolio of assets, and a global industry leader in cell culture manufacturing.
The Frederick Manufacturing Center has been recognized with a number of awards, including an Economic Development Project Award from the Department of Economic Development for the City of Frederick, and a Silver Award as part of the Healthy Workplace Award Program, a joint effort among Frederick’s Regional Health System, the county Health Department, and the Chamber of Commerce, honoring businesses for their commitment to employee health and well-being.
By John Yee, MD, MPH, Vice President, Head of Medical Affairs, US Diabetes
Every year, researchers come together at the American Diabetes Association (ADA) Scientific Sessions, where the latest advances in diabetes prevention, diagnosis and treatment are showcased. This year’s 74th annual Scientific Sessions, held June 13-17 in San Francisco, brought together 18,000 participants from across the U.S. and around the globe, making it the world’s largest diabetes meeting. AstraZeneca presented 43 abstracts summarizing new diabetes research, including a Phase III study on an investigational combination therapy and data that supports the safety and efficacy of approved AstraZeneca products. AstraZeneca’s portfolio of marketed products within three growing classes of non-insulin, anti-diabetes treatments was also highlighted at the meeting.
The data shared at ADA demonstrates AstraZeneca’s dedication to advancing science by continuing to evaluate the efficacy and safety of our approved medications and investigating new treatment options to help patients control the disease. We plan to extend our efforts in the fight against diabetes through our recently expanded portfolio.
In addition to highlighting our portfolio on the Session floor at ADA, our AstraZeneca team proudly participated in the ADA 5K on Sunday morning, June 15. Our employees demonstrated their collective commitment to those living with diabetes by getting moving during the ADA’s Run/Walk.
At AstraZeneca, we are proud to provide meaningful medicines that may help people living with diabetes better manage a complex disease and we are committed to showing our support.