Rally for Medical Research Hill Day

Held every September, this Capitol Hill Day event continues the momentum established in 2013, and includes nearly 300 national organizations coming together in support of the Rally for Medical Research.

The purpose of the Rally is to call on our nation’s policymakers to make funding for National Institutes of Health (NIH) a national priority and raise awareness about the importance of continued investment in medical research that leads to MORE PROGRESS, MORE HOPE and MORE LIVES SAVED.

The next Rally for Medical Research Hill Day is Sept. 22, 2016.

Sign up to receive updates, including a link to register once it becomes available.

World Asthma Day

World Asthma Day

 

Asthma is a common condition that causes your airways to become narrow and swollen. This can make it hard to breathe. Asthma symptoms include coughing, wheezing, and chest tightness or pain.

Many adults struggle with asthma even though they take medication to treat it. That’s why researchers are working to develop medications that may better treat asthma in the future.

Learn more at http://curec.lk/1Y54ths

Important Recall Notice: All Auvi-Q Epinephrine Auto-Injectors

Sanofi US Issues Voluntary Nationwide Recall of Auvi-Q®
Due to Potential Inaccurate Dosage Delivery

 

[Press Release]

Company Contact

Karen Sutherland

Tel. : +1 908-989-0726

Email : USMediaRelations@Sanofi.com

 

 

FOR IMMEDIATE RELEASE – October 28, 2015 – Bridgewater, N.J. – Sanofi US is voluntarily recalling all Auvi-Q® (epinephrine injection, USP). The recall involves all Auvi-Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016.The products have been found to potentially have inaccurate dosage delivery.
If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life-threatening condition. As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada. None of these device malfunction reports have been confirmed. In these reports, patients have described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported among these cases.

 

Auvi-Q (epinephrine injection, USP) is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions. Auvi-Q is packaged with two active devices and one trainer device in a corrugate box. Auvi-Q was distributed throughout the United States via wholesalers, pharmacies and hospitals. All Auvi-Q is being recalled.

 

auvi-q-recall

 

Sanofi US is notifying its distributors and customers who include doctors, pharmacies, wholesalers and other customers in the supply chain by letter, fax, email and phone calls and is arranging for return and reimbursement of all recalled products.

 

Customers with questions regarding this recall can go to www.Auvi-Q.com and call 1-866-726-6340 Monday through Friday 8 a.m. to 8 p.m. ET for information about how to return their Auvi-Q devices. Customers may also email cs@sanofi.com. Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new epinephrine auto-injectors with proof of purchase.

 

Customers should immediately contact their healthcare provider (HCP) for a prescription for an alternate epinephrine auto-injector. In the event of a life-threatening allergic reaction (anaphylaxis), patients should only use their Auvi-Q device if another epinephrine auto-injector is not available, and then call 911 or local medical emergency services. Customers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.


Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

 

Sanofi US is committed to patient safety and the quality of Auvi-Q, and will continue to work closely with customers and regulatory authorities to resolve this issue in a timely manner.

 

Important Safety Information
Auvi-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after use. Each Auvi-Q contains a single dose of epinephrine. Auvi-Q should only be injected into your outer thigh. DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY. If you accidentally inject Auvi-Q into any other part of your body, seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

 

If you take certain medicines, you may develop serious life-threatening side effects from epinephrine. Be sure to tell your doctor about all the medicines you take, especially medicines for asthma. Side effects may be increased in patients with certain medical conditions, or who take certain medicines. These include asthma, allergies, depression, thyroid disease, Parkinson’s disease, diabetes, high blood pressure, and heart disease.

 

The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These side effects go away quickly, especially if you rest.

 

You are encouraged to report negative side effects of prescription drugs.

In the US, contact the FDA by visiting www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please click here for Full Prescribing Information.

 

About Sanofi US

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

 

Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US. For more information on Sanofi US, please visithttp://www.sanofi.us and http://www.news.sanofi.us/social-media or call 1-800-981-2491.

 

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

 

From http://community.kidswithfoodallergies.org/blog/important-recall-notice-all-auvi-q-epinephrine-auto-injectors-1

Beta-O2’s ßAir Bio-artificial Adrenal Device Shows Potential to Treat Adrenocortical Insufficiency and Other Stress-related Disorders

ROSH HAAYIN, Israel, February 19, 2015 /PRNewswire/ —

Beta-O2 announced today the results of a series of pre-clinical studies demonstrating that the company’s ßAir Bio-artificial Adrenal device could offer a treatment for adrenocortical insufficiency and other stress-related disorders. The results are published in the current issue of the Proceedings of the National Academy of Sciences of the United States of America (PNAS). PNAS is one of the world’s most-cited and comprehensive multidisciplinary scientific journals, publishing more than 3,800 research papers annually.

The article, titled “Transplantation of bovine adrenocortical encapsulated in alginate can be viewed here .

The studies cited in the article were led by Professor Stefan Bornstein and Dr. Mariya Balyura at University Hospital Carl Gustav Carus Dresden.

Professor Bornstein said, “The Bio-artificial Adrenal supersedes an immunosuppression completely. The donor cells will be protected against the immune system responses of the patient. The system lets hormones pass the half-permeable walls into the body of the receiver. Our vision is that people in the future may even receive adrenal cells from another species, as, for example, from the pig. The device creates the biotechnical conditions for it.”

Professor Bornstein continued, “I am convinced that Beta-O2’s ßAir Bio-artificial Adrenal device will revolutionize the therapy of adrenocortical insufficiency. Many more patients could benefit from transplantation because the recipients wouldn’t need any immunosuppressive drugs, at all.”

ßAir is an implantable device that provides immune protection and optimal living conditions for cells implanted within it. It has thus far proven successful in providing a viable environment for islets of Langerhans or beta cells, to thrive and naturally produce insulin on demand, a necessary function missing in people with type 1 diabetes. The product for type 1 diabetes is called the ‘ßAir Bio-artificial Pancreas’. Three patients are currently implanted with the ßAir Bio-artificial Pancreas as part of an ongoing clinical study in Sweden.

“The news today indicates that the same immune protection system being used to treat type 1 diabetes patients in the clinical trial in Sweden, also appears to work well for other types of functional cells, such as adrenal cells. We found that when placed in the ßAir, the life span of the adrenal cells significantly increased. The capacity of the adrenal cells for stable, long-term basal hormone release significantly improved as well, as did their response to various stimulating hormones. Additionally, as described in the PNAS article, we learned that ßAir has xeno transplantation or cross species capabilities. For example, using the ßAir, pig adrenal cells can be transplanted into a living being other than a pig and still remain healthy and function properly,” said Dr. Dan J. Gelvan, chairman of the board of Beta-O2.

Dr. Gelvan continued, “What all this means is that transplantation of a ‘ßAir Bio-artificial Adrenal’ with cells from another species could prove to be a treatment option for patients with adrenocortical insufficiency and other stress-related disorders. This is important because current treatment options for adrenal insufficiency are limited and have unpleasant side effects. The study findings reported in the PNAS article are also significant as they offer a sneak preview of the huge potential of ßAIR. If it can provide a viable environment for many different types of cells, then ultimately it may be prove to afford an effective treatment, if not a cure, for a long list of illnesses.”

About Beta-O2 Technologies Ltd.

Beta-O2 Technologies Ltd. is a biomedical company developing a proprietary implantable bioreactor, the ßAir. The company’s flagship product is called the ßAir Bio-artificial Pancreas. It is in development as a treatment and potential cure for type 1 diabetes (T1D). ßAir was first designed to address the main problems of the otherwise successful procedures in which islets of Langerhans (i.e. pancreatic endocrine cells) are transplanted in diabetic patients, such as the need for life-long immunosuppressive pharmacological treatment and limited functionality of the transplanted islets over time due to an insufficient oxygen supply. The company’s second pipeline product is the ßAir Bio-artificial Adrenal for the treatment of adrenocortical insufficiency and other stress-related disorders. This product is currently at the pre-clinical stage of development. Beta-O2 investors include Aurum Ventures, Sherpa Innoventures, SCP Vitalife Partners, Pitango Venture Capital and Saints Capital.

For more information, please visit http://www.beta-o2.com .

Press contact:
Marjie Hadad
MH Communications
+972-54-536-5220
marjie@netvision.net.il

 

SOURCE Beta-O2 Technologies Ltd

Johns Hopkins’ Dr. Alfredo Quinones-Hinojosa

Johns Hopkins’ Dr. Alfredo Quinones-Hinojosa writes:

In 2006, the ABC show “Hopkins” aired. Episodes 1 and 7 featured my patients. I would like to share these videos with you and encourage you to view them to witness what it is like inside the hospital. The emotions are real and many people who follow this page have experienced this first hand. One day we will find a cure for brain cancer.

Episode 1:

Episode 7:

See all:

 

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