2015 - US News

MedWatch Safety Alert RSS Feed

A1 Slim by Kiriko: Recall - Undeclared Drug Ingredients (Sat, 07 Oct 2017)
Product tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.
>> Read More

Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall - One Shipment of Product Exposed to Subfreezing Temperatures (Fri, 06 Oct 2017)
When subjected to freezing, emulsion droplets will increase in size, forming aggregates that can block pulmonary circulation/lead to serious adverse health consequences that can be life-threatening.
>> Read More

Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation: FDA Statement - Case of Hemorrhagic Occlusive Retinal Vasculitis (Tue, 03 Oct 2017)
Prophylactic use of intraocular vancomycin, alone or in a compounded drug, during cataract surgery is generally not recommended because of the risk of HORV.
>> Read More

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The latest FDA guidance on Reprocessing Medical Devices in Healthcare Settings
Validation Methods and Labeling
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 Boston Scientific Receives FDA Approval for WATCHMAN™ Left Atrial Appendage Closure Device 

MARLBOROUGH, Mass., March 13, 2015 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval for the WATCHMAN Left Atrial Appendage Closure Device. The WATCHMAN Device offers a new stroke risk reduction option for high-risk patients with non-valvular atrial fibrillation who are seeking an alternative to long-term warfarin therapy. The WATCHMAN Device will be made available to U.S. centers involved in our clinical studies and additional, specialized centers as physicians are trained on the implant procedure.


Experience the interactive Multimedia News Release here: http://www.multivu.com/players/English/7223452-boston-scientific-watchman-fda-approval


The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.


"The WATCHMAN Device is an important step forward in stroke management for patients with AF," said Vivek Reddy, M.D., Director of the Cardiac Arrhythmia Service at the Mount Sinai Medical Center and co-principal investigator of the PROTECT AF and PREVAIL studies. "We know that up to 40 percent of patients who are eligible for oral anticoagulation do not take it for numerous reasons1, highlighting the need for additional treatment options. The WATCHMAN Device is a breakthrough treatment providing those patients who are suitable for warfarin with an implant-based alternative to long-term warfarin therapy while still reducing the risk of stroke."  


The FDA approval of the WATCHMAN Device is based on the robust WATCHMAN clinical program which consists of numerous studies, with more than 2,400 patients and nearly 6,000 patient-years of follow-up. The WATCHMAN clinical program provided strong evidence that the WATCHMAN Device can be implanted safely2 and reduces the risk of stroke in eligible patients while enabling most patients to discontinue warfarin3. Additionally, a meta-analysis of all of the randomized trial data demonstrated that while ischemic stroke reduction favored warfarin, the WATCHMAN Device provided patients with a comparable protection against all-cause stroke and statistically superior reductions in hemorrhagic stroke, disabling stroke, and cardiovascular death compared to warfarin over long-term follow-up.4


"Today marks a defining moment in the company's journey towards establishing left atrial appendage closure therapy in the United States.  Boston Scientific is proud to offer this potentially life-changing stroke risk treatment option to high-risk patients with AF who have a reason to seek a non-drug alternative to warfarin.   This therapy could free them from the challenges of long-term warfarin therapy," said Joe Fitzgerald, executive vice president and president, Rhythm Management, Boston Scientific.  "FDA approval of the WATCHMAN Device is another example of Boston Scientific delivering on its commitment to bring meaningful innovations to patient care."


The WATCHMAN Device has been commercially available internationally since 2009 and is the leading device in percutaneous left atrial appendage closure globally.  It is registered in 75 countries and more than 10,000 patients have been treated with the WATCHMAN Device.


Investor Event and Webcast Information

Boston Scientific, in connection with its attendance at the 2015 American College of Cardiology 64th Annual Scientific Session in San Diego, CA, will host an investor event and live webcast to discuss the WATCHMAN Device on Sunday, March 15.  The event, which will include a question and answer session, is scheduled to begin at 1:00 p.m. PT and adjourn at approximately 2:30 p.m. PT and will be hosted by Joe Fitzgerald, executive vice president and president, Rhythm Management, and Kenneth Stein, M.D., senior vice president and chief medical officer, Rhythm Management. Vivek Reddy, M.D., Director of the Cardiac Arrhythmia Service at the Mount Sinai Medical Center will also present. 


A live webcast of the event will be available via the Boston Scientific website. Webcast registration is available on the Investor Relations section of the website at www.bostonscientific.com/investors. Registration at least 15 minutes prior to the scheduled start time is encouraged to ensure a timely connection.


A replay of the webcast will be archived and accessible at www.bostonscientific.com/investors approximately one hour following the completion of the conference call.


About Atrial Fibrillation and Stroke 

Non-valvular atrial fibrillation (AF) is an irregular heartbeat that can lead to blood clots, stroke, heart failure and other heart-related complications.  AF is the most common cardiac arrhythmia, currently affecting more than five million Americans.5 Patients with AF have a five-fold increased risk of stroke due to blood stagnating from the improperly beating atrium and the resulting blood clot formation.6 Twenty percent of all strokes occur in patients with AF.7 Stroke is more severe for patients with AF, as they have a 70 percent chance of death or permanent disability.8


The most common treatment for stroke risk reduction in patients with AF is blood-thinning warfarin therapy.  Despite its proven efficacy, long-term warfarin therapy is not well-tolerated by some patients due to numerous quality-of-life tradeoffs - like dietary restrictions and regular blood monitoring - and carries a significant risk for bleeding complications. 


About the WATCHMAN LAAC Device 

The WATCHMAN LAAC Device is a catheter-delivered heart implant designed to close the left atrial appendage (LAA) in order to prevent the migration of blood clots from the LAA, and thus, reduce the incidence of stroke and systemic embolism for higher risk patients with non-valvular AF.  The LAA is a thin, sack-like appendix arising from the heart and is believed to be the source of >90 percent of stroke-causing clots that come from the left atrium in patients with non-valvular AF.4 Images of the WATCHMAN Device are available at http://bostonscientific.mediaroom.com/image-gallery?mode=gallery&cat=1760.


About Boston Scientific 

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world.  As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.  For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.


Cautionary Statement Regarding Forward-Looking Statements 

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words.  These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance.  These forward-looking statements include, among other things, statements regarding our products, our business plans, product launches and availability, clinical trials and data impact, competitive offerings, and product performance and impact.  If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.  These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release.  As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. 


Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors.  All of these factors are difficult or impossible to predict accurately and many of them are beyond our control.  For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter.  We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.  This cautionary statement is applicable to all forward-looking statements contained in this document.


CONTACTS 

Media:

Nisha Deo

508-683-5571 (office) 

408-893-9243 (cell) 

Media Relations 

Boston Scientific Corporation 

Nisha.deo@bsci.com


Investors: 

Susie Lisa, CFA 

508-652-5345 (office)  

Investor Relations 

Boston Scientific Corporation 

investor_relations@bsci.com

2015 - International News

Johnson & Johnson Invested in Research and Development

Research and development

For a big pharma company like Johnson & Johnson (JNJ), research and development, or R&D, plays a vital role in maintaining a healthy revenue stream. These expenses relate to the process of discovering, testing, and developing new products and improving the existing range of products. These expenses also ensure product efficacy and regulatory compliances before the launch.

Article-8Enlarge Graph

The above chart compares the R&D expenses for Johnson & Johnson, Pfizer (PFE), Merck & Co. (MRK), Eli Lily and Company (LLY), and Bristol-Myers Squibb Co. (BMY). As a percentage of sales, the R&D expenses for Johnson & Johnson were around 11.4% in 2014. For the Pharmaceuticals segment, the R&D expenses were about 8.3%. For the Consumer Products segment, the expenses were nearly 0.85%. For the Medical Devices and Diagnostics segment, the expenses were about 2.2%.

The company has its own R&D centers strategically located in Asia-Pacific, Boston, California, and London. It offer entrepreneurs quick access to all of the resources for the Johnson & Johnson Family of Companies.

The company invests in R&D to ensure the delivery of high quality and innovative products. It develops new drugs through R&D to be ready with new products and patents by the time existing patents expire. This is a constant process. As a result, R&D is important for any company’s growth. The in-process R&D, or IPR&D, refers to recently discontinued or delayed development projects.

For each segment, the contribution of R&D as of December 2014 is listed below:

Pharmaceuticals segment

  • ten major new product filings and over 25 brand line extensions between 2013 and 2017
  • 11 new products already launched between 2009 and 2013
  • nearly 50 compounds in early development
  • nearly 100 ongoing discovery projects

Medical Devices and Diagnostics segment

  • 30 major new product filings expected between 2014 and 2016

Consumer Products segment

  • 20 key product launches expected globally in 2015

Patent expiry

Johnson & Johnson lost exclusivity on two patented drugs in 2013—Aciphex and Concerta. Velcade is a cancer treatment drug. It lost exclusivity in 2014. One of the key drugs is Remicade. It’s for autoimmune diseases. It’s expected to lose exclusivity in the European Union in 2015. It’s expected to lose exclusivity in the US in 2018.

Teva Pharmaceutical Industries (TEVA) lost exclusivity on Copaxone. AstraZeneca (AZN) lost exclusivity on Nexium. Merck & Co. (MRK) lost exclusivity on Nasonex. Eli Lily and Company (LLY) lost exclusivity on Evista in 2014. Johnson & Johnson forms 8.23% of the total assets of the iShares US Pharmaceuticals (IHE) and 10.54% of the SPDR Health Care Select Sector ETF (XLV).

Understanding Johnson & Johnson’s Growth Strategies

Growth and capex

The pharmaceuticals industry is capital intensive. The industry requires large investments in order to have manufacturing and research and development, or R&D, facilities. Johnson & Johnson (JNJ) is working on various organic and inorganic growth strategies in order to maintain its position as a leading pharmaceutical company worldwide.

 

Article-9Enlarge Graph

Johnson & Johnson’s net spending in the purchase of property, plant, and machinery in 2013 was over $3 billion. It was more than 100% of the net spending in 2012. This indicates that the company is spending on capital assets.

Acquisitions for growth

The figures represented in the above chart are net of cash acquired. Under the inorganic growth strategy, the company constantly acquires smaller companies. In 2013, certain businesses were acquired for $835 million in cash and $193 million of assumed liabilities. The 2013 acquisitions included Aragon Pharmaceuticals, Shanghani Elsker For Mother & Baby Co. Ltd., and Flexible Stenting Solutions, Inc.

In 2012, certain businesses were acquired for $17.8 billion in cash and stock and nearly $1.2 billion of assumed liabilities. The 2012 acquisitions include Synthes, Guangzhou Bioseal Biotech Co. Ltd., Angiotech Pharmaceuticals, Corimmun GmbH, Calibra Medical, and Spectrum Vision LLC.

The above graph shows the company’s focus on organic and inorganic growth. The company’s spending on capital assets indicates its willingness for organic growth. The spending on the acquisitions indicates its willingness for inorganic growth. Recently, the company acquired many companies in order to strengthen its presence in all three of its segments—Pharmaceuticals, Consumer Products, and Medical Devices and Diagnostics.

Johnson & Johnson also opted to divest its businesses. In 2013, the company opted to divest women’s sanitary protection products in the US, Canada, and the Caribbean markets. In 2014, the company opted to divest its Ortho-Clinical Diagnostics business.

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