Monday, February 29, 2016
Sunday, February 28, 2016
Saturday, February 27, 2016
Phoenix, Charlotte, Miami Among Business Destinations This Week
If you’re going out of town on business this week, you may be headed for Phoenix, Charlotte or Miami. Those are three big destinations for business events this week.
Phoenix, of course, is the home of CRM provider Infusionsoft. And next week is the company’s ICON16 event (see details below) with a promised focus on small business this year.
Phoenix, Charlotte, Miami Among Business Destinations This Week
10 Essential Building Blocks for Successful Businesses
There are so many things that go into building a successful business. Each business can arrange those building blocks differently. But there are some essential elements that should go into every business plan. Here, members of the small business community share some essential building blocks for successful businesses.
10 Essential Building Blocks for Successful Businesses
10 Essential Building Blocks for Successful Businesses
Caterpillar to end production of on-highway vocational trucks - Renewable Energy From Waste
Equipment manufacturer also announces personnel and divisional changes.
Caterpillar to end production of on-highway vocational trucks - Renewable Energy From Waste
Caterpillar to end production of on-highway vocational trucks - Renewable Energy From Waste
Sprout Social Raises $42 Million
Sprout Social, a social media engagement software vendor, has raised $42 million from Goldman Sachs’ Merchant Banking Division and New Enterprise Associates. The company has now raised a total of $60 million across five rounds of funding.
The investment will help the company expand its product range and cater to the growing business demand for social media management tools.
Sprout Social Raises $42 Million
KC Man, Woman Charged with Bank Robbery
Department of Justice
U.S. Attorney’s Office
Western District of Missouri
FOR IMMEDIATE RELEASE
Thursday, February 25, 2016
KC Man, Woman Charged with Bank Robbery
KANSAS CITY, Mo. – Tammy Dickinson, United States Attorney for the Western District of Missouri, announced that a Kansas City, Mo., couple were charged in federal court today for robbing the U.S. Bank inside the Price Chopper grocery store on 103rd Street in Kansas City, Mo., on Saturday afternoon.
Austin D. Bales, 23, and Sherry L. Ridout, 22, both of Kansas City-North, were charged with bank robbery in a federal criminal complaint filed in the U.S. District Court in Kansas City, Mo.
According to an affidavit filed in support of today’s criminal complaint, Ridout approached a bank teller at U.S. Bank, 1030 W. 103rd St., at approximately 3:50 p.m. Saturday, Feb. 20, 2016. Ridout, talking on her cell phone, reached into her left jacket pocket and produced a note, which she placed on the teller counter. Ridout allegedly told the teller to give her all of the money from the top drawer. The note, according to the affidavit, said something along the lines of: “We have the bank surrounded, won’t hesitate to come back there, only clean bills, keep your hands visible, money is replaceable, Lifes aren’t.”
The teller gave Ridout $1,500, the affidavit says.
After bank surveillance photos of Ridout were broadcast by local media, the affidavit says, investigators received several phone calls that identified her as the robber and identified Bales as her boyfriend.
On Wednesday, Feb. 24, 2016, police officers conducted a traffic stop near the Walmart at 5261 N.E. Antioch Rd., Kansas City, Mo., of a van that matched the description of a vehicle identified in connection to the bank robbery. A witness had told investigators she saw Ridout being dropped off and later picked up by a van that fled the area after the robbery. When police officers stopped the van yesterday, it was being driven by Bales’s father with Bales and Ridout in the back seat.
Law enforcement officers searched the residence of Bales’s father, where Bales and Ridout were living in the basement, and found a Walmart bag containing apparent shredded U.S. currency and a Sucrets box containing a white substance that field tested positive for amphetamine.
Dickinson cautioned that the charge contained in this indictment is simply an accusation, and not evidence of guilt. Evidence supporting the charge must be presented to a federal trial jury, whose duty is to determine guilt or innocence.
This case is being prosecuted by Assistant U.S. Attorney Joseph M. Marquez. It was investigated by the Kansas City, Mo., Police Department and the FBI.
Arkansas Man Sentenced for Armed Robberies of Bank, 11 Other Businesses in Five States
Department of Justice
U.S. Attorney’s Office
Western District of Missouri
FOR IMMEDIATE RELEASE
Monday, February 22, 2016
Arkansas Man Sentenced for Armed Robberies of Bank, 11 Other Businesses in Five States
JEFFERSON CITY, Mo. – Tammy Dickinson, United States Attorney for the Western District of Missouri, announced that a Bella Vista, Ark., man was sentenced in federal court today for a series of a dozen armed robberies at a Missouri bank and 11 other businesses in a five-state crime spree during the summer of 2013.
Timothy Patrick Hoyt, 45, of Bella Vista, was sentenced by U.S. District Judge Brian C. Wimes to eight years and one month in federal prison without parole.
On Sept. 9, 2015, Hoyt pleaded guilty to the charges contained in a federal indictment in the Western District of Missouri, as well as the charges contained in four separate cases in four different federal districts in Kansas, South Dakota, Nebraska and Oklahoma, all of which have been transferred to the Western District of Missouri.
Hoyt admitted that he used what appeared to be a handgun (but which later was identified as a .177-caliber pellet or BB gun that Hoyt shoplifted from a Walmart store near Blackwater, Mo.) to rob a bank in Missouri and 10 other businesses, including eight fast food restaurants, across five states between June 26 and Aug. 6, 2013.
Hoyt pleaded guilty to all four counts of the indictment filed in the Western District of Missouri. Hoyt stole $5,123 from Alliant Bank, 118 Main St., Blackwater, on June 26, 2013, with what appeared to be a handgun. Hoyt also used what appeared to be a handgun to rob the Subway restaurant at 330 N. Massey Blvd., Nixa, Mo., on July 12, 2013; the Subway restaurant at 1820 W. 32nd St., Joplin, Mo., on July 14, 2013; and the Sally Beauty Supply Store at 2007-C W. Foxwood Dr., Raymore, Mo., on Aug. 6, 2013.
Hoyt also pleaded guilty to using what appeared to be a handgun to rob the Subway restaurant at 715 N. G Street, Wellington, Kan., on July 17, 2013; the Domino’s Pizza Restaurant at 1108 S. Minnesota Ave., Sioux Falls, S. D., on July 19, 2013; the Subway restaurant at 1116 E. 10th St., Sioux Falls on July 20, 2013; the Godfather’s Pizza restaurant at 15234 W. Maple Rd., Omaha, Neb., on July 23, 2013; and the Arby’s restaurant at 6919 S. Lewis Ave., Tulsa, Okla., on July 27, 2013.
In addition to those robberies with which Hoyt has been charged, he also admitted that he used what appeared to be a handgun to rob the Papa Murphy’s Pizza restaurant at 302 W. 28th St., Sioux City, Iowa, on July 21, 2013; the Payless ShoeSource store at 7714 State Ave., Kansas City, Kan., on July 26, 2013; and the Papa Murphy’s Pizza restaurant at 3418 8th St. S.W., Altoona, Iowa, on Aug. 7, 2013.
Hoyt was arrested after robbing the Papa Murphy’s Pizza restaurant in Altoona.
This case was prosecuted by Assistant U.S. Attorney Lawrence E. Miller. It was investigated by FBI; the Cooper County, Mo., Sheriff’s Department; the Altoona, Iowa, Police Department; the Nixa, Mo., Police Department; the Joplin, Mo., Police Department; the Raymore, Mo., Police Department; the Wellington, Kan., Police Department; the Sioux Falls, S.D., Police Department; the Sioux City, Iowa, Police Department; the Omaha, Neb., Police Department; the Kansas City, Kan., Police Department; and the Tulsa, Okla., Police Department.
Friday, February 26, 2016
Lilly Receives Positive CHMP Opinion for Ixekizumab for the Treatment of Moderate-to-Severe Plaque Psoriasis (NYSE:LLY)
Lilly Receives Positive CHMP Opinion for Ixekizumab for the Treatment of Moderate-to-Severe Plaque Psoriasis (NYSE:LLY)
Bristol-Myers Squibb Receives Two Positive CHMP Opinions for Opdivo® (nivolumab) for Patients with Previously Treated Advanced Non-Squamous Non-Small Cell Lung Cancer and Renal Cell Carcinoma
From Bristol-Myers Squibb:
Bristol-Myers Squibb Receives Two Positive CHMP Opinions for Opdivo® (nivolumab) for Patients with Previously Treated Advanced Non-Squamous Non-Small Cell Lung Cancer and Renal Cell Carcinoma
CHMP recommends expanding the existing lung indication for Opdivo to include previously treated metastatic non-squamous non-small cell lung cancer patients, regardless of PD-L1 expression
CHMP recommends Opdivo in previously treated advanced renal cell carcinoma patients based on the study, CheckMate -025, demonstrating an overall survival benefit
Friday, February 26, 2016 7:13 am EST
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Opdivo (nivolumab) for two new indications – adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and adults with advanced renal cell carcinoma (RCC) after prior therapy. Both indications are supported by Phase 3 studies in which Opdivo demonstrated a survival benefit versus a standard of care. The CHMP positive opinions will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Opdivo is already approved by the EC for advanced melanoma and previously treated advanced squamous NSCLC.
Michael Giordano, M.D., senior vice president, head of Development, Oncology, Bristol-Myers Squibb, commented, “We are committed to advancing our mission to makeOpdivo available to a broader range of patients with a wide range of cancers who are in critical need of new treatment options. Today’s two positive CHMP opinions are important achievements and mean we are closer to reaching this goal for those with advanced non-squamous non-small cell lung cancer and renal cell carcinoma. We look forward to the European Commission's decision and the opportunity to bring an additional treatment option to these patients as quickly as possible."
In lung cancer, the CHMP adopted the positive opinion based on a review of the global Phase 3 study, CheckMate -057, which evaluated the survival of patients with non-squamous NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen. In the trial, Opdivo demonstrated superior overall survival (OS) in previously treated metastatic non-squamous NSCLC compared to chemotherapy, with a 27% reduction in the risk of death (HR: 0.73 [95% CI: 0.59, 0.89; p=0.0015]), based on a prespecified interim analysis. The median OS was 12.2 months in the Opdivo arm (95% CI: 9.7, 15.0) and 9.4 months in the docetaxel arm (95% CI: 8.0, 10.7). Fifty-one percent of patients were alive at one year in the Opdivo arm (95% CI: 45-56) vs. 39% in the docetaxel arm (95% CI: 33-45). The safety profile of Opdivo in CheckMate -057 was consistent with prior studies. In the overall patient population, which included both PD-L1 expressors and non-expressors, the most frequent serious adverse reactions in at least 2% of patients receiving Opdivo were pneumonia, pulmonary embolism, dyspnea, pleural effusions and respiratory failure. The most common adverse reactions in patients treated with Opdivo (reported in >20% of patients) were fatigue (49%), musculoskeletal pain (36%), cough (30%), decreased appetite (29%) and constipation (23%).
In renal cell carcinoma, the CHMP adopted the positive opinion based on a review of the Phase 3 study, CheckMate -025, which evaluated Opdivo versus everolimus in patients with advanced clear-cell RCC after prior therapy, with OS as the primary endpoint. Patients treated with Opdivo in this study achieved a more than five month improvement in OS with median OS of 25 months for Opdivo and 19.6 months for everolimus (hazard ratio: 0.73; [98.5% CI, 0.57-0.93; p=0.0018]), with OS benefit seen regardless of PD-L1 expression. Opdivo is the first and only anti-PD-1 therapy to demonstrate a significant survival benefit in this population through a randomized Phase 3 study. In addition, patients treated with Opdivo also experienced a significant improvement in their health-related quality of life and had significantly lower symptom burden compared to patients receiving everolimus. The safety profile of Opdivo in CheckMate -025 was consistent with prior studies. Serious adverse events occurred in 47% of patients receiving Opdivo. The most frequent serious adverse reactions reported in at least 2% of patients receiving Opdivo were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In the study, the most common adverse reactions in patients receiving Opdivo versus everolimus (reported in >20% of patients) were asthenic conditions (56% vs. 57%), cough (34% vs. 38%), nausea (28% vs. 29%), rash (28% vs. 36%), dyspnea (27% vs. 31%), diarrhea (25% vs. 32%), constipation (23% vs. 18%), decreased appetite (23% vs. 30%), back pain (21% vs. 16%), and arthralgia (20% vs. 14%).
Clinical results from CheckMate -057 and CheckMate -025 were presented at the 2015 European Cancer Congress, and published in The New England Journal of Medicine.
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally, resulting in more than 1.5 million deaths each year, according to the World Health Organization. Non-small cell lung cancer (NSCLC) is one of the most common types of the disease and accounts for approximately 85% of cases. About 25% to 30% of all lung cancers are squamous cell carcinomas, and non-squamous NSCLC accounts for approximately 50% to 65% of all lung cancer cases. Survival rates vary depending on the stage and type of the cancer when it is diagnosed. Globally, the five-year survival rate for Stage I NSCLC is between 47% and 50%; for Stage IV NSCLC, the five-year survival rate drops to 2%.
About Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 100,000 deaths worldwide each year. Clear-cell RCC is the most prevalent type of RCC and constitutes 80% to 90% of all cases. RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. Globally, the five-year survival rate for those diagnosed with metastatic, or advanced kidney cancer, is 12.1%.
Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, we have a vision for the future of cancer care that is focused on Immuno-Oncology, now considered a major treatment choice alongside surgery, radiation, chemotherapy and targeted therapies for certain types of cancer.
We have a comprehensive clinical portfolio of investigational and approved Immuno-Oncology agents, many of which were discovered and developed by our scientists. Our ongoing Immuno-Oncology clinical program is looking at broad patient populations, across multiple solid tumors and hematologic malignancies, and lines of therapy and histologies, with the intent of powering our trials for overall survival and other important measures like durability of response. We pioneered the research leading to the first regulatory approval for the combination of two Immuno-Oncology agents, and continue to study the role of combinations in cancer.
We are also investigating other immune system pathways in the treatment of cancer including CTLA-4, CD-137, KIR, SLAMF7, PD-1, GITR, CSF1R, IDO, and LAG-3. These pathways may lead to potential new treatment options – in combination or monotherapy – to help patients fight different types of cancers.
Our collaboration with academia, as well as small and large biotech companies is responsible for researching the potential Immuno-Oncology and non-Immuno-Oncology combinations, with the goal of providing new treatment options in clinical practice.
At Bristol-Myers Squibb, we are committed to changing survival expectations in hard-to-treat cancers and the way patients live with cancer.
About Opdivo
Cancer cells may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo is a PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells, and blocks the binding of PD-L1 and PD-L2, preventing the PD-1 pathway’s suppressive signaling on the immune system, including the interference with an anti-tumor immune response.
Opdivo’s broad global development program is based on Bristol-Myers Squibb’s understanding of the biology behind Immuno-Oncology. Our company is at the forefront of researching the potential of Immuno-Oncology to extend survival in hard-to-treat cancers. This scientific expertise serves as the basis for the Opdivo development program, which includes a broad range of Phase 3 clinical trials evaluating overall survival as the primary endpoint across a variety of tumor types. The Opdivo trials have also contributed toward the clinical and scientific understanding of the role of biomarkers and how patients may benefit from Opdivo across the continuum of PD-L1 expression. To date, the Opdivo clinical development program has enrolled more than 18,000 patients.
Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 46 countries including the United States, Japan, and in the European Union.
U.S. FDA APPROVED INDICATIONS
OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
IMPORTANT SAFETY INFORMATION
Immune-Mediated Pneumonitis
Immune-mediated pneumonitis, including fatal cases, occurred with OPDIVO treatment. Across the clinical trial experience with solid tumors, fatal immune-mediated pneumonitis occurred with OPDIVO. Monitor patients for signs with radiographic imaging and symptoms of pneumonitis. Administer corticosteroids for Grade 2 or greater pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In Checkmate 057, immune-mediated pneumonitis, including interstitial lung disease, occurred in 3.4% (10/287) of patients: Grade 3 (n=5), Grade 2 (n=2), and Grade 1 (n=3). In Checkmate 025, pneumonitis, including interstitial lung disease, occurred in 5% (21/406) of patients receiving OPDIVO and 18% (73/397) of patients receiving everolimus. Immune-mediated pneumonitis occurred in 4.4% (18/406) of patients receiving OPDIVO: Grade 4 (n=1), Grade 3 (n=4), Grade 2 (n=12), and Grade 1 (n=1).
Immune-Mediated Colitis
Immune-mediated colitis can occur with OPDIVO treatment. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. As a single agent, withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon restarting OPDIVO. In Checkmate 057, diarrhea or colitis occurred in 17% (50/287) of patients receiving OPDIVO. Immune-mediated colitis occurred in 2.4% (7/287) of patients: Grade 3 (n=3), Grade 2 (n=2), and Grade 1 (n=2). In Checkmate 025, diarrhea or colitis occurred in 25% (100/406) of patients receiving OPDIVO and 32% (126/397) of patients receiving everolimus. Immune-mediated diarrhea or colitis occurred in 3.2% (13/406) of patients receiving OPDIVO: Grade 3 (n=5), Grade 2 (n=7), and Grade 1 (n=1).
Immune-Mediated Hepatitis
Immune-mediated hepatitis can occur with OPDIVO treatment. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 immune-mediated hepatitis. In Checkmate 057, one patient (0.3%) developed immune-mediated hepatitis. In Checkmate 025, there was an increased incidence of liver test abnormalities compared to baseline in AST (33% vs 39%), alkaline phosphatase (32% vs 32%), ALT (22% vs 31%), and total bilirubin (9% vs 3.5%) in the OPDIVO and everolimus arms, respectively. Immune-mediated hepatitis requiring systemic immunosuppression occurred in 1.5% (6/406) of patients receiving OPDIVO: Grade 3 (n=5) and Grade 2 (n=1).
Immune-Mediated Endocrinopathies
Hypophysitis, adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus can occur with OPDIVO treatment. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency during and after treatment, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Administer insulin for type 1 diabetes. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.
In Checkmate 025, hypophysitis occurred in 0.5% (2/406) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 1 (n=1). In Checkmate 057, 0.3% (1/287) of OPDIVO-treated patients developed adrenal insufficiency. In Checkmate 025, adrenal insufficiency occurred in 2.0% (8/406) of patients receiving OPDIVO: Grade 3 (n=3), Grade 2 (n=4), and Grade 1 (n=1). In Checkmate 057, Grade 1 or 2 hypothyroidism, including thyroiditis, occurred in 7% (20/287) and elevated thyroid stimulating hormone occurred in 17% of patients receiving OPDIVO. Grade 1 or 2 hyperthyroidism occurred in 1.4% (4/287) of patients. In Checkmate 025, thyroid disease occurred in 11% (43/406) of patients receiving OPDIVO, including one Grade 3 event, and in 3.0% (12/397) of patients receiving everolimus. Hypothyroidism/thyroiditis occurred in 8% (33/406) of patients receiving OPDIVO: Grade 3 (n=2), Grade 2 (n=17), and Grade 1 (n=14). Hyperthyroidism occurred in 2.5% (10/406) of patients receiving OPDIVO: Grade 2 (n=5) and Grade 1 (n=5). In Checkmate 025, hyperglycemic adverse events occurred in 9% (37/406) patients. Diabetes mellitus or diabetic ketoacidosis occurred in 1.5% (6/406) of patients receiving OPDIVO: Grade 3 (n=3), Grade 2 (n=2), and Grade 1 (n=1).
Immune-Mediated Nephritis and Renal Dysfunction
Immune-mediated nephritis can occur with OPDIVO treatment. Monitor patients for elevated serum creatinine prior to and periodically during treatment. For Grade 2 or 3 increased serum creatinine, withhold and administer corticosteroids; if worsening or no improvement occurs, permanently discontinue. Administer corticosteroids for Grade 4 serum creatinine elevation and permanently discontinue. In Checkmate 057, Grade 2 immune-mediated renal dysfunction occurred in 0.3% (1/287) of patients receiving OPDIVO. In Checkmate 025, renal injury occurred in 7% (27/406) of patients receiving OPDIVO and 3.0% (12/397) of patients receiving everolimus. Immune-mediated nephritis and renal dysfunction occurred in 3.2% (13/406) of patients receiving OPDIVO: Grade 5 (n=1), Grade 4 (n=1), Grade 3 (n=5), and Grade 2 (n=6).
Immune-Mediated Rash
Immune-mediated rash can occur with OPDIVO treatment. Severe rash (including rare cases of fatal toxic epidermal necrolysis) occurred in the clinical program of OPDIVO. Monitor patients for rash. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4. In Checkmate 057, immune-mediated rash occurred in 6% (17/287) of patients receiving OPDIVO including four Grade 3 cases. In Checkmate 025, rash occurred in 28% (112/406) of patients receiving OPDIVO and 36% (143/397) of patients receiving everolimus. Immune-mediated rash, defined as a rash treated with systemic or topical corticosteroids, occurred in 7% (30/406) of patients receiving OPDIVO: Grade 3 (n=4), Grade 2 (n=7), and Grade 1 (n=19).
Immune-Mediated Encephalitis
Immune-mediated encephalitis can occur with OPDIVO treatment. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In Checkmate 057, fatal limbic encephalitis occurred in one patient (0.3%) receiving OPDIVO.
Other Immune-Mediated Adverse Reactions
Based on the severity of adverse reaction, permanently discontinue or withhold treatment, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. In < 1.0% of patients receiving OPDIVO, the following clinically significant, immune-mediated adverse reactions occurred: uveitis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, and sarcoidosis. Across clinical trials of OPDIVO as a single agent administered at doses of 3 mg/kg and 10 mg/kg, additional clinically significant, immune-mediated adverse reactions were identified: motor dysfunction, vasculitis, and myasthenic syndrome.
Infusion Reactions
Severe infusion reactions have been reported in <1.0% of patients in clinical trials of OPDIVO. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In Checkmate 057, Grade 2 infusion reactions requiring corticosteroids occurred in 1.0% (3/287) of patients receiving OPDIVO. In Checkmate 025, hypersensitivity/infusion-related reactions occurred in 6% (25/406) of patients receiving OPDIVO and 1.0% (4/397) of patients receiving everolimus.
Embryo-fetal Toxicity
Based on its mechanism of action, OPDIVO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO- containing regimen and for at least 5 months after the last dose of OPDIVO.
Lactation
It is not known whether OPDIVO is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment.
Serious Adverse Reactions
In Checkmate 057, serious adverse reactions occurred in 47% of patients receiving OPDIVO. The most frequent serious adverse reactions reported in ≥2% of patients were pneumonia, pulmonary embolism, dyspnea, pleural effusion, and respiratory failure. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO. The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia.
Common Adverse Reactions
In Checkmate 057, the most common adverse reactions (≥20%) reported with OPDIVO were fatigue (49%), musculoskeletal pain (36%), cough (30%), decreased appetite (29%), and constipation (23%). In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO vs everolimus were asthenic conditions (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%).
About the Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Ltd (Ono) Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us onLinkedIn, Twitter, and YouTube.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that Opdivo will receive regulatory approval in the European Union for the indication described in this release. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2015 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Thursday, February 25, 2016
lifeIMAGE Joins CommonWell Health Alliance - lifeIMAGE
Interoperable Network for Medical Image Exchange Helps Patients, Health Care Providers, Payers Through Improved Sharing of Clinical Data
lifeIMAGE Joins CommonWell Health Alliance - lifeIMAGE
lifeIMAGE Joins CommonWell Health Alliance - lifeIMAGE
Small Beer Distributors Being Trampled by Big Box Stores
New York’s beer market may be large enough to accommodate all the local industry players, but the big money is going to big box stores like Costco and BJ’s at the expense of smaller independent distributors.
According to an article published in Crain’s New York Business last month, the trade group for independent beer distributors in New York hired an investigator to look into the mega-stores and see if they are circumventing the system, undercutting them and stealing their bodega business.
Small Beer Distributors Being Trampled by Big Box Stores
USDA's Commitment to Develop Food and Agricultural Workforce of the Future
From the #USDA:
Dr. Ann Bartuska, Deputy Under Secretary for the USDA Research, Education, and Economics (REE) Mission Area, speaking at a Workshop at the National Academy of Sciences, Engineering, and Medicine on February 10, 2016. The Workshop brought together stakeholders from universities, government, non-government organizations, and the private sector to discuss growing needs in the agricultural workforce.
Nearly 99% of farms in the United States are family operated, and they account for roughly 90% of agricultural production. With statistics like these, it’s not surprising that many people associate jobs in agriculture with small-town America, farmers and tractors, and corn fields and cattle.
While the importance of farmers cannot be overstated, the diversity of careers available in the agricultural sector is staggering and often underappreciated. According to a 2013 study funded by USDA’s National Institute of Food and Agriculture (NIFA), an average of 57,900 jobs will open every year from 2015 to 2020 and require a bachelor’s degree or higher in food, agriculture, natural resources, or environmental studies. These jobs will include a range of sectors, including management and business; science, technology, engineering, and mathematics (STEM); food and biomaterials production; and education, communication, and government services. Strikingly, it is also expected that 39% of positions will go unfilled.
Numbers like these have many people in the agricultural sector scratching their heads in confusion. How can we attract young people into agricultural jobs?
To recruit, educate, and retain the next generation of agricultural professionals, USDA supports numerous educational programs, a few of which include: curricula development for K-12 classrooms; grants to educate young farmers and ranchers; pre- and post-doctoral fellowships that support young scientists; and scholarships dedicated to improving diversity within the agricultural workforce. In addition to these efforts, USDA recognizes that in order to attract young people into careers in agriculture, the stakeholder community must come together to discuss how we communicate about jobs in agriculture.
To initiate this conversation, the National Academy of Sciences (NAS) recently hosted a two-day Workshop that brought together stakeholders from universities, government, non-government organizations, and the private sector to discuss growing needs in the agricultural workforce. During the meeting, sponsored in part by NIFA, participants brainstormed new ways to excite students about agriculture throughout all levels of education and discussed the needs for novel curricula that provide students with transferrable, high-tech skillsets. By supporting these discussions and others, USDA continues to identify ways to communicate with students that their interests in computer science, big data analysis, drone technologies, genomics, molecular biology, economics, international trade, and others, are perfectly aligned with the needs of the future agricultural workforce.
Court of appeals sides with plaintiffs over Indiana recycling facility contract - Renewable Energy From Waste
Judge rules contract with Indianapolis and Covanta failed to comply with waste disposal statute.
Court of appeals sides with plaintiffs over Indiana recycling facility contract - Renewable Energy From Waste
Court of appeals sides with plaintiffs over Indiana recycling facility contract - Renewable Energy From Waste
5 Amazing African American Owned Handmade Businesses
I’m a big believer in giving credit where credit is due.
As it concerns the entrepreneurs you’ll discover here, credit is due all day long, all year long, every day, and every month.
5 Amazing African American Owned Handmade Businesses
Mark Zuckerberg loses patience over racial insensitivity at Facebook headquarters - Feb. 25, 2016
Mark Zuckerberg has always encouraged Facebook employees to think for themselves, but one issue is trying his patience.
People have been crossing out "black lives matter" on the walls of Facebook's headquarters and writing "all lives matter."
Mark Zuckerberg loses patience over racial insensitivity at Facebook headquarters - Feb. 25, 2016
People have been crossing out "black lives matter" on the walls of Facebook's headquarters and writing "all lives matter."
Mark Zuckerberg loses patience over racial insensitivity at Facebook headquarters - Feb. 25, 2016
The University of Kansas Hospital To Leverage Cerner's Population Health Management Platform for Rural Communities
From Cerner:
The University of Kansas Hospital To Leverage Cerner's Population Health Management Platform for Rural Communities
February 25, 2016
The University of Kansas Hospital, a nationally recognized academic medical center, has extended its collaboration with Cerner, a global leader in health care technology, to leverage Cerner’sHealtheIntent population health management platform to coordinate and manage care in rural Kansas communities.
“Managing the health of populations requires new strategic approaches as the health care landscape continues to shift from a volume- to value-driven system,” said Brad Carey, vice president and general manager, population health, Cerner. “Providing meaningful patient data beyond the traditional acute care setting will enable care providers to improve the quality of care and focus on proactive health and prevention."
The University of Kansas Hospital will utilize HealtheCare, Cerner’s knowledge-driven, community care management solution, which is powered by algorithms to identify, stratify and prioritize individuals for assignment to aligned care managers. The solution enables providers to conduct comprehensive and relevant assessments, which establishes condition-specific goals and interventions to enable optimal health outcomes.
HealtheCare will be leveraged as part of The University of Kansas Hospital’s Kansas Heart and Stroke Collaborative. The collaborative is an innovative care delivery and payment model to improve rural Kansas’ heart health and stroke outcomes, supporting reduced total cost of care. The three-year grant was awarded to The University of Kansas Hospital as part of the Healthcare Innovation Awards, sponsored by the Center for Medicare and Medicaid Services.
“Rural communities have many patients with chronic conditions, such as heart disease and stroke, where care coordination and patient education are important to improve outcomes,” said Dr. Robert Moser, director of the Kansas Heart and Stroke Collaborative of The University of Kansas Hospital. “Leveraging HealtheCare will enable our Heart and Stroke Collaborative partners and local health coaches to engage at-risk patients at the right time, providing the optimal care and resources they need to assist in their treatment.”
The extended agreement is part of a broader strategic collaboration in place since 2012. The University of Kansas Hospital was one of the first health care organizations in the Midwest to include their primary care physicians in Cerner’s Primary Health Network. Cerner’s Primary Health Network model combines the foundational wellness offerings with innovative population health management services and technology to create an employer-driven network where providers and individuals are rewarded for health improvement and productivity.
“Cerner and The University of Kansas Hospital are jointly committed to the improvement of health in our communities,” said Chris Wilson, executive director of innovation, The University of Kansas Hospital. “Proactively engaging individuals in their health care will enable deeper insights for entire populations that can transform the health care industry.”
Cerner’s population health management platform and solutions will be featured in Booth 2032 at HIMSS16, Feb. 29 – March 4, at Sands Expo Center in Las Vegas.
Cerner Pledges Commitment to White House Precision Medicine Initiative
From Cerner:
Cerner Pledges Commitment to White House Precision Medicine Initiative
February 25, 2016
Cerner, a global leader in health care technology, announced its participation in “Sync for Science,” the Obama administration’s precision medicine initiative (PMI) designed to give patients the tools to donate their own health data to help improve health outcomes and treat disease.
Central to the President’s PMI is development of a research cohort to engage 1 million or more Americans who would volunteer their health data for research purposes. Cerner will pilot the use of open, standardized application program interfaces to enable patients to share their electronic health record data as part of the initiative.
“Cerner is committed to helping advance precision medicine through patient-enabled research to help break down data silos,” said Dr. David McCallie, senior vice president, Medical Informatics, Cerner. “It’s an investment in the future of health care, which will benefit the industry overall.”
Cerner is one of 30 organizations that have pledged their commitment to “Sync for Science” and will participate in the Precision Medicine Initiative Summit on Thursday, Feb. 25, at the White House.
Apple to court: Government can't force us to write code - Feb. 25, 2016
Apple told a court that it shouldn't have to help the FBI unlock a San Bernardino shooter's iPhone, claiming its computer code is protected by the First Amendment's right to free speech and that the company shouldn't be "conscripted" to work for the government.
Apple said in a court filing Thursday that "this is not a case about one isolated iPhone."
Apple to court: Government can't force us to write code - Feb. 25, 2016
Apple said in a court filing Thursday that "this is not a case about one isolated iPhone."
Apple to court: Government can't force us to write code - Feb. 25, 2016
Donald Trump to be witness in federal case accusing him of fraud - Feb. 25, 2016
Donald Trump is slated to appear as a witness in the case charging him and the former Trump University with fraud.
The plaintiffs and defense attorneys in the case both have listed Trump on their witness lists recently submitted to the court.
Donald Trump to be witness in federal case accusing him of fraud - Feb. 25, 2016
The plaintiffs and defense attorneys in the case both have listed Trump on their witness lists recently submitted to the court.
Donald Trump to be witness in federal case accusing him of fraud - Feb. 25, 2016
Apple's next goal: an unbreakable iPhone - Feb. 25, 2016
Now that the FBI has discovered Apple can actually hack into its own iPhones, Apple engineers see their next goal as making a version of the device that even Apple can't break into.
Apple engineers are now in a race against time to see if they can design an unbreakable iPhone in the next few months. They hope the added security can appear in the next iteration of Apple's operating system and its next iPhone model, according to several security researchers in direct contact with Apple employees.
Apple's next goal: an unbreakable iPhone - Feb. 25, 2016
Apple engineers are now in a race against time to see if they can design an unbreakable iPhone in the next few months. They hope the added security can appear in the next iteration of Apple's operating system and its next iPhone model, according to several security researchers in direct contact with Apple employees.
Apple's next goal: an unbreakable iPhone - Feb. 25, 2016
Metals meltdown has ended, for now - Feb. 25, 2016
The metals market has finally stopped melting down -- at least for the moment.
After crashing to crisis levels late last year, raw materials that serve as key barometers of global growth are suddenly showing signs of life.
Metals meltdown has ended, for now - Feb. 25, 2016
After crashing to crisis levels late last year, raw materials that serve as key barometers of global growth are suddenly showing signs of life.
Metals meltdown has ended, for now - Feb. 25, 2016
What are Some Keys to Effective Communication
Communication in the workplace has always posed a challenge, but 21st century trends may mean even more misunderstandings.
As the US becomes more diverse, so do American workplaces, and that increases the likelihood of cultural and cross-gender misunderstandings. Moreover, many businesses now have workers spread out in different states and countries.
What are Some Keys to Effective Communication
Checklist for Negotiating a Business Deal
Over the years I spent in the corporate world, I was fortunate enough to attend several different negotiation seminars and courses.
Each had its own nomenclature and structure. Some negotiating courses were better for negotiating huge multimillion dollar acquisitions and divestitures. Others were focused on supplier-customer negotiations.
Checklist for Negotiating a Business Deal
ISIS supporters threaten Mark Zuckerberg and Jack Dorsey - Feb. 24, 2016
A group of ISIS supporters has threatened to take down Facebook and Twitter -- as well as their leaders.
Photos of Mark Zuckerberg and Jack Dorsey appear multiple times in a 25-minute video created by a group that calls itself the Sons Caliphate Army. The images of the two CEOs are sometimes engulfed in flames, or marked with bullet holes.
ISIS supporters threaten Mark Zuckerberg and Jack Dorsey - Feb. 24, 2016
Photos of Mark Zuckerberg and Jack Dorsey appear multiple times in a 25-minute video created by a group that calls itself the Sons Caliphate Army. The images of the two CEOs are sometimes engulfed in flames, or marked with bullet holes.
ISIS supporters threaten Mark Zuckerberg and Jack Dorsey - Feb. 24, 2016
Wednesday, February 24, 2016
10 DIY Tips for Choosing a Small Business Security Camera
When it comes to keeping your business secure, there are more choices than ever for small businesses. No longer do you have to resort to using expensive professionally installed systems if you don’t want to or don’t have the resources to. There are DIY security options out there that you can consider for your business. Here are some tips for choosing a security camera system for your business.
10 DIY Tips for Choosing a Small Business Security Camera
10 DIY Tips for Choosing a Small Business Security Camera
Progressive Waste Solutions reports financial results for Q4 and year - Renewable Energy From Waste
CEO Dan Pio says new municipal contracts combined with recent acquisitions will contribute to a solid performance in the first quarter of 2016.
Progressive Waste Solutions reports financial results for Q4 and year - Renewable Energy From Waste
Progressive Waste Solutions reports financial results for Q4 and year - Renewable Energy From Waste
Pfizer Announces FDA Approval of XELJANZ® XR (tofacitinib citrate) Extended-Release Tablets, the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis
From Pfizer:
Pfizer Announces FDA Approval of XELJANZ® XR (tofacitinib citrate) Extended-Release Tablets, the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis
XELJANZ XR provides RA patients a new once-daily dosing option
Wednesday, February 24, 2016 11:15 am EST
Dateline:
NEW YORK
Public Company Information:
NYSE:
PFE
US7170811035
"Pfizer continues to be an innovator in inflammation and immunology. The introduction of the first and only once-daily oral JAK inhibitor for RA, XELJANZ XR, builds upon Pfizer’s tradition of developing patient-centered therapies"
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved XELJANZ® XR (tofacitinib citrate) extended-release 11 mg tablets for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX). XELJANZ XR is the first and only once-daily oral RA treatment in its class, known as Janus kinase (JAK) inhibitors.
“Pfizer continues to be an innovator in inflammation and immunology. The introduction of the first and only once-daily oral JAK inhibitor for RA, XELJANZ XR, builds upon Pfizer’s tradition of developing patient-centered therapies,” said Michael Corbo, Category Development Lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business.
“The availability of XELJANZ XR provides physicians with a new treatment option for people with RA who may prefer an oral once-daily treatment,” said Dr. Roy Fleischmann, clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center and Co-Medical Director, Metroplex Clinical Research Center.
About XELJANZ and XELJANZ XR
XELJANZ®/XELJANZ XR® (tofacitinib citrate) is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ XR 11 mg is the first and only once-daily oral JAK inhibitor for the treatment of moderate to severe rheumatoid arthritis (RA).
As the developer of XELJANZ/XELJANZ XR, Pfizer is a leader in JAK innovation. XELJANZ/XELJANZ XR do not require injections or infusions. XELJANZ/XELJANZ XR can be taken with or without methotrexate.
XELJANZ is approved in more than 45 countries around the world for the treatment of moderate to severe RA as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs).
Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of XELJANZ through a robust clinical development program. The efficacy and safety profile of XELJANZ has been studied in approximately 6,200 patients with moderate to severe RA, amounting to more than 19,400 patient-years of drug exposure in the global clinical development program.
XELJANZ is the only JAK inhibitor included in the 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis.1
XELJANZ/XELJANZ XR U.S. Label Information
XELJANZ/XELJANZ XR is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ/XELJANZ XR is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well. XELJANZ/XELJANZ XR may be used as a single agent or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs). Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine is not recommended.
- It is not known if XELJANZ/XELJANZ XR is safe and effective in people with hepatitis B or C.
- XELJANZ/XELJANZ XR is not for people with severe liver problems.
- It is not known if XELJANZ/XELJANZ XR is safe and effective in children.
Important Safety Information
- XELJANZ/XELJANZ XR can lower the ability of the immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Healthcare providers should test patients for TB before starting XELJANZ/XELJANZ XR, and monitor them closely for signs and symptoms of TB and other infections during treatment. People should not start taking XELJANZ/XELJANZ XR if they have any kind of infection unless their healthcare provider tells them it is okay.
- People may be at a higher risk of developing shingles.
- XELJANZ/XELJANZ XR may increase the risk of certain cancers by changing the way the immune system works. Lymphoma and other cancers, including skin cancers, can happen in patients taking XELJANZ/XELJANZ XR.
- The risks and benefits of treatment should be considered prior to initiating XELJANZ/XELJANZ XR in patients with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
- Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was observed in clinical studies with XELJANZ.
- Use of live vaccines should be avoided concurrently with XELJANZ/XELJANZ XR. Update immunizations in agreement with current immunization guidelines prior to initiating XELJANZ/XELJANZ XR therapy.
- Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr virus-associated post-transplant lymphoproliferative disorder).
- Some people taking XELJANZ/XELJANZ XR can get tears in their stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
- XELJANZ/XELJANZ XR should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis), or who have a narrowing within their digestive track. Patients should tell their healthcare provider right away if they have fever and stomach-area pain that does not go away or a change in bowel habits.
- XELJANZ/XELJANZ XR can cause changes in certain lab test results including low blood cell counts, increases in certain liver tests, and increases in cholesterol levels. Healthcare providers should do blood tests before starting patients on XELJANZ/XELJANZ XR and while they are taking XELJANZ/XELJANZ XR, to check for these side effects. Normal cholesterol levels are important to good heart health. Healthcare providers may stop XELJANZ/XELJANZ XR treatment because of changes in blood cell counts or liver test results.
- Use of XELJANZ/XELJANZ XR in patients with severe hepatic impairment is not recommended.
- Patients should tell their healthcare providers if they plan to become pregnant or are pregnant.
It is not known if XELJANZ/XELJANZ XR will harm an unborn baby. To monitor the outcomes of pregnant women exposed to XELJANZ/XELJANZ XR, a registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972.
- Patients should tell their healthcare providers if they plan to breastfeed or are breastfeeding. Patients and their healthcare provider should decide if they will take XELJANZ/XELJANZ XR or breastfeed. They should not do both.
- In carriers of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while using XELJANZ/XELJANZ XR. Healthcare providers may do blood tests before and during treatment with XELJANZ/XELJANZ XR.
- Common side effects include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, and nasal congestion, sore throat, and runny nose (nasopharyngitis).
Please click the direct link to the full prescribing information for XELJANZ/XELJANZ XR, including boxed warning and Medication Guide: http://labeling.pfizer.com/ShowLabeling.aspx?id=959.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disease that causes a range of symptoms, including pain and swelling in the joints,2,3 particularly those in the hands, feet and knees.3 Although the exact cause of RA is unknown,3 it is considered to be an autoimmune disease, because the immune system in people with RA mistakes the body’s healthy tissues for a threat and attacks them.3 Some people are at increased risk of developing RA, including people with a family history of RA, smokers and women.4 Three times as many women are affected by RA compared to men.3 RA affects approximately 23.7 million people worldwide5and 1.6 million people in the United States.6,7 It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age.3
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News,LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is as of February 24, 2016. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about XELJANZ and XELJANZ XR, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development; uncertainties regarding the commercial success of XELJANZ and XELJANZ XR; whether and when any applications for XELJANZ or XELJANZ XR may be filed with regulatory authorities in any other jurisdictions; whether and when regulatory authorities in other jurisdictions in which such applications are pending or will be submitted may approve such applications, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of XELJANZ and XELJANZ XR; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
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1 Singh, J. A., Saag, K. G., Bridges, S. L., et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis & Rheumatology. doi: 10.1002/art.39480
2 Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001; 358:903-911.
3 Medline Plus, “Rheumatoid Arthritis” Accessed 11 October 2015. Available athttp://www.nlm.nih.gov/medlineplus/ency/article/000431.htm.
4 Mayo Clinic, “Rheumatoid Arthritis.” Accessed 14 September 2015. Available at http://www.mayoclinic.com/health/rheumatoid-arthritis/DS00020/DSECTION=risk-factors.
5 Annals of Rheumatic Diseases, “The global burden of rheumatoid arthritis: estimates from the Global Burden of Disease 2010 study.” Accessed 14 July 2015. Available at http://ard.bmj.com/content/early/2014/02/18/annrheumdis-2013-204627.
6 Sacks, J., Lou, Y., Helmick, C. Prevalence of Specific Types of Arthritis and Other Rheumatic Conditions in the Ambulatory Health Care System in the United States 2001-2005. Arthritis Care and Research. 2010. 62(4): 460- 464.
7 Howden, L., Meyer, J., 2010 U.S. Census Bureau results --- U.S. Census Bureau, 2010 Census Summary File 1.
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