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250-511 - Administration of Symantec(TM) Data Loss(R) Prevention 11 - Dump Information

Vendor : Symantec
Exam Code : 250-511
Exam Name : Administration of Symantec(TM) Data Loss(R) Prevention 11
Questions and Answers : 176 Q & A
Updated On : November 12, 2018
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250-511 Questions and Answers

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250-511 Administration of Symantec(TM) Data Loss(R) Prevention 11

Study Guide Prepared by Killexams.com Symantec Dumps Experts


Killexams.com 250-511 Dumps and Real Questions

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250-511 exam Dumps Source : Administration of Symantec(TM) Data Loss(R) Prevention 11

Test Code : 250-511
Test Name : Administration of Symantec(TM) Data Loss(R) Prevention 11
Vendor Name : Symantec
Q&A : 176 Real Questions

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Symantec Administration of Symantec(TM) Data

Symantec warns of China-based mostly espionage campaign focused on satellites | killexams.com Real Questions and Pass4sure dumps

A China-based mostly cyber community is engaging in an in depth hacking crusade via focused on satellite, telecom and protection corporations in the u.s. and Southeast Asia, a U.S. cybersecurity enterprise warned this week.

The rationale of the hacking community, referred to as "Thrip," is likely national cyber espionage, protection researchers at Symantec Corp. noted on Tuesday.

"Thrip’s attack on telecoms and satellite tv for pc operators exposes the probability that the attackers could intercept or even alter communications traffic from organizations and patrons," Symantec pointed out in an announcement, including that the most stressful discovery is an try to handle satellites by using infecting linked computer systems with malware.

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"The attack group gave the impression to be certainly drawn to the operational aspect of the enterprise, trying to find and infecting computer systems operating utility that monitors and controls satellites. this means to us that Thrip’s causes go beyond spying and can additionally encompass disruption," Symantec wrote in a separate blog submit.

Satellites play a principal role in telecommunications, receiving and transmitting cellphone and internet alerts in addition to mapping and geolocation information.

Symantec referred to in Tuesday's statement that it has tracked Thrip since 2013 and lately accompanied that the cyber group looks to have "found new equipment and recommendations used by means of the neighborhood in this most contemporary set of attacks."

The hazard of the better hacking toolbox is extra compounded by way of Thrip's skill to dwell neatly hidden.

"They function very quietly, blending in to networks, and are most effective found out the use of artificial intelligence that may establish and flag their actions," Symantec Chief executive Greg Clark observed in a statement.

The enterprise says it discovered the new attacks via its synthetic intelligence-primarily based targeted assault Analytics, which helped the researchers spot the malicious habits that turned into hiding in respectable IT administration equipment.


Samsam ransomware continues to goal hospitals | killexams.com Real Questions and Pass4sure dumps

quick

Dive quick:
  • targeted ransomware SamSam continues to pose a significant risk to healthcare corporations, and recovery can also be problematic and expensive, cybersecurity enterprise Symantec stories.
  • Of the sixty seven businesses hit by way of SamSam this 12 months, 24% were in healthcare and greater than half have been within the U.S. A handful passed off in France, Portugal, ireland, Israel and Australia.
  • SamSam users benefit access to a firm's community and spend time mapping out the device, often the usage of professional network administration tools, before encrypting computer systems and demanding a ransom. Getting the attackers to decrypt all computers can cost tens of lots of dollars, Symantec says. 
  • Dive perception:

    SamSam attacks have been expanding. among the healthcare corporations SamSam targeted this yr are Allscripts and Hancock health.

    Healthcare is a well-liked cybertarget for a few explanations. Many companies use legacy equipment that runs on ancient and unsupported operating techniques, failure to put into effect patches and updates leaves systems inclined and ongoing consolidation within the industry can expose cybersecurity changes. after which there are affected person health information replete with personal data that may be sold on the darkish net.

    in response to a Ponemon Institute evaluation for IBM safety, healthcare groups had the optimum breach-connected expenses of any trade at $408 per lost or stolen listing — well-nigh triple the cross-trade regular of $148.

    When successful, a SamSam assault can disrupt operations and probably destroy or alter a must-have business assistance, resulting in prolonged and expensive cleanups. And paying a ransom is not any guarantee attackers will decrypt the hijacked computers. Symantec warns that hackers may additionally now not send a decryption key or might put into effect the decryption procedure in a method that damages info.

    The company recommends following cybersecurity most fulfilling practices, including — but now not limited to — backing up important information.

    Cyberthreat specialists advocate corporations use a human-computing device teaming method to hunt down cyberattackers earlier than a breach occurs. Key components of a successful program consist of beefing up personnel training and protection teams, deploying the latest firewalls and net gateways and developing early warning traps to attract attackers out of the shadows. 

    "It basically is ready discovering the basic doors unlocked, the windows which had been not totally closed within the atmosphere," Vincent Weafer, COO/CTO at TriagingX and former vp of McAfee Labs, informed Healthcare Dive in an prior interview. 

    accurate picture credit score: Adobe inventory

    Symantec Helps find Cyber Espionage exercise concentrated on satellite, Telecom, Geospatial Imaging and protection companies within the US and Southeast Asia | killexams.com Real Questions and Pass4sure dumps

    MOUNTAIN VIEW, Calif.--(enterprise WIRE)--

    Symantec Corp. (SYMC), the realm’s leading cyber security enterprise, today announced that Symantec’s artificial intelligence-based mostly centered attack Analytics (TAA) know-how helped researchers expose a brand new attack campaign from a bunch referred to as Thrip, which has infiltrated satellite tv for pc communications, telecoms, geospatial imaging, and protection organizations in the u.s. and Southeast Asia. TAA’s advanced AI technology become instrumental in the discovery of the assault, alerting Symantec’s attack Investigations crew to activity that on the floor seemed innocuous however set them on the path to uncovering the latest crusade performed via the Thrip community. Symantec has been monitoring Thrip given that 2013, and has found out new equipment and recommendations used by means of the group in this most contemporary set of attacks.

    TAA leverages AI and superior laptop learning to brush through Symantec’s facts lake of telemetry in order to spot patterns linked to targeted attacks. This technology nearly automates what previously took hundreds of hours of analyst time and is attainable in Symantec’s advanced possibility insurance plan (ATP) product. From an initial alert caused by way of TAA in January 2018, Symantec researchers had been capable of observe a trail that enabled them to determine that the campaign originated from machines based mostly in mainland China. the use of these thoughts, TAA detected suspicious habits despite the group’s use of professional working gadget facets and network administration tools in an try and stay away from detection. TAA also uncovered the use of custom malware in these assaults, as well as deciding upon the types of companies centered. Cyber espionage is the group’s probably reason, but given the community has published a methodology of compromising operational programs, it might undertake a more aggressive, disruptive stance should still it choose to accomplish that.

    “here is seemingly espionage,” mentioned Greg Clark, Symantec CEO. “The Thrip group has been working considering 2013 and their latest campaign uses standard working gadget equipment, so targeted businesses received’t observe their presence. They operate very quietly, blending in to networks, and are handiest found out the usage of artificial intelligence that may establish and flag their movements. Alarmingly, the community seems keenly interested in telecom, satellite operators, and defense corporations. We stand able to work with appropriate authorities to tackle this critical risk.”

    Symantec has sharpened its efforts on network-resident malware, because the many vulnerabilities which are greatly customary in IOT instruments latest a brand new attack surface of severe pastime.

    Thrip’s assault on telecoms and satellite operators exposes the chance that the attackers may intercept and even alter communications traffic from organisations and consumers. This has added to starting to be privateness considerations that have been very seen lately with the deployment of the brand new GDPR laws as smartly because the VPNFilter attacks on internet routers. Symantec has spoke back through opening a new privateness center and information coverage lab with the intention to deliver buyers with extra manage over their records, and companies with equipment to aid them responsibly manage the facts they handle. Symantec also offers a wide variety of privacy solutions, comparable to Symantec VIP and Norton WiFi privacy.

    Symantec has been maintaining valued clientele from Thrip-linked recreation because 2013. the following protections are in area to offer protection to shoppers against Thrip:

    File-primarily based insurance policy

    valued clientele of Symantec’s DeepSight Intelligence Managed Adversary and threat Intelligence (MATI) carrier have bought distinct reviews on “ATG14” (also known as Thrip), which aspect strategies of detecting and thwarting actions of this adversary.

    For greater suggestions, please seek advice from the Symantec threat Intelligence blog.

    About Symantec

    Symantec corporation (SYMC), the realm's main cyber protection business, helps agencies, governments and individuals secure their most crucial information wherever it lives. businesses the world over look to Symantec for strategic, built-in options to protect in opposition t refined assaults across endpoints, cloud and infrastructure. Likewise, a world neighborhood of more than 50 million americans and households depend on Symantec's Norton and LifeLock product suites to offer protection to their digital lives at home and throughout their instruments. Symantec operates one of the crucial world's largest civilian cyber intelligence networks, permitting it to look and offer protection to in opposition t the most superior threats. For additional information, please seek advice from www.symantec.com or join with us on fb, Twitter, and LinkedIn.

    View supply version on businesswire.com: https://www.businesswire.com/information/home/20180619006286/en/


    250-511 Administration of Symantec(TM) Data Loss(R) Prevention 11

    Study Guide Prepared by Killexams.com Symantec Dumps Experts


    Killexams.com 250-511 Dumps and Real Questions

    100% Real Questions - Exam Pass Guarantee with High Marks - Just Memorize the Answers



    250-511 exam Dumps Source : Administration of Symantec(TM) Data Loss(R) Prevention 11

    Test Code : 250-511
    Test Name : Administration of Symantec(TM) Data Loss(R) Prevention 11
    Vendor Name : Symantec
    Q&A : 176 Real Questions

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    Microsoft team collaboration software gains momentum | killexams.com real questions and Pass4sure dumps

    Microsoft is poised to become a leader in team collaboration software with the popularity of Skype for Business and growing interest in its team chat app, Microsoft Teams, according to a report from Spiceworks Inc., an IT social network based in Austin, Texas.

    The report surveyed 448 IT professionals in small, midsize and large businesses on their current use of team collaboration software and adoption plans. The report found 42% of companies have deployed team collaboration software, with Skype for Business leading the pack, followed by Google Hangouts and Slack.

    When organizations look to the future of team collaboration software, Microsoft gains momentum. Nearly 11% of organizations plan to adopt Skype for Business, while 17% plan to adopt Microsoft Teams. According to the report, Microsoft Teams is on track to surpass Slack and Google Hangouts deployments by the end of 2018.

    Organizations gave Skype for Business top marks for security, manageability and reliability, while Slack was viewed as more user-friendly and compatible with third-party apps.

    Email encryption services see growing relevance

    As organizations move their email to the cloud and data breaches become more prevalent, demand has risen for email encryption services to protect sensitive information.

    According to a report from market research firm Technavio, the demand for email encryption services has increased in markets such as healthcare, government and financial services. However, the email encryption market is fragmented and competitive, with players ranging from multinational vendors to smaller, regional vendors.

    The report named five leading vendors in the email encryption market.

    Cisco is considered a leader for its wide range of services beyond email encryption and its ability to serve various businesses of all sizes. Proofpoint was named a leader for its email encryption services to protect an organization's messaging infrastructure from threats, such as phishing, spam and malware.

    Symantec is a market leader for its encryption and data loss prevention services that range from mobile, cloud and on-premises environments. Trend Micro was named a leader for its innovative approach to email and web security. Zix is a leader for its data loss prevention and BYOD services that meet compliance requirements for financial, healthcare and government verticals.

    NetSfere expands messaging security

    NetSfere updated its mobile messaging service to expand support for secure communication with external users.

    NetSfere users can now communicate with guest users who are members of other NetSfere messaging groups and external users without NetSfere accounts. NetSfere also added personal web links to support secure internal and external messaging.

    All NetSfere conversations are encrypted by default. The service offers additional IT administration controls, such as disabling attachments by file type and platform, and prohibiting forwarding attachments to other users.

    Anurag Lal, CEO of Infinite Convergence Solutions Inc., based in Chicago, which owns NetSfere, said the updates make collaboration easier for users, while providing IT with additional layers of security and control.


    U.S. FDA Approves LORBRENA® (lorlatinib) for Previously-Treated ALK-Positive Metastatic NSCLC | killexams.com real questions and Pass4sure dumps

    Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved LORBRENA® [lor-BREN-ah] (lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. This represents the third FDA approval Pfizer has received for an oncology treatment, including two lung cancer medicines, within two months.

    "Over the years, Pfizer has transformed research, management and treatment for patients with ALK-positive non-small cell lung cancer. Building upon our extensive understanding of tumor complexity and treatment resistance, LORBRENA was discovered by Pfizer scientists and developed specifically to inhibit tumor mutations that may drive resistance to other ALK tyrosine kinase inhibitors,” said Andy Schmeltz, Global President, Pfizer Oncology. "We believe that LORBRENA will benefit patients with ALK-positive metastatic non-small cell lung cancer that have progressed on prior therapy and continue to deliver on our commitment to addressing unmet needs of cancer patients.”

    Since Pfizer introduced XALKORI® (crizotinib) as the first TKI for the treatment of ALK-positive metastatic NSCLC in 2011, the availability of these medicines has created an opportunity to provide patients with treatment options other than chemotherapy. However, lung cancer remains the leading cause of cancer-related death around the world.

    While many ALK-positive metastatic NSCLC patients respond to initial TKI therapy, they typically experience tumor progression.1,2 Additionally, options for patients who progress after treatment with second-generation ALK TKIs, alectinib, brigatinib and ceritinib, are limited.3 The approval of LORBRENA represents a new option for patients who have progressed on a second-generation ALK TKI, providing an opportunity to remain on oral therapy.

    "The last decade has witnessed dramatic improvements in the treatment of metastatic ALK-positive non-small cell lung cancer due to earlier generation ALK biomarker-driven therapies. Yet almost all patients still relapse due to drug resistance, with a large proportion of patients developing new or worsening brain metastases,” said Alice T. Shaw, MD, PhD, Professor of Medicine at Harvard Medical School, and Director of the Center for Thoracic Cancers at Massachusetts General Hospital. "In a clinical study which included patients with or without brain metastases, LORBRENA demonstrated clinical activity in patients with metastatic ALK-positive non-small cell lung cancer who had failed other ALK biomarker-driven therapies.”

    The approval was based on a non-randomized, dose-ranging and activity-estimating, multi-cohort, multicenter Phase 1/2 study, B7461001, evaluating LORBRENA for the treatment of patients with ALK-positive metastatic NSCLC, who were previously treated with one or more ALK TKIs. A total of 215 patients with ALK-positive metastatic NSCLC were enrolled across various subgroups based on prior treatment. Among these patients, overall response rate (ORR) was 48 percent (95% CI: 42%, 55%) and importantly, 57 percent had previous treatment with more than one ALK TKI. In the trial, 69 percent of patients had a history of brain metastases and intracranial response rate was 60 percent (95% CI: 49%, 70%).

    "Since leading with the first approval of a biomarker-driven treatment for ALK-positive non-small cell lung cancer in 2011, Pfizer scientists and clinicians have remained committed to researching and developing medicines that can further advance the care of these patients,” said Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development. "LORBRENA’s approval is an important milestone for patients, having demonstrated marked activity in a study that included a broad range of individuals with ALK-positive non-small cell lung cancer. This includes patients who were heavily pretreated and facing limited options after receiving first- and second-generation ALK tyrosine kinase inhibitors.”

    Among 295 ALK-positive or ROS1-positive metastatic NSCLC patients who received LORBRENA 100 mg once daily in study B7461001, the most common (= 20%) adverse reactions were edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea. The most common (=20%) laboratory abnormalities were hypercholesterolemia, hypertriglyceridemia, anemia, hyperglycemia, increased AST, hypoalbuminemia, increased ALT, increased lipase, and increased alkaline phosphatase. Serious adverse reactions occurred in 32 percent of the 295 patients. The most frequent serious adverse reactions reported were pneumonia (3.4%), dyspnea (2.7%), pyrexia (2%), mental status changes (1.4%), and respiratory failure (1.4%). Fatal adverse reactions occurred in 2.7 percent of patients and included pneumonia (0.7%), myocardial infarction (0.7%), acute pulmonary edema (0.3%), embolism (0.3%), peripheral artery occlusion (0.3%), and respiratory distress (0.3%). Permanent discontinuation of LORBRENA for adverse reactions occurred in eight percent of patients; approximately 48 percent of patients required dose interruptions and 24 percent required at least one dose reduction. The full prescribing information for LORBRENA can be found here.

    Pfizer is committed to ensuring that patients living with lung cancer have access to this innovative therapy. Patients in the U.S. who are prescribed LORBRENA have access to Pfizer Oncology TogetherTM, which offers personalized patient support including financial assistance and additional resources to help them manage day-to-day life with their condition.

    About LORBRENA® (lorlatinib)

    LORBRENA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

    This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

    LORBRENA is currently approved in Japan for the treatment of ALK fusion gene-positive unresectable advanced and/or recurrent non-small cell lung cancer with resistance or intolerance to ALK tyrosine kinase inhibitor(s).

    IMPORTANT LORBRENA SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

    Contraindications: LORBRENA is contraindicated in patients taking strong CYP3A inducers, due to the potential for serious hepatotoxicity.

    Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers: Severe hepatotoxicity occurred in 10 of 12 healthy subjects receiving a single dose of LORBRENA with multiple daily doses of rifampin, a strong CYP3A inducer. Grade 4 ALT or AST elevations occurred in 50% of subjects, Grade 3 in 33% of subjects, and Grade 2 in 8% of subjects. Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating LORBRENA. Avoid concomitant use of LORBRENA with moderate CYP3A inducers. If concomitant use of moderate CYP3A inducers cannot be avoided, monitor AST, ALT, and bilirubin 48 hours after initiating LORBRENA and at least 3 times during the first week after initiating LORBRENA. Depending upon the relative importance of each drug, discontinue LORBRENA or the CYP3A inducer for persistent Grade 2 or higher hepatotoxicity.

    Central Nervous System (CNS) Effects: A broad spectrum of CNS effects can occur. These include seizures, hallucinations, and changes in cognitive function, mood (including suicidal ideation), speech, mental status, and sleep. Withhold and resume at the same or reduced dose or permanently discontinue based on severity.

    Hyperlipidemia: Increases in serum cholesterol and triglycerides can occur. Grade 3 or 4 elevations in total cholesterol occurred in 17% and Grade 3 or 4 elevations in triglycerides occurred in 17% of the 332 patients who received LORBRENA. Eighty percent of patients required initiation of lipid-lowering medications, with a median time to onset of start of such medications of 21 days. Initiate or increase the dose of lipid-lowering agents in patients with hyperlipidemia. Monitor serum cholesterol and triglycerides before initiating LORBRENA, 1 and 2 months after initiating LORBRENA, and periodically thereafter. Withhold and resume at same dose for the first occurrence; resume at same or reduced dose of LORBRENA for recurrence based on severity.

    Atrioventricular (AV) Block: PR interval prolongation and AV block can occur. In 295 patients who received LORBRENA at a dose of 100 mg orally once daily and who had a baseline electrocardiography (ECG), 1% experienced AV block and 0.3% experienced Grade 3 AV block and underwent pacemaker placement. Monitor ECG prior to initiating LORBRENA and periodically thereafter. Withhold and resume at reduced or same dose in patients who undergo pacemaker placement. Permanently discontinue for recurrence in patients without a pacemaker.

    Interstitial Lung Disease (ILD)/Pneumonitis: Severe or life-threatening pulmonary adverse reactions consistent with ILD/pneumonitis can occur. ILD/pneumonitis occurred in 1.5% of patients, including Grade 3 or 4 ILD/pneumonitis in 1.2% of patients. Promptly investigate for ILD/pneumonitis in any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis. Immediately withhold LORBRENA in patients with suspected ILD/pneumonitis. Permanently discontinue LORBRENA for treatment-related ILD/pneumonitis of any severity.

    Embryo-fetal Toxicity: LORBRENA can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective non-hormonal method of contraception, since LORBRENA can render hormonal contraceptives ineffective, during treatment with LORBRENA and for at least 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with LORBRENA and for 3 months after the final dose.

    Adverse Reactions: Serious adverse reactions occurred in 32% of the 295 patients; the most frequently reported serious adverse reactions were pneumonia (3.4%), dyspnea (2.7%), pyrexia (2%), mental status changes (1.4%), and respiratory failure (1.4%). Fatal adverse reactions occurred in 2.7% of patients and included pneumonia (0.7%), myocardial infarction (0.7%), acute pulmonary edema (0.3%), embolism (0.3%), peripheral artery occlusion (0.3%), and respiratory distress (0.3%). The most common (=20%) adverse reactions were edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea; the most common (=20%) laboratory abnormalities were hypercholesterolemia, hypertriglyceridemia, anemia, hyperglycemia, increased AST, hypoalbuminemia, increased ALT, increased lipase, and increased alkaline phosphatase.

    Drug Interactions: LORBRENA is contraindicated in patients taking strong CYP3A inducers. Avoid concomitant use with moderate CYP3A inducers and strong CYP3A inhibitors. If concomitant use of moderate CYP3A inducers cannot be avoided, monitor ALT, AST, and bilirubin as recommended. If concomitant use with a strong CYP3A inhibitor cannot be avoided, reduce the LORBRENA dose as recommended. Concomitant use of LORBRENA decreases the concentration of CYP3A substrates.

    Lactation: Because of the potential for serious adverse reactions in breastfed infants, instruct women not to breastfeed during treatment with LORBRENA and for 7 days after the final dose.

    Hepatic Impairment: No dose adjustment is recommended for patients with mild hepatic impairment. The recommended dose of LORBRENA has not been established for patients with moderate or severe hepatic impairment.

    Renal Impairment: No dose adjustment is recommended for patients with mild or moderate renal impairment. The recommended dose of LORBRENA has not been established for patients with severe renal impairment.

    About Non-Small Cell Lung Cancer

    Lung cancer is the leading cause of cancer death worldwide.4 NSCLC accounts for about 85 percent of lung cancer cases and remains difficult to treat, particularly in the metastatic setting.5 Approximately 75 percent of NSCLC patients are diagnosed late with metastatic or advanced disease where the five-year survival rate is only five percent.2,6,7

    ALK gene rearrangement is a genetic alteration that drives the development of lung cancer in some patients.8,9 Epidemiology studies suggest that approximately three to five percent of NSCLC tumors are ALK-positive.10,11

    About Pfizer in Lung Cancer

    Pfizer Oncology is committed to addressing the unmet needs of patients with lung cancer, the leading cause of cancer-related deaths worldwide and a particularly difficult-to-treat disease. Pfizer strives to address the diverse and evolving needs of patients with non-small cell lung cancer (NSCLC) by developing efficacious and tolerable therapies, including biomarker-driven therapies and immuno-oncology (IO) agents and combinations. By combining leading scientific insights with a patient-centric approach, Pfizer is continually advancing its work to match the right patient with the right medicine at the right time. Through our growing research pipeline and collaboration efforts, we are committed to delivering renewed hope to patients living with NSCLC.

    About XALKORI® (crizotinib)

    XALKORI is a tyrosine kinase inhibitor (TKI) indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. XALKORI has received approval for patients with ALK-positive NSCLC in more than 90 countries including Australia, Canada, China, Japan, South Korea and the European Union. XALKORI is also approved for ROS1-positive NSCLC in more than 60 countries.

    XALKORI® Important Safety Information

    Hepatotoxicity: Drug-induced hepatotoxicity with fatal outcome occurred in 0.1% of patients treated with XALKORI across clinical trials (n=1719). Transaminase elevations generally occurred within the first 2 months. Monitor liver function tests, including ALT, AST, and total bilirubin, every 2 weeks during the first 2 months of treatment, then once a month, and as clinically indicated, with more frequent repeat testing for increased liver transaminases, alkaline phosphatase, or total bilirubin in patients who develop transaminase elevations. Permanently discontinue for ALT/AST elevation >3 times ULN with concurrent total bilirubin elevation >1.5 times ULN (in the absence of cholestasis or hemolysis); otherwise, temporarily suspend and dose-reduce XALKORI as indicated.

    Interstitial Lung Disease (Pneumonitis): Severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis can occur. Across clinical trials (n=1719), 2.9% of XALKORI-treated patients had any grade ILD, 1.0% had Grade 3/4, and 0.5% had fatal ILD. ILD generally occurred within 3 months after initiation of treatment. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Exclude other potential causes and permanently discontinue XALKORI in patients with drug-related ILD/pneumonitis.

    QT Interval Prolongation: QTc prolongation can occur. Across clinical trials (n=1616), 2.1% of patients had QTcF (corrected QT by the Fridericia method) =500 ms and 5.0% had an increase from baseline QTcF =60 ms by automated machine-read evaluation of ECGs. Avoid use in patients with congenital long QT syndrome. Monitor ECGs and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or who are taking medications that prolong the QT interval. Permanently discontinue XALKORI in patients who develop QTc >500 ms or =60 ms change from baseline with Torsade de pointes, polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmia. Withhold XALKORI in patients who develop QTc >500 ms on at least 2 separate ECGs until recovery to a QTc =480 ms, then resume at a reduced dose.

    Bradycardia: Symptomatic bradycardia can occur. Across clinical trials, bradycardia occurred in 12.7% of patients treated with XALKORI (n=1719). Avoid use in combination with other agents known to cause bradycardia. Monitor heart rate and blood pressure regularly. In cases of symptomatic bradycardia that is not life-threatening, hold XALKORI until recovery to asymptomatic bradycardia or to a heart rate of =60 bpm, re-evaluate the use of concomitant medications, and adjust the dose of XALKORI. Permanently discontinue for life-threatening bradycardia due to XALKORI; however, if associated with concomitant medications known to cause bradycardia or hypotension, hold XALKORI until recovery to asymptomatic bradycardia or to a heart rate of =60 bpm. If concomitant medications can be adjusted or discontinued, restart XALKORI at 250 mg once daily with frequent monitoring.

    Severe Visual Loss: Across clinical trials, the incidence of Grade 4 visual field defect with vision loss was 0.2% (n=1719). Discontinue XALKORI in patients with new onset of severe visual loss (best corrected vision less than 20/200 in one or both eyes). Perform an ophthalmological evaluation. There is insufficient information to characterize the risks of resumption of XALKORI in patients with a severe visual loss; a decision to resume should consider the potential benefits to the patient.

    Vision Disorders: Most commonly visual impairment, photopsia, blurred vision or vitreous floaters, occurred in 63.1% of 1719 patients. The majority (95%) of these patients had Grade 1 visual adverse reactions. 0.8% of patients had Grade 3 and 0.2% had Grade 4 visual impairment. The majority of patients on the XALKORI arms in Studies 1 and 2 (>50%) reported visual disturbances which occurred at a frequency of 4-7 days each week, lasted up to 1 minute, and had mild or no impact on daily activities.

    Embryo-Fetal Toxicity: XALKORI can cause fetal harm when administered to a pregnant woman. Advise of the potential risk to the fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least 45 days (females) or 90 days (males) respectively, following the final dose of XALKORI.

    ROS1-positive Metastatic NSCLC: Safety was evaluated in 50 patients with ROS1-positive metastatic NSCLC from a single-arm study, and was generally consistent with the safety profile of XALKORI evaluated in patients with ALK-positive metastatic NSCLC. Vision disorders occurred in 92% of patients in the ROS1 study; 90% of patients had Grade 1 vision disorders and 2% had Grade 2.

    Adverse Reactions: Safety was evaluated in a phase 3 study in previously untreated patients with ALK-positive metastatic NSCLC randomized to XALKORI (n=171) or chemotherapy (n=169). Serious adverse events were reported in 34% of patients treated with XALKORI, the most frequent were dyspnea (4.1%) and pulmonary embolism (2.9%). Fatal adverse events in XALKORI-treated patients occurred in 2.3% of patients, consisting of septic shock, acute respiratory failure, and diabetic ketoacidosis. Common adverse reactions (all grades) occurring in =25% and more commonly (=5%) in patients treated with XALKORI vs chemotherapy were vision disorder (71% vs 10%), diarrhea (61% vs 13%), edema (49% vs 12%), vomiting (46% vs 36%), constipation (43% vs 30%), upper respiratory infection (32% vs 12%), dysgeusia (26% vs 5%), and abdominal pain (26% vs 12%). Grade 3/4 reactions occurring at a =2% higher incidence with XALKORI vs chemotherapy were QT prolongation (2% vs 0%), esophagitis (2% vs 0%), and constipation (2% vs 0%). In patients treated with XALKORI vs chemotherapy, the following occurred: elevation of ALT (any grade [79% vs 33%] or Grade 3/4 [15% vs 2%]); elevation of AST (any grade [66% vs 28%] or Grade 3/4 [8% vs 1%]); neutropenia (any grade [52% vs 59%] or Grade 3/4 [11% vs 16%]); lymphopenia (any grade [48% vs 53%] or Grade 3/4 [7% vs 13%]); hypophosphatemia (any grade [32% vs 21%] or Grade 3/4 [10% vs 6%]). In patients treated with XALKORI vs chemotherapy, renal cysts occurred (5% vs 1%). Nausea (56%), decreased appetite (30%), fatigue (29%), and neuropathy (21%) also occurred in patients taking XALKORI.

    Drug Interactions: Exercise caution with concomitant use of moderate CYP3A inhibitors. Avoid grapefruit or grapefruit juice which may increase plasma concentrations of crizotinib. Avoid concomitant use of strong CYP3A inducers and inhibitors. Avoid concomitant use of CYP3A substrates with narrow therapeutic range in patients taking XALKORI. If concomitant use of CYP3A substrates with narrow therapeutic range is required in patients taking XALKORI, dose reductions of the CYP3A substrates may be required due to adverse reactions.

    Lactation: Because of the potential for adverse reactions in breastfed infants, advise females not to breastfeed during treatment with XALKORI and for 45 days after the final dose.

    Hepatic Impairment: Crizotinib concentrations increased in patients with pre-existing moderate (any AST and total bilirubin >1.5x ULN and =3x ULN) or severe (any AST and total bilirubin >3x ULN) hepatic impairment. Reduce XALKORI dose in patients with moderate or severe hepatic impairment. The recommended dose of XALKORI in patients with pre-existing moderate hepatic impairment is 200 mg orally twice daily or with pre-existing severe hepatic impairment is 250 mg orally once daily.

    Renal Impairment: Decreases in estimated glomerular filtration rate occurred in patients treated with XALKORI. Administer XALKORI at a starting dose of 250 mg taken orally once daily in patients with severe renal impairment (CLcr <30 mL/min) not requiring dialysis.

    For more information and full prescribing information, please visit www.XALKORI.com.

    About Pfizer Oncology

    At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference on the lives of patients. Today, Pfizer Oncology has an industry-leading portfolio of 13 approved cancer medicines across 21 indications, including breast, prostate, kidney, lung and hematology. We also have one of the deepest oncology biosimilars pipelines, with two medicines approved globally and several assets in mid to late-stage development for the treatment of cancer or as supportive care. Pfizer Oncology is striving to change the trajectory of cancer.

    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 health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care 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, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and 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 November 2, 2018. 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 LORBRENA (lorlatinib), including its 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, uncertainties regarding the commercial success of LORBRENA; the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; whether and when applications for LORBRENA may be filed in any other jurisdictions; whether and when any such applications for LORBRENA that maybe be pending or filed may be approved by regulatory authorities, 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 and, if approved, whether LORBRENA will be commercially successful; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of LORBRENA; 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, 2017 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.

    1 Lin JJ, Riely GJ & Shaw AT, Targeting ALK: Precision Medicine Takes on Drug Resistance, Cancer Discovery Volume 7, Issue 2, pp. 137-155, 2017

    2 Shaw AT, et al. Alectinib versus crizotinib in treatment-naïve advanced ALK-positive non-small cell lung cancer (NSCLC): Primary results of the global phase III ALEX study. Presented at: ASCO Annual Meeting; 2017 Jun 2-6; Chicago, IL, USA. Abstract #LBA9008.

    3 Mano H. Second-Generation ALK Inhibitors, Clinical Advances in Hematology & Oncology Volume 13, Issue 7 July 2015.

    4 World Health Organization. International Agency for Research on Cancer. GLOBOCAN 2018: Lung fact sheet. http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed September 2018.

    5 Reade CA, Ganti AK. EGFR targeted therapy in non-small cell lung cancer: potential role of cetuximab. Biologics. 2009; 3: 215–224.

    6 Yang P, Allen MS, Aubry MC, et al. Clinical features of 5,628 primary lung cancer patients: experience at Mayo Clinic from 1997 to 2003. Chest. 2005;128(1):452–462

    7 American Cancer Society. Detailed Guide: Lung Cancer (Non-Small Cell). Available at: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-survival-rates. Accessed February 2018.

    8 Chiarle R, Voena C, Ambrogio C, et al. The anaplastic lymphoma kinase in the pathogenesis of cancer. Nat Rev Cancer. 2008;8(1):11-23.

    9 Guérin A, Sasane M, Zhang J et al. ALK rearrangement testing and treatment patterns for patients with ALK-positive non-small cell lung cancer. Cancer Epidemiol. 2015 Jun;39(3):307-12. doi: 10.1016

    11 Garber K. ALK, lung cancer, and personalized therapy: portent of the future? J Natl Cancer Inst. 2010;102:672-675.


    ARCA biopharma Announces Second Quarter 2018 Financial Results and Provides Corporate Update | killexams.com real questions and Pass4sure dumps

    WESTMINSTER, Colo., Aug. 09, 2018 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today reported financial results for the quarter ended June 30, 2018.

    “The second quarter of this year saw an important milestone for the Gencaro development program with the completion of an End-of-Phase 2 FDA meeting that provided important guidance for the next steps in our development of Gencaro as potentially the first genetically-targeted treatment for atrial fibrillation,” commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer.  “With work underway on completing the Gencaro Phase 3 trial protocol and continued progress with IND enabling activities for AB171 in PAD and HF, we believe ARCA is advancing our pipeline of genetically-targeted therapeutics to address the unmet medical needs of patients with cardiovascular disease.”

    Pipeline Update

    Gencaro (bucindolol hydrochloride) - a pharmacologically unique beta-blocker and mild vasodilator being developed for the potential treatment of patients with atrial fibrillation (AF) and chronic heart failure with reduced left ventricular ejection fraction (HFrEF).

  • In April 2018, Medtronic, Inc. and ARCA agreed to extend their current U.S., Canadian and European Clinical Trial Collaboration Agreement for one additional year.
  • In May 2018, results from ARCA’s GENETIC-AF Phase 2B clinical trial were presented in a “Late Breaking Clinical Trials” oral presentation at the European Society of Cardiology (ESC) Heart Failure 2018 World Congress.
  • In June 2018, ARCA held an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to review the GENETIC-AF data and potential future Gencaro development plans.
  • FDA concurrence to proceed into Phase 3 was reached. ARCA anticipates submitting a Special Protocol Assessment (SPA) application for the proposed Gencaro Phase 3 clinical trial in the third quarter of 2018. Progress to Phase 3 is dependent on the Company receiving additional funding.
  • AB171 – a thiol-substituted isosorbide mononitrate being developed as a potential genetically-targeted treatment for heart failure (HF) and peripheral arterial disease (PAD).

  • Chemistry, manufacturing and controls (CMC) activities were continued in the second quarter.
  • IND-enabling non-clinical studies are anticipated to begin in the first half of 2019.
  • Second Quarter 2018 Summary Financial Results

    Cash, cash equivalents and marketable securities totaled $9.6 million as of June 30, 2018, compared to $11.8 million as of December 31, 2017. ARCA believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations, at its projected cost structure, through the end of the first quarter of 2019.

    Research and development (R&D) expenses for the quarter ended June 30, 2018 totaled $1.2 million compared to $4.5 million for the corresponding period of 2017.  The $3.3 million decrease in research and development expenses in the second quarter of 2018 as compared to the second quarter 2017 was primarily due to decreased clinical expenses following the completion of the GENETIC-AF clinical trial.  The Company expects R&D expenses in 2018 to be lower than 2017 as the GENETIC-AF clinical trial has been completed.

    General and administrative (G&A) expenses for the quarter ended June 30, 2018 were $1.0 million, relatively unchanged compared to the $1.1 million in the second quarter of 2017.  ARCA expects G&A expenses in 2018 to be consistent with those in 2017 as it maintains administrative activities to support ongoing operations.

    Total operating expenses for the quarter ended June 30, 2018 were $2.2 million compared to $5.6 million for the second quarter of 2017.  The decrease in total operating expenses for the second quarter of 2018 was primarily due to the decrease in R&D expense due to the completion of the GENETIC-AF clinical trial.

    Net loss was $2.1 million, or $0.15 per share, for the second quarter of 2018 compared to $5.5 million, or $0.59 per share, for the second quarter of 2017.

    About ARCA biopharma

    ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA’s lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for the potential treatment of patients with atrial fibrillation (AF) and chronic heart failure with reduced left ventricular ejection fraction (HFrEF) which recently completed a Phase 2B clinical trial. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted AF prevention treatment. ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. The Gencaro development program has been granted Fast Track designation by FDA. ARCA is also developing AB171, a thiol-substituted isosorbide mononitrate, as a potential genetically-targeted treatment for peripheral arterial disease (PAD) and for heart failure (HF). For more information, please visit www.arcabio.com.

    Story Continues

    Safe Harbor Statement

    This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the ability of ARCA’s financial resources to support its operations through the end of the first quarter of 2019, potential future development plans for Gencaro, the expected features and characteristics of Gencaro or AB171, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat AF, AB171’s potential to treat HF, future treatment options for patients with AF, and the potential for Gencaro to be the first genetically-targeted AF prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties.  Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA’s financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes.  These and other factors are identified and described in more detail in ARCA’s filings with the Securities and Exchange Commission, including without limitation ARCA’s annual report on Form 10-K for the year ended December 31, 2017, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.

    Investor & Media Contact:Derek Cole720.940.2163derek.cole@arcabio.com

    (Tables follow)

      ARCA BIOPHARMA, INC.   BALANCE SHEET DATA  (in thousands)  (unaudited)     June 30, 2018   December 31, 2017 Cash, cash equivalents & marketable securities $9,635   $11,752 Working capital $8,950   $10,229 Total assets $10,067   $12,365 Total stockholders’ equity $8,998   $10,275        

     

        ARCA BIOPHARMA, INC.       STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS   (unaudited)         Three Months Ended     Six Months Ended     June 30,     June 30,     2018     2017     2018     2017                                     (in thousands, except share and per share amounts)   Costs and expenses:                               Research and development $ 1,154     $ 4,508     $ 2,874     $ 7,754   General and administrative   1,002       1,051       2,055       2,186   Total costs and expenses   2,156       5,559       4,929       9,940   Loss from operations   (2,156 )     (5,559 )     (4,929 )     (9,940 )                                 Interest and other income   43       39       84       84   Interest expense   (3 )     (2 )     (6 )     (4 ) Net loss $ (2,116 )   $ (5,522 )   $ (4,851 )   $ (9,860 )                                 Change in unrealized loss on marketable securities   —       4       2       14   Comprehensive loss $ (2,116 )   $ (5,518 )   $ (4,849 )   $ (9,846 )                                 Net loss per share:                               Basic and diluted $ (0.15 )   $ (0.59 )   $ (0.35 )   $ (1.07 ) Weighted average shares outstanding:                               Basic and diluted   13,923,512       9,324,822       13,772,947       9,210,186                                  

    A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740



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