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BioMed News Bytes: Antigenics, King, Shire, Delcath

Wed, 21 Oct 2009 14:32:05 GMT

On 6/1/09, Antigenics (NASDAQ: AGEN) announced results of an interim analysis from the Company’s ongoing global patient survival registry, which showed that patients with kidney cancer at intermediate risk of disease recurrence demonstrated an approximately 46% lower risk of death when treated with Oncophage (vitespen) cancer vaccine compared with observation ([More...]

Another Blow For Genzyme (GENZ)

Tue, 18 Aug 2009 18:47:14 GMT

Genzyme Corp. (GENZ) suffered yet another setback yesterday when Protalix BioTherapeutics Inc. announced that the US Food and Drug Administration (FDA) has approved the treatment protocol for its experimental drug for Gaucher disease. This means that the drug, prGCD, will be available for the treatment of Gaucher patients prior to its commercialization. The FDA had approached both Protalix and Shire Plc (SHPGY) last month to consider submitting a treatment protocol that would allow the use of their Gaucher disease treatments under an expanded access program in order to make up for a shortage in the supply of Cerezyme, which is the leading treatment for Gaucher. As a reminder, Genzyme has been[More...]

Genzyme's Problems Continue

Sat, 08 Aug 2009 18:29:06 GMT

Genzyme Corp. (GENZ) suffered a setback earlier this week when Shire Plc. (SHPGY) announced positive phase III results on velaglucerase alfa, an enzyme replacement therapy, which is being developed for the treatment of Gaucher disease. Shire has initiated the process of submitting its New Drug Application (NDA) for velaglucerase alfa under the U.S. Food and Drug Administration’s (FDA) fast track process. Once approved, velaglucerase alfa, will be competing directly with Genzyme’s lead product, Cerezyme. Although Cerezyme holds a leading position in the treatment of Gaucher disease, the patient population for the disease is not large. As such, the entry of additional players in the market could restrict the company’s future sales growth[More...]

FDA Calendar Updates: Genzyme FDA Woes Benefit Protalix, Shire

Fri, 31 Jul 2009 21:07:00 GMT

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 293 entries as of 7/31/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings),[More...]

Shire (NasdaqGS: SHPGY) Provides Update On ADHD Drug

Tue, 19 May 2009 14:53:21 GMT

Shire (SHPGY) has an expected PDUFA decision date during 2H09 for its NDA resubmission to the FDA in late January 2009 for marketing approval of Intuniv (guanfacine extended release - a non-controlled drug that is already available in regular formulations on a generic basis, but is dosed multiple times per day on this basis) for the proposed treatment of attention deficit hyperactivity disorder (ADHD) in children. If FDA approval is received, Shire expects to launch Intuniv in the U.S. during 4Q (...)[More...]

Ahead Of The Fed

Mon, 04 Aug 2008 14:43:00 GMT

Good morning. Premarket futures are lower following mixed economic data and declines in markets overseas. Tomorrow we have another Fed meeting with most expecting no change in their interest rate policy. Premarket gainers: PSPT, EMKR, STEC, FSYS, [More...]

Analyst Comments: EOG Resources, Charlotte Russe, VeraSun Energy, Thornburg Mortgage, Amicus Therapeutics

Thu, 31 Jul 2008 19:55:00 GMT

EOG Resources, Inc.'s (EOG) quarterly results came in better-than-expected, reflecting increased volumes and improved commodity-price realizations, partly offset by higher costs. Domestic natural gas production grew 19%, while liquids volumes rose 51% over last year. Additionally, the company raised its quarterly dividend by 12.5% to $0.135 a share. With robust growth from most of its core areas, EOG remains on track to achieve production growth of 15% this year and approximately 14% over the following two years. We maintain our Buy recommendation on EOG shares and see the stock as a core holding in the large-cap exploration and production (E&P) space. EOG is targeting 2008 production growth of approximately 15%. Driving this growth will be the company's U.S. operations, estimated to grow approximately 23% year-over-year all organic. The U.S. growth will mainly come from[More...]

Weak Economic Data

Thu, 31 Jul 2008 14:47:00 GMT

Good morning. A plethora of disappointing economic data (GDP, jobless claims, Monster Employment Index) have offset a number of better than expected earnings reports this morning. Premarket futures are pointing to a weak start to the last trading day of July. Premarket gainers: CADX, IMCL, MOT, PDGI, [More...]

Big Earnings Week

Mon, 21 Jul 2008 14:12:00 GMT

Good morning. Premarket activity suggests that we'll see a positive day following a better than expected earnings report from Bank Of America (BAC) and news that Roche has offered to buy the rest of Genentech (DNA). Oil prices are also on the rise this morning. Premarket gainers: DNA, BAC, FRE, FNM, CRNT, ANAD, NTES, [More...]

Shire Pharma Looks Past Adderall

Thu, 26 Jun 2008 20:56:49 GMT

Shire Limited's (SHPGY) attention deficit hyperactivity disorder (ADHD) franchise continues to perform very well, increasing market share to over 31 percent. Strong top-line growth should continue in 2008 as a number of new drugs ramp. Beyond 2008, we expect revenue growth to significantly slow due to the presence of generic Adderall XR. We believe that Shire will...[More...]

Evening Standard, London, Market Report Column

Wed, 19 Aug 2009 19:45:00 GMT

Aug. 19--Leading shares reversed yesterday's gains in early trading as City investors headed for the exit following a late sell-off in Asia this morning.
Shares in Hong Kong suffered a 2.4 percent sell-off just before the close of business, reflecting more big losses on the Chinese mainland.
In Shanghai, shares suffered their second-biggest sell-off of the week as punters braced themselves for a further tightening of fiscal policy.

[More...]

Daily Mail, London, Market Report Column

Tue, 18 Aug 2009 20:49:00 GMT

Aug. 18--TRADERS POCKET HOLIDAY PROFITS: It is peak holiday season and many fund managers have left the City to soak up the sun.
So what better time for those marketmakers who desperately need to replenish short book positions, to "shake the tree" and hope that a few nervous investors fall out?
Nervousness certainly spread to Asian markets overnight and China's Shanghai Composite index posted its biggest percentage drop (5.8pc) since November.

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Daily Mail, London, Market Report Column - Apr 24 2009 3:54PM

Fri, 24 Apr 2009 19:48:00 GMT

Apr. 24--Anything to take dealers' minds off the parlous state of the UK economy was welcomed with open arms following the calamitous Budget.
Speculators chased testing group Intertek 131p higher before the shares closed 78p better at 1004p on rumours of a £2.2bn, or £14 a share, bid from SGS, a Swiss rival and one of the world's largest consumer goods testers.
It reported a strong set of full-year results in March, which resulted in broker Altium upgrading current year pre-tax profit estimates to £165m from £148m.

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Shire Opens Office in Japan, Appoints New MD

Fri, 20 Feb 2009 18:25:45 GMT

Global specialty biopharmaceutical company Shire plc has officially opened a new representative office in Japan and has appointed Soh Fujiwara as Managing Director for Japanese operations.[More...]

Movers: AIG, Lehman, Healthways, LDK Solar, Noven Pharma

Tue, 26 Aug 2008 14:50:00 GMT

Fitch Ratings has placed its ratings of American International Group (AIG) and its insurance and financial services subsidiaries on Rating Watch Negative.
Previously, Fitch had a Negative Rating Outlook on AIG and the majority of its insurance-related subsidiaries rated by Fitch, and a Stable Rating Outlook on AIG's financial services subsidiaries, including AIG Capital Corp. [AIGCC], International Lease Finance Corp. [ILFC], and American General Finance Inc. [AGF].
Also, Credit Suisse lowers third quarter estimate, cuts target, rates AIG neutral.

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Impax Laboratories Commences Shipment of Generic Adderall XR® Capsules, 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg

Thu, 01 Oct 2009 19:49:00 GMT

Impax Laboratories, Inc. (NASDAQ:IPXL) today announced that it is commencing shipment of its authorized generic version of Adderall XR® Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30mg, through Global Pharmaceuticals, Impax's generic division.
Shire Pharmaceuticals markets Adderall XR® for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
In January 2006, Impax Laboratories entered into a license and promotional agreement with Shire as part of a settlement of patent litigation between the parties.

[More...]

Shire Builds Competitive Position of its HGT Business through Research Collaboration with Santaris Pharma A/S on LNA Drug Platform

Mon, 24 Aug 2009 11:56:00 GMT

Shire plc , the global specialty biopharmaceutical company, announces today that it has entered into a research-based collaboration with Santaris Pharma A/S, a leading player in RNA-based therapeutics, to develop its proprietary Locked Nucleic Acid technology in a range of rare diseases, thereby enabling Shire to build on its already strong competitive position for its Human Genetic Therapies business. LNA technology has the benefit of a very quick validated target to proof of concept turnaround, thereby increasing the speed and lowering the cost of development.[More...]

Shire Initiates Two Adult ADHD Outreach Programs

Mon, 17 Aug 2009 12:56:00 GMT

Shire Initiates Two Adult ADHD Outreach Programs[More...]

Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

Mon, 03 Aug 2009 05:56:00 GMT

Shire plc , the global specialty biopharmaceutical company, today reported positive results from the first of three Phase III studies of velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease. The Company also announced that the U.S. Food and Drug Administration has accepted its treatment protocol for velaglucerase alfa and that Shire has begun its rolling submission of the New Drug Application for velaglucerase alfa allowed under the Fast Track process.[More...]

FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents

Tue, 28 Jul 2009 05:56:00 GMT

Shire plc , the global specialty biopharmaceutical company, announces that it has received a Complete Response letter today for INTUNIV Extended Release from the Food and Drug Administration . This decision comes following labeling discussions with the FDA that did not result in agreement in time to meet the PDUFA date.[More...]

Study Published in Child and Adolescent Psychiatry and Mental Health Demonstrated Once-Daily Vyvanse(R) (lisdexamfetamine dimesylate) CII Provided Significant Improvement of ADHD Symptoms for Children at 13 Hours After Administration

Wed, 22 Jul 2009 12:58:00 GMT

Shire plc , the global specialty biopharmaceutical company, today announced that a study published online in the peer-reviewed journal Child and Adolescent Psychiatry and Mental Health found once-daily Vyvanse CII significantly reduced the symptoms of Attention-Deficit/Hyperactivity Disorder in children aged 6 to 12 from the first time point measured up to the last time point assessed after administration. In this pediatric analog classroom study, treatment with Vyvanse was associated with significant improvement in behavior and attention in children at each time point measured, with improvement at 13 hours after administration.'Pediatric patients may require ADHD symptom improvement both at school and after school,'said Sharon Wigal, PhD, lead investigator of the study, clinical professor of pediatrics and director of clinical trials in the Child Development Center at the University of California, Irvine. 'These published data are the first to have shown duration of effect of an oral ADHD stimulant in children aged 6 to 12 at 13 hours after administration. Physicians and caregivers who are seeking a long-acting medication that provides ADHD symptom improvement from morning through homework and family time may want to consider this Vyvanse study data.'On May 22, 2009, the US Food and Drug Administration approved a change to the prescribing information for Vyvanse to include supplemental data that demonstrated significant ADHD symptom improvement in children aged 6 to 12 from the first time point measured up to 13 hours postdose. Vyvanse is now the first and only oral ADHD stimulant treatment to have efficacy at 13 hours after administration for pediatric patients included in its product labeling.'Shire is proud to be at the forefront of ADHD research and treatment development and is committed to providing patients with effective ADHD medications, such as Vyvanse,' said Liza Squires, MD, Research and Development Business Unit Leader for Shire. 'These findings provided further support that Vyvanse can be an important treatment option for children who require duration of ADHD symptom improvement throughout the day.' Vyvanse Demonstrated Significant Symptom Improvement at 13 Hours After AdministrationThe study was a randomized, double-blind, placebo-controlled, analog classroom study that assessed the efficacy and safety of Vyvanse in 129 children aged 6 to 12 years with ADHD. Following a four-week, open-label, dose-optimization phase with Vyvanse at 30 mg, 50 mg, and 70 mg doses, patients entered a two-week, double-blind, crossover phase where they were randomized into two groups. One group received their optimal dose of Vyvanse the first week and placebo the second week. The second group received placebo the first week and their optimal dose of Vyvanse the second week.The primary objective of this study was to assess the time of onset of Vyvanse compared with placebo, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham Deportment rating scale. Secondary objectives included assessment of the duration of efficacy of VYVANSE compared with placebo, as measured by the SKAMP-D scale, and assessment of efficacy and time of onset of Vyvanse compared with placebo as measured by SKAMP Attention , and Permanent Product Measure of Performance scales. In the study, Vyvanse demonstrated significant efficacy versus placebo at 1.5 hours, the first time point measured. Further, Vyvanse treatment was associated with significant efficacy as measured by both subjective and objective assessments from the first time point through the last time point assessed during the classroom day, and at all time points in between .Safety was also evaluated during the study. The adverse event profile for Vyvanse was similar to other currently marketed stimulants. The most frequently reported adverse events in the dose-optimization phase for patients taking Vyvanse were decreased appetite, insomnia, headache, irritability, upper abdominal pain, and affect lability.Vyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children aged 6 to 12 years and approved in April 2008 to treat ADHD in adults, is currently available in six dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. To date, more than 6 million Vyvanse prescriptions have been filled, bringing the current US market share to over 12 percent based on weekly branded prescription volume. Additionally, Shire has executed agreements with 10 of Shire's top 11 managed care organizations to cover Vyvanse in a preferred formulary position.Vyvanse is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine. The conversion of Vyvanse to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in GI transit times. Additional information about Vyvanse and Full Prescribing Information, including Medication Guide, are available at www.vyvanse.com.About VYVANSEVyvanse is indicated for the treatment of ADHD. Efficacy based on two controlled trials in children aged 6 to 12 and one controlled trial in adults.Tell the doctor about any heart conditions, including structural abnormalities, that you, your child, or a family member, may have. Inform the doctor immediately if you or your child develops symptoms that suggest heart problems, such as chest pain or fainting.Vyvanse should not be taken if you or your child has advanced disease of the blood vessels ; symptomatic heart disease; moderate to severe high blood pressure; overactive thyroid gland ; known allergy or unusual reactions to drugs called sympathomimetic amines ; seizures; glaucoma; a history of problems with alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor within the last 14 days.Tell the doctor before taking Vyvanse if you or your child is being treated for or has symptoms of depression or bipolar disorder; has abnormal thought or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell the doctor immediately if you or your child develops any of these conditions or symptoms while taking Vyvanse.Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with amphetamine use.Talk to your health care provider if your child experiences slowing of growth . Children should have their height and weight checked periodically while taking Vyvanse. Your health care provider may stop Vyvanse treatment if a problem is found during these check-ups.Vyvanse was generally well tolerated in clinical studies. The most common side effects reported in studies of Vyvanse were: children - decreased appetite, difficulty falling asleep, stomachache, and irritability; adult - decreased appetite, difficulty falling asleep, and dry mouth. Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics, and Tourette's syndrome have been associated with use of drugs of this type. Tell the doctor if you or your child has blurred vision while taking Vyvanse.About ADHD ADHD is one of the most common psychiatric disorders in children and adolescents. Worldwide prevalence of ADHD is estimated at 5.3 percent , according to a comprehensive systematic review of this topic published in 2007 in the American Journal of Psychiatry. In the United States, approximately 7.8 percent of all school-aged children, or about 4.4 million children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the Centers for Disease Control and Prevention . The disorder is also estimated to affect 4.4 percent of US adults aged 18 to 44 based on results from the National Comorbidity Survey Replication. When this percentage is extrapolated to the full US population aged 18 and over, approximately 9.8 million adults are believed to have ADHD.ADHD is a psychiatric behavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. The specific etiology of ADHD is unknown and there is no single diagnostic test for this syndrome. Adequate diagnosis requires the use of medical and special psychological, educational and social resources, utilizing diagnostic criteria such as Diagnostic and Statistical Manual of Mental Disorders-IV or International Classification of Diseases 10 .Although there is no 'cure' for ADHD, there are accepted treatments that specifically target its symptoms. Standard treatments include educational approaches, psychological, or behavioral modification, and medication. SHIRE PLCShire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder , human genetic therapies and gastrointestinal diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.For further information on Shire, please visit the Company's Web site: www.shire.com."SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.[More...]

Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease

Thu, 16 Jul 2009 05:56:00 GMT

Shire plc , the global specialty biopharmaceutical company, announces it has received Fast Track designation from the U.S. Food and Drug Administration for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type I Gaucher disease. Shire is working with the FDA to determine subsequent steps and timing for the filing of its NDA.[More...]

Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease

Mon, 06 Jul 2009 18:57:00 GMT

Shire plc , the global specialty biopharmaceutical company, announces that, at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment for Gaucher Disease patients, it has filed a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Gaucher Disease.[More...]

Study Showed VYVANSE(R) (lisdexamfetamine dimesylate) CII Provided Significant Efficacy at 14 Hours After Administration in Adults with ADHD in an Adult Simulated Workplace Environment

Wed, 01 Jul 2009 12:58:00 GMT

VYVANSE is the first stimulant to establish duration of efficacy from two hours up to 14 hours after administration in adults with ADHD[More...]

FDA Approves Labeling Change for VYVANSE(R) (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD

Mon, 01 Jun 2009 12:56:00 GMT

ADHD symptom control demonstrated from the first time point measured through 13 hours postdose[More...]