All Posts Tagged With: "HAE"
(VPHM) Update on ViroPharma Industrial Facility
ViroPharma Inc. (VPHM) recently announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Cinryze’s industrial scale manufacturing facility.
The regulatory...
(VPHM) ViroPharma Drug Earns Priority Review
ViroPharma Inc. (VPHM) recently announced that the Canadian regulatory body has granted priority review status to the company’s new drug submission (NDS) for Cinryze. ViroPharma is seeking the drug’s...
(VPHM) ViroPharma Going Strong
ViroPharma Inc. (VPHM) posted third quarter 2011 earnings (including special items) of 35 cents per share, surpassing the Zacks Consensus Estimate of 33 cents, but lower than the year-ago figure of 45 cents.
Excluding...
(VPHM) ViroPharma and Halozyme Therapeutics Begin Trial
ViroPharma Inc. (VPHM) and its partner Halozyme Therapeutics (HALO) recently announced the initiation of a mid-stage trial on its drug...
(VPHM) ViroPharma Quarterly Earnings Report Misses Due to Higher Expenses
ViroPharma Inc. (VPHM) posted second quarter fiscal 2011 earnings of 36 cents per share, missing the Zacks Consensus Estimate by 3 cents and the year-ago figure by a penny. Despite higher revenues, earnings...
(ACOR) Company News for August 2, 2011 – Corporate Summary
• Allstate Corporation (NYSE:ALL) reported Q2 loss of $1.23, lower than the Zacks Consensus Estimate of $1.53 per share. Revenues for the quarter increased by 5% year-over-year to $8.08 billion,...
(CHMP) ViroPharma’s Epilepsy Drug Recommended
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently gave the go ahead to ViroPharma Inc.’s (VPHM) Buccolam (midazolam, oromucosal solution). The company...
(SHPGY) Shire to Produce More Replagal
UK-based Shire (SHPGY) recently announced that the European Medicines Agency (EMA) has increased the company’s manufacturing flexibility for Replagal (agalsidase alfa), an enzyme replacement therapy approved...
(SHPGY) Shire’s Firazyr Earns FDA Panel Backing
Recently, the Pulmonary-Allergy Drugs Advisory Committee of the US Food and Drug Administration (FDA) issued a positive opinion and recommended the US approval of Shire’s (SHPGY) Firazyr (icatibant).
Shire...
(MDT) Medical Devices Stock Outlook – June 2011 – Industry Outlook
A host of macro headwinds (including price and procedure volume pressure) which hit the MedTech industry last year continued to haunt the sector during the March quarter and encumber growth. Although a number of these issues are expected to linger through the remainder of...
(VPHM) ViroPharma’s HAE Drug Gets EU Nod
ViroPharma Inc. (VPHM) recently announced that the European Commission (EC) granted Centralized Marketing Authorization to Cinryze for the treatment of hereditary angioedema (HAE).
The drug is indicated...
(HAE) Haemonetics to Discuss Plans
Haemonetics (HAE) will hold its annual investor and analyst day on May 12, 2011 at its corporate headquarters in Braintree, Massachusetts. Other than guidance for fiscal 2012, the company will discuss issues...
(MDT) Medical Devices Industry Outlook – April 2011 – Industry Outlook
Last year was challenging for medical device companies given the exigent economic conditions and an uncertain healthcare environment. The MedTech industry was hit by several macro headwinds in 2010 including price/volume and utilization pressure and a more restrictive regulatory...
(MDT) Medical Devices Industry Outlook December 2010 – Industry Outlook
Industry Dynamics
The global medical devices industry is fairly large, intensely competitive and highly innovative with 2009 worldwide sales in excess of $220 billion. The U.S. accounts for approximately 41% of this market. The industry is divided into...
(CMS) Medical Devices Industry Outlook – August 2010 – Zacks Analyst Interviews
Prelude
The global medical devices industry is fairly large, intensely competitive and highly innovative with annual worldwide sales in 2009 in excess of $220 billion. The U.S. accounts for approximately 41% of this market.
The industry is divided...
(CMS) Medical Devices Industry Outlook – August 2010 – Industry Outlook
Prelude
The global medical devices industry is fairly large, intensely competitive and highly innovative with annual worldwide sales in 2009 in excess of $220 billion. The U.S. accounts for approximately 41% of this market.
The industry is divided...
(MDT) Medical Devices Stock Review – May 2010 – Industry Outlook
The global medical devices industry is fairly large, with annual worldwide sales in 2009 in excess of $220 billion. The U.S. accounts for approximately 41% of this market. The industry is divided into different categories such as Cardiology, Oncology, Neuro, Orthopedic, Aesthetic...
(MASI) Masimo Wins New Customer Nassau University Medical Center
Masimo Corp. (MASI) recently reported that its new customer, Nassau University Medical Center (NUMC), has completed its system-wide conversion to Masimo SET pulse oximetry technology. The conversion allows...
(HAE) Haemonetics Enters New Agreement
Haemonetics Corp. (HAE) recently entered a new reagent development and supply agreement with Quotient Biodiagnostics Group and its wholly-owned subsidiary Alba Bioscience Limited. Per the agreement, Haemonetics...
(MASI) Masimo Analysts Maintain Neutral Rating
We continue to maintain our ‘Neutral’ rating on Masimo Corp. (MASI) with a target price of $28 based on a P/E of 28.0x our fiscal 2010 EPS estimate of $1. The company’s fourth quarter fiscal 2009 results...
(HAE) Haemonetics Receives U.S. Food and Drug Administration Approval
Haemonetics Corp. (HAE) recently received the U.S. Food and Drug Administration (FDA) approval for its expanded nomogram to collect two Red Blood Cells on the Cymbal Automated Blood Collection System from...
(HAE) Haemonetics Corporation Misses Earnings Estimates
Haemonetics Corporation (HAE) reported third quarter fiscal 2010 earnings per share of 71 cents, missing the Zacks Consensus Estimate of 72 cents. Earnings in the year-ago quarter were 63 cents.
The...
(MDRX) Medical Devices Stock Review – Feburary 2010 – Industry Outlook
The global medical devices industry is fairly large, with annual worldwide sales in excess of $200 billion. The U.S. accounts for approximately 41% of this market. The industry is divided into different categories such as Cardiology, Oncology, Neuro, Orthopedic, Aesthetic...
(MASI) Masimo Corporation Announces Positive Results From Clinical Study
Masimo Corporation (MASI) recently announced positive results form its 21-month clinical study on the impact of the Masimo Patient SafetyNet remote monitoring and clinician notification system. Results indicated...
(KERX) Healthcare Stock Watch: Short List of Booming (and Busting) Companies
by Marc Lichtenfeld, Healthcare Expert
Wednesday, January 20, 2010: Issue...
(MASI) Masimo Corporation Can Now Earn While Patients Test Device Effectiveness
Masimo Corporation (MASI) has recently received a new Current Procedural Terminology (CPT) code from the American Medical Association, 88738, for its noninvasive hemoglobin (SpHb) measurement. Medicare has...
(HAE) Haemonetics Files Patent Infringement Lawsuit Against Fenwal Inc
Haemonetics Corporation (HAE) has recently filed a new lawsuit against Fenwal Inc. regarding the latter’s continued patent infringement with the release of its red cell collection kits. Fenwal allegedly...
(MASI) Masimo Completes Conversion of New Customer
Masimo Corp. (MASI) reported that its new customer, Brookdale University Hospital and Medical Center in Brooklyn, New York, has completed its system-wide conversion to Masimo SET pulse oximetry technology....
(MASI) Masimo Corporation Earns FDA New Product Approval
Masimo Corporation (MASI) recently received the U.S. Food and Drug Administration (FDA) approval for its new product, Masimo Rainbow SET Acoustic Monitoring. The new product enables noninvasive and continuous...
(MASI) Masimo Corporation Renews Deal with Advocate Health Care
Masimo Corporation (MASI) announced that one of its prominent customers, Advocate Health Care, has recently renewed its multi-year, system-wide contract for Masimo SET pulse oximetry technology. Advocate...