All Posts Tagged With: "PLX"
(PLX) Protalix BioTherapeutics Sees FDA Setback for Gaucher Drug
Protalix BioTherapeutics, Inc. (PLX) was dealt a huge blow recently with the US Food and Drug Administration (FDA) issuing a complete response letter (CRL) for the company’s Gaucher disease candidate, taliglucerase...
(PFE) Pfizer and Protalix BioTherapeutics Seek EU Approval
Pfizer (PFE) and its partner Protalix BioTherapeutics Inc. (PLX) recently announced that they have submitted the Marketing Authorization...
(SNY) Sanofi-Aventis Makes Hostile Bid for Genzyme
French pharma giant Sanofi-Aventis (SNY) recently went hostile with its bid to acquire biotech company Genzyme Corporation (GENZ). Sanofi...
(GENZ) Genzyme Rejects Sanofi-Aventis’ Aquisition Offer
Genzyme Corp. (GENZ) recently rejected Sanofi-Aventis’ (SNY) offer to acquire the company for $69 per share. Earlier in the day, Sanofi...
(PLX) Protalix Biotherarapeutics – Added to Barchart Van Meerten Speculative Portfolio
Protalix Biotherapeutics (PLX) was added to the Barchart Van Meerten Speculative portfolio this morning. They are engaged in the provision of practice management services to the Affiliated Practices pursuant...
(SHPGY) Shire Plc Earns European Approval for Vpriv
Recently, Shire Plc. (SHPGY) received a boost when the European Commission approved its Gaucher disease product Vpriv (velaglucerase alfa) for marketing in 30 European countries. The decision to approve...
(GENZ) Genzyme Second Quarter 2010 Earnings Miss by a Wide Margin
Genzyme Corporation (GENZ) reported second quarter earnings of 6 cents per share (excluding one-time items but including the impact of stock-based compensation expense), well below the Zacks Consensus Estimate...
(SHPGY) Shire plc Hears Good News From European Medicines Agency
Recently Shire plc (SHPGY) announced that its Gaucher disease product VPRIV (velaglucerase alfa) has received a favorable opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products...
(GENZ) Genzyme Corporation Earnings Scorecard
Following the release of first quarter results on April 21, 2010, several analysts covering Genzyme Corporation (GENZ) have lowered their earnings estimates for 2010 and 2011. Genzyme is still suffering from...
(GENZ) Genzyme First Quarter Earnings Beat by a Penny
Genzyme Corporation (GENZ) reported first quarter earnings of 24 cents per share, above the Zacks Consensus Estimate of 19 cents but well below the year-ago earnings of 70 cents.
With the company facing...
(SHPGY) Shire Presents Positive Data on Vpriv
Shire Plc. (SHPGY) recently presented positive phase III data on its Gaucher disease product, Vpriv. The trial was conducted to study the safety of switching patients from Genzyme’s (
(GENZ) Genzyme Corporation Sees FDA Consent Decree Likely
Just when Genzyme Corp. (GENZ) was slowly making some progress in addressing its manufacturing issues, the company announced that the US Food and Drug Administration (FDA) intends to take enforcement action...
(GENZ) Genzyme Likely to See FDA Enforcement Action
Just when Genzyme Corp. (GENZ) was slowly making some progress in addressing its manufacturing issues, the company announced that the US Food and Drug Administration (FDA) intends to take enforcement action...
(GENZ) Hospira Inks Manufacturing Deal with Genzyme
Genzyme Corp. (GENZ) has entered into a contract manufacturing agreement with Hospira (HSP) for its key drugs Incorporatedluding Cerezyme...
(PLX) Protalix Biotherapeutics’ Drug Advances
Good news for Protalix Biotherapeutics (PLX) once again! The company completed the submission of its New Drug Application (NDA) with the US Food and Drug Administration (FDA) for taliglucerase alfa, which...
(GENZ) Genzyme Resumes Cerezyme Shipment
Genzyme Corp. (GENZ) recently reported progress on the resumption of supply of new lots of Cerezyme from its Allston Landing manufacturing facility, which was temporarily shut down due to contamination issues....
(SHPGY) Shire Plc’s Drug Seeks European Medicines Agency Approval
Shire plc (SHPGY) continues to make progress with its Gaucher disease candidate, velaglucerase alfa. The company recently submitted a marketing authorization application (MAA) to the European Medicines Agency...
(GENZ) Genzyme Corp Haunted by Contamination Issues
Biotech company Genzyme Corp. (GENZ), faced yet another setback recently when the U.S. Food and Drug Administration (FDA) announced that vials of five drugs marketed by the company were found to be contaminated.
The...
(GENZ) Genzyme Misses & Slashes Earnings Guidance Again for 2009
This morning, Genzyme Corp (GENZ) reported third quarter earnings of 19 cents per share, which was well below the Zacks Consensus Estimate of 31 cents and the year ago earnings of 93 cents. Moreover, revenues declined 9% to $1.06 billion.
As expected,...
(GENZ) Genzyme Struggles to Restore Order
On Wednesday, Genzyme Corp. (GENZ) provided a mixed update on its supply schedule for Cerezyme and Fabrazyme. The...
(PLX) Protalix BioTherapeutics Wins Orphan Drug Status
Yesterday, Protalix BioTherapeutics, Inc. (PLX) announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to prGCD for the treatment of Gaucher disease, an enzyme disorder that can cause liver and neurological problems.
The...