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TXT Pfizer Walks Away From Remoxy Development [143 Words] [ Price : $8.95]
Pfizer tells its development partner Pain Therapeutics that it has decided to discontinue its agreement to develop and commercialize Remoxy (oxycodone) extended-release capsules due to unresolved issues outlined in a 2011 complete response letter.
10/27/2014
 
 
TXT Baxter Recalls 2 Intravia Container Lots [88 Words] [ Price : $8.95]
Baxter International recalls two lots of Intravia containers in the U.S. and Canada due to complaints about particulate matter found inside the fluid path.
10/27/2014
 
 
TXT Group Challenges FDA on Animal Data Reliance [262 Words] [ Price : $8.95]
The Center for Responsible Science says FDA should refine its recently released “Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Availability” to provide more clarification on the risks inherent in relying on animal models to support clinical investigations.
10/27/2014
 
 
TXT FDA Wants More Data from Sarepta on Duchenne Drug [406 Words] [ Price : $8.95]
FDA deals Sarepta Therapeutics another blow by asking for additional data to be included in the company’s planned NDA for eteplirsen for treating Duchenne muscular dystrophy.
10/27/2014
 
 
TXT FDA OKs St. Jude Medical TactCath Quartz Ablation Catheter [216 Words] [ Price : $8.95]
FDA approves a St. Jude Medical PMA for its TactiCath Quartz irrigated ablation catheter, a real-time objective measure of the force that the catheter applies to a patient’s heart wall during an ablation procedure.
10/27/2014
 
 
TXT Rich Pharma Submits IND to FDA for Blood Diseases [98 Words] [ Price : $8.95]
Rich Pharmaceuticals submits an IND application to FDA for a Phase 2 clinical trial of its RP-323 in patients with acute myelocytic leukemia and myelodysplastic syndrome.
10/24/2014
 
 
TXT CBER Guide on ‘Same Surgical Procedure’ Under HCT/P Rule [144 Words] [ Price : $8.95]
A new CBER draft guidance outlines certain exemptions for procedures involving human cells, tissues or cellular or tissue-based products.
10/24/2014
 
 
TXT FDA Approves Baxter BLA for Acquired Hemophilia A Therapy [203 Words] [ Price : $8.95]
FDA approves a Baxter Healthcare BLA for Obizur [antihemophilic factor (recombinant), porcine sequence] for treating bleeding episodes in adults with acquired hemophilia A.
10/24/2014
 
 
TXT FDA Warning Letter on Hikma Pharma’s Portugal Plant [284 Words] [ Price : $8.95]
FDA issues a Warning Letter to Hikma Pharmaceuticals, citing GMP issues related to environmental monitoring at its plant in Portugal.
10/24/2014
 
 
TXT Dallas Jury Clears J&J Unit in Hip Implant Case [141 Words] [ Price : $8.95]
A Dallas jury finds that Johnson & Johnson’s DePuy unit did not market defective metal-on-metal hip implants.
10/24/2014
 
 
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