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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.
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.
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.
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.
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.
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.
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A new CBER draft guidance outlines certain exemptions for procedures involving human cells, tissues or cellular or tissue-based products.
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.
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.
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.
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