By Andrew McDonald:AP Pharma (APPA.PK) intends to resubmit the New Drug Application (NDA) for APF530 in 1H12 after working quietly and diligently on addressing all the issues raised in a March 2010 complete response letter (CRL), which the FDA issued in response to the original NDA filing (May 2009).
By Markus Aarnio:Arena Pharmaceuticals (ARNA) is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, or GPCRs-- an important class of validated drug targets-- in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases.
FDA reviewers have recommended that the FDA issue a complete response letter for the NDA for rivaroxaban (Xarelto, Johnson & Johnson). This story will be updated later today with with more details, but here?s the bottom line from the FDA?s review: Based on our review of the clinical data, we recommend a complete response. Reasons ...
By M.E. Garza:
We anticipate that shares of Arena Pharmaceuticals (ARNA) will continue to creep up after Analysts at Piper Jaffray have upgraded the firm and raised the share price target from $1.50 to $3.
By Smith On Stocks:The FDA had apparently slammed the door shut on approval of Johnson & Johnson’s (JNJ) Xarelto (rivaroxaban) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF). The FDA reviewer in his briefing papers to the committee had recommended that the product be given a Complete Response Letter (not approvable at this time).
Mike Havrilla submits:Below is a summary of generic/specialty pharmaceutical company Lannett’s (AMEX:LCI) current financials and expected upcoming FDA catalysts. I received the following email feedback from the CFO, Mr. Keith Ruck, in mid-April regarding the status of the pending FDA decisions after recently announced conclusion of the FDA pre-approval inspections.Mr.
Steven Breazzano submits:Long investors in Protalix BioTherapeutics (AMEX: PLX) awoke Friday morning to a press release announcing a CRL (Complete Response Letter) from the FDA. While the stock immediately sold off to the mid 6’s before recovering to mid 7’s (a 19% dis
By Larry SmithTranscept (TSPT) believes that the results of the highway driving study of Intermezzo reasonably answer the concerns of the FDA that caused the agency to issue a Complete Response Letter to the NDA in October of 2009. It plans to re-submit the NDA in the first quarter of 2011.Complete Story »