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Adma Biologics receives CRL from FDA for pending biologics license application

Friday, 29 Jul 2016 08:29pm EDT

Adma Biologics Inc : CRL did not cite any concerns with clinical safety and efficacy data for ri-002 submitted by adma in bla . FDA has not requested any additional clinical studies be conducted prior to fda approval of ri-002 for pidd. . Adma biologics receives complete response letter from fda for pending biologics license application . FDA identified in crl certain outstanding inspection issues and deficiencies at adma's third-party contract manufacturers .FDA in CRL requested documentation of corrections for a number of issues related to adma's third-party contract manufacturers.

Adma Biologics receives CRL from FDA for pending biologics license application

Friday, 29 Jul 2016 07:14pm EDT

Adma Biologics Inc : CRL did not cite any concerns with clinical safety and efficacy data for ri-002 submitted by adma in bla . FDA has not requested any additional clinical studies be conducted prior to fda approval of ri-002 for pidd. . Adma biologics receives complete response letter from fda for pending biologics license application . FDA identified in crl certain outstanding inspection issues and deficiencies at adma's third-party contract manufacturers .FDA in CRL requested documentation of corrections for a number of issues related to adma's third-party contract manufacturers.

Alkermes says U.S. District Court issued unambiguous opinion in favor of co, U.S. FDA - SEC filing

Friday, 29 Jul 2016 12:55pm EDT

Alkermes Plc: On July 28 U.S. District Court for District of Columbia issued unambiguous opinion in favor of co and U.S. FDA - SEC filing . U.S. District Court unambiguous opinion affirming in all respects FDA's decision to approve Aristada for treatment of schizophrenia .U.S. District Court unambiguous opinion also "denying action filed by Otsuka for declaratory and injunctive relief".

Biofrontera gets favourable CHMP assessment for field-directed therapy

Thursday, 28 Jul 2016 03:30am EDT

Biofrontera AG : Receives favourable CHMP assessment for field-directed therapy and files BCC application . European Commission will issue formal approval in coming weeks . Expands market opportunity for Ameluz beyond actinic keratosis lesions (AK) to field cancerization .Submitted additional label extension application for treatment of basal cell carcinoma (BCC).

Diamyd Medical: Companion Medical receives FDA clearance

Thursday, 28 Jul 2016 02:30am EDT

Diamyd Medical AB : Companion Medical Inc. receives 510 clearance from the FDA for the InPen system, an intelligent insulin administration system and smartphone application .The InPen application is cleared for Apple iOS and an Android version is planned for later in 2016.

Regulus says working to resolve issues outlined in letter from US FDA about clinical hold

Wednesday, 27 Jul 2016 04:10pm EDT

Regulus Therapeutics Inc : Received written communication from u.s. FDA outlining information required to resolve clinical hold for its IND for RG-101 . Says On Track To Deliver Follow Up results from on-going RG-101 studies . Working to resolve issues outlined in letter and anticipate a decision from FDA in q4 . "we remain on track to deliver follow-up results from ongoing rg-101 studies" . Fda requested detailed safety data analysis from preclinical and clinical studies among other things . Fda will notify regulus of its decision within 30 days of receipt of complete response to issues .Timelines of on-going studies have not been impacted by clinical hold.

Clearside Biomedical provides update on phase 2 TANZANITE trial

Tuesday, 26 Jul 2016 07:30am EDT

Clearside Biomedical Inc : 78 percent of patients required no additional treatment in trial arm with Concomitant Suprachoroidally Administered Zuprata™ and Intravitreally Administered Eylea . Patients reached an average BCVA improvement of 19 letters over a 3-month period . Expects to have an end-of-phase 2 meeting with U.S. Food and Drug Administration (FDA) in second half of 2016 .Upon FDA feedback,intends to commence phase 3 clinical program for treatment of macular edema associated with RVO in H1 of 2017.

Immunicum will receive patent application in China on CD70

Tuesday, 26 Jul 2016 03:01am EDT

Immunicum AbB :Announced that a patent application in China regarding the company's CD70-technology will be granted.

MediciNova receives notice of allowance for new patent covering MN-001 and MN-002 for the treatment of fibrosis

Tuesday, 26 Jul 2016 01:47am EDT

MediciNova Inc :Says it received a notice of allowance from the U.S. Patent And Trademark Office (Uspto) for a pending patent application which covers Mn-001 (Tipelukast) and Mn-002 (A Major Metabolite Of Mn-001) for the treatment of “Fibrosis” which includes a broad range of fibrosis / fibrotic disease in different organs due to different causes.

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