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Glaxosmithkline says Shingrix approved in US

Friday, 20 Oct 2017

Oct 20 (Reuters) - GlaxoSmithKline Plc :Shingrix approved in the us for prevention of shingles in adults aged 50 and over‍​ ‍​.Pooled clinical trial for Shingrix showed greater than 90 percent efficacy across all age groups ‍​.Following this approval from FDA, and pending recommendation from ACIP, Shingrix will be available shortly‍​.

DBV Technologies peanut allergy treatment fails to meet main goal in late-stage study

Friday, 20 Oct 2017

Oct 20 (Reuters) - Dbv Technologies Sa :DBV Technologies announces topline results of phase III clinical trial in peanut-allergic patients four to 11 years of age‍​.DBV Technologies - topline results show statistically significant response with a favorable tolerability profile.DBV Technologies - primary endpoint did not reach 15% lower bound of CI that was proposed in study’s statistical analysis plan‍​.DBV Technologies - DBV will continue ongoing discussions with FDA, and plans to proceed with the BLA preparation process.

Concordia International seeks to realign capital structure under CBCA

Friday, 20 Oct 2017

Oct 20 (Reuters) - Concordia International Corp ::Concordia International Corp. takes next step to realign its capital structure by commencing proceedings under the Canada Business Corporations Act.Seeking to reduce its existing secured and unsecured debt obligations by more than $2 billion​.Intends to continue operating its business as usual during CBCA proceedings​.Company had approximately $340 million of cash on hand as of September 30, 2017​.Some ‍payments owed to unsecured lenders will not be paid as scheduled & are expected to be addressed as part of recapitalization.Proposed recapitalization transaction may result in dilution of outstanding common shares of company​.It is commencing a court proceeding under Canada Business Corporations Act​.Under CBCA process, Concordia's management will continue to lead day-to-day operations​.

Azurrx Biopharma, Mayoly Spindler announce IMPD submission

Friday, 20 Oct 2017

Oct 20 (Reuters) - Azurrx Biopharma Inc ::Azurrx Biopharma and Mayoly Spindler announce MS1819-SD investigational medicinal product dossier (IMPD) submission.Azurrx Biopharma - ‍IMPD submitted via European Medicines Agency clinical trial portal for approval prior to opening of clinical centers in France.

Evans Medical says bankers to takeover company assets used as collateral

Friday, 20 Oct 2017

Oct 20 (Reuters) - Evans Medical Plc :SERVED EX-PARTE ORDER OF THE FEDERAL HIGH COURT GRANTING BANKERS RIGHT TO TAKEOVER CO'S ASSETS USED AS COLLATERAL AGAINST FACILITIES.RECEIVER MANAGER BEEN APPOINTED AND HAS TAKEN OVER THE ASSETS OF THE COMPANY‍​.BEGUN DISCUSSIONS WITH TWO LENDERS, DISCUSSIONS PROGRESSING FAVOURABLY, OPTIMISTIC ARRANGEMENT WILL BE ARRIVED AS SOON AS POSSIBLE.

Curasan cuts revenue and earnings outlook for 2017

Friday, 20 Oct 2017

Oct 20 (Reuters) - CURASAN AG :SHIFTS IN REVENUE TO LEAD TO REDUCED SALES AND EARNINGS.CUTS REVENUE AND EARNINGS OUTLOOK FOR 2017.OUTLOOK 2017: GROSS REVENUES OF EUR 6.9 MILLION TO EUR 7.2 MILLION AND NET LOSS OF EUR 3.9 MILLION TO EUR 4.2 MILLION.

Health Canada grants priority review status to trifluridine and tipiracil for refractory metastatic colorectal cancer

Friday, 20 Oct 2017

Oct 20 (Reuters) - Otsuka Holdings Co Ltd <4578.T>:Taiho Pharma Canada - Health Canada accepted for review new drug submission for trifluridine, tipiracil,NDS granted priority review status​.Taiho Pharma Canada - Health Canada's review of NDS under priority review is expected to be completed in early 2018​.

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