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Dato
27.10.2016
BONESUPPORT™ Raises $37 million (SEK 327 million) to Drive Product Sales and Deliver Further Value from CERAMENT™ Injectable Drug Eluting Bioceramic Platform

Dr. Håkan Björklund of Tellacq AB, former CEO of Nycomed, becomes Chairman-Elect 

CERAMENT BVF, CERAMENT G AND CERAMENT V continue to increase sales rapidly driven by a growing body of compelling clinical data

Lund, Sweden, 27 October 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces that it has raised $37 million (SEK 327 million) in a combination of equity and debt finance. These new funds will be used to deliver further value from its unique CERAMENT platform. The oversubscribed equity financing was led by Tellacq AB and was supported by the Company’s current major shareholders, including HealthCap, Lundbeckfond Ventures, Industrifonden, AP3 (The Third Swedish National Pension Fund)  and Carl Westin. The debt finance was provided by Kreos Capital. 

Dato
20.10.2016
SANIFIT ANNOUNCES INITIATION OF FIRST CLINICAL TRIAL OF SNF472 IN PATIENTS WITH CALCIPHYLAXIS
San Diego, USA and Palma, Spain, October 20, 2016 - Laboratoris Sanifit S.L., a clinical-stage biopharmaceutical company focused on treatments for calcification disorders, today announced successful initiation of the first clinical trial of its lead candidate, SNF472, for the treatment of the orphan disease calciphylaxis (calcific uraemic arteriolopathy, CUA).
Dato
05.10.2016
Vtesse Announces Dosing of First Patient in Germany for Phase 2b/3 Clinical Trial of VTS-270 in Niemann-Pick Type C1 Disease

Clinicians Continue to Enroll Children with NPC at Trial Sites in France, Spain, Turkey, the United States and the United Kingdom. 

Expansion to Australia Expected Soon

GAITHERSBURG, Md., Oct. 5, 2016 /PRNewswire/ -- Vtesse, Inc., a company committed to developing drugs that will benefit patients with extremely rare, life-threatening diseases, announced today that the first German patient has been dosed in its global, pivotal clinical trial of its investigational drug VTS-270 for Niemann-Pick Type C1 disease ("NPC"). VTS-270 is a well-characterized mixture of HPbCD with a specific compositional fingerprint that distinguishes it from other HPbCD mixtures. 

Dato
29.09.2016
scPharmaceuticals Announces Presentations on Subcutaneous Furosemide at HFSA Annual Meeting

Complete bioavailability and equivalent diuresis after subcutaneous administration under experimental conditions

Equivalent diuresis when compared to high dose IV in heart failure patients in need of treatment of fluid overload

LEXINGTON, Mass., September 19, 2016 /PRNewswire/ -- scPharmaceuticals, Inc., a privately held biopharmaceutical company developing transformative pharmaceutical products for subcutaneous delivery, announced today the presentation of results of two studies at the 20th Annual Heart Failure Society of America (HFSA) Scientific Meeting in Orlando, Florida.

Dato
19.09.2016
PsiOxus Therapeutics Announce Executive Team Reorganization with Two New C Level Appointments in the US

OXFORD, United Kingdom (BUSINESS WIRE) PsiOxus Therapeutics, Ltd. (PsiOxus) today announced the appointment of Dr Charles “Charlie” Morris as Chief Development Officer and Karen LaRochelle as Chief Business Officer, both of whom will be based in the United States. These are the first C Level appointments in the US for the Oxford, UK based company as part of a planned expansion both in the UK and the US.

Dato
09.09.2016
River Vision Announces Receipt of Breakthrough Designation from US FDA
NEW YORK, NY – September 6, 2016.  River Vision Development Corp. (RVDC) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for RV001 (teprotumumab) for the treatment of active moderate to severe Thyroid Eye Disease (TED), also called Graves’ Orbitopathy (GO). The designation is granted to products intended to treat a serious or life threatening disease or condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies.
Dato
05.09.2016
BONESUPPORT™‘s CERAMENT™|G Highly Effective Adjunct in the Single Stage Surgical Management of Chronic Osteomyelitis – Results from Prospective Study of 100 patients Published in The Bone and Joint Journal

Single stage surgical procedure achieves 96% infection eradication rate

Lund, Sweden, 1 September 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioresorbable bone graft substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced the publication of a paper in The Bone and Joint Journal: Single-stage treatment of chronic osteomyelitis with a new absorbable gentamicin-loaded, calcium sulphate/hydroxyapatite biocomposite - A prospective series of 100 cases. McNally et al, The Bone and Joint Journal, 2016, Vol. 98-B, No. 9, p1289-96.

Dato
31.08.2016
BONESUPPORT™‘s CERAMENT™|G and CERAMENT™ V to be Featured Extensively at the 35th Annual Meeting of the European Bone & Joint Infection Society (EBJIS) in Oxford, UK
Lund, Sweden, 30 August 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced that presentations and posters covering research with its CERAMENT G and CERAMENT V will feature extensively at the upcoming 35th Annual Meeting of the European Bone & Joint Infection Society (EBJIS) taking place September 1-3 in Oxford, UK – which is a key congress for physicians and surgeons managing patients with bone infections. CERAMENT G and CERAMENT V are the only CE-marked injectable antibiotic eluting bone graft substitutes which provide local sustained delivery of gentamicin and vancomycin, respectively.
Dato
16.08.2016
Acacia Pharma announces Positve Results From Pivotal Phase 3 Trial of BAREMSIS™ For The Treatment of PONV

AREMSIS now shown to treat PONV, as well as prevent it

Cambridge, UK – 12th August 2016: Acacia Pharma Group plc (“Acacia Pharma”), the supportive care company developing products for US and international markets, announces positive results from a pivotal Phase 3 study investigating BAREMSIS™ (amisulpride injection, formerly APD421) for the treatment of established post-operative nausea & vomiting (“PONV”). These data further support the efficacy of BAREMSIS which has previously been shown to prevent PONV alone, and in combination with standard anti-emetics in pivotal Phase 3 prophylaxis studies.

Dato
10.08.2016
BONESUPPORT™ Receives FDA Approval to Initiate IDE Clinical Study with CERAMENT™G

FORTIFY Study to Assess CERAMENT G as part of Surgical Repair of Open

Diaphyseal Tibial Fractures

Lund, Sweden, 9 August – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced that it has received approval from the US Food and Drug Administration (FDA) to begin an IDE (Investigational Device Exemption) study with CERAMENT G. CERAMENT G is an injectable antibiotic-eluting bone graft substitute that provides local sustained delivery of gentamicin. CERAMENT G received CE mark approval in February 2013 and is now marketed in 19 countries outside the US.

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