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Novartis scores FDA breakthrough-designation for rare disease product

Authored by Karl Simpson Breakthrough Therapy designation has been given by the FDA to Novartis for their development asset , which is an orphan drug being developed to treat patients with sporadic inclusion body myositis, a rare and potentially life … Continue reading

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Epigenetics interest garners Syndax Pharmaceuticals $26.6m Series B

Authored by Karl Simpson Epigenetics is an area which is receiving a good deal of interest currently, not only in the area cancer research but also in other therapeutic areas too, such as autoimmune and inflammation. Massachusetts based Syndax Pharmaceuticals … Continue reading

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Bionor Pharma new strategy aims at ‘Functional Cure for HIV’

Authored by Karl Simpson Bionor Pharma ASA is a promising biotech based out of Norway, which in the second quarter of 2013 reported a net loss of NOK 21.3m adding to losses in the first quarter which brings the company … Continue reading

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FDA and EMA to collaborate on orphan drugs and meet industry

Authored by Karl Simpson Orphan Drugs are never far from the mainstream regulatory debate and on October 4th, the FDA is to host a meeting to discuss this very topic. The meeting which has been entitled ‘The Food and Drug … Continue reading

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Harbour Antibodies Secures funding for Antibody Development

Authored by James Sheppard The Netherlands and US based biotech company Harbour Antibodies announced that they had received $3.3m to accelerate the development and discovery of novel antibody based human therapies. The funding round was led by Atlas Ventures. In … Continue reading

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NPS Pharma enrols first patient in global registry for Hypoparathyroidism

Authored by James Sheppard The US based biopharmaceutical company NPS Pharmaceuticals announced that they had initiated the initial enrolment of PARADIGHM. PARADIGHM is a global natural history registry for patients with hypoparathyroidism. Patients will be enrolled into the programme and … Continue reading

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Massachusetts biotech continues to excite with new investments

Authored by Karl Simpson Massachusetts is a booming biotech cluster and this week has seen a number of funding events that once again signal the level of innovation and investor interest the cluster attracts. First up, David Mott’s New Enterprise … Continue reading

Posted in M&A Finance and Funding, Orphan Drugs and Rare Diseases, Pharmaceutical business | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | Leave a comment

BrainStorms’s Cell Therapy receives Orphan Drug Designation in EU

Authored by James Sheppard The Israel based biotechnology company, BrainStorm Cell Therapeutics, announced that the European Medicine Agency (EMA) had given Orphan Drug Designation to its lead asset NurOwn. NurOwn is a stem cell therapy consisting of autologous bone marrow-derived … Continue reading

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