Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2014-03-17 | autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 | Novartis (Switzerland) | B-lymphoblastic leukaemia/lymphoma | Granting of the orphan status in the EU |
2014-03-17 | genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor | Oncos Therapeutic (Finland) | ovarian cancer |
Granting of the orphan status in the US |
2014-03-17 | synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues | Voisin Consulting (France) | ATTR amyloidosis | Granting of the orphan status in the EU |
2014-05-22 | humanised monoclonal antibody against CD38 | Sanofi (France) | plasma cell myeloma/multiple myeloma |
Granting of the orphan status in the US |
2014-03-19 | fipamezole | Santhera Pharmaceuticals (Switzerland) | neurodegenerative diseases | |
2014-03-20 | follitropin alfa (biosimilar) | Teva Pharmaceuticals (Israel) | treatment of • women who do not produce eggs and do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs); • women who are undergoing assisted reproductive techniques (fertility treatment) such as in-vitro fertilisation. Ovaleap is given to stimulate the ovaries to produce more than one egg at a time; • women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH). Ovaleap is given together with a medicine containing LH to stimulate the eggs to mature in the ovaries; • men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease). |
|
2014-03-23 | etarfolatide | Endocyte (USA) Merck&Co (USA) | detection of adult patients with ovarian cancer suitable for treatment with vintafolide (Vynfinit®) | |
2014-03-23 | folic acid | Endocyte (USA) Merck&Co (USA) | administration prior to 99mTc-etarfolatide, a folate receptor (FR) targeted radiodiagnostic imaging agent for use in ovarian cancer | |
2014-03-23 | vintafolide | Endocyte (USA) Merck&Co (USA) | platinum-resistant ovarian cancer who express the folate receptor on all target lesions | |
2014-03-24 | siltuximab | Janssen-Cilag International - a J&J company (USA) | multicentric Castleman’s disease |
Granting of a Market Authorisation in the EU |
2014-06-04 | recombinant human collagen alpha-1 (VII) chain homo-trimer (rC7) | Shire (USA-UK) | dystrophic epidermolysis bullosa |
Granting of the orphan status in the EU |
2015-04-13 | colorectal cancer screening test | MDX Health (Belgium) Exact Sciences (USA) | colorectal cancer |
Reimbursement |
2015-02-03 | insulin human [rDNA origin] inhalation powder | MannKind Corporation (USA - CA) | type 1 diabetes type 2 diabetes |
Product launch |
2014-12-02 | enzalutamide | Astellas Pharma (Japan) | adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated | Granting of a Market Authorisation in the EU |
2016-09-19 | hydrogel containing soluble yeast beta-glucan (SBG) | Biotec Pharmacon (Norway) | treatment of chronic wounds including treatment of diabetic foot ulcer |
Reimbursement |
2017-07-11 | safinamide | Newron Pharmaceuticals (Italy) Zambon (Italy) |
|
Product launch |
2014-12-19 | BRACAnalysis® as a companion diagnostic with olaparib | Myriad Genetics (USA - UT) | ovarian cancer |
Granting of a Market Authorisation in the US |
2014-04-12 | Critical Pharmaceuticals (UK) | |||
2014-04-12 | gene therapy | Celladon (USA - CA) | heart failure in NYHA class III or IV chronic heart failure patients who are NAb negative |
Granting of the Breakthrough Therapy status |
2014-04-15 | tolcapone | SOM Biotech (Spain) | transthyretin amyloidosis (ATTR) |
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