Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2012-11-05 | everolimus | Novartis (Switzerland) | renal angiomyolipoma associated with tuberous sclerosis complex (TSC) | Granting of a Market Authorisation in the EU |
2012-09-28 | botulinum toxin type A | management of urinary incontinence in adult patients with neurogenic detrusor overactivity (NDO) due to subcervical spinal cord injury (SCI) (traumatic or non-traumatic) or multiple sclerosis (MS), who are not adequately managed with anticholinergics |
Granting of a patent | |
2014-03-20 | masitinib | AB Science (France) | Gleevec®-resistant gastrointestinal stromal tumor (GIST) |
Refusal of a Market Authorisation in the EU |
2012-10-10 | 3 mg drospirenone/0.02 mg ethinylestradiol | Bayer (Germany) | oral contraception |
Granting of a Market Authorisation in the EU |
2012-10-16 | turoctocog alfa | Novo Nordisk (Denmark) | hemophilia A | |
2012-10-18 | undisclosed hospital-based product | Flamel Technologies (France) | undisclosed | |
2012-10-21 | florbetapir 18F | Eli Lilly (USA) | Radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of Beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment | |
2012-10-21 | mirabegron | Astellas (Japan) | symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome | |
2012-10-21 | pegloticase | Savient Pharma (USA) now Crealta Pharmaceuticals | severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated |
Granting of a patent |
2012-10-25 | lurasidone | Dainippon Sumitomo Pharma (Japan) Takeda Pharmaceutical (Japan) | schizophrenia | |
2014-01-08 | QVA149 (indacaterol/glycopyrronium bromide) | Novartis (Switzerland) | chronic obstructive pulmonary disease (COPD) |
Submission of a Market Application in the US |
2012-10-29 | calcipotriene and betamethasone dipropionate | Leo Pharma (Denmark) | body plaque psoriasis | |
2012-10-29 | omacetaxine mepesuccinate | Teva Pharmaceuticals (Israel) | treatment of adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs) |
|
2012-10-29 | regorafenib | Bayer Healthcare (Germany) | treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with two kinase inhibitors | Granting of a Market Authorisation in the EU |
2013-11-20 | trastuzumab emtansine (T-DM1) | Genentech (USA), a member of Roche Group (Switzerland) | people with HER2-positive, unresectable locally advanced or metastatic breast cancer (mBC) who have received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy |
Granting of a Market Authorisation in the EU |
2017-03-22 | tofacitinib | Pfizer (USA - NY) |
|
Granting of a Market Authorisation in the EU |
2012-11-08 | IMA901 | immatics biotechnologies (Germany) | treatment of renal cell carcinoma in HLA-A*02 positive patients |
Granting of the orphan status in the USA |
2012-11-19 | alisertib | Takeda Pharmaceutical (Japan) | peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated) | |
2012-11-19 | Cyclo(-gamma-aminobutyryl-L-phenylalanyl-L-tryptophanyl-D-tryptophanyl-L-lysyl-L-threonyl-L phenylalanyl-N-3-carboxypropyl)-glycine amide | Dr Ulrich Granzer (Germany) Aspireo Pharmaceuticals (Israel) | acromegaly | |
2012-11-19 | voclosporin | Granzer Regulatory Consulting & Services (Germany) | non-infectious uveitis |
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