Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2015-01-19 | Rienso® (EU)/Feraheme® (USA) | Takeda Pharmaceutical (Japan) AMAG Pharmaceuticals (USA - MA) | anaemia due to iron deficiency in patients with any underlying condition |
Withdrawal of a market application in the EU |
2015-02-26 | pegfilgrastim - biosimilar version of Neulasta® | Amgen (USA - CA) | reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy. | Granting of a Market Authorisation in the EU |
2015-02-26 | febuxostat | Menarini (Italy) | prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome |
Positive opinion for the granting of a Market Authorisation in the EU |
2015-01-14 | Diaxonhit (France) | diagnosis of prosthetic bone and joint infections |
Product launch | |
2015-02-26 | efavirenz | BMS (USA - NY) | treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 months of age and older and weighing at least 3.5 kg |
Positive opinion for the granting of a Market Authorisation in the EU |
2016-02-26 | adalimumab | Abbvie (USA - IL) | severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA |
Positive opinion for the granting of a Market Authorisation in the EU |
2015-01-19 | afoxolaner and milbemycin oxime | Sanofi (France) Merial (France) | treatment of flea and tick infestations prevention of heartworm disease treatment of intestinal worms (roundworms, hookworms and whipworm) |
Granting of a Market Authorisation in the EU |
2014-06-23 | (2\'R,3\'S)-2\'-hydroxy-N-carboxy-3\'-amino-5\'-methyl-hexanoic,N-tert-butyl ester, 13 ester 5B-20-epoxy-1B,2a,4a,7B,9a,10a,13a-heptahydroxy-4,10-diacetate-2-benzoate-(1\"S)-7,9-acrolein acetal-11(15-1)-abeotaxane | Cortice Biosciences (USA - NY) | progressive supranuclear palsy |
Granting of the orphan status in the US |
2014-02-21 | (6-[4-Deoxy-4-[(2E,4E)-tetradecadienoylglycyl] amino-L-glyceroB-L-manno-heptopyranosyl]amino-9H-purine) | DARA BioSciences (USA - NC) | parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy that is refractory to conventional analgesics |
Granting of the orphan status in the US |
2014-11-14 | (S)-perillyl alcohol temozolomide | NeOnc Technologies (USA - CA) | glioma |
Granting of the orphan status in the US |
2015-01-05 | (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N\\\'-(pyrazin-2-yl)acrylohydrazide | Karyopharm Therapeutics (USA - MD) Clinipace GmbH (Germany) | multiple myeloma |
Granting of the orphan status in the US |
2014-12-03 | 18-(p[131I]-iodophenyl)octadecyl phosphocholine | Cellectar Biosciences (USA - WI) | multiple myeloma |
Granting of the orphan status in the US |
2014-04-14 | 6-(1H-Indazol-6-yl)-N-(4-morpholinophenyl)imidazo-[1,2-alpha]pyrazin-8-amine bis-methanesulfonate | Gilead Sciences (USA - CA) | chronic lymphocytic leukemia |
Granting of the orphan status in the US |
2014-06-12 | 6-[4-Deoxy-4-[(2E,4E)-tetradecadienoylglycyl] amino-L-glyceroB-L-manno-heptopyranosyl]amino-9H-purine) | DARA BioSciences (USA - NC) | multiple myeloma |
Granting of the orphan status in the US |
2014-10-09 | A-dmDT390-bisFv(UCHT1) | Angimmune (USA - MD) | cutaneous T-cell lymphoma |
Granting of the orphan status in the US |
2014-04-20 | Ac-Ile-Cys-Val-Trp(1-Me)-Gln-Asp-Trp-Gly-Ala-His-Arg-Cys-Thr-AEEA-Lys-PEG 40KDa-Lys-AEEA-Thr-Cys-Arg-His-ALa-Gly-Trp-Asp-Gln-(1-Me)Trp-Val-Cys-Ile-Ac | Apellis Pharmaceuticals (USA - KY) | paroxysmal nocturnal hemoglobinuria |
Granting of the orphan status in the US |
2014-09-04 | adenoassociated virus vector (AAV) carrying a modified AAV serotype 2 backbone and coding sequence of human thymidine phosphorylase preceded by a human thyroxin-binding globulin promoter | Columbia University Medical Center (USA - NY) | Mitochondrial Neurogastrointestinal Encephalomyopathy (MNGIE) |
Granting of the orphan status in the US |
2014-10-17 | ibrutinib | Johnson&Johson (J&J) (USA - NJ) | previously treated patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) |
Granting of a Market Authorisation in the EU |
2014-09-04 | adenovirus serotype-5 (Ad5) vector that contains a modified non-oncogenic fused early 6 (E6) and early 7 (E7) gene of the human papillomavirus (HPV); (Ad5 [E1-, E2b-]-E6/E7) | Etubics Corporation (USA - WA) | human papillomavirus (HPV)-associated head and neck squamous cell carcinoma (HNSCC) |
Granting of the orphan status in the US |
2014-08-07 | anti-Beta1 integrin monoclonal antibody | Oncosynergy (USA - CA) | glioblastoma |
Granting of the orphan status in the US |
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