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Products

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Number of results: 2618
Date Compound Product name Company Disease Action mechanism Type of Information
2016-12-15 C1 esterase inhibitor Cinryze® Viropharma (USA), now Shire (UK - USA)

treatment and prevention of angioedema attacks in patients with C1 inhibitor deficiency

enzyme inhibitor/C1 esterase inhibitor. The C1 inhibitor protein is required to control the ‘complement’ and ‘contact’ systems, collections of proteins… Positive opinion for the granting of a Market Authorisation in the EU
2016-12-15 chlormethine Ledaga® Actelion (Switzerland)

cutaneous T-cell lymphoma

mycosis fungoides-type cutaneous T-cell lymphoma

alkylating agent. Chlormethine is a well-known anticancer medicine that belongs to the group ‘alkylating agents’. Alkylating agents kill cancer cells by… Positive opinion for the granting of a Market Authorisation in the EU
2016-12-15 alectinib hydrochloride Alecensa® Chugai (Japan) Roche (Switzerland) Genentech (USA - CA)

ALK fusion gene positive non-small cell lung cancer (NSCLC)

kinase inhibitor/tyrosine kinase inhibitor/ALK inhibitor. Alecensa® (alectinib hydrochloride) is an oral ALK inhibitor created by Chugai Kamakura Research Laboratories. It… Positive opinion for the granting of a Market Authorisation in the EU
2016-12-15 ustekinumab Stelara® Janssen-Cilag International, a J&J company (USA - NJ)

treatment of moderate to severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies

monoclonal antibody. Stelara® is a human interleukin (IL)-12 and IL-23 antagonist. IL-12 and IL-23 are naturally occurring proteins that are… Submission of a Market Application in the US
2016-12-15 biosimilar rituximab - biosimilar version of Mabthera®/Rituxan® Truxima® (CT-P10) Celltrion (Republic of Korea)

non-Hodgkin’s lymphoma

chronic lymphocytic leukaemia

rheumatoid arthritis

granulomatosis with polyangiitis and microscopic polyangiitis

biosimilar product/monoclonal antibody. Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of… Submission of a Market Application in the EU
2016-12-15 5-aminolevulinic acid Ameluz® Biofrontera Bioscience (Germany)

actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2) and of field cancerization

Positive opinion for the granting of a Market Authorisation in the EU
2016-12-15 pembrolizumab Keytruda® Merck&Co (USA - NJ)

patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test

monoclonal antibody/immune checkpoint inhibitor. Keytruda® (pembrolizumab - MK-3475) is an investigational, highly selective monoclonal anti-PD-1 antibody designed to restore the natural… Positive opinion for the granting of a Market Authorisation in the EU
2016-12-15 simoctocog alfa (recombinant blood coagulation factor VIII) Vihuma® Octapharma (Switzerland)

hemophilia A

protein/coagulation factor. Simoctocog alfa is a recombinant blood coagulation factor VIII (B02BD02) - a replacement therapy to increase plasma levels of… Positive opinion for the granting of a Market Authorisation in the EU
2016-12-14 crisaborole topical ointment (AN2728) Eucrisa® Anacor Pharmaceuticals (US - CA), now Pfizer (USA - NY)

mild-to-moderate atopic dermatitis in children and adults

phosphodiesterase 4 inhibitor. Crisaborole topical ointment, 2%, is an investigational non-steroidal topical anti-inflammatory PDE-4 inhibitor. This novel boron-containing small molecule inhibits… Granting of a Market Authorisation in the US
2016-12-13 Matrix applied characterised autologous cultured chondrocytes MACI™ (Matrix applied characterised autologous cultured chondrocytes) Vericel (USA - MA)

repair of symptomatic, full-thickness cartilage defects of the knee in adult patients

cell therapy. MACI™ is a cell therapy product. This advanced therapy medicinal product (ATMP) is to be available as an implantation matrix consisting… Granting of a Market Authorisation in the US
2016-12-13 follitropin delta Rekovelle® hormone. Follitropin delta (also known as FE 999049) is the first recombinant follicle stimulating hormone (rFSH) derived from a human cell… Granting of a Market Authorisation in the EU
2016-12-13 3-aminopropyl-butyl phosphinic acid 3-aminopropyl-butyl phosphinic acid Speragen (USA - TX)

succinic semialdehyde dehydrogenase deficiency

Granting of the orphan status in the US
2016-12-12 obeticholic acid in combination with ursodeoxycholic (UDCA) Ocaliva® in combination with ursodeoxycholic (UDCA) Intercept Pharmaceuticals (USA - NY)

primary sclerosing cholangitis/primary biliary cirrhosis

farnesoid X receptor agonist. Obeticholic acid (OCA) is a bile acid analog and a first-in-class farnesoid X receptor (FXR) agonist being developed for… Granting of a Market Authorisation in the EU
2016-12-12 dusquetide dusquetide (SGX942) Soligenix (USA - NJ)

oral mucositis

peptide. SGX942 is an innate defense regulator (IDR), which contains a new class of short, synthetic peptide, having the chemical… Granting of a Fast Track status
2016-12-12 recombinant human monoclonal IgG1 antibody against programmed death ligand-1 (anti-PD-L1) avelumab Merck Serono (Germany)

gastric cancer

monoclonal antibody/immune checkpoint inhibitor. MSB0010718C (avelumab) is a fully human IgG1 monoclonal antibody that binds to the PD-L1 (programmed death-ligand 1) protein,… Granting of the orphan status in the EU
2016-12-12 adeno-associated viral vector serotype 8 encoding engineered rhodopsin DNA-binding repressor and human rhodopsin expression cassettes adeno-associated viral vector serotype 8 encoding engineered rhodopsin DNA-binding repressor and human rhodopsin expression cassettes FondazioneTelethon (Italy)

retinitis pigmentosa

gene therapy Granting of the orphan status in the EU
2016-12-12 arsenic trioxide capsule (oral) arsenic trioxide Medsenic (France)

graft-versus-host disease

Granting of the orphan status in the EU
2016-12-12 cabiralizumab cabiralizumab Albany Regulatory Consulting (UK)

tenosynovial giant cell tumour, localised and diffuse type

monoclonal antibody Granting of the orphan status in the EU
2016-12-12 propranolol propranolol The Anticancer Fund (Belgium)

soft tissue sarcoma

Granting of the orphan status in the EU
2016-12-12 68Ga-DOTA-pABzA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[(CH2-CH(CH3)2]2 68Ga-DOTA-pABzA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[(CH2-CH(CH3)2]2 Advanced Accelerator Applications (France)

diagnosis of gastrointestinal stromal tumours

Granting of the orphan status in the EU