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CHMP recommends Idefirix for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.. Hansa BioPharma

Written by | 28 Jun 2020

Hansa Biopharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending conditional approval of… read more.

CHMP recommends approval of Qutavina teriparatide biosimilar for osteoporosis.- EuroGenerics Holdings

Written by | 28 Jun 2020

The Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Qutavina (teriparatide), from EuroGenerics Holdings,… read more.

CHMP recommends Gencebok for the treatment of primary apnoea of premature newborns.- Gennisium Pharma

Written by | 28 Jun 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Gencebok, intended for the… read more.

FDA approves Mycapssa for long-term maintenance treatment in acromegaly patients.- Chiasma Inc.,

Written by | 28 Jun 2020

Chiasma, Inc. announced that the FDA approved Mycapssa (octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide…. read more.

CHMP recommends approval of Veklury for COVID-19 (novel coronavirus).- Gilead Sciences

Written by | 28 Jun 2020

The EU Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Veklury (remdesivir),… read more.

CHMP recommends Livogiva, a teriparatide biosimilar for the treatment of osteoporosis. Alvogen

Written by | 28 Jun 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Livogiva ( formerly PF… read more.

CHMP negative for Turalio, a medicine intended for the treatment of tenosynovial giant cell tumour.- Plexxikon/Daiichi Sankyo

Written by | 28 Jun 2020

The European Medicines Agency has recommended the refusal of the marketing authorisation for Turalio, a medicine intended for the treatment of tenosynovial giant cell tumour from Plexxicon/Daiichi Sankyo…. read more.

CHMP positive for treatment of plaque psoriasis with Cosentyx in children and adolescents aged 6 to <18 years.- Novartis

Written by | 27 Jun 2020

Novartis, announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx (secukinumab) for the treatment… read more.

Complete Response for abicipar pegol to treat neovascular (wet) age-related macular degeneration. Allergan/AbbVie + Molecular Partners .

Written by | 27 Jun 2020

Allergan, an AbbVie Company and Molecular Partners a clinical-stage biotechnology company developing a new class of custom-built protein therapeutics known as DARPin therapeutics, announced that the FDA has… read more.

CHMP positive for treatment of plaque psoriasis with Cosentyx in children and adolescents aged 6 to <18 years.- Novartis

Written by | 27 Jun 2020

Novartis, announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx (secukinumab) for the treatment… read more.

CHMP recommends Xolair an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps.- Novartis

Written by | 27 Jun 2020

Novartis has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Xolair (omalizumab) as… read more.

Elocta gains increased access for people with haemophilia A in the UK.- SOBI

Written by | 27 Jun 2020

Through an agreement with National Health Service (NHS) and Sobi,( Swedish Orphan Biovitrium) people living with haemophilia A in the United Kingdom will have increased access to Elocta… read more.

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