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EU approves Ultomiris for patients with atypical hemolytic uremic syndrome.- Alexion Pharma

Written by | 30 Jun 2020

Alexion Pharmaceuticals announced that the European Commission has approved Ultomiris (ravulizumab)—the first and only long-acting C5 complement inhibitor administered every eight weeks*—for the treatment of adults and children… read more.

Phase III LOTUS study of Stelara in Systemic Lupus Erythematosus discontinued.- Janssen Pharma

Written by | 29 Jun 2020

The Janssen Pharmaceutical Companies of Johnson & Johnson announced its decision to discontinue the Phase III LOTUS study of Stelara (ustekinumab) in Systemic Lupus Erythematosus (SLE) due to… read more.

Abbott’s optical coherence tomography imaging changed treatment decisions in 88% of artery blockages.

Written by | 28 Jun 2020

Abbott announced new data from the company’s LightLab Initiative that showed optical coherence tomography (OCT) imaging significantly changes how physicians decide to treat a vessel compared to traditional… read more.

CSL Behring to acquire global license rights to adeno-associated virus gene therapy program, AMT 061 for hemophilia B from uniQure.

Written by | 28 Jun 2020

CSL Behring announced that it has agreed to acquire exclusive global license rights to commercialize an adeno-associated virus (AAV) gene therapy program, AMT 061 (etranacogene dezaparvovec), for the… read more.

CHMP recommends Aybintio, a bevacizumab biosimilar.-Samsung Bioepis + Merck Inc.

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 Aybintio, intended for the… read more.

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.

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