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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.

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 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 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.

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 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 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.

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.

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