BioMarin

Showing 12 posts of 12 posts found.

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FDA approves BioMarin’s Roctavian for adults with severe haemophilia A

June 30, 2023
Medical Communications BioMarin, FDA, Haematology, Roctavian, haemophilia

Global biotechnology company BioMarin Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved Roctavian (valoctocogene roxaparvocec-rvox) …

NICE issues draft guidance recommending sapropterin for PKU in children

February 25, 2021
BioMarin, NICE, PKU

NICE has issued draft guidance which recommends BioMarin’s Kuvan (sapropterin) at a dose of up to 10 mg/kg for treating phenylketonuria …

novato-south-campus

BioMarin receives FDA nod for its would-be blockbuster

May 25, 2018
Medical Communications, Sales and Marketing BioMarin, biotech, drugs, pharma, pharmaceutical

BioMarin is confident that its newly approved treatment for phenylketonuria (PKU) is set to become a blockbuster and it’s priced the …

location-shanbally

FDA approves BioMarin’s Irish facility

June 13, 2017
Manufacturing and Production BioMarin, Ireland, cork, vimizin

The FDA has approved BioMarin’s bulk biologic manufacturing plant, based in Cork, Ireland. The facility will manufacture an ingredient of …

blue_jeans

Strong early data on haemophilia gene therapy boosts Biomarin

July 28, 2016
Medical Communications, Research and Development BioMarin, gene therapy, haemophilia a

Biomarin has presented interim results from a Phase I/II study that is being hailed as positive “proof-of-concept” data for their …

Biomarin withdraws regulatory submissions for Duchenne muscular dystrophy drug

June 1, 2016
Research and Development, Sales and Marketing BioMarin, Duchenne Muscular Dystrophy, EMA, FDA, Kyndrisa, failure, rejection

Biomarin (NASDAQ: BMRN) has announced that it has withdrawn its marketing authorisation application for Duchenne muscular dystrophy drug, Kyndrisa (drisapersen), …

FDA

FDA says no to BioMarin’s Duchenne Muscular Dystrophy drug

January 14, 2016
Medical Communications, Sales and Marketing BioMarin, Duchenne Muscular Dystrophy, FDA, Kyndrisa, drisapersen

The FDA has rejected BioMarin’s Duchenne Muscular Dystrophy (DMD) drug Kyndrisa, saying there was not enough evidence that the drug …

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Companies face mixed fortunes in ultra-orphan approvals

November 26, 2015
Medical Communications, Research and Development BioMarin, Duchenne Muscular Dystrophy, FDA, Genzyme, NICE, ultra-orphan drugs

UK regulator NICE has recommended Vimizin, a drug for a very rare genetic disorder, after the manufacturer and NHS England …

Biomarin image

BioMarin to buy Prosensa in $840 million deal

November 25, 2014
Sales and Marketing BioMarin, Prosensa, drisapersen, dystrophy

Rare-disease drug firm BioMarin has finalised its purchase of muscular disease specialist Prosensa in a deal worth over $840 million. …

Biomarin image

Vimizin shown green light

February 19, 2014
Research and Development, Sales and Marketing BioMarin, FDA, congenital enzyme disorder, vimizin

Regulators have shown the green light to BioMarin Pharmaceutical’s Vimizim as a treatment for a rare enzyme deficiency which affects …

Pharma manufacturing news in brief

December 20, 2011
Manufacturing and Production ADC Biotechnology, BioMarin, GE Healthcare, Lonza and Neptune Technologies, M+W Group

Facility news from BioMarin, Lonza and Neptune Technologies, plus plans to boost biomanufacturing capacity in the developing world and new …

Pfizer sells Irish manufacturing facility to BioMarin

June 27, 2011
Manufacturing and Production BioMarin, Ireland, Pfizer, pharma manufacturing news

Pfizer is selling its Irish manufacturing facility in Shanbally, Cork, to US biopharmaceutical company BioMarin for $48.5 million, creating up …

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