BioMarin
FDA approves BioMarin’s Roctavian for adults with severe haemophilia A
June 30, 2023Medical 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NICE issues draft guidance recommending sapropterin for PKU in children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, 2021BioMarin, 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NICE has issued draft guidance which recommends BioMarin’s Kuvan (sapropterin) at a dose of up to 10 mg/kg for treating phenylketonuria …
BioMarin receives FDA nod for its would-be blockbuster
May 25, 2018Medical 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 …
FDA approves BioMarin’s Irish facility
June 13, 2017Manufacturing 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 …
Strong early data on haemophilia gene therapy boosts Biomarin
July 28, 2016Medical 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, 2016Research 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Biomarin (NASDAQ: BMRN) has announced that it has withdrawn its marketing authorisation application for Duchenne muscular dystrophy drug, Kyndrisa (drisapersen), …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 says no to BioMarin’s Duchenne Muscular Dystrophy drug
January 14, 2016Medical 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 …
Companies face mixed fortunes in ultra-orphan approvals
November 26, 2015Medical 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 to buy Prosensa in $840 million deal
November 25, 2014Sales 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. …
Vimizin shown green light
February 19, 2014Research 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, 2011Manufacturing 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, 2011Manufacturing 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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