Showing 11 posts of 11 posts found.


Japan approves AstraZeneca’s Soliris for paediatric patients with gMG

August 24, 2023
Medical Communications AstraZeneca, MHLW, Musculo-skeletal disorder, gMG, paediatric, soliris

AstraZeneca has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Soliris (eculizumab) for the extended use …

FDA approves first new ADHD drug in a decade

April 6, 2021
Manufacturing and Production ADHD, FDA, paediatric

The FDA have approved the first new drug for the treatment of attention deficit hyperactivity disorder (ADHD) in over a …


Novartis posts 82% remission rate in CAR T paediatric study

December 5, 2016
Research and Development, Sales and Marketing CAR T, CAR-T, Novartis, leukaemia, paediatric

Novartis has released the results of its global, paediatric study of the treatment of leukaemia in children and young adults …


FDA approves first therapy for paediatric psoriasis treatment

November 7, 2016
Sales and Marketing Amgen, Enbrel, paediatric, psoriasis

Amgen’s Enbrel has been given approval by the FDA for expanded use to treat children with chronic moderate-to-severe plaque psoriasis. …


Shire gets positive opinion from EMA on rare gastrointestinal disease treatment

May 27, 2016
Medical Communications, Research and Development, Sales and Marketing CHMP, EMA, Revestive, Shire, gastrointestinal, paediatric, short bowel syndrome, treatment

Shire (LSE: SHP) has announced that it has received a positive opinion from the European Medicines Agency’s (EMA) Committee for …


FDA grants priority review for Amgen leukaemia drug

May 4, 2016
Research and Development, Sales and Marketing Amgen, FDA, blincyto, leukaemia, lymphoblastic leukaemia, paediatric

Amgen has announced that the US Food and Drug Administration (FDA) has granted priority review status for the supplemental Biologics …


Bluebird Bio gene therapy posts encouraging results in treatment of rare brain disease

April 21, 2016
Medical Communications, Research and Development Bluebird Bio, Phase II, gene therapy, lenti-d, paediatric, phase 2, phase 3, phase III, rare brain disease

Bluebird bio (NASDAQ: BLUE) has announced positive interim data from a Phase II/III trial evaluating their Lenti-D gene therapy in …


Amgen’s drug reduces rates of bleeding in rare childhood disorder

April 21, 2016
Research and Development, Sales and Marketing Amgen, blood disorder, children, nplate, paediatric, platelet, rare, romisplostim

Amgen (NASDAQ: AMGN) has announced the results of a Phase III trial, published in The Lancet, which shows that Nplate …

Europe map

EMA readies paediatric trials network

May 14, 2010
Research and Development EMA, EMEA, paediatric, paediatric trials

The European Medicines Agency is about to press the start button on its long-planned network for clinical studies in children. …

FDA to study effects of medication during pregnancy

January 20, 2010
Research and Development, Sales and Marketing FDA, paediatric

A new US-based collaborative research programme to study the effects of medication on mothers and their babies has been launched. …

UK children recruited for H1N1 vaccine trials

October 2, 2009
Research and Development, Sales and Marketing h1n1, paediatric, vaccines

The UK has commenced a two-week swine flu vaccine trial, a month ahead of its planned programme to vaccinate 11 …

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