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RSS FeedPosted by Michael Wonder on 04 May 2020
FDA approves Fensolvi (leuprolide acetate) for injectable suspension for paediatric patients with central precocious puberty
4 May 2020 - Fensolvi is the only six-month, subcutaneously administered leuprolide acetate approved for the treatment of paediatric patients two ...
Posted by Michael Wonder on 04 May 2020
NDA filing for potential new ADHD treatment, KP415, accepted by FDA
4 May 2020 - Corium, GPC’s portfolio company, to lead all commercialisation activities for KP415. ...
Posted by Michael Wonder on 04 May 2020
EU approves label update for AstraZeneca's Lokelma
4 May 2020 - European regulators have approved a label update for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) to include a ...
Posted by Michael Wonder on 04 May 2020
COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines
4 May 2020 - As researchers race to develop vaccines and therapeutics against COVID-19, EMA has published an overview of how ...
Posted by Michael Wonder on 04 May 2020
Gilead’s investigational anti-viral remdesivir receives U.S. FDA emergency use authorisation for the treatment of COVID-19
1 May 2020 - Authorisation enables broader use of remdesivir to treat hospitalised patients with severe COVID-19 disease in the United ...
Posted by Michael Wonder on 04 May 2020
Banner Life Sciences announces final FDA approval of Bafiertam for multiple sclerosis
30 April 2020 - Bafiertam (monomethyl fumarate), the bioequivalent alternative to Biogen’s Tecfidera (dimethyl fumarate), is a new oral treatment option ...
Posted by Michael Wonder on 04 May 2020
Vertex receives European CHMP positive opinion for Kalydeco (ivacaftor) for children and adolescents with cystic fibrosis between the ages 6 months and 18 years with the R117H mutation in the CFTR gene
1 May 2020 - If approved, Kalydeco (ivacaftor) will be the first and only medicine in Europe to treat the underlying ...
Posted by Michael Wonder on 04 May 2020
AstraZeneca to make Oxford vaccine as COVID-19 race heats up
30 April 2020 - AstraZeneca agreed to make an experimental coronavirus vaccine developed by Oxford University researchers as the race ...
Posted by Michael Wonder on 04 May 2020
Boris Johnson’s global vaccine push as he revealed the birth of his son helped him fight COVID-19
4 May 2020 - Boris Johnson will hold a virtual meeting online, and demand countries around the world pull together ...
Posted by Michael Wonder on 03 May 2020
Pharming receives European Commission approval for treatment of acute hereditary angioedema attacks in children with Ruconest
30 April 2020 - European Commission decision was received six weeks earlier than expected. ...
Posted by Michael Wonder on 03 May 2020
Pharmaceutical giant’s plan to end Australia’s reliance on Indian and Chinese medicines after COVID-19
2 May 2020 - Australia’s dangerous dependence on India and China to make vital medicines for the sick has come to ...
Posted by Michael Wonder on 03 May 2020
Pierre Fabre receives positive CHMP opinion for Braftovi (encorafenib) in combination with cetuximab for the treatment of adult patients with BRAF V600E-mutant metastatic colorectal cancer
1 May 2020 - If approved, the combination has the potential to be the first targeted regimen specifically for patients with ...
Posted by Michael Wonder on 02 May 2020
Genmab announces U.S. FDA approval of subcutaneous formulation of daratumumab, Darzalex Faspro (daratumumab and hyaluronidase-fihj), for the treatment of patients with multiple myeloma
1 May 2020 - Approval based on data from Phase III COLUMBA and Phase II PLEIADES studies. ...
Posted by Michael Wonder on 01 May 2020
COVID-19 update: FDA issues Emergency Use Authorisation for potential COVID-19 treatment
1 May 2020 - Today, the U.S. FDA issued an emergency use authorization for the investigational antiviral drug remdesivir for the ...
Posted by Michael Wonder on 01 May 2020
CHMP grants positive opinion for Darzalex (daratumumab) subcutaneous formulation for the treatment of patients with multiple myeloma
30 April 2020 - New subcutaneous formulation reduces the time taken for patients to receive daratumumab treatment from hours to approximately ...