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RSS FeedPosted by Michael Wonder on 10 Jun 2020
EU expands reach of Vertex' CF drug Kalydeco
10 June 2020 - EU regulators have expanded the treatment scope of Vertex' Kalydeco (ivacaftor) to include a new subset ...
Posted by Michael Wonder on 10 Jun 2020
Sandoz Canada receives Health Canada approval to launch two oncology biosimilars: Ziextenzo and Riximyo
9 June 2020 - These two approvals mark an important milestone for Sandoz Canada, bringing its biosimilars into oncology at a ...
Posted by Michael Wonder on 10 Jun 2020
Cardiff Oncology announces expanded access program for onvansertib in KRAS mutated metastatic colorectal cancer as follow-on to fast track designation
9 June 2020 - Expanded Access Program provides pathway for patients to gain access to treatment with onvansertib outside of clinical ...
Posted by Michael Wonder on 10 Jun 2020
Mallinckrodt completes rolling submission of biologics license application for StrataGraft regenerative skin tissue to U.S. FDA
9 June 2020 - StrataGraft skin tissue is in development as potential new treatment option for patients with deep partial-thickness thermal ...
Posted by Michael Wonder on 09 Jun 2020
The US government's supply of the only proven COVID-19 drug runs out at the end of the month
8 June 2020 - The US government's current supply of remdesivir, the only drug known to work against COVID-19, will ...
Posted by Michael Wonder on 09 Jun 2020
Europe wants to make its own drugs, but it needs American blood plasma
8 June 2020 - Europe wants to be master of its own destiny in producing essential drugs and finding COVID-19 ...
Posted by Michael Wonder on 09 Jun 2020
BioCryst announces berotralstat expanded access program for patients with hereditary angioedema in United States
9 June 2020 - BioCryst Pharmaceuticals today announced that the company has established an expanded access program with oral, once-daily ...
Posted by Michael Wonder on 09 Jun 2020
The coronavirus pandemic is reigniting a fierce debate over compounded drugs
9 June 2020 - In hopes of alleviating potential drug shortages and other issues wrought by the coronavirus pandemic, the ...
Posted by Michael Wonder on 09 Jun 2020
Mylan and Lupin receive European marketing authorisation for Nepexto, biosimilar etanercept
4 June 2020 - Mylan and Lupin today announced that the European Commission (EC) has granted marketing authorization for Nepexto, ...
Posted by Michael Wonder on 09 Jun 2020
First adjuvanted quadrivalent influenza vaccine by Seqirus receives EU approval
8 June 2020 - The European Commission has today given regulatory approval for the first adjuvanted quadrivalent influenza vaccine to become ...
Posted by Michael Wonder on 09 Jun 2020
Insmed receives FDA breakthrough therapy designation for brensocatib in patients with non-cystic fibrosis bronchiectasis
8 June 2020 - Full results from phase 2 WILLOW study of brensocatib in non-cystic fibrosis bronchiectasis to be presented at ...
Posted by Michael Wonder on 08 Jun 2020
NICE publishes appraisal consultation for isatuximab in combination with pomalidomide and dexamethasone for treating patients with relapsed and refractory multiple myeloma
4 June 2020 - The appraisal committee has considered the evidence submitted by the company and the views of non-company consultees ...
Posted by Michael Wonder on 08 Jun 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #7
8 June 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...
Posted by Michael Wonder on 08 Jun 2020
EMA receives application for conditional authorisation of first COVID-19 treatment in the EU
8 June 2020 - EMA has now received an application for conditional marketing authorisation of the antiviral medicine remdesivir for ...
Posted by Michael Wonder on 08 Jun 2020
CytoDyn receives BLA acknowledgment letter from the FDA
8 June 2020 - PDUFA date could be set by the FDA on 10 July. ...