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RSS FeedPosted by Michael Wonder on 19 Mar 2019
GW Pharmaceuticals announces the sale of priority review voucher for $105 million
18 March 2019 - GW Pharmaceuticals today announced that GW Research Ltd. has entered into a definitive agreement to sell its ...
Posted by Michael Wonder on 19 Mar 2019
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
18 March 2019 - Systemic sclerosis, also known as scleroderma, is a rare chronic connective tissue disease. ...
Posted by Michael Wonder on 19 Mar 2019
New treatment option now available in Canada for newly diagnosed patients with advanced lung cancer
18 March 2019 - Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy reduced the risk of death by half compared ...
Posted by Michael Wonder on 18 Mar 2019
U.S. FDA accepts BLA filing of Aimmune Therapeutics’ AR101 for peanut allergy
18 March 2019 - If approved, AR101 will be the first medicine for this life-threatening condition. ...
Posted by Michael Wonder on 18 Mar 2019
Allergan announces FDA approval of Avycaz (ceftazidime and avibactam) for paediatric patients
18 March 2019 - Label now includes new data on use of Avycaz for treatment of cUTI and cIAI in paediatric ...
Posted by Michael Wonder on 18 Mar 2019
The policy initiatives Scott Gottlieb championed at the FDA will remain after he departs
18 March 2019 - The resignation of Scott Gottlieb as commissioner of the Food and Drug Administration raises a big ...
Posted by Michael Wonder on 18 Mar 2019
New early breast cancer drug to reduce risk of recurrence or death approved for Australian women
18 March 2019 - Nerlynx (neratinib) now approved by the Therapeutic Goods Administration for Australian women. ...
Posted by Michael Wonder on 18 Mar 2019
CytoDyn reaches historical milestone, submits first of three sections of BLA to FDA for leronlimab (PRO 140) as a combination therapy for HIV
18 March 2019 - FDA previously granted rolling review for BLA. ...
Posted by Michael Wonder on 18 Mar 2019
Praluent (alirocumab) now approved in European Union to reduce the risk of cardiovascular events in patients with established cardiovascular disease
15 March 2019 - Approval is based on ODYSSEY OUTCOMES trial of 18,924 patients who recently suffered an acute coronary syndrome ...
Posted by Michael Wonder on 17 Mar 2019
Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on efforts to evaluate materials in medical devices to address potential safety questions
15 March 2019 - We’re in an unprecedented era of innovation in medical devices with advances in materials science that ...
Posted by Michael Wonder on 16 Mar 2019
European Commission approves Roche’s MabThera (rituximab) for a rare auto-immune disease
15 March 2019 - MabThera is now approved in Europe to treat four auto-immune diseases. ...
Posted by Michael Wonder on 15 Mar 2019
Spectrum Pharmaceuticals provides BLA filing update for Rolontis (eflapegrastim)
15 March 2019 - Spectrum Pharmaceuticals announced today that due to the U.S. FDA's request for additional manufacturing-related information for ...
Posted by Michael Wonder on 15 Mar 2019
Health Canada begins release of clinical data on drugs and devices
14 March 2019 - Health Canada launched two public databases on Wednesday as the first step in making clinical information ...
Posted by Michael Wonder on 15 Mar 2019
Eton Pharmaceuticals submits new drug application for DS-200
14 March 2019 - FDA previously granted DS-200 fast track designation. ...
Posted by Michael Wonder on 15 Mar 2019
Karyopharm announces FDA extension of review period for selinexor new drug application
14 March 2019 - PDUFA action date extended by three months to July 6, 2019. ...