Blog
RSS FeedPosted by Michael Wonder on 28 Jul 2016
TGA approves Brenzys (etanercept)
28 July 2016 - The TGA has approved a biosimilar to Pfizer's Enbrel. ...
Posted by Michael Wonder on 28 Jul 2016
TGA approves Belkyra (deoxycholic acid)
28 July 2016 - The TGA has approved Allergan's Belkyra (deoxycholic acid). ...
Posted by Michael Wonder on 28 Jul 2016
FDA approves Adlyxin to treat type 2 diabetes
28 July 2016 - The U.S. FDA approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along ...
Posted by Michael Wonder on 27 Jul 2016
Vertex seeks deal after NICE rejects CF drug Orkambi
27 July 2016 - NICE has rejected Vertex’s cystic fibrosis drug, Orkambi (lumacaftor+ivacaftor) for routine funding on the National Health Service ...
Posted by Michael Wonder on 27 Jul 2016
Shire and BMS secure NICE recommendations for oncology drugs
27 July 2016 - NICE has issued final guidance recommending Shire’s Oncaspar (pegaspargase) and Bristol-Myers Squibb’s Opdivo (nivolumab) plus Yervoy (ipilimumab) ...
Posted by Michael Wonder on 27 Jul 2016
NICE publishes final guidance on the use of nivolumab in combination with ipilimumab for treating advanced melanoma
27 July 2016 - NICE publishes further guidance on the use of nivolumab (Opdivo) in patients wth melanoma. ...
Posted by Michael Wonder on 27 Jul 2016
AbbVie racks up three more indications for Humira
27 July 2016 - The TGA has approved three new indications for Abbvie's Humira (adalimumab). ...
Posted by Michael Wonder on 27 Jul 2016
TGA approves Targin (oxycodone hydrochloride with naloxone hydrochloride trihydrate) for new indication
27 July 2016 - The TGA has approved Mundipharma's Targin (oxycodone hydrochloride and naloxone hydrochloride trihydrate). ...
Posted by Michael Wonder on 27 Jul 2016
TGA finally approves Latisse (bimatoprost)
27 July 2016 - The TGA has approved a new use for Allergan's bimatoprost. ...
Posted by Michael Wonder on 26 Jul 2016
CADTH recommends reimbursement of Sunvepra
20 July 2016 - CADTH has recommended that asunaprevir (Sunvepra) be reimbursed in Canada. ...
Posted by Michael Wonder on 26 Jul 2016
Allergan receives positive opinion for Truberzi (eluxadoline) for treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults
25 July 2016 - Significant step towards bringing the only licensed prescription medication for IBS-D to patients in 28 countries of ...
Posted by Michael Wonder on 25 Jul 2016
What constitutes a new medicine?
26 July 2016 - The EMA's definition of a new medicine is a very liberal one. ...
Posted by Michael Wonder on 25 Jul 2016
Praluent recommended for reimbursement by CADTH
20 July 2016 - CADTH has recommended that alirocumab (Praluent) be reimbursed in Canada. ...
Posted by Michael Wonder on 25 Jul 2016
AbbVie receives U.S. FDA approval of once daily Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the treatment of genotype 1 chronic hepatitis C
25 July 2016 - New extended-release formulation is the first all-oral, co-formulated treatment containing the three direct-acting antiviral components of Viekira ...
Posted by Michael Wonder on 25 Jul 2016
Ocular Therapeutix receives complete response letter from FDA for its NDA for Dextenza for the treatment of post-surgical ocular pain
25 July 2016 - Outstanding items pertain to manufacturing process and controls. ...