Blog
RSS FeedPosted by Michael Wonder on 28 Jan 2017
Meeting highlights from the CHMP 23-26 January 2017 meeting
27 January 2017 - The EMA’s CHMP recommended eight medicines for approval at its January meeting. ...
Posted by Michael Wonder on 27 Jan 2017
Institute for Clinical and Economic Review releases evidence report on disease-modifying therapies for multiple sclerosis, including daclizumab and ocrelizumab
26 January 2017 - Report finds alemtuzumab represents best long-term cost-effectiveness; prices for most drugs not well-aligned with added value ...
Posted by Michael Wonder on 27 Jan 2017
Recommendations made by the PBAC - December 2016
27 January 2016 - The outcomes from the December 2016 PBAC meeting are now available. ...
Posted by Michael Wonder on 26 Jan 2017
U.S. FDA approves 72 mcg dose of Linzess (linaclotide) for adults with chronic idiopathic constipation
26 January 2017 - New dosage strength expected to be available in first quarter of 2017. ...
Posted by Michael Wonder on 26 Jan 2017
Final yes from NICE for Gilead’s Epclusa
26 January 2017 - NICE has now published final guidance endorsing Epclusa as an option for the treatment of adults ...
Posted by Michael Wonder on 26 Jan 2017
Narcan (naloxone hydrochloride) 2 mg nasal spray approved by FDA
25 January 2017 - Adapt Pharma to provide 2 mg as an additional dosing option for naloxone nasal spray ...
Posted by Michael Wonder on 26 Jan 2017
Approval of proposal for clostridium botulinum type A toxin (Botox) in DHB hospitals
26 January 2017 - PHARMAC is pleased to announce the approval of an agreement with Allergan to amend the contractual ...
Posted by Michael Wonder on 25 Jan 2017
NICE guidance on ibrutinib for previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia in the presence of 17p deletion or TP53 mutation
25 January 2017 - NICE published guidance that recommended ibrutinib for chronic lymphocytic leukaemia in adults who have had at ...
Posted by Michael Wonder on 25 Jan 2017
Health Canada approves Revlimid plus dexamethasone as a first-line treatment for patients newly diagnosed with multiple myeloma, not eligible for transplant
24 January 2017 - Celgene announced today that Health Canada has expanded the indication for Revlimid (lenalidomide capsules), in multiple myeloma. ...
Posted by Michael Wonder on 23 Jan 2017
Conditional marketing authorisations give patients access to important new medicines earlier
23 January 2017 - EMA publishes report with data collected between 2006 and June 2016. ...
Posted by Michael Wonder on 22 Jan 2017
ICER releases draft evidence report on treatments for rheumatoid arthritis
20 January 2017 - Public comment period now open - comments accepted until 17 February. ...
Posted by Michael Wonder on 20 Jan 2017
Allergan announces FDA approval of Rhofade (oxymetazoline hydrochloride) 1% cream for the topical treatment of persistent facial erythema associated with rosacea in adults
19 January 2017 - Once daily treatment reduces persistent facial erythema associated with rosacea through 12 hours. ...
Posted by Michael Wonder on 20 Jan 2017
FDA approves Trulance for chronic idiopathic constipation
19 January 2017 - The U.S. FDA today approved Trulance (plecanatide) for the treatment of chronic idiopathic constipation in adult ...
Posted by Michael Wonder on 18 Jan 2017
FDA grants fast track designation for aTyr's Resolaris to treat limb girdle muscular dystrophy 2B and removes partial clinical hold for Resolaris
18 January 2017 - First reported fast track designation for LGMD2B treatment. ...
Posted by Michael Wonder on 18 Jan 2017
Teva receives FDA approval for Vantrela ER (hydrocodone bitartrate) extended release tablets formulated with proprietary abuse deterrence technology
18 January 2017 - Vantrela ER label describes the product’s abuse-deterrent properties against abuse in the three most common routes—oral, ...