Blog
RSS FeedPosted by Michael Wonder on 04 May 2016
Prescription medicines: new or extended uses of registered medicines
4 May 2016 - Throughout the year the TGA will be publishing information relating to new or extended uses of registered ...
Posted by Michael Wonder on 03 May 2016
Eisai announces FDA approval of Fycompa (perampanel) oral suspension for adjunctive therapy in the treatment of partial-onset seizures and primary generalized tonic-clonic seizures
2 May 2016 - Eisai Inc. today announced that the U.S. FDA has approved Fycompa (perampanel) oral suspension as adjunctive therapy ...
Posted by Michael Wonder on 03 May 2016
Flamel Technologies receives FDA approval of Akovaz
2 May 2016 - Flamel Technologies today announced that the U.S. FDA has approved the Company’s new drug application for ...
Posted by Michael Wonder on 02 May 2016
Ibrutinib: indication of an additional clinical benefit in one of three therapeutic indications
2 May 2016 - The IQWIG in Germany has found ibrutinib has an additional clinical benefit for certain patients with ...
Posted by Michael Wonder on 02 May 2016
Umeclidinium for symptom relief in COPD: additional benefit is not proven
2 May 2016 - No sighificant differences for moderate disease and no data for severe disease. ...
Posted by Michael Wonder on 02 May 2016
Mepolizumab in severe asthma: additional benefit is not proven
2 May 2016 - Appropriate comparator therapy not implemented so the indirect comparison is unsuitable. ...
Posted by Michael Wonder on 02 May 2016
Cystic fibrosis patients campaign for drug Orkambi to be listed on Pharmaceutical Benefits Scheme
2 May 2016 - Without subsidy, it costs about US $260,000 each year. ...
Posted by Michael Wonder on 02 May 2016
April 2016 NCE registrations - TGA
2 May 2016 - The TGA registered two new chemical entities (medicines) and two new blood products in April 2016. ...
Posted by Michael Wonder on 02 May 2016
FDA approves Bayer's Gadavist (gadobutrol) injection as first contrast agent for use with magnetic resonance angiography of supra-aortic arteries
29 April 2016 - Bayer announced today that the U.S. FDA has approved Gadavist (gadobutrol) injection for use with magnetic resonance ...
Posted by Michael Wonder on 01 May 2016
Teva announces FDA approval of ProAir RespiClick (salbutamol sulphate) inhalation powder for paediatric asthma patients ages 4 to 11
29 April 2016 - Teva Pharmaceuticals announced today that the U.S. FDA has approved ProAir RespiClick (salbutamol sulphate) inhalation powder for ...
Posted by Michael Wonder on 01 May 2016
Highlights from the CHMP 25-28 April 2016 meeting
29 April 2016 - Six medicines, including one new antibacterial, recommended for authorisation in the EU. ...
Posted by Michael Wonder on 01 May 2016
New medicine to help in the fight against antimicrobial resistance
29 April 2016 - Zavicefta is recommended for approval for patients with limited treatment options. ...
Posted by Michael Wonder on 01 May 2016
New treatment for rare white blood cell cancer
29 April 2016 - Treatment of follicular lymphoma to be added to Gazyvaro’s approved uses. ...
Posted by Michael Wonder on 01 May 2016
FDA approves first drug to treat hallucinations and delusions associated with Parkinson’s disease
29 April 2016 - The U.S. FDA today approved Nuplazid (pimavanserin tartrate), the first drug approved to treat hallucinations and delusions ...
Posted by Michael Wonder on 01 May 2016
FDA approves first generic Crestor
29 April 2016 - The U.S. FDA today approved the first generic version of Crestor (rosuvastatin calcium). ...