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RSS FeedPosted by Michael Wonder on 22 Jul 2016
Highlights from the CHMP 18-21 July 2016 meeting
22 July 2016 - Eight medicines recommended for approval; use of Truvada extended to include pre-exposure prophylaxis (PrEP) against HIV-1 infection. ...
Posted by Michael Wonder on 22 Jul 2016
Two new medicines for advanced kidney cancer
21 July 2016 - Cabometyx and Kisplyx provide additional treatment options for patients with unmet medical need. ...
Posted by Michael Wonder on 22 Jul 2016
First medicine for HIV pre-exposure prophylaxis recommended for approval in the EU
22 July 2016 - Truvada to enhance existing HIV prevention strategies. ...
Posted by Michael Wonder on 22 Jul 2016
Pediapharm receives Health Canada approval for rupatadine
21 July 2016 - Pediapharm is very pleased to announce Health Canada's approval of rupatadine fumarate (10 mg tablets and 1 ...
Posted by Michael Wonder on 21 Jul 2016
pERC issues final recommendation for Imbruvica (ibrutinib)
19 July 2016 - Canada's pCODR Expert Review Committee has issued a final recommendation for Janssen's ibrutinib for patients with ...
Posted by Michael Wonder on 21 Jul 2016
Lilly’s Alimta wins NICE support
21 July 2016 - NHS use of Eli Lilly's Alimta to treat patients with lung cancer has been endorsed in final ...
Posted by Michael Wonder on 21 Jul 2016
Health Canada approves Invokamet for the treatment of adults with type 2 diabetes mellitus
20 July 2016 - Janssen announced today that Invokamet, a twice daily fixed-dose therapy combining Invokana (canagliflozin) and metformin hydrochloride into ...
Posted by Michael Wonder on 20 Jul 2016
U.S. FDA approves Belviq XR, a once-daily formulation of lorcaserin for chronic weight management
19 July 2016 - Eisai Co., Ltd. announced today that the U.S. FDA has approved a new drug application for Belviq ...
Posted by Michael Wonder on 20 Jul 2016
Valeant and Progenics announce FDA approves Relistor tablets for the treatment of opioid-induced constipation in adults with chronic non-cancer pain
19 July 2016 - Valeant Pharmaceuticals and Progenics Pharmaceuticals, Inc. today announced that the U.S. FDA has approved Relistor (methylnaltrexone bromide) ...
Posted by Michael Wonder on 20 Jul 2016
Decision to award sole supply of progestogen-only long-acting intra-uterine system (LIUS) in the community and DHB hospitals
20 July 2016 - PHARMAC is pleased to announce the approval of a sole supply agreement with Bayer New Zealand Limited ...
Posted by Michael Wonder on 20 Jul 2016
NICE publishes final guidance recommending ataluren for children with Duchenne muscular dystrophy
20 July 2016 - NICE has published final guidance recommending ataluren for treating children aged 5 and over with Duchenne muscular ...
Posted by Michael Wonder on 20 Jul 2016
Bristol-Myers Squibb announces availability of FDA approved Orencia (abatacept) ClickJect, a self-administered subcutaneous autoinjector, for adults with moderate to severe rheumatoid arthritis
20 July 2016 - Bristol-Myers Squibb announced today the commercial launch of the Orencia ClickJect Autoinjector, a new self-administered autoinjector for ...
Posted by Michael Wonder on 19 Jul 2016
FDA knocks back Novartis copy of Amgen's drug Neulasta
19 July 2016 - U.S. regulators have declined to approve Novartis' so-called biosimilar copy of Amgen's Neulasta drug that fights infections ...
Posted by Michael Wonder on 19 Jul 2016
U.S. FDA expands indication for type 2 diabetes treatment Synjardy (empagliflozin/metformin hydrochloride) to include treatment-naïve adults
19 July 2016 - The U.S. FDA has approved an expanded indication for Synjardy (empagliflozin and metformin hydrochloride) tablets to include ...
Posted by Michael Wonder on 19 Jul 2016
U.S. FDA approves Prezista (darunavir) for use in pregnant women with HIV
18 July 2016 - Data show Prezista is a safe and effective treatment option in pregnant women, with no reports of ...