Blog
RSS FeedPosted by Michael Wonder on 24 Mar 2017
Bristol-Myers Squibb receives positive CHMP opinion recommending Opdivo (nivolumab) for the treatment of squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy
24 March 2017 - Positive opinion based on overall survival benefit demonstrated in the Phase 3 CheckMate -141 trial. ...
Posted by Michael Wonder on 24 Mar 2017
European Commission approves Amgevita (biosimilar adalimumab) for the treatment of certain inflammatory diseases
23 March 2017 - First biosimilar adalimumab approved in the European Union. ...
Posted by Michael Wonder on 23 Mar 2017
FDA approves first treatment for rare form of skin cancer
23 March 2017 - The U.S. FDA today granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric ...
Posted by Michael Wonder on 21 Mar 2017
FDA approves drug to treat Parkinson’s disease
21 March 2017 - The U.S. FDA today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease ...
Posted by Michael Wonder on 18 Mar 2017
AstraZeneca receives complete response letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for hyperkalaemia
17 March 2017 - AstraZeneca today announced that the US FDA has issued a complete response letter regarding the new ...
Posted by Michael Wonder on 17 Mar 2017
Shire receives European approval for label extension of Cinryze to prevent and treat hereditary angioedema (HAE) attacks in paediatric patients with HAE
16 March 2017 - Cinryze is now the first and only hereditary angioedema treatment approved for routine prevention in paediatrics. ...
Posted by Michael Wonder on 16 Mar 2017
Cardiome receives Notice of Compliance from Health Canada for its Brinavess NDS
14 March 2017 - Cardiome Pharma Corporation announced today that it received a Notice of Compliance for Brinavess (vernakalant hydrochloride, IV) ...
Posted by Michael Wonder on 16 Mar 2017
Marathon's $89,000 drug scrutinised for ‘unusual’ approval
16 March 2017 - Marathon Pharmaceuticals is under new scrutiny as Washington lawmakers press U.S. regulators about the “unusual circumstances” ...
Posted by Michael Wonder on 15 Mar 2017
Ipsen announces Health Canada approval of Dysport Therapeutic (abobotulinumtoxinA) for the treatment of patients with cervical dystonia and adult upper limb spasticity
14 March 2017 - Ipsen Biopharmaceuticals Canada today announced that Health Canada has approved Dysport Therapeutic (abobotulinumtoxinA) for the treatment ...
Posted by Michael Wonder on 15 Mar 2017
FDA approves Merck’s Keytruda (pembrolizumab) for adult and paediatric patients with classical Hodgkin lymphoma refractory to treatment, or who have relapsed after three or more prior lines of therapy
14 March 2017 - Only anti-PD-1 therapy approved for the treatment of patients with difficult-to-treat classical Hodgkin's lymphoma regardless of prior ...
Posted by Michael Wonder on 14 Mar 2017
Novartis wins U.S. approval for breast cancer drug; to compete with Pfizer's Ibrance
14 March 2017 - Kisqali priced 18-20% cheaper than Pfizer's Ibrance. ...
Posted by Michael Wonder on 13 Mar 2017
Novartis Kisqali (ribociclib, LEE011) receives FDA approval as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor
13 March 2017 - Approved based on a first-line Phase III trial that met its primary endpoint of progression-free survival ...
Posted by Michael Wonder on 07 Mar 2017
Actelion is granted marketing authorisation by the European Commission for Ledaga (chlormethine gel) for the treatment of MF-CTCL
7 March 2017 - Actelion announced today that the European Commission has granted marketing authorisation for the use of Ledaga ...
Posted by Michael Wonder on 03 Mar 2017
Trump calls the FDA ‘slow and burdensome,’ but it’s faster than ever
2 March 2017 - Two days before Christmas, the Food and Drug Administration gave Thomas Crawford an unexpected gift: approval ...
Posted by Michael Wonder on 03 Mar 2017
FDA approves first treatment for frequent urination at night due to overproduction of urine
3 March 2017 - The U.S. FDA today approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two ...