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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Opdivo approved via UK’s early drug access scheme
The UK's drug regulator has approved Bristol-Myers Squibb's new lung cancer drug Opdivo for use in the country under a ...
Posted by Michael Wonder on 05 Aug 2015
Envarsus receives European marketing authorization for treatment of both kidney and liver transplant patients
Veloxis Pharmaceuticals A/S and Chiesi Farmaceutici S.p.A. today announced that the European Commission (EC) has granted marketing authorization for Envarsus for the ...
Posted by Michael Wonder on 05 Aug 2015
Sobi's partner Biogen submits marketing authorisation application for Alprolix (rFIXFc) in Europe
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that partner Biogen has submitted a Marketing Authorisation Application (MAA) for Alprolix (rFIXFc) to ...
Posted by Michael Wonder on 05 Aug 2015
Last call for commenting on \"Biological Qualifier An INN Proposal\
The WHO has published a document entitled “Biological Qualifier An INN Proposal” on its website. ...
Posted by Michael Wonder on 05 Aug 2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 June 2014
The CHMP recommended six new medicines for approval at its 23-26 June 2014 meeting. ...
Posted by Michael Wonder on 05 Aug 2015
European Commission approves Scenesse
Clinuvel Pharmaceuticals Ltd announced today that the European Commission has ratified the recommendation of the European Medicines Agency (EMA), granting marketing ...
Posted by Michael Wonder on 05 Aug 2015
Eisai submits marketing approval applications for anticancer agent lenvatinib simultaneously in Europe and US
Eisai Co., Ltd. announced today that it has submitted applications to regulatory authorities in the U.S. and Europe (the FDA and ...
Posted by Michael Wonder on 05 Aug 2015
Novartis Cosentyx is the first IL-17 inhibitor to receive EU approval for first-line treatment of moderate-to-severe psoriasis patients
Novartis announced today that the European Commission has approved Cosentyx (secukinumab, formerly known as AIN457) as a first-line systemic treatment of moderate-to-severe plaque ...
Posted by Michael Wonder on 05 Aug 2015
European Commission approves Rezolsta, a new once-daily, fixed-dose HIV therapy combining darunavir and cobicistat
Janssen-Cilag International NV (Janssen) today announced that the European Commission (EC) has approved the use of Rezolsta (darunavir/cobicistat) in combination with ...
Posted by Michael Wonder on 05 Aug 2015
Merck receives positive CHMP opinion for Keytruda (pembrolizumab) for the treatment of advanced melanoma
Merck, known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human ...
Posted by Michael Wonder on 05 Aug 2015
European Commission approves Bristol-Myers Squibb’s Daklinza (daclatasvir) across multiple genotypes for the treatment of chronic hepatitis C infection
Bristol-Myers Squibb Company today announced that the European Commission has approved Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), for ...
Posted by Michael Wonder on 05 Aug 2015
EU approves Roche's Avastin plus chemotherapy for women with advanced cervical cancer
Roche announced today that the European Commission (EU) approved Avastin (bevacizumab) in combination with standard chemotherapy (paclitaxel and cisplatin or, alternatively, ...
Posted by Michael Wonder on 05 Aug 2015
Moventig approved in the European Union for opioid-induced constipation
AstraZeneca today announced that Moventig (naloxegol) has been granted Marketing Authorisation by the European Commission (EC) for the treatment of opioid-induced ...
Posted by Michael Wonder on 05 Aug 2015
AbbVie's Humira (adalimumab) receives positive CHMP opinion to treat adult patients with active moderate to severe hidradenitis suppurativa, a chronic inflammatory skin disease
AbbVie, a global biopharmaceutical company, today announced that the European Committee for Medicinal Products for Human Use (CHMP) of the ...
Posted by Michael Wonder on 05 Aug 2015
First malaria vaccine receives positive scientific opinion from EMA
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion for Mosquirix (Plasmodium ...