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RSS FeedPosted by Michael Wonder on 06 Jul 2016
Takeda receives European Commission approval of Adcetris (brentuximab vedotin) for consolidation treatment in post-transplant Hodgkin's lymphoma
6 July 2016 - Approval based on AETHERA Phase 3 data demonstrating 75 percent improvement in progression-free survival for patients treated ...
Posted by Michael Wonder on 06 Jul 2016
EMA goes electronic for PDCO opinions and subsequent EMA decisions
6 July 2016 - As of 1 August 2016, PDCO opinions and subsequent EMA decisions will be transmitted to applicants electronically ...
Posted by Michael Wonder on 05 Jul 2016
FDA approves treatment for AIDS symptoms
5 July 2016 - Insys says agency OKs Dronabinol oral solution after earlier application was rejected in 2014. ...
Posted by Michael Wonder on 05 Jul 2016
UK cost agency rejects Bristol's Opdivo for kidney cancer
5 July 2016 - Bristol-Myers Squibb's immunotherapy drug Opdivo is not worth using on the state health service for treating kidney ...
Posted by Michael Wonder on 05 Jul 2016
FDA approves first absorbable stent for coronary artery disease
5 July 2016 - The U.S. FDA today approved the first fully absorbable stent to treat coronary artery disease. The Absorb ...
Posted by Michael Wonder on 05 Jul 2016
Biogen and AbbVie’s once-monthly Zinbryta (daclizumab) approved in European Union for treatment of multiple sclerosis
5 July 2016 - Zinbryta significantly reduced multiple measures of disease activity in patients with relapsing forms of multiple sclerosis. ...
Posted by Michael Wonder on 04 Jul 2016
NICE backs Ferring’s Firmagon
4 July 2016 - Men with advanced hormone-dependent prostate cancer and spinal metastases are to gain routine access to Ferring's Firmagon ...
Posted by Michael Wonder on 04 Jul 2016
Allergan receives positive opinion through European decentralised procedure for Belkyra (deoxycholic acid) for patients with submental fullness
1 July 2016 - Belkyra (deoxycholic acid) expected to be the first non-surgical prescription medicine to treat submental fullness (or double ...
Posted by Michael Wonder on 04 Jul 2016
European Commission approves extended indication for Amgen's Kyprolis (carfilzomib) for the treatment of relapsed multiple myeloma patients
4 July 2016 - New indication allows Kyprolis to be used in combination with dexamethasone alone for appropriate patients. ...
Posted by Michael Wonder on 02 Jul 2016
Necitumumab in NSCLC: small additional benefit for patients with metastases
1 July 2016 - Survival advantage, but also disadvantages. ...
Posted by Michael Wonder on 02 Jul 2016
Ticagrelor prevention after myocardial infarction: little additional benefit
1 June 2016 - The IQWIG has re-examined the benefits of the use of ticagrelor (Brilique) after acute coronary syndrome. ...
Posted by Michael Wonder on 01 Jul 2016
AbbVie's Humira (adalimumab) receives U.S. FDA approval to treat adults with non-infectious intermediate, posterior and panuveitis
30 June 2016 - Approval marks the 10th approved indication for Humira in the United States and follows recent European Commission ...
Posted by Michael Wonder on 30 Jun 2016
pERC issues final recommendation for cobimetinib hemifumarate (Cotellic)
30 June 2016 - The Pan Canadian Expert Review Committee has issued a final recommendation on the use of cobimetinib ...
Posted by Michael Wonder on 30 Jun 2016
PHARMAC's credibility questioned by Labour
29 June 2016 - The acceptance of Keytruda's effectiveness after PHARMAC's budget was boosted undermines the medicines funding agency's credibility, Labour ...
Posted by Michael Wonder on 30 Jun 2016
Darzalex (daratumumab) approved by Health Canada as the first human anti-CD38 monoclonal antibody for the treatment of multiple myeloma
30 June 2016 - Darzalex is a new therapy providing an important option for multiple myeloma patients who have received three ...