Blog
RSS FeedPosted by Michael Wonder on 09 Jul 2018
Statement by FDA Commissioner on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids
9 July 2018 - The opioid epidemic continues to take an emotional, physical and financial toll on Americans. The U.S. ...
Posted by Michael Wonder on 07 Jul 2018
FDA takes steps to encourage more informative labelling on prescription drug and biological products’ indications and usage
6 July 2018 - Today, the U.S. Food and Drug Administration issued a draft guidance to provide recommendations for consideration ...
Posted by Michael Wonder on 05 Jul 2018
A risky drug approval lesson
4 July 2018 - What the FDA can learn from progress against muscular dystrophy. ...
Posted by Michael Wonder on 05 Jul 2018
Clovis Oncology receives EMA validation for its application for a new indication for Rubraca (rucaparib) as maintenance treatment for women with recurrent ovarian cancer
5 July 2018 - The filing is based on positive phase 3 ARIEL3 clinical trial data in which rucaparib significantly improved ...
Posted by Michael Wonder on 05 Jul 2018
European Commission approves expanded indication for Sprycel (dasatinib) to include treatment of children with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase
5 July 2018 - Approval includes the first powder for oral suspension formulation of a tyrosine kinase inhibitor developed for administration ...
Posted by Michael Wonder on 05 Jul 2018
Theratechnologies submits novel single-vial formulation of Egrifta (tesamorelin for injection) for FDA approval
4 July 2018 - Theratechnologies today announced that it has filed a supplemental new drug application with the FDA for ...
Posted by Michael Wonder on 05 Jul 2018
Health Canada approves Erleada (apalutamide tablets), the first treatment for men with non-metastatic castration-resistant prostate cancer
4 July 2018 - Erleada decreased the risk of metastasis or death in patients by 70% and improved median metastasis-free survival ...
Posted by Michael Wonder on 05 Jul 2018
International work-sharing pilot - apalutamide (Erlyand)
5 July 2018 - Apalutamide (Erlyand) is the first medicine to be registered on the Australian Register of Therapeutic Goods ...
Posted by Michael Wonder on 04 Jul 2018
FDA approves Xeomin (incobotulinumtoxina) for adult patients with sialorrhoea
3 July 2018 - First and only neurotoxin approved for this indication in the United States. ...
Posted by Michael Wonder on 04 Jul 2018
CHMP recommends EU marketing authorisation for Veyvondi [vonicog alfa, recombinant von Willebrand factor] for adults with von Willebrand disease
2 July 2018 - Veyvondi is currently only approved in the US for adults with VWD. ...
Posted by Michael Wonder on 03 Jul 2018
Seeking to hire new talent, FDA hints it wants flexibility to pay more staff higher salaries
2 July 2018 - In a recent report to Congress, the FDA expressed gratitude for a 2016 law that enabled ...
Posted by Michael Wonder on 03 Jul 2018
EU green light for Cimzia to treat psoriasis
3 July 2018 - The EMA has approved a label extension for UCB’s Cimzia allowing its use to treat adults ...
Posted by Michael Wonder on 03 Jul 2018
Deloitte survey finds biopharma companies are accelerating adoption of real-world evidence
28 June 2018 - A recent survey shows that 90% of biopharma companies are making significant investments in real-world evidence ...
Posted by Michael Wonder on 03 Jul 2018
Cellerant Therapeutics announces FDA grants regenerative medicine advanced therapy designation for romyelocel-L to prevent infections during neutropenia
2 July 2018 - RMAT designation confers similar advantages as breakthrough therapy designation. ...
Posted by Michael Wonder on 02 Jul 2018
Fortress Biotech announces Cyprium Therapeutics’ CUTX-101 (copper histidinate) granted FDA fast track designation for treatment of classic Menkes disease
2 July 2018 - Fortress Biotech today announced that the U.S. FDA has granted fast track designation to Cyprium Therapeutics’ (“Cyprium”) ...