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RSS FeedPosted by Michael Wonder on 11 Feb 2019
European Commission approves Bristol-Myers Squibb’s Sprycel (dasatinib) in combination with chemotherapy for treatment of paediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia
11 February 2019 - Bristol-Myers Squibb today announced that the European Commission has approved Sprycel (dasatinib) in combination with chemotherapy ...
Posted by Michael Wonder on 11 Feb 2019
Fake drugs could put patients at risk after no-deal Brexit
8 February 2019 - Patients could be put at risk from fake medicines if the UK exits the EU without ...
Posted by Michael Wonder on 11 Feb 2019
RegenxBio receives rare paediatric disease designation for RGX-181 gene therapy for the treatment of CLN2 form of Batten disease
31 January 2019 - Novel, one-time investigational treatment for CLN2 disease designed to halt progression of this rare, paediatric, neurodegenerative disease. ...
Posted by Michael Wonder on 11 Feb 2019
Finch Therapeutics’ investigational drug CP101 granted breakthrough therapy designation from FDA for recurrent C. difficile infection
8 February 2019 - Designation to accelerate Finch’s efforts to provide an effective therapy for patients fighting recurrent C. difficile infection. ...
Posted by Michael Wonder on 08 Feb 2019
J&J becomes first drug maker to add prices to television ads
8 February 2019 - Johnson & Johnson said on Thursday it will start adding the price of its medicines to ...
Posted by Michael Wonder on 08 Feb 2019
EMA launches checklist to facilitate validation for initial marketing authorisation applications
8 February 2019 - A survey launched by EMA in September 2016 shows that validation issues occur in 90% of ...
Posted by Michael Wonder on 08 Feb 2019
New safety features for medicines sold in the EU
8 February 2019 - As of 9 February 2019, most prescription medicines and some over-the-counter medicines for human use supplied ...
Posted by Michael Wonder on 08 Feb 2019
Generic drug approvals surge, but hundreds still aren't for sale
7 February 2019 - The Trump administration has been trumpeting a huge increase in FDA generic drug approvals the past ...
Posted by Michael Wonder on 08 Feb 2019
Advanced Accelerator Applications announces Health Canada approval for Lutathera, a treatment for gastro-enteropancreatic neuroendocrine tumours
7 February 2019 - First ever approved peptide receptor radionuclide therapy in Canada. ...
Posted by Michael Wonder on 08 Feb 2019
Number needed to treat: conveying the likelihood of a therapeutic effect
7 February 2019 - Effectively communicating clinical trial results to patients and clinicians is a requirement for appropriate application in ...
Posted by Michael Wonder on 08 Feb 2019
FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines
7 February 2019 - A key element of the U.S. FDA’s mission is focused on helping to ensure that all ...
Posted by Michael Wonder on 07 Feb 2019
Incyte announces U.S. FDA has extended the review period for ruxolitinib (Jakafi) in acute graft-versus-host disease
7 February 2019 - Incyte announced today that the U.S. FDA has extended the review period for the supplemental new ...
Posted by Michael Wonder on 07 Feb 2019
What is a biosimilar, exactly?
5 February 2019 - They’re meant to save money for the health care system, carve into pharma’s profits, and finally ...
Posted by Michael Wonder on 07 Feb 2019
Zogenix submits new drug application to U.S. FDA and marketing authorisation application to EMA for Fintepla for the treatment of Dravet syndrome
6 February 2019 - Zogenix today announced it has completed its rolling submission of a new drug application to the ...
Posted by Michael Wonder on 06 Feb 2019
FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder
6 February 2019 - The U.S. FDA today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma ...