Blog
RSS FeedPosted by Michael Wonder on 30 Apr 2018
FDA to conduct priority review of cemiplimab as a potential treatment for advanced cutaneous squamous cell carcinoma
30 April 2018 - The U.S. FDA has accepted priority review the biologics license application for cemiplimab for the treatment ...
Posted by Michael Wonder on 30 Apr 2018
Access to biosimilars in EU expected to continue to outpace US and Canada
27 April 2018 - Biosimilar experts from across the EU continued to show how rapidly biosimilars have gained market share, ...
Posted by Michael Wonder on 28 Apr 2018
Total costs of chimeric antigen receptor T-cell immunotherapy
26 April 2018 - In 2017, the US FDA approved the drugs tisagenlecleucel (Kymriah; Novartis) and axicabtagene ciloleucel (Yescarta; Kite Pharma) ...
Posted by Michael Wonder on 27 Apr 2018
ICER releases draft condition update report on treatments for plaque psoriasis
27 April 2018 - Public comment period now open until 25 May; requests to make oral comment during public meeting ...
Posted by Michael Wonder on 27 Apr 2018
The breakthrough therapy designation for promising cancer drugs is good for patients
27 April 2018 - One exciting component of the FDA Safety and Innovation Act was the creation of the breakthrough ...
Posted by Michael Wonder on 27 Apr 2018
FDA moves to encourage A.I. in medicine, drug development
26 April 2018 - It is establishing a new incubator focused on health technology. ...
Posted by Michael Wonder on 27 Apr 2018
The million dollar cancer treatment: who will pay?
26 April 2018 - So far, few patients have received the new drugs, as commercial health plans and Medicare wrestle with ...
Posted by Michael Wonder on 27 Apr 2018
FDA grants breakthrough therapy designation to Omeros’ MASP-2 inhibitor OMS721 for the treatment of high-risk haematopoietic stem cell transplant-associated thrombotic microangiopathy
26 April 2018 - Discussions on-going with FDA and European regulators for expedited approval. ...
Posted by Michael Wonder on 27 Apr 2018
CMS Administrator Verma unveils new strategy to fuel data-driven patient care, transparency
26 April 2018 - New Medicare Advantage data resource released. ...
Posted by Michael Wonder on 27 Apr 2018
ICER posts draft scoping document on medication-assisted treatments for opioid use disorder
26 April 2018 - Document open to public comment until 16 May 2018; report expected to review buprenorphine implant, extended-release ...
Posted by Michael Wonder on 26 Apr 2018
Mission possible: moving the needle forward to advance health equity
26 April 2018 - Every April our country observes National Minority Health Month to spotlight what we’re doing to eliminate health ...
Posted by Michael Wonder on 26 Apr 2018
FDA grants fast track designation for OrphoMed’s ORP-101 for treatment of IBS-D
25 April 2018 - OrphoMed announced today that the U.S. FDA has granted fast track designation for the Company’s lead ...
Posted by Michael Wonder on 26 Apr 2018
Synlogic receives fast track designation for SYNB1618, a synthetic biotic medicine for the treatment of phenylketonuria
25 April 2018 - Phase 1/2a clinical study of SYNB1618 evaluating safety and tolerability as well as exploratory endpoints expected ...
Posted by Michael Wonder on 26 Apr 2018
Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada
26 April 2018 - The clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into ...
Posted by Michael Wonder on 26 Apr 2018
Enzychem Lifesciences' fast track designation for chemo-radiation induced oral mucositis had been granted by the FDA
24 April 2018 - On 14 March, the U.S. FDA has granted Enzychem Lifesciences fast track designation of clinical study of ...