Blog
RSS FeedPosted by Michael Wonder on 02 Oct 2019
Trade agreement drug monopoly is obsolete given faster, better drug discovery
2 October 2019 - For decades, the brand-name drug industry has relentlessly promoted the message that any reduction in its ...
Posted by Michael Wonder on 01 Oct 2019
Novartis and Microsoft announce collaboration to transform medicine with artificial intelligence
1 October 2019 - Multi-year alliance underpins the Novartis commitment to leverage data & artificial intelligence to transform how medicines are ...
Posted by Michael Wonder on 01 Oct 2019
Heron Therapeutics resubmits new drug application to FDA for HTX-011 for the management of post-operative pain
1 October 2019 - Heron Therapeutics today announced that it has resubmitted its new drug application to the U.S. FDA ...
Posted by Michael Wonder on 01 Oct 2019
FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software
1 October 2019 - Today, the U.S. FDA is informing patients, health care professionals, IT staff in health care facilities and ...
Posted by Michael Wonder on 01 Oct 2019
US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017
1 October 2019 - With the advent of patient-focused drug development, the US FDA has redoubled its efforts to review patient-reported ...
Posted by Michael Wonder on 01 Oct 2019
AstraZeneca provides an update on US regulatory review of PT010 in COPD
1 October 2019 - AstraZeneca today announced that the US FDA has issued a complete response letter regarding the new ...
Posted by Michael Wonder on 01 Oct 2019
Fees for redeeming priority review vouchers fall to all-time low in FY2020
30 September 2019 - The US FDA on Friday announced the fees for using a priority review voucher to speed ...
Posted by Michael Wonder on 01 Oct 2019
Ultragenyx and Kyowa Kirin announce U.S. FDA approves label update for Crysvita (burosumab) for the treatment of X-linked hypophosphataemia
30 September 2019 - Expanded label includes additional clinical data highlighting superiority over conventional therapy for paediatric patients and extends current ...
Posted by Michael Wonder on 01 Oct 2019
Geron announces fast track designation granted to imetelstat for relapsed/refractory myelofibrosis
30 September 2019 - Geron Corporation today announced that the United States FDA has granted fast track designation to imetelstat for ...
Posted by Michael Wonder on 30 Sep 2019
Alphabet taps former FDA commissioner to oversee health strategy and policy
30 September 2019 - Califf will lead strategy and policy for Alphabet’s health subsidiaries, according to Duke University. ...
Posted by Michael Wonder on 30 Sep 2019
Gilead wins $6 million deal to distribute HIV drug it donated
28 September 2019 - 4,250 uninsured patients expected to get PrEP for free in next six months. ...
Posted by Michael Wonder on 30 Sep 2019
AI needs patients’ voices in order to revolutionise health care
30 September 2019 - Patients’ stories — what doctors call patient histories — are the bedrock of medicine. “Listen to ...
Posted by Michael Wonder on 30 Sep 2019
U.S. FDA approves Invokana (canagliflozin) to treat diabetic kidney disease and reduce the risk of hospitalisation for heart failure in patients with type 2 diabetes and diabetic kidney disease
30 September 2019 - Approval is based on the landmark Phase 3 CREDENCE renal outcomes study - the only completed renal ...
Posted by Michael Wonder on 30 Sep 2019
FDA issues draft guidance on patient-focused drug development: methods to identify what is important to patients
30 September 2019 - Today the U.S. FDA issued a draft guidance on Patient-Focused Drug Development: Methods to Identify What Is ...
Posted by Michael Wonder on 30 Sep 2019
Harnessing the patient voice in real world evidence: the essential role of patient-reported outcomes
30 September 2019 - Real-world evidence is increasingly valued by regulators and payers. ...