Blog
RSS FeedPosted by Michael Wonder on 18 Sep 2019
'A child's health should not be a postcode lottery': anger of cystic fibrosis sufferers forced to pay £20,000 for drug abroad
17 September 2019 - Patients have formed a buyers' club to source a version of Orkambi after the drug's manufacturer and ...
Posted by Michael Wonder on 17 Sep 2019
News NHS England explores funding options for cystic fibrosis drug
17 September 2019 - NHS England is “committed to exploring and developing alternative routes” to enable people with cystic fibrosis ...
Posted by Michael Wonder on 07 Sep 2019
Lonsurf (trifluridine/tipiracil) receives marketing authorisation in Europe for patients with previously treated metastatic gastric cancer
6 September 2019 - Servier and its partner Taiho Pharmaceutical announced today that the European Commission has approved the use ...
Posted by Michael Wonder on 23 Aug 2019
‘Life saving’ news for Gold Coast family after little Beau allowed to take drug Orkambi to slow cystic fibrosis diagnosis
23 August 2019 - When this Gold Coast girl blew out candles for her 10th birthday yesterday, she did not wish ...
Posted by Michael Wonder on 22 Aug 2019
PTAC continues to find new ways to reject new medicines (Part 2)
23 August 2019 - More startling insights from the minutes of the May 2019 PTAC meeting. ...
Posted by Michael Wonder on 20 Aug 2019
FDA accepts new drug application for VX-445 (elexacaftor), tezacaftor and ivacaftor combination treatment
20 August 2019 - FDA grants priority review of the application and sets a PDUFA target action date of 19 ...
Posted by Michael Wonder on 19 Aug 2019
Quebec becomes first province to list Lonsurf (trifluridine/tipiracil) for public reimbursement for adult patients with metastatic colorectal cancer
19 August 2019 - Cancer treatment taken orally shown to extend overall survival in patients whose disease has progressed following treatment ...
Posted by Michael Wonder on 12 Aug 2019
‘Not acceptable’ disappointment as cystic fibrosis drug not approved in Scotland
12 August 2019 - People with cystic fibrosis in Scotland will continue to be denied potentially life-extending drugs after they ...
Posted by Michael Wonder on 12 Aug 2019
Cystic fibrosis drugs rejected for use by NHS in Scotland
12 August 2019 - Two "life-changing" cystic fibrosis drugs have been rejected for routine use by the NHS in Scotland. ...
Posted by Michael Wonder on 03 Aug 2019
AbbVie's Maviret (glecaprevir/pibrentasvir) approved by European Commission to shorten treatment duration to eight weeks for treatment naïve patients with chronic hepatitis C and compensated cirrhosis
2 August 2019 - Maviret is now available as a shorter, 8-week, once-daily option for treatment-naïve, compensated cirrhotic, chronic hepatitis C ...
Posted by Michael Wonder on 29 Jul 2019
ViiV Healthcare submits regulatory application to European Medicines Agency for investigational cabotegravir to be used in combination with rilpivirine as the first monthly, injectable treatment for HIV
29 July 2019 - The marketing application is based on phase III ATLAS and FLAIR pivotal trials in which the once-monthly, ...
Posted by Michael Wonder on 29 Jul 2019
Lonsurf (trifluridine/tipiracil) receives positive opinion from CHMP in the EU for patients with previously treated metastatic gastric cancer
26 July 2019 - Servier and its partner Taiho Pharmaceutical announced today that the CHMP of the EMA has issued a ...
Posted by Michael Wonder on 23 Jul 2019
FDA reinforces need for applicants to submit thorough and timely safety information for combination medical products
22 July 2019 - Today, the U.S. FDA released a final guidance, “Post-marketing Safety Reporting for Combination Products,” for applicants ...
Posted by Michael Wonder on 22 Jul 2019
Vertex submits new drug application to the U.S. FDA for triple combination regimen of VX-445 (elexacaftor), tezacaftor and ivacaftor in cystic fibrosis
22 July 2019 - Application supported by positive results from two global Phase 3 studies in people with CF ages 12 ...
Posted by Michael Wonder on 15 Jul 2019
Teva announces FDA approval of AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) inhalation powder
15 July 2019 - The first digital maintenance asthma inhaler therapy with integrated sensors joins Teva’s digital rescue inhaler therapy to ...