'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 ...

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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 ...

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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 ...

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‘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 ...

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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. ...

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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 ...

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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 ...

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‘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 ...

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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. ...

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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 ...

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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, ...

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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 ...

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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 ...

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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 ...

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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 ...

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