New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 1, 2013
11:31 EDTVRTXVertex cystic fibrosis drug to be made available in Ireland
Dr. James Reilly TD, Ireland's Minister for Health, announced that Kalydeco, a medicine for the treatment of cystic fibrosis in patients who have the G551D mutation, will be made available for patients in Ireland from March 1st. The decision was made following a request from the Director General Designate of the HSE, Tony O'Brien for a policy direction, prior to its implementation. As with all new drugs Kalydeco was assessed by the National Centre for Pharmacoeconomics in January. The assessment acknowledged the benefits of the drug including significant improvements in lung function, increased body weight, improvement in patients’ quality of life and a 55% reduction in pulmonary exacerbations. The assessment did however highlight the high cost of the drug at over EUR234K per patient per annum and the significant budget impact at over EUR28M per annum. The NCPE recommended against reimbursing the drug at the submitted price but suggested mechanisms such as a risk sharing scheme in addition to a price reduction could enable patients to gain access to Kalydeco. The NCPE recommendation led to follow-up discussions between the HSE Corporate Pharmaceutical Unit and the company, Vertex Pharmaceuticals. These discussions provided a mechanism where the drug could be made available to patients whilst at the same time reducing significantly the budget impact of the drug. They were considered by the HSE Drugs Group and a positive recommendation was made supporting the provision of Kalydeco for Irish CF patients.
News For VRTX From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
May 28, 2015
09:00 EDTVRTXPfizer has 'significant capacity' for additional deals, says JPMorgan
Subscribe for More Information
May 21, 2015
11:04 EDTVRTXVertex has conference call hosted by JPMorgan
JPMorgan Analyst Kasimov hosts a conference call with CFO Ian Smith on May 26 at 1 pm.
10:30 EDTVRTXVertex management to meet with Maxim
Subscribe for More Information
May 19, 2015
07:56 EDTVRTXGilead for Achillion rumor not ridiculous, but highly unlikely, TheStreet says
Subscribe for More Information
May 17, 2015
13:46 EDTVRTXVertex reports Orkambi data, says 'significant improvements' in primary endpoint
Vertex Pharmaceuticals announced that the New England Journal of Medicine published data from the two phase 3 studies of Orkambi, or lumacaftor/ivacaftor, a medicine designed to treat the underlying cause of cystic fibrosis in people ages 12 and older with two copies of the F508del mutation. In November 2014, Vertex submitted an NDA to the FDA for the combination of lumacaftor and ivacaftor. On May 12th, the FDA’s Pulmonary Allergy Drugs Advisory Committee voted 12-1 to recommend approval of Orkambi for people ages 12 and older with two copies of the F508del mutation. The FDA is expected to make a decision by July 5. The New England Journal reports that the studies enrolled 1108 patients who underwent randomization and received Orkambi. In both studies, there were significant improvements in the primary end point in both lumacaftor–ivacaftor dose groups. The difference between active treatment and placebo with respect to the mean absolute improvement in the percentage of predicted FEV ranged 2.6%-4%, which corresponded to a mean relative treatment difference of 4.3 to 6.7%. Pooled analyses showed that the rate of pulmonary exacerbations was 30%-39% lower than in the placebo group. The rate of events leading to hospitalization or the use of intravenous antibiotics was also lower. The incidence of adverse events was generally similar to the placebo group.
May 15, 2015
09:31 EDTVRTXAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use