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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 patientsí 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
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November 23, 2015
08:34 EDTVRTXVertex names Michael J. Parini EVP, chief legal officer
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November 20, 2015
10:34 EDTVRTXVertex approval in Europe to bring gradual uptake, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff says Vertex Pharmaceuticals must now gain reimbursement in each individual country after the European Union approved Orkambi as expected. The approval will ultimately add around 12,000 homozygous F508del cystic fibrosis patients appropriate for the drug, but uptake will be gradual and dependent on the pace of reimbursement. He reiterates an Overweight rating on Vertex with a $180 price target.
05:36 EDTVRTXVertex receives EU approval for Orkambi
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November 18, 2015
05:41 EDTVRTXVertex receives 2 EU approvals for Kalydeco
Vertex Pharmaceuticals announced that the European Commission has approved expansion of the indication for Kalydeco to include children ages 2 to 5 with cystic fibrosis, or CF, who have one of nine gating mutations in the cystic fibrosis transmembrane conductance regulator, or CFTR, gene and to include people with CF ages 18 and older who have an R117H mutation. Ivacaftor was previously approved in the European Union, or EU, for use in people with CF ages 6 and older who have one of nine gating mutations. In Europe, approximately 125 children with CF ages 2 to 5 have one of the nine gating mutations included in today's approval and approximately 350 adults with CF have an R117H mutation. Vertex will now begin the country-by-country reimbursement approval processes for each new indication.
November 16, 2015
07:16 EDTVRTXHayman Capital gives quarterly update on stakes
NEW STAKES: Impax (IPXL), CF Industries (CF), GW Pharmaceuticals (GWPH), ProNAi Therapeutics (DNAI). INCREASED STAKES: BioMarin (BMRN), NMI Holdings (NMIH), Vertex (VRTX), Endo (ENDP). DECREASED STAKES: Mylan (MYL). LIQUIDATED STAKES: Perrigo (PRGO), Oasis Petroleum (OAS), Whiting Petroleum (WLL), Newfield Exploration (NFX), SM Energy (SM).

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