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June 18, 2014
08:33 EDTJNJ, VRTXVertex licenses VX-787 to Janssen for treatment of influenza
Vertex Pharmaceuticals (VRTX) announced that it has entered into a licensing agreement with Janssen Pharmaceuticals (JNJ) for the worldwide development and commercialization of VX-787, a novel medicine discovered by Vertex for the treatment of influenza. As part of the agreement, Vertex will receive an up-front payment of $30M from Janssen and has the potential to receive additional development and commercial milestone payments as well as royalties on future product sales. Vertex completed a Phase 2a study of VX-787 in 2013 that showed statistically significant improvements in viral and clinical measurements of influenza infection. VX-787 is designed to directly inhibit replication of the influenza virus. Under the terms of the collaboration, Janssen will have full global development and commercialization rights to VX-787. Vertex will receive a $30M up-front payment from Janssen and could receive additional development and commercial milestone payments as well as royalties on future product sales. The collaboration, and the related $30M up-front payment, is subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
News For VRTX;JNJ From The Last 14 Days
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July 2, 2015
16:28 EDTVRTXOn The Fly: Top stock stories for Thursday
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14:51 EDTVRTXVertex expects payers to provide 'broad access' for Orkambi
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14:50 EDTVRTXVertex to resume trading at 3:00 PM ET
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14:42 EDTVRTXVertex says 'too early to comment' on international Orkambi pricing
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14:33 EDTVRTXVertex sets Orkambi price at $259,000, sees delivery to pharmacies 'within days'
Following today's confirmation from Vertex that Orkambi has received FDA approval, the company held a conference call providing an update on the drug. Vertex remarked that it is "ready to launch this medicine." Vertex will offer a co-pay assistance program for the drug, with certain eligibility criteria. Company believes it can achieve a similar patient cost situation as Kalydeco. Sets price of Orkambi at $259,000 per year. Expects delivery to pharmacy network "within days."
13:52 EDTVRTXVertex to hold a conference call
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13:47 EDTVRTXVertex confirms FDA approval of ORKAMBI
Vertex Pharmaceuticals announced that the U.S. FDA approved ORKAMBI, the first medicine to treat the underlying cause of cystic fibrosis in people ages 12 and older with two copies of the F508del mutation. It is only indicated for these patients, who can be identified with a genetic test. People with two copies of the F508del mutation represent the largest group of people with CF. Of the 30,000 people in the United States with CF, approximately 8,500 ages 12 and older have two copies of the F508del mutation. ORKAMBI will be available for shipment to specialty pharmacies in the United States within days.
12:47 EDTVRTXVertex to return to profitability with approval, says Piper Jaffray
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12:00 EDTVRTXVertex receives FDA approval for Orkambi
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11:50 EDTVRTXVertex trading halted, pending news
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July 1, 2015
16:33 EDTJNJGilead submits NDA to FDA for single tablet regimen for HIV containing R/F/TAF
Gilead Sciences (GILD) announced that it has submitted a New Drug Application, or NDA, to the FDA for an investigational, once-daily single tablet regimen that combines Gileadís emtricitabine 200 mg and tenofovir alafenamide, or TAF, 25 mg with rilpivirine 25 mg, or R/F/TAF, from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), for the treatment of HIV-1 infection in adult and pediatric patients 12 years of age and older. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naÔve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen. A Priority Review voucher acquired from Knight Therapeutics in November 2014 was submitted to the FDA along with the R/F/TAF NDA. Under the Prescription Drug User Fee Act, or PDUFA, the anticipated target action date for the R/F/TAF NDA is six months after the FDAís acceptance of the filing. TAF is a novel, investigational nucleotide reverse transcriptase inhibitor, or NRTI, that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gileadís Viread, as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials in combination with other antiretroviral agents. In addition to R/F/TAF, two other TAF-based HIV treatments are also under FDA review.
June 30, 2015
07:32 EDTVRTXVertex should get Orkambi approval by Monday or sooner, says Piper Jaffray
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June 29, 2015
15:28 EDTVRTXVertex management to meet with UBS
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07:47 EDTVRTXCerulean appoints Stuart A. Arbuckle to board of directors, effective June 26
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