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Stock Market & Financial Investment News

News Breaks
July 25, 2014
07:17 EDTGILD, JNJEMA recommends approval for Gilead, Janssen blood cancer drugs
The European Medicines Agency's Committee for Medicinal Products for Human Use, at its July meeting, recommended granting marketing authorizations for two new medicines with novel mechanisms of action for the treatment of different forms of rare cancers of the blood. Imbruvica and Zydelig are recommended for authorization in the treatment of adult patients with chronic lymphocytic leukemia who have received at least one prior treatment, as well as a first-line treatment for patients with a specific genetic mutation that makes them unsuitable for chemo-immunotherapy. Imbruvica, an orphan medicine, is also recommended for use in the treatment of adult patients with mantle cell lymphoma that has come back after previous treatments or is not responding to other treatments. Zydelig is also to be used for adult patients with follicular lymphoma that has not responded to two previous treatments. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on EU-wide marketing authorizations. Once marketing authorisations have been granted, decisions about price and reimbursement will then take place at the level of each Member State considering the potential role/use of these medicines in the context of the national health system of that country. The marketing-authorization applicant for Imbruvica is Janssen-Cilag International (JNJ) and the marketing-authorization applicant for Zydelig is Gilead Sciences (GILD).
News For GILD;JNJ From The Last 14 Days
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September 25, 2014
08:27 EDTGILDGilead viral suppression data for TAF better than expected, says UBS
UBS said the viral suppression data reported by Gilead from two studies of tenofovir alafenamide, or TAF, in HIV-1 treatment was better than expected and the firm expects the results to have a positive impact on adoption. The firm maintains its Buy rating and $125 price target on Gilead.
September 24, 2014
17:59 EDTJNJOdds of Colgate-Palmolive takeover rise amid slew of megamergers, Bloomberg says
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09:34 EDTGILDActive equity options trading on open
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09:28 EDTGILDGilead price target raised to $118 from $111 at Piper Jaffray
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08:39 EDTGILDGilead's two TAF Phase 3 trials meet primary objectives
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05:12 EDTGILDGilead submits NDA to Japan for fixed-dose combination of Ledipasvir/Sofosbuvir
Gilead Sciences announced that the company has submitted a New Drug Application, or NDA, to Japanís Pharmaceutical and Medical Devices Agency, or PMDA, for approval of an investigational once-daily fixed-dose combination of the NS5A inhibitor ledipasvir, or LDV, 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir, or SOF, 400 mg for the treatment of chronic genotype 1 hepatitis C virus, or HCV, infection in adults. The data submitted in the NDA, which include a Japanese Phase 3 study showing 100 percent SVR12 rates, support the use of LDV/SOF for 12 weeks in treatment-naÔve and treatment-experienced patients with chronic genotype 1 HCV infection, including those with cirrhosis. Patients who achieve SVR12 are cured of HCV infection. If approved, LDV/SOF would simplify HCV treatment for genotype 1 patients in Japan to one daily tablet, eliminating the need for interferon and ribavirin, or RBV. LDV/SOF is currently under regulatory review in the United States and European Union.
September 23, 2014
08:07 EDTJNJ, GILDFDA Pediatric Advisory Committee to hold a meeting
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September 22, 2014
09:15 EDTGILDIntercept recent weakness a buying opportunity, says Summer Street
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07:50 EDTJNJDoctors continue to use morcellators despite FDA warning, J&J halt, WSJ says
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07:07 EDTJNJSynageva appoints Robert Bazemore as COO
Synageva announced the appointment of Robert Bazemore as Chief Operating Officer. Bazemore will oversee the planned global commercial launch of the company's lead program, sebelipase alfa for LAL Deficiency, and will have responsibility for the company's global commercial, market access and medical affairs operations. Bazemore last served at Johnson & Johnson (JNJ) in varoius roles including Vice President, Ethicon New Growth Platforms and President of Janssen Biotech, a part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
September 19, 2014
11:26 EDTGILDStocks with call strike movement; TSLA GILD
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09:37 EDTGILDActive equity options trading on open
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06:25 EDTGILDGilead granted marketing aurhotization from European Commission for Zydelig
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06:11 EDTGILDGilead price target raised to $139 from $111 at Citigroup
Citigroup raised its price target for Gilead shares to $139 saying management looks "very optimistic" that FY15 hepatitis C treatment volumes could be up substantially over FY14 rates globally. Citi also expects recent buybacks to boost Q4 earnings substantially and that future stock buybacks will drive appreciation. The firm keeps a Buy rating on Gilead.
September 18, 2014
12:12 EDTGILDStocks with call strike movement; PIR GILD
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08:17 EDTGILDGilead trial failure not material, says FBR Capital
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September 17, 2014
11:52 EDTGILDStocks with call strike movement; X GILD
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08:36 EDTJNJJanssen-Cilag announces results from post-hoc canagliflozin analysis
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08:12 EDTJNJJanssen-Cilag announces results from Phase 3 Invokana trial
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06:04 EDTGILDGilead's simtuzumab Phase 2 study for pancreatic cancer does not meet endpoint
Gilead announced results from a Phase 2 study evaluating simtuzumab, an investigational inhibitor of lysyl oxidase-like-2, in combination with gemcitabine for patients with previously untreated advanced pancreatic cancer. In the study, the addition of simtuzumab to gemcitabine did not significantly increase progression-free survival compared to placebo plus gemcitabine. There was no difference in adverse events between patients taking simtuzumab versus placebo. Simtuzumab is being evaluated in several ongoing Phase 2 trials, including for advanced colorectal cancer, myelofibrosis, as monotherapy for idiopathic pulmonary fibrosis, and for liver fibrosis. Other agents in Gileadís oncology pipeline are currently being evaluated in clinical trials for the treatment of pancreatic cancer.
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