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Stock Market & Financial Investment News

News For MRK;JNJ;GSK;PFE;BMY;SNY From The Last 14 Days
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July 2, 2015
16:37 EDTPFEPfizer announces FDA acceptance for review of NDA for Xeljanz
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09:31 EDTPFEXRpro Sciences acquires assets related to ion channel platform from Pfizer
XRpro Sciences announced its acquisition of assets related to the ion channel biology platform from Pfizer that had previously been obtained as part of Pfizer's 2011 acquisition of Icagen. XRPro Sciences also acquired all of Pfizer's rights to the "Icagen" name and trademark. XRPro Sciences is re-launching the Icagen brand and will provide comprehensive services for ion channel and transporter drug discovery, combining Icagen's industry-leading scientific expertise and extensive portfolio of assays and cell lines with XRpro Sciences' proprietary, label-free X-ray fluorescence technology. The new Icagen will continue to operate out of the existing facility in Research Triangle Park, North Carolina in addition to the current XRpro Sciences Inc. site in Cambridge, Massachusetts. Pfizer scientists associated with the ion channel biology platform will transition to the new Icagen, ensuring continuity of their extensive scientific expertise.
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 Gilead’s 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-naïve 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 FDA’s 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 Gilead’s 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.
16:00 EDTPFEOptions Update; July 1, 2015
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June 29, 2015
08:39 EDTMRKMerck says Phase 3 Emend data shows it provides 'greater protection' from nausea
Merck announced results from a Phase 3 study investigating the safety and efficacy of single-dose Emend for Injection, Merck’s substance P/neurokinin receptor antagonist, in combination with other anti-vomiting medicines, for the prevention of chemotherapy-induced nausea and vomiting, or CINV, in adult cancer patients receiving moderately emetogenic chemotherapy, or MEC. In the study, the first to evaluate an intravenous NK-1 receptor antagonist for the prevention of CINV associated with MEC, the single-dose Emend for Injection regimen provided greater protection from nausea and vomiting following administration of chemotherapy versus an active control of placebo with other anti-vomiting medicines. These data were presented in an oral session at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology Annual Meeting on “Supportive Care in Cancer” in Copenhagen.
June 26, 2015
10:38 EDTGSKCourt revives lawsuit over GlaxoSmithKline Lamictal drug, Bloomberg reports
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08:31 EDTBMYAlexandria Real Estate announces lease with Bristol-Myers in Cambridge
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June 25, 2015
14:03 EDTSNYSanofi initiated with a Buy at HSBC
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14:01 EDTGSKGlaxoSmithKline initiated with a Buy at HSBC
Price target GBP 17.
09:34 EDTBMYBristol-Myers expects Waltham site to close in early 2018
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09:32 EDTBMYBristol-Myers opens research site in Cambridge, discontinues virology research
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June 24, 2015
13:37 EDTGSKGSK says CDC committee votedfor meningococcal group B vaccines
GlaxoSmithKline (GSK) announced that the U.S. Centers for Disease Control Advisory Committee on Immunization Practices voted for a Category B recommendation for meningococcal group B vaccination, including Bexsero, in individuals aged 16 to 23. Bexsero was approved by the FDA in January for use in individuals aged 10 through 25 years and acquired by GSK in March following the closure of the three-part transaction with Novartis (NVS).
13:23 EDTPFEPfizer says CDC committee votes to recommend MenB vaccine
Pfizer announced that the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to recommend that decisions to vaccinate adolescents and young adults 16 through 23 years of age against serogroup B meningococcal disease should be made at the individual level with healthcare providers. It added, "Specifically, the ACIP voted that a serogroup B meningococcal vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16 through 18 years of age." Pfizer's Trumenba is FDA-approved for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. The ACIP recommendation will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval, Pfizer said.
11:02 EDTPFEPfizer lung cancer treatment granted FDA orphan drug designation
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09:07 EDTPFE, MRKCAR-T cancer drug researchers seen as M&A targets, Bloomberg says
Juno Therapeutics (JUNO), Kite Pharma (KITE) and Bluebird Bio (BLUE) are trading well above their IPO levels as takeovers predictions have spurred interest and share increases for the developers of CAR-T gene therapies, said Bloomberg's "Real M&A" column, quoting Dimo Dimov, a professor at the University of Bath’s School of Management, as having said that companies such as Pfizer (PFE), Merck (MRK), Roche (RHHBY) and AstraZeneca (AZN) are "closely watching" the firms. Cellectis (CLLS), which is working with Pfizer on its own approach to CAR-T therapy, has said it wants to bring its therapy to market and doesn’t anticipate a sale, the report noted. Reference Link
07:29 EDTBMYFDAnews to hold a summit
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June 23, 2015
14:17 EDTPFEGlycoMimetics to receive $20M payment from Pfizer
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14:01 EDTPFEPfizer announces enrollment of first patient in RESET study
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09:53 EDTPFEPfizer management to meet with FBN Securities
Meeting to be held in New York on June 25 hosted by FBN Securities.
07:25 EDTGSK, PFEPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.
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