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News Breaks
June 12, 2014
07:46 EDTPFE, GSK, JNJViiv Healthcare announces collaboration with Janssen
ViiV Healthcare announced that they have entered into an agreement with Janssen R&D Ireland Ltd for the development and commercialisation of a single-tablet combining dolutegravir and Janssen's non-nucleoside reverse transcriptase inhibitor rilpivirine. This represents ViiV Healthcare's first external collaboration to develop a single-tablet regimen with another company's branded product and builds on ViiV Healthcare's strategy to expand its portfolio of dolutegravir-based regimens, which started with the approval of dolutegravir for use in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus infection in adults and children aged 12 years and older weighing at least 40 kg in the US, and HIV infected adults and adolescents above 12 years of age in Europe. As part of this agreement, the two companies will investigate the potential of combining dolutegravir and rilpivirine into a single-tablet in order to expand the treatment options available to people living with HIV. Studies included in the new development programme are expected to begin by 1Q15 and will investigate the two drug combination regimen as an HIV maintenance therapy for patients already virally suppressed on a three drug regimen. The companies will further investigate the development of paediatric fixed-dose formulations which combine dolutegravir and rilpivirine. ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (GSK) and Pfizer (PFE), and Janssen is part of Johnson & Johnson (JNJ).
News For GSK;PFE;JNJ From The Last 14 Days
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July 2, 2015
18:37 EDTPFE, GSKViiV, Desano enter strategic manufacturing agreement for Tivicay
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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 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.
16:00 EDTPFEOptions Update; July 1, 2015
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June 26, 2015
10:38 EDTGSKCourt revives lawsuit over GlaxoSmithKline Lamictal drug, Bloomberg reports
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June 25, 2015
14:01 EDTGSKGlaxoSmithKline initiated with a Buy at HSBC
Price target GBP 17.
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 EDTPFECAR-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 Bathís 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 doesnít anticipate a sale, the report noted. Reference Link
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 EDTPFE, GSKPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.
June 22, 2015
08:52 EDTPFEPortola, Bristol-Myers, and Pfizer announce results from Phase 3 ANNEXA study
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07:01 EDTPFE, GSKPfizer to acquire Nimenrix, Mencevax from GlaxoSmithKline for $130M
Pfizer (PFE) announced that it has entered into an agreement with GlaxoSmithKline (GSK) to acquire its quadrivalent meningitis ACWY vaccines, Nimenrix and Mencevax, for a total consideration of approximately $130M. This transaction will add two high-quality and complementary vaccines to Pfizerís portfolio, allowing the company to reach a broader global population. Nimenrix is a single dose meningococcal ACWY-TT conjugated vaccine designed to protect against Neisseria meningitidis, an uncommon but highly contagious disease that can lead to disability and death. Mencevax is a single-dose meningococcal ACWY unconjugated polysaccharide vaccine used to control outbreaks of meningococcal infection and for travelers to countries where the disease is endemic or highly epidemic. Pfizer does not expect this transaction to have any significant impact on its 2015 financial performance. The transaction is subject to customary closing conditions as well as regulatory approvals in several markets, and is expected to occur in the second half of 2015. Pfizerís legal advisors for the transaction were Ropes & Gray and Clifford Chance.

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