WuXi Biologics and GSK Enter into License Agreement on Multiple Novel Bi- & Multi-specific T Cell Engagers
* WuXi Biologics will provide an exclusive license to GSK for one preclinical bi-specific T cell engaging (TCE) antibody and the option of three additional bi-/multi-specific TCE antibodies developed using WuXi Biologics' proprietary technology platforms * WuXi Biologics will receive an upfro...
GSK partners with Samsung Biologics to secure additional manufacturing capacity for innovative biopharmaceutical portfolio
LONDON and SONGDO, South Korea, May 21, 2020 /PRNewswire/ -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Samsung Biologics (207940.KS) have entered into a partnership to provide GSK with additional capacity to manufacture and supply GSK's innovative biopharmaceutical therapies. Under the terms of th...
GSK announces European Medicines Agency (EMA) accepted marketing authorisation application for belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma
- Belantamab mafodotin accepted for accelerated assessment by the EMA's Committee for Human Medicinal Products (CHMP) - Submission based on data from the pivotal DREAMM-2 study of immunoconjugate targeting B-cell maturation antigen (BCMA) recently published inThe Lancet Oncology LONDON, Feb. 3,...
US Food and Drug Administration (FDA) grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma
* Biologics License Application based on results from the pivotal DREAMM-2 study of immunoconjugate targeting B-cell maturation antigen (BCMA) in heavily pre-treated patient population who was refractory to an immunomodulatory drug and a proteasome inhibitor, and refractory or intolerant to an ...
Pivotal DREAMM-2 study demonstrated a clinically meaningful overall response rate with belantamab mafodotin (GSK2857916) for patients with relapsed/refractory multiple myeloma
* Overall response rate (ORR) of 31% with 2.5 mg/kg regimen and no new safety signals in heavily pre-treated patient population who were refractory to an immunomodulatory drug and a proteasome inhibitor, and were refractory or intolerant to an anti-CD38 antibody * Data published in The Lancet...
Phase 3 PRIMA trial of Zejula® (niraparib) is the first study to show a PARP inhibitor significantly improves PFS, regardless of biomarker status, when given as monotherapy in women with first-line platinum responsive advanced ovarian cancer
* The PRIMA study, presented in a Presidential Symposium at the 2019 European Society for Medical Oncology congress and simultaneously published inThe New England Journal of Medicine,demonstrates that niraparib treatment resulted in a 38% reduction in the risk of disease progression or death in...
ViiV Healthcare Announces Positive New Dolutegravir Data for the Treatment of People Living With HIV Co-Infected With Tuberculosis
LONDON, March 6, 2018 /PRNewswire/ -- INSPIRING study results contribute to the extensive body of evidence for dolutegravir, the leading integrase strand transfer inhibitor, in diverse and hard to treat patient populations ViiV Healthcare, the global specialist HIV company, majority owned by G...
ViiV Healthcare Announces Superior Efficacy of Dolutegravir Versus Lopinavir/Ritonavir in Second-line HIV Treatment in Resource-limited Settings
LONDON, July 25, 2017 /PRNewswire/ -- DAWNING study modified to allow patients the opportunity to receive dolutegravir-based regimens ViiV Healthcare, the global specialist HIV company, majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive inte...
ViiV Healthcare Launches Phase III Programme Evaluating a Two-drug Regimen Combining Dolutegravir and Lamivudine for HIV-1 Treatment
LONDON , Aug. 16, 2016 /PRNewswire/ -- ViiV Healthcare today announced the start of a phase III programme to support regulatory filings for a two-drug regimen of dolutegravir (Tivicay®) and lamivudine (Epivir®) as a treatment for HIV-1 infection in adults who have not received prior antire...
ARIA Study Shows Superior Efficacy of Triumeq(R) for Treatment-naive Women Living with HIV
LONDON, England and DURBAN, South Africa, July 18, 2016 /PRNewswire/ -- ViiV Healthcare today presented 48-week data from the phase IIIb, open-label, international, multi-centre ARIA study which showed superior efficacy for Triumeq® (dolutegravir/abacavir/lamivudine) compared with atazanavir boos...
ViiV Healthcare Announces First Phase II HIV Prevention Study Results for Investigational Long-acting Injectable Cabotegravir
LONDON, Feb. 25, 2016 /PRNewswire/ -- ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today presented positive results from the 41 week phase IIa ECLAIR study, which evaluated the safety, tolerability, dosing and sat...
ViiV Healthcare Announces Phase II Study Results for First Two Drug, Long-acting Injectable Regimen for HIV-1 Treatment
LONDON, Feb. 24, 2016 /PRNewswire/ -- ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today presented positive results from the LATTE-2 study at the Conference on Retroviruses and Opportunistic Infections (CROI) inBo...
GSK's Global HIV Business ViiV Healthcare Completes Transactions to Acquire Bristol-Myers Squibb's R&D HIV Assets
LONDON, Feb. 23, 2016 /PRNewswire/ -- GlaxoSmithKline plc (LSE: GSK) today announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, has completed two previously announced transactions with Bristol-Myers Squibb ...
Mylan receives tentative FDA approval for paediatric formulations of abacavir/lamivudine through innovative collaboration with ViiV Healthcare and Clinton Health Access Initiative
LONDON and PITTSBURGH, Dec. 5, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine ...
ViiV Healthcare receives FDA approval for Triumeq® (abacavir, dolutegravir and lamivudine), a new single-pill regimen for the treatment of HIV-1 infection
LONDON, Aug. 23, 2014 /PRNewswire/ -- ViiV Healthcare announced today that the US Food and Drug Administration (FDA) has approved Triumeq® (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection.1 Triumeq is ViiV Healthcare's first dolutegravir-based ...
