FDA Advisory Committee Recommends Approval of Pfizer's Selzentry
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee voted (10 to 4) to recommend the approval of Selzentry® (maraviroc) tablets for use in treatment-naïve adult patients with CCR5-tropic HIV-1 virus as part of combination therapy.
Access to HIV medication
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- Category: Boehringer Ingelheim
Boehringer Ingelheim has repeatedly and clearly stated that patents must not prevent access from life-saving drugs for HIV patients living in resource limited settings. In line with this and in order to accelerate access to anti-retroviral medicines, the company has initiated non-assert declarations in May 2007, well before the idea of the UNITAID patent pool was conceived.
GSK expands presence in China through strategic cooperation
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- Category: GlaxoSmithKline
GlaxoSmithKline (GSK) and Jiangsu Walvax Biotech Company (Walvax) have announced a cooperation agreement to form a long-term Joint Venture (JV) to develop and manufacture paediatric vaccines for use in China. The JV will produce vaccines for measles, mumps, and rubella (MMR) (Priorix™) and potentially other paediatric vaccines. GSK will also transfer the technology to enable the JV to manufacture the vaccines locally over time.
Sandoz launches somatropin, the first-ever Japanese biosimilar
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- Category: Novartis
Sandoz announced the launch of its recombinant human growth hormone somatropin in Japan, the first-ever biosimilar to be approved and launched on the world's second largest pharmaceutical market.
Takeda to Establish Four Sales and Marketing Subsidiaries
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- Category: Takeda
Takeda Pharmaceutical Company Limited (Osaka, Japan, "Takeda") will establish four new commercial subsidiaries covering Mexico, Turkey, Sweden, Norway, Denmark, Belgium and Luxembourg. The new subsidiaries - Takeda Pharmaceuticals Mexico, S.A. de C.V., Takeda Pharmaceuticals Trade, LLP (Turkey), Takeda Pharmaceuticals Nordics AB (Sweden), and Takeda Pharmaceuticals Benelux SPRL (Belgium) - are part of Takeda's strategic global expansion efforts.
Novartis oral MS therapy FTY720 significantly reduces relapses and disability progression
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- Category: Novartis
Initial results from the two-year Phase III FREEDOMS study show that oral FTY720 (fingolimod) was significantly superior to placebo in reducing both relapses and disability progression in patients with relapsing-remitting multiple sclerosis (MS)[1] - one of the leading causes of neurological disability in young adults[3].
Merck Submits Application for Cladribine Tablets
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- Category: Merck Group
Merck KGaA announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Cladribine Tablets, Merck's proprietary investigational oral formulation of cladribine, as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS).
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