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Share Price Information for Glaxosmithkline (GSK)

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Share Price: 1,612.00
Bid: 1,613.00
Ask: 1,614.00
Change: 12.00 (0.75%)
Spread: 1.00 (0.062%)
Open: 1,608.00
High: 1,619.00
Low: 1,604.50
Prev. Close: 1,600.00
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GSK's ViiV seeks approval for new one-tablet HIV-1 treatment

Fri, 14th Sep 2018 09:20

(Sharecast News) - ViiV Healthcare - the HIV specialist majority-owned by GlaxoSmithKline, alongside minority shareholders Pfizer and Shionogi - announced the submission of a marketing authorisation application to the European Medicines Agency on Friday, for a single-tablet, two-drug regimen of dolutegravir and lamivudine for the treatment of the HIV-1 infection.The company said the submission was based on the global GEMINI 1 and 2 studies, which included more than 1400 HIV-1 infected adults with baseline viral loads up to 500,000 c/mL.It presented the results of those studies at the 2018 International AIDS Society meeting in July."We continue to demonstrate our commitment as a company to developing new medicines for people living with HIV and providing options for reducing the number of medicines they will have to take as part of life-long treatment," said ViiV Healthcare chief executive officer Deborah Waterhouse."This regulatory submission, if approved, will make available a two-drug regimen option with dolutegravir and lamivudine instead of the traditional three-drug regimen and is an important step in the evolution of HIV treatment."John C Pottage Jr, the company's chief scientific and medical officer, said that ViiV wanted to make HIV a smaller part of people's lives throughout their treatment journey, and was "committed" to challenging the status quo with innovations that were based on our belief that no patient should take more medicines than they needed."If approved, a single-tablet, 2-drug regimen of dolutegravir and lamivudine would mark a new era in HIV treatment for people newly diagnosed with HIV," Dr Pottage explained.ViiV said that s new drug application to the US FDA was also planned for the single tablet regimen for October, using a priority review voucher.Other global regulatory submissions of dolutegravir and lamivudine as a single-tablet, two-drug regimen for HIV-1 therapy were also anticipated in the coming months.
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18 Sep 2023 07:18

US FDA approves GSK treatment for myelofibrosis

(Sharecast News) - GSK announced on Monday that the US Food and Drug Administration (FDA) has granted approval for 'Ojjaara', or momelotinib, as a treatment for adults suffering from intermediate or high-risk myelofibrosis with anaemia, including cases of primary myelofibrosis or secondary myelofibrosis.

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15 Sep 2023 21:52

GSK's Ojjaara approved in US for myelofibrosis patients with anaemia

(Alliance News) - GSK PLC on Friday said Ojjaara, also known as momelotinib, has been approved in the US and the "first and only" treatment indicated for myelofibrosis patients with anaemia.

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11 Sep 2023 08:24

Japan accepts GSK's regulatory filing for momelotinib for blood cancer

(Alliance News) - GSK PLC on Monday reported regulatory progress for momelotinib, as Japan's Ministry of Health, Labour & Welfare accepted a review for the blood cancer-focused drug.

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11 Sep 2023 07:54

LONDON BRIEFING: Restaurant Group sells Frankie & Benny's and Chiquito

(Alliance News) - Stocks in London are called higher on Monday, ahead of a busy week of interest rate decisions and economic data.

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6 Sep 2023 09:32

LONDON BROKER RATINGS: Shore says 'buy' B&M; Peel Hunt likes Halfords

(Alliance News) - The following London-listed shares received analyst recommendations Wednesday morning:

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4 Sep 2023 06:00

More UK babies to need hospital treatment over delay of GSK's RSV jab

(Alliance News) - The nation's top children's doctor has warned a delay on a new vaccine to combat respiratory syncytial virus, or RSV, will mean more babies and infants will need hospital treatment this winter.

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1 Sep 2023 09:11

GSK antibody accepted for Japan review, Goldman Sachs reduces stake

(Alliance News) - GSK PLC on Friday said a new drug application for its monoclonal antibody mepolizumab has been accepted for review by the Japanese government.

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1 Sep 2023 07:49

LONDON BRIEFING: Stocks seen higher; UK house prices continue to fall

(Alliance News) - Stocks in London are set to open higher on Friday as markets looked ahead to a data-heavy day.

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1 Sep 2023 07:12

Japan considering GSK's Nucala drug for sinusitis treatment

(Sharecast News) - Japanese regulators are reviewing a new drug application for GSK's Nucala treatment to be used for the treatment of form of adult sinusitis, the biopharma giant announced on Friday.

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23 Aug 2023 12:10

LONDON MARKET MIDDAY: Stocks rise but pound slumps on sub-par UK data

(Alliance News) - Stocks in Europe were on the up heading into Wednesday afternoon, with equity markets in a confident mood on the eve of the Jackson Hole central banking event, shaking off tepid economic data which hurt the pound and euro.

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23 Aug 2023 08:17

GSK gets positive results from shingles trial of Shingrix in China

(Alliance News) - GSK PLC on Wednesday celebrated positive results from the first-ever efficacy trial of its preventative shingles treatment, Shingrix, in China.

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23 Aug 2023 07:04

GSK reports positive results from shingles vaccine trials in China

(Sharecast News) - GSK reported significant positive findings from its first efficacy trial of the 'Shingrix' shingles vaccine in China on Wednesday.

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22 Aug 2023 13:09

UK's Wood Group raises profit forecast on contract wins; shares rise

CFO David Kemp to retire

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21 Aug 2023 22:37

US FDA approves Pfizer's maternal RSV vaccine to protect infants

Aug 21 (Reuters) - The U.S. Food and Drug Administration on Monday approved Pfizer's respiratory syncytial virus (RSV) vaccine for use in women during the middle of the third trimester of pregnancy to protect their babies.

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17 Aug 2023 19:53

Charity says HIV drug deal with GSK's ViiV on ice over price secrecy

(Alliance News) - The Doctors Without Borders, or MSF, charity said Thursday a deal aimed to bring long-term preventative HIV treatment to vulnerable populations was on hold after the drugmaker imposed pricing confidentiality.

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