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Pin to quick picksGlaxosmithkline Share News (GSK)

Share Price Information for Glaxosmithkline (GSK)

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Share Price: 1,733.50
Bid: 1,732.50
Ask: 1,733.00
Change: 5.00 (0.29%)
Spread: 0.50 (0.029%)
Open: 1,733.00
High: 1,739.50
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GlaxoSmithKline's COPD biologic rejected by FDA advisory board

Thu, 26th Jul 2018 08:16

(Sharecast News) - GlaxoSmithKline's application to market a new biologic drug for chronic obstructive pulmonary disease has been rejected by the advisory board of the US medical watchdog, though the company remains confident in the drug as a COPD treatment. GSK said it would continue to work with the US Food & Drug Administration to address outstanding questions after the regulator's pulmonary allergy drugs advisory committee voted 16-3 against approving the use of mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with COPD.The committee voted on the basis of data presented that the risk-benefit profile of mepolizumab was not adequate to support approval and also voted 16-3 that there was not substantial evidence of the efficacy of the treatment.One positive was that the committee suggested further data to characterise the patient population that would be most likely to benefit from this targeted biologic therapy after voting 17-2 that there was adequate evidence of the safety of the drug.As FDA advisory committees recommendations are non-binding, GSK is still working towards a 7 September goal date for approval as a prescription drug.GSK's respiratory research and development chief, Dave Allen, said: "Having participated in today's advisory committee meeting and heard the recommendation we will continue to work with the FDA to address outstanding questions. We remain confident our data supports mepolizumab as a targeted treatment for patients continuing to experience COPD exacerbations guided by blood eosinophil count."Mepolizumab has been approved under the brand name Nucala in over 20 other markets as an add-on maintenance treatment for patients with severe eosinophilic asthma, and in the US, Canada and Japan as add-on maintenance treatment for patients with eosinophilic granulomatosis with polyangiitis, but is not currently approved for use in COPD anywhere in the world. No biologic therapies have yet been approved for COPD sufferers.GSK shares fell 2% to 1,510p on Thursday morning.Analysts at Shore Capital said the submission was based on data from the METREX and METREO trials which produced mixed results: "Namely, in patients with high blood eosinophil count in METREX, there was a statistically significant effect for Nucala, but in Metreo (which enrolled only high blood eosinophil patients), the effect size didn't reach statistical significance, although the point estimates for a 100mg dose of the drug in both trials was fairly consistent."Notably, in METREO, a 300mg dose had a weaker effect size vs. a 100mg dose, which may have warranted further questions from the regulator."
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31 Jan 2024 08:55

LONDON MARKET OPEN: Stocks lack direction ahead of Fed, BoE

(Alliance News) - Stock prices in London lacked direction at the open on Wednesday, as investors nervously look ahead to interest rate decisions from the US Federal Reserve and Bank of England.

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31 Jan 2024 07:46

LONDON BRIEFING: Stocks called up; GSK revenue and profit up

(Alliance News) - Stocks in London are called to open higher, as markets share of nerves around the next set of interest rate decisions.

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29 Jan 2024 08:51

GSK seeks expanded use of RSV vaccine in EU, wins approval for Omjjara

(Alliance News) - GSK PLC on Monday celebrated regulatory progress for two of its products in the EU.

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29 Jan 2024 07:43

LONDON BRIEFING: Superdry looks at saving costs; Ferrexpo loses case

(Alliance News) - Stocks in London are expected to start the week on a cautious note, as investors nervously look ahead to two key interest rate decisions.

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29 Jan 2024 07:07

GSK gets EU approval to sell blood cancer treatment Omijara

(Sharecast News) - Biopharma giant GSK has been given the green light by European regulators to sell Omjjara, its treatment for patients with a rare type of blood cancer.

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26 Jan 2024 10:47

Citi hikes target price for GSK but stays 'neutral'

(Sharecast News) - Shares in biopharma giant GSK were rising on Friday, helped by forecast upgrades from Citi, which raised its target price on the stock from 1,535p to 1,700p.

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24 Jan 2024 15:08

Private equity firm Yellow Wood close to deal to acquire ChapStick-sources

Jan 24 (Reuters) - Private equity firm Yellow Wood Partners is in advanced talks to acquire ChapStick, a lip balm brand, from Haleon Plc, the former consumer health division of drug developer GSK Plc, four people familiar with the matter said.

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24 Jan 2024 14:34

UK earnings, trading statements calendar - next 7 days

Thursday 25 January 
Britvic PLCTrading Statement
Conduit Holdings LtdTrading Statement
CVS Group PLCTrading Statement
Dr Martens PLCTrading Statement
Fevertree Drinks PLCTrading Statement
Foxtons Group PLCFull Year Results
Fuller, Smith & Turner PLCTrading Statement
Halfords Group PLCTrading Statement
Idox PLCFull Year Results
IG Group Holdings PLCHalf Year Results
Intermediate Capital Group PLCTrading Statement
Mitie Group PLCTrading Statement
NCC Group PLCHalf Year Results
Newmark Security PLCHalf Year Results
Next 15 Group PLCTrading Statement
PPHE Hotel Group LtdTrading Statement
Secure Trust Bank PLCTrading Statement
St James's Place PLCTrading Statement
Time Finance PLCHalf Year Results
Titon Holdings PLCFull Year Results
Wizz Air Holdings PLCQ3 Results
Workspace Group PLCTrading Statement
Friday 26 January 
Paragon Banking Group PLCTrading Statement
Record PLCTrading Statement
Superdry PLCHalf Year Results
Taylor Maritime Investments LtdTrading Statement
WH Smith PLCTrading Statement
YouGov PLCTrading Statement
Monday 29 January 
Team Internet Group PLCTrading Statement
Tuesday 30 January 
Diaceutics PLCTrading Statement
Diageo PLCHalf Year Results
Kromek Group PLCHalf Year Results
Luceco PLCTrading Statement
Oxford Cannabinoid Technologies Holdings PLCHalf Year Results
Pets at Home Group PLCTrading Statement
Renewi PLCTrading Statement
Saga PLCTrading Statement
SSP Group PLCTrading Statement
SThree PLCFull Year Results
Synthomer PLCTrading Statement
Wednesday 31 January 
Aberforth Smaller Companies Trust PLCFull Year Results
abrdn Private Equity Opportunities Trust PLCFull Year Results
Ecora Resources PLCTrading Statement
GSK PLCFull Year Results
ITM Power PLCHalf Year Results
NWF Group PLCHalf Year Results
  
Comments and questions to newsroom@alliancenews.com
  
A full 21-day events calendar is provided each day with a subscription to Alliance News UK Professional.
  
Copyright 2024 Alliance News Ltd. All Rights Reserved.

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22 Jan 2024 21:22

Fate of most remaining Zantac lawsuits weighed by Delaware judge

Jan 22 (Reuters) - GSK, Pfizer and other pharmaceutical companies are urging a judge in Delaware this week to find that evidence plaintiffs' lawyers want to use in about 72,000 lawsuits claiming that the discontinued heartburn drug Zantac caused cancer is not supported by science.

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22 Jan 2024 17:08

Fate of most remaining Zantac lawsuits weighed by Delaware judge

Jan 22 (Reuters) - GSK, Pfizer and other pharmaceutical companies will urge a judge in Delaware this week to find that evidence plaintiffs' lawyers want to use in about 72,000 lawsuits claiming that the discontinued heartburn drug Zantac caused cancer is not supported by science.

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22 Jan 2024 09:34

IN BRIEF: Oxford Nanopore appoints Keher to CFO as Cowper becomes COO

Oxford Nanopore Technologies - Oxford, England-based company specialising in nanopore DNA-sequencing - Appoints Nick Keher as chief financial officer and director, effective immediately. Keher will replace Tim Cowper as he moves into a new role as Oxford Nanopore's chief operating officer. The company says that Cowper has been performing the majority of COO duties for the past five years, and that he will lead the company's efforts to expand its international footprint. The company also says that new CFO Keher possesses "significant experience of financial leadership of complex, scientific businesses", having served in similar roles at Clinigen Group PLC, BenevolentAI SA, Royal Bank of Canada, Investec PLC and GSK PLC.

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17 Jan 2024 09:38

UPDATE: GSK raises GBP978 million as cuts stake in Haleon to 4.2%

(Alliance News) - GSK PLC early Wednesday confirmed it agreed to sell 300 million shares in Haleon PLC, reducing its remaining stake in the consumer healthcare products spin-off to just 4.2%.

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17 Jan 2024 08:05

GSK raises £978m through Haleon share sale

(Sharecast News) - GSK said on Wednesday that it has raised around £978m from the sale of shares in Haleon.

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17 Jan 2024 07:46

LONDON BRIEFING: UK inflation surprises as unexpectedly rises to 4.0%

(Alliance News) - Stocks in London are called to open lower on Wednesday, following some hotter-than-expected consumer price data from the UK.

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17 Jan 2024 07:31

GSK raises $1.24 bln from latest Haleon stake sale

Jan 17 (Reuters) - GSK has raised 978 million pounds ($1.24 billion) from a discounted sale of a stake in its spun-off consumer healthcare business Haleon, the British drugmaker said on Wednesday.

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