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Share Price: 1,773.50
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GlaxoSmithKline in $105 mln settlement with U.S. states over marketing

Wed, 04th Jun 2014 17:02

June 4 (Reuters) - British drugmaker GlaxoSmithKline Plc has agreed to pay $105 million to settle allegations by44 U.S. states and the District of Columbia that it promoted itsmedicines for unapproved uses, several states attorneys generalannounced on Wednesday.

Glaxo was accused of illegally marketing its big-sellingasthma drug Advair for use by mild asthma sufferers and theantidepressants Paxil and Wellbutrin for use by children andteenagers without FDA approval. Several antidepressants havebeen associated with increased risk of suicide in youngerpatients.

"GlaxoSmithKline put its business interests ahead of what wasbest for vulnerable patients," Illinois Attorney General LisaMadigan said in a statement.

While doctors are allowed to prescribe medicines in any waythey see fit - including so called off-label uses -pharmaceutical companies are allowed to promote their productsonly for indications specifically approved by the U.S. Food andDrug Administration.

"Consumers shouldn't have to wonder whether financialincentives are negatively influencing their medical care,"Michigan Attorney General Bill Schuette said in a statementannouncing his state's $2.6 million portion of the settlement.

Under the settlement, Glaxo is banned from disseminatinginformation describing any off-label use of a product, unlesssuch information and materials are consistent with applicableFDA regulations and FDA guidance.

The settlement also requires Glaxo to continue its "PatientFirst Program" that reduces the level of financial incentives bythe company to sales representatives in order to reducedeceptive marketing tactics for five years. (Reporting by Bill Berkrot; Editing by Leslie Adler)

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3 Oct 2023 18:19

IN BRIEF: GSK's Jemperli approved in UK for endometrial cancer

GSK PLC - London-based pharmaceutical company - On Monday, announces that the UK Medicines & Health Products Regulatory Agency has authorised a new indication for Jemperli, also known as dostarlimab. The drug is used as a treatment for some types of endometrial cancer and an be used to treat patients that have a tumour abnormality called mismatch repair deficient/microsatellite instability-high when the cancer is at an advanced stage when first diagnosed or has returned after previous treatment. It is now authorised to be used together with chemotherapy to slow the progression of these cancers. GSK says it is the first medicine licensed as first line treatment for primary advanced or recurrent endometrial cancer.

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3 Oct 2023 11:59

LONDON MARKET MIDDAY: HSBC and StanChart help FTSE 100 outperform

(Alliance News) - London's FTSE 100 grew in confidence as Tuesday morning progressed, going into the afternoon in the green and outperforming European peers.

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25 Sep 2023 09:13

LONDON BROKER RATINGS: Jefferies raises AstraZeneca to 'buy'

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

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25 Sep 2023 08:37

TOP NEWS: GSK's Arexvy vaccine approved for adults over 60 in Japan

(Alliance News) - GSK PLC on Monday said the Japan Ministry of Health, Labour & Welfare has approved Arexvy for adults over 60.

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25 Sep 2023 07:28

GSK's RSV vaccine gets approval in Japan

(Sharecast News) - GSK announced on Monday that its vaccine, Arexvy, has received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for preventing respiratory syncytial virus (RSV) disease in adults aged 60 and over.

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19 Sep 2023 09:30

GSK says new HIV PrEP medication authorised by European Commission

(Alliance News) - GSK PLC on Tuesday said the European Commission has authorised ViiV Healthcare's "superior" drug Apretude to reduce the risk of sexually acquired HIV-1 infection.

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LONDON BROKER RATINGS: Jefferies likes Energean; JPMorgan raises IDS

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

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LONDON BRIEFING: Phoenix Group hails "impressive" first-half

(Alliance News) - Stocks in London are called lower on Monday, as investors focus on the week's upcoming central bank decisions.

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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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