The sale of Breo Ellipta has got approval from the US Food and Drug Administration as a once-daily treatment for asthma in patients aged 18 and older, said GlaxoSmithKline and Theravance Inc.
The FDA said the treatment could not be approved for use in younger asthma sufferers as it's not safe for them. The agency said that only additional data could confirm Breo's safety and efficacy in that population.
The FDA gave its nod to the treatment after an FDA advisory panel of experts had voted 16-4 for use in adults. However, it voted 19-1 that data was not substantial enough to prove that it's safe for use in children aged 12 to 17.
According to Reuters, GlaxoSmithKline Plc’s new respiratory treatment for chronic breathing problems is being reviewed to ensure the safety of the drug over long term use to treat asthma patients.
According to the US Food and Drugs Administration (FDA), they are conducting review of the treatment and are also carrying out the discussion on approval of the combination treatment, Breo Ellipta.
The agency has already approved the inhaled drug combination of vilanterol and corticosteroid for treatment of chronic obstructive pulmonary disease, which is a breathing disability. It becomes severe over time and generally smokers are only affected by it.
Beijing, May 14 : The probe into bribery by GlaxoSmithKline (GSK) in China is complete and the case has been handed over to prosecutors, police said Wednesday.
Prosecutors have started their examination of the case that involves 46 suspects, including British national Mark Reilly, manager of GSK China, Xinhua reported.
After 10 months of investigation, police found that Reilly had ordered his subordinates to offer bribes.
Reilly allegedly pressed his sales teams to bribe hospitals, doctors, other medical institutions and organisations through various means and gained illegal revenue worth billions.
Pharmaceutical major, GlaxosmithKline is nearing a deadline set by the US Food and Drug Administration to ensure the regulator on quality standards at its Currabinny plant in Cork.
The regulator had set the deadline for the company to explain how it intends to comply with the rules set by the authorities. The recent letter issued by the US regulator was a setback for the company's reputation as the company focuses greatly on its supply chain and establishments linked to its global network.
Glaxosmithkline, a substantial, multinational pharmaceutical organization placed in Brentford, London, has issued a complete and aggregate review of the greatly prominent weight reduction drug known as "Alli" in both Puerto Rico and the United States.
The organization known as GSK has accepted client objections in seven states, including Florida, New York and Texas, around various bottles that held different tablets and containers of shifted colors and shapes notwithstanding the real blue Alli pills. It has been accounted for that a couple of jugs were additionally missing their names.
New Delhi, Feb 20 : The Cabinet Committee on Economic Affairs Thursday approved a proposal of GlaxoSmithKline Pte Limited, Singapore, to acquire 24.33 percent in the subsidiary company of the GSK Group in India.
The approval would result in foreign investment of around Rs. 6,390 crore in the country.
The acquisition would be made by way of a voluntary open offer under SEBI (SAST Regulations) in the pharmaceutical sector, said an official release. (IANS)
British drug maker GlaxoSmithKline (GSK) has decided to put an end to two very common controversial industry practices - paying doctors to promote the company's products and tying sales representatives' compensation to the number of prescriptions doctors write.
GSK Chief Executive Andrew Witty confirmed on Tuesday that the company would stop paying doctors for promoting its products and also stop tying representative's compensation to number of prescriptions doctors write.
U. K.-based pharmaceuticals giant GlaxoSmithKline Plc (GSK) on Monday confirmed that it would invest nearly $1 billion (Rs 6,389 crore) to increase its stake in its Indian arm.
GSK announced that it would acquire more than 2.06 crore shares or nearly 24.33 per cent stake in GlaxoSmithKline Pharmaceuticals Ltd (GSK Pharma) at a price of Rs 3,100 per share through an open offer.
Pharmaceutical giant, Glaxo has said that it sales has fallen by a disappointing 61 per cent in China during the third quarter as the company faces a massive investigation into bribery in the country.
Britain's biggest drugmaker's business has been impacted due to the ongoing investigation into its business by the authorities in China. The crisis in China affected its turnover to be below market expectations at £6,610 million. The company's third quarter core earnings per share (EPS) was recorded at 28.9p and the company expects the EPS to grow around 3-4 per cent on a constant exchange rates basis.
Authorities in China have released more information about the accusations against GlaxoSmithKline relating to bribery and corruption in China.
British drugs giant, GlaxoSmithKline (GSK) has reportedly admitted to the Chinese authorities that some of its executives might have broken the law in China.
Three senior level management officials of GlaxoSmithKline are now in China to prepare a response to the allegations of bribery and corruption in the country.
UK's largest drug-maker, GlaxoSmithKline (GSK) has infused more capital in its Indian subsidiary to increase its stake from 43.2 per cent to 72.5 per cent.
The additional investment in the Indian unit indicates that the company is looking to expand its presence in the emerging Indian market. David Redfern, GSK's chief strategy officer pointed out that the move will allow the company to increase its exposure to the Indian market.
London-listed pharmaceutical & healthcare giant GlaxoSmithKline (GSK) Plc has announced a $940-million (Rs 5,220-crore) open offer to raise its stake in its Indian subsidiary GlaxoSmithKline Consumer Healthcare.
On Monday, GlaxoSmithKline Plc announced that it wanted to acquire up to 13,389,410 shares of GlaxoSmithKline Consumer Healthcare, increasing its stake in the company by 31.8 per cent, from 43.2 per cent to 75 per cent.
The open offer represents a premium of 28 per cent to Friday's closing price of the stock.
Healthcare and drug major, GlaxoSmithKline has said that it is planning to increase its stake in its Indian subsidiary, GlaxoSmithKline Consumer Healthcare.
The UK based parent company is planning to increase its stake to upto 75 percent that this could involve an infusion of Rs 5,220 crore. It has made an open offer to acquire additional 31.8 per cent stake in the Indian unit. The company currently holds from 43.2 percent stake in the unit.
GlaxoSmithKline Pharmaceuticals Ltd has reported a fall of 7.6 per cent in net profit at Rs 145.86 crore in the second quarter of the year compared to Rs 157 crore a year ago.
The sales of the Indian firm of the Indian unit of British drug maker grew 4.47 per cent to Rs 607.56 crore even as net sales of the company’s pharmaceutical business grew
6.5% during the quarter.
Pharmaceutical Company, GlaxoSmithKlines has declared that it is making a provision of £2.2 billion through which it will be paying for all the legal costs pertaining to its diabetes drug Avandia.
It also said that all the legal charges are going to be put up on the final quarter results of 2010; and if that happens then the whole profit for the quarter is going to be wiped out.
Washington, Oct 27: British pharmaceutical giant GlaxoSmithKline (GSK) will pay $750 million to settle a US government lawsuit related to the manufacture and sale of adulterated drugs, the US Justice Department said Tuesday.
GSK was accused of manufacturing and selling certain adulterated drugs that were made at its now-closed facility in Cidra, Puerto Rico.
Among the 20 affected drugs were anti-depressant Paxil CR, diabetes treatment Avandamet, anti-nausea medication Kytril and an ointment for skin infections Bactroban.
Leading pharma firm of the country, GlaxoSmithKline Pharmaceuticals (GSK) has declared its June quarter financial results for the fiscal year 2010-11. The company has reported to register a marginal net profit rise in the quarter under review.
GlaxoSmithKline Pharmaceuticals has posted a net profit of Rs 129 crore during the April-June quarter of fiscal year 2010-11. The company has registered a net profit of Rs 124.35 crore in the corresponding quarter in the previous year.
Multinational drug-maker GlaxoSmithKline Pharmaceuticals Ltd. has decided to invest more to support its growth. The leading pharmaceutical company is expected to increase its expenses towards its sales growth and promotional efforts.
However, the company's forth quarter financial report has been quite impressive and it has managed to register reasonable amount of net profit as well as net revenue. The company has seen a remarkable 28% growth in the net sales growth for the first quarter of 2010.