A committee of outside advisers to the U.S. Food and Drug Administration (FDA) recommended a vaccine from GlaxoSmithKline (GSK) against the respiratory syncytial virus (RSV) for adults over age 60. The vote from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) for GSK’s Arexvy (RSVPreF3-AS01) vaccine comes a day after the 12 members voted to endorse Pfizer’s vaccine candidate, Abrysvo…
GSK’s Oncology Business Suffers Fresh Blow With Zejula Setback
Britain’s GSK said on Friday it would limit the use of its ovarian cancer drug Zejula in the United States as a second treatment option to keep cancer at bay in patients whose tumors carry certain mutations. The news marks a second setback for GSK’s oncology portfolio this week, after the company on Monday revealed…
GSK’s Blood Cancer Drug Fails Main Goal of Trial, Shares Fall
GSK’s blood cancer drug Blenrep failed the main goal of a late-stage study designed to show it was better than an existing treatment on the market, the company said on Monday. Oncology is a key area of focus for GSK as a standalone prescription medicine and vaccine business and its shares fell 3 percent after…
GSK Says FDA Approves Kidney Disease Drug for Children
GSK Plc. said on Wednesday the Food and Drug Administration (FDA) had cleared its kidney disease drug Benlysta for the treatment of children aged 5–17 years. The clearance makes Benlysta the first treatment approved by the U.S. regulator for children with lupus nephritis, a kind of kidney inflammation. Lupus nephritis is a complication of an…
Pfizer to Exit GSK’s Consumer Health Arm After Spin-Off
LONDON—Pfizer plans to exit its 32 percent stake in Haleon, a consumer health joint venture with British drugmaker GSK, after the business is spun off as an independent listed company in July, GSK said on Wednesday. Pfizer previously signalled it would seek to sell its shareholding in Haleon, the world’s largest consumer health business and…
GSK to Get $1.25 Billion to Settle HIV Drug Patent Row With Gilead
Britain’s GlaxoSmithKline will receive $1.25 billion from Gilead Sciences as part of a settlement between its HIV medicines unit and the U.S.-based drugmaker, ending a long-drawn patent dispute. The settlement, announced by GSK on Tuesday, relates to Gilead’s antiretroviral drug Biktarvy, a medicine used to check the AIDS-causing virus, which GSK said in 2018 infringed…
GSK Rejects 50-Billion-Pound Unilever Offer for Consumer Assets
GlaxoSmithKline on Saturday said it had rejected a 50-billion-pound offer from Unilever for its consumer goods arm, saying it “fundamentally undervalued” the business and its future prospects and that it would stick to its plan of spinning off the unit. Unilever confirmed the approach earlier on Saturday, saying the Glaxo unit would be a “strong…
Government Control Led to Lack of Monoclonal Antibodies, Says Medical Supplies CEO
The head of a medical supplies company involved in the distribution and supply of monoclonal antibodies across southeastern and northeastern regions of the nation, told NTD in a Jan. 12 interview that government takeover of the monoclonal antibody supply chain has exacerbated backlogs and shortages. “The way the products are being distributed right now, relying on…
GSK to Develop Longer-Acting Therapy for HIV With Japan’s Shionogi
GlaxoSmithKline PLC (GSK) said on Tuesday it would develop an HIV treatment with Japan’s Shionogi for use in regimens with dosing gaps of three months or more, as the drugmaker seeks to build on the success of its previous long-acting therapies. The British firm said it would pay Shionogi 20 million pounds ($27.36 million) upfront,…
EU Signs Deal With GSK for Supply of Potential COVID-19 Drug
BRUSSELS—The European Union has signed a contract with GlaxoSmithKline (GSK) for the supply of up to 220,000 treatments of its investigational monoclonal antibody therapy sotrovimab against COVID-19, it said on Wednesday. The drug, which is developed together with U.S. firm Vir Biotechnology, can be used for the treatment of high-risk coronavirus patients with mild symptoms…
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