GlaxoSmithKline PLC is a global healthcare company. The Company operates through two segments: Pharmaceuticals and Vaccines. The Company focuses on its research across six areas: Respiratory diseases, human immunodeficiency virus (HIV)/infectious diseases, Vaccines, Immuno-inflammation, Oncology and Rare diseases. The Company makes a range of prescription medicines and vaccines products. The Pharmaceuticals business discovers, develops and commercializes medicines to treat a range of acute and chronic diseases. The Vaccines business provides vaccines for people of all ages from babies and adolescents to adults and older people. It has a portfolio of medicines in respiratory and HIV. Its Pharmaceuticals business includes Respiratory, HIV, Specialty products, and Classic and Established products. Its Vaccines business has a portfolio of over 40 pediatric, adolescent, adult, older people and travel vaccines.
Glaxo announced a deal with Alector to jointly develop and co-commercialize the latter’s two progranulin-elevating monoclonal antibodies, AL001 and AL101 for neurodegenerative diseases. While AL001 is being developed in a phase III study for frontotemporal dementia due to a progranulin gene mutation (FTD-GRN), AL101 is in early-stage development and has been designed for treating more common neurodegenerative diseases like Parkinson’s disease and Alzheimer’s disease. For the deal, Glaxo will make an upfront payment of $700 million to Alector while the latter will also be entitled to up to $1.5 billion in potential milestone payments, profit sharing and royalties. https://finance.yahoo.com/news/pharma-stock-roundup-gsks-deal-121012474.html
GlaxoSmithKline (ticker: GSK) and Johnson & Johnson (JNJ) were both early investors in CVRx (CVRX), a maker of minimally invasive devices to treat heart failure and cardiovascular diseases. When CVRx’s initial public offering converted pre-IPO preferred stock to common shares, GlaxoSmithKline owned 732,583 CVRx shares through a unit. Johnson & Johnson had overall ownership of 4.1 million shares, including stock options and warrants exercisable for 611,944 shares, leaving it CVRx’s largest shareholder. But a GlaxoSmithKline unit bought another 275,000 CVRx shares through the IPO, paying the offering price of $18 each, a total of $4.95 million, according to a form GlaxoSmithKline filed with the Securities and Exchange Commission. The purchase raised GlaxoSmithKline’s stake to 1 million shares, making it CVRx’s fifth largest shareholder, according to S&P Capital IQ. https://www.barrons.com/articles/glaxosmithkline-buys-cvrx-stock-51625781798?siteid=yhoof2&tesla=y
Britain's GlaxoSmithKline on Friday laid out plans to set up a new life sciences campus within its R&D site in Stevenage, England, raising up to 400 million pounds ($552.76 million) by selling some land at the facility. The London-listed drugmaker said it expects to select a private-sector developer later this year and sell 33 acres of the 92-acre site. Work on the project, backed by the UK government, is expected to begin in 2022. GSK, locking horns with activist investor Elliott, is preparing for a planned spin-off of its consumer healthcare venture and focus on its prescription drugs and vaccines business, with heavy investments to develop a new line of products. "Our goal is for Stevenage to emerge as the top destination for medical and scientific research by the end of the decade," said GSK senior executive Tony Wood. GSK hopes to create up to 5,000 jobs in the next five to 10 years with the addition of the new campus. Stevenage is one of GSK's two global R&D hubs and houses the UK's largest cell and gene therapy cluster. https://finance.yahoo.com/news/gsk-seeks-expand-england-r-063312716.html
GlaxoSmithKline Plc said on Friday its anaemia drug for patients with kidney disease succeeded in late-stage experimental trials, marking an important milestone for the British drugmaker as it bolsters its pipeline of new drugs. The drug, daprodustat, belongs to a new class of medicines that works by copying the body's response to hypoxia, or low oxygen levels, and boosts production of red blood cells by mimicking the body's response to high altitude. GSK said results from five late stage studies showed the drug improved haemoglobin levels in patients who had not received any standard care, and helped maintain the levels in those who did. Daprodustat was also well-tolerated in both dialysis and non-dialysis patients. https://finance.yahoo.com/news/1-gsk-drug-shows-promise-121218995.html
July 20 (Reuters) - Europe's drug regulator said on Tuesday it had started a real-time review of the COVID-19 vaccine developed by French drugmaker Sanofi (SASY.PA) and Britain's GlaxoSmithKline (GSK.L), the fifth shot currently under such a review. The decision to start the "rolling review" of the vaccine, Vidprevtyn, was based on preliminary results from lab studies and early stage clinical trials in adults, the European Medicines Agency (EMA) said. Late-stage global trials for the protein-based coronavirus vaccine candidate began in May. Sanofi and GSK hope to get approvals by the end of 2021 after early-stage results showed the vaccine produces a robust immune response EU begins real-time review of Sanofi-GSK COVID-19 vaccine | Reuters
Shingrix approved in the US for prevention of shingles in immunocompromised adults GlaxoSmithKline plc today announced that the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. Immunocompromised individuals are at greater risk of shingles and associated complications than immunocompetent individuals. Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine, given intramuscularly in two doses, was initially approved by FDA in 2017 for the prevention of shingles in adults 50 years of age or older. Shingrix is not indicated for prevention of primary varicella infection (chickenpox). The approval for this new population expands the number of people who can be protected against shingles by Shingrix. https://www.gsk.com/en-gb/media/pre...tion-of-shingles-in-immunocompromised-adults/
GSK delivers strong Q2 sales of £8.1 billion, +6% AER, +15% CER Total EPS 27.9p -39% AER, -28% CER; Adjusted EPS 28.1p +46% AER +71% CER Sales growth driven by strong commercial execution and favourable prior year comparison Pharmaceuticals £4.2 billion +3% AER, +12% CER with growth in New and Specialty products (+25% CER) including Respiratory +36% CER, Immuno-Inflammation +46% CER, Oncology +69% CER, total HIV +14% CER Vaccines £1.6 billion +39% AER, +49% CER reflecting strong growth in Meningitis +46% CER, Established Vaccines +28% CER, Shingrix +1% CER with improved performance notably in the US and £258 million pandemic adjuvant sales. Continue to expect strong growth from Shingrix in H2 Consumer Healthcare £2.3 billion -4% AER, +3% CER (+7% CER excluding divestments/brands under review) Effective cost control supports delivery of adjusted earnings per share growth Total Group operating margin 20.7%. Total EPS 27.9p -39% AER, -28% CER Adjusted Group operating margin 26.7%. Adjusted EPS 28.1p +46% AER, +71% CER (H1 -10% AER, +2% CER). This included a contribution to growth from COVID-19 solutions of approximately +20% AER, +21% CER in Q2 (+7% AER, +7% CER in H1) Q2 net cash flow from operations £1.3 billion. Free cash flow £316 million Continued R&D delivery and strengthening of pipeline FDA rolling review of cabotegravir for prevention of HIV (PrEP) completed Positive phase III headline results for daprodustat, potential transformative medicine for anaemia due to chronic kidney disease 3 new strategic collaborations announced, iTeos, Alector* and Halozyme strengthen pipeline in next generation immuno-oncology, immuno-neurology and HIV Emergency use authorisations for sotrovimab; Phase III started for Sanofi-GSK adjuvanted COVID-19 vaccine and EMA rolling review initiated Investor Update in June outlined new outlooks for growth and plans to maximise shareholder value GSK expects to deliver step-change in sales, operating profit growth and performance from 2022, driven by high quality Vaccines and Specialty Medicines portfolio and late-stage pipeline Proposed demerger to create new world-leading Consumer Healthcare company confirmed for mid-2022 Confident in delivering 2021 EPS guidance and reconfirm 2022 outlook 2021 Adjusted EPS to decline by mid-to-high single-digit percentage at CER 2022 meaningful improvements expected in revenues and margins 2021 guidance and 2022 outlook exclude any contribution from COVID-19 solutions Dividend of 19p/share declared for Q2 2021. Continue to expect 80p/share for 2021 https://www.gsk.com/en-gb/media/pre...-q2-sales-of-81-billion-plus6-aer-plus15-cer/
Drugs giant GlaxoSmithKline (GSK) has been reinstated on the Government-backed prompt payment code list nearly two years after being kicked off for failing to pay invoices in a timely manner. The move comes just days after it was revealed that Tesco voluntarily left the code back in June days before tighter rules were introduced for large firms to pay 95% of smaller suppliers within 30 days, down from 60 days previously. GSK’s turnaround in the past two years sees the company in line with the new rules, having previously only managed to pay 28% of suppliers within 60 days via its consumer healthcare division and just 12% via its overall UK business. https://finance.yahoo.com/news/gsk-returns-prompt-payment-code-152949178.html
GlaxoSmithKline plc GSK announced that the FDA has granted accelerated approval to anti PD-1 inhibitor Jemperli (dostarlimab-gxly) for a new indication. The drug is now approved for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours, whose disease progressed on or after prior treatment, having no satisfactory alternative treatment option available, as detected by an FDA-approved test. This is the second FDA-approved indication for Jemperli. The approval was based on collective data from the dMMR endometrial cancer cohort A1 and the dMMR solid-tumour (non-endometrial cancer) cohort F of the ongoing multi-center open-label GARNET study. Data from the same showed that treatment with Jemperli led to an objective response rate of 41.6% across dMMR solid tumors, with a complete response rate of 9.1% and a partial response rate of 32.5%. Also, 95% of patients had duration of response of six months or longer. Shares of Glaxo have risen 15% so far this year compared with the industry’s rally of 18.4%. https://finance.yahoo.com/news/glaxos-gsk-jemperli-gets-fda-150403513.html
Tue, August 31, 2021 GlaxoSmithKline (GSK) and South Korean pharmaceutical firm SK Bioscience have started a Phase 3 trial of their Covid-19 vaccine combination. GSK told the stock market on Tuesday that the advance follows “positive” interim results in the Phase 1 and 2 studies. It said the partners are now aiming for global supply through the Covax facility in the first half of 2022, subject to data and regulatory reviews. However, latest figures show that around 88% of over-16s in the UK have already received at least one vaccine dose. Thomas Breuer, chief global health officer, GSK, said, “While many countries have made good progress with vaccination, there remains a need for accessible and affordable Covid-19 vaccines to ensure equitable access and to protect people across the world. “We are pleased to contribute with GSK’s pandemic adjuvant and to be working with SK to deliver the vaccine at scale via Covax if it is approved.” The late-stage trial will enrol around 4,000 participants from a range of countries to evaluate the vaccine candidate’s safety and immunogenicity compared with the Oxford AstraZeneca vaccine. GSK said the study will be one of the first global late-stage trials to compare two different vaccine candidates. SK Bioscience chief executive Jaeyong Ahn said: “We are grateful that we were able to advance to the Phase 3 study with the unprecedented support of global initiatives, including GSK, Coalition for Epidemic Preparedness Initiative, and the Bill & Melinda Gates Foundation. “Taking this important step towards overcoming the global pandemic situation, SK and GSK will bring our technical expertise together for the development of an adjuvanted protein-based vaccine candidate, GBP510.” https://finance.yahoo.com/news/gsk-sk-bioscience-start-stage-065957009.html
GBp 1,384.80 Oct 4 (Reuters) - London-based drugmaker GlaxoSmithKline PLC said on Monday it signed a deal to supply 10,000 doses of its COVID-19 monoclonal antibody therapy to the Canadian government. "With the emergence of variants of concern across the country, in particular the Delta variant, new therapies like sotrovimab are important to treating the disease in its early stages," said Ranya El Masri, head of government affairs and market access for GSK Canada. The drug, sotrovimab, developed in partnership with Vir Biotechnology Inc was approved by Canada in July to treat mild to moderate COVID-19 patients, above 12 years of age, who are at high risk for progressing to hospitalization or death. The deal allows Canada's provincial and territorial healthcare systems to gain access to sotrovimab from this month and provides an option to the Canadian government to purchase additional doses next year based on its needs, GSK said. Sotrovimab has also been approved for treating COVID-19 in the United States, Japan and the European Union, among others. (Reporting by Oishee Majumdar in Bengaluru; Editing by Shinjini Ganguli) https://finance.yahoo.com/news/gsk-supply-10-000-doses-164546717.html
Malaria vaccine is working well .... Issued: 6 October, London UK Based on the recommendation of its global advisory bodies for immunization and malaria, WHO has recommended the wider use of GSK’s RTS,S malaria vaccine in children living in sub-Saharan Africa and other regions with moderate to high malaria transmission. Malaria vaccine pilot programmes in Ghana, Kenya and Malawi have shown high impact in real-life childhood vaccination settings, strong community demand and that RTS,S can be effectively delivered through routine child immunization platforms. Recommendation follows shortly after new data show that RTS,S, in combination with seasonal administration of antimalarials, lowers clinical episodes of malaria, hospital admissions with severe malaria, and deaths by around 70%. https://www.gsk.com/en-gb/media/pre...out-of-its-rts-sas01e-rts-s-malaria-vaccine/#
Gordon Singer, head of Elliott Investment Management’s London office, asked Glaxo Chairman Jonathan Symonds to explain what was holding back Glaxo’s value creation and stock during a meeting with top shareholders Thursday, according to a person on the call, who didn’t want to be identified because the event was private. Britain’s largest drugmaker called the meeting to provide an update on its plans to split next year, seeking to reassure shareholders of its progress amid pressure from activist investors, according to another person with knowledge of the gathering. During the discussion, Symonds repeated the company’s commitment to successfully separating the consumer division from the pharmaceutical and vaccines business and defended Walmsley for doing what the board asked her to, according to one of the people at the meeting. Symonds reiterated the existing timelines for the changes and also focused on the board’s progress in appointing new members, another person said. The company expects to appoint a new chair for the consumer business by year-end. Glaxo has also committed to beefing up the pharma and scientific expertise on the board of the pharmaceutical and vaccines business that will remain after the split. The company’s shares have risen 4.4% this year, trailing peers such as AstraZeneca PLc and NovoNordisk A/S. Glaxo rose 1.5% in London trading Thursday, giving the company a market value of about 70 billion pounds ($95 billion). https://finance.yahoo.com/news/activist-elliott-presses-gsk-progress-003755576.html
(Reuters) - GlaxoSmithKline on Monday laid out plans for a new, 120 million pound ($164 million) headquarters for its soon-to-be-independent consumer healthcare business and also said its remaining pharmaceuticals and vaccines staff will relocate. GSK is due to be split in two in the middle of next year in its biggest shake-up in two decades with the consumer healthcare arm, a joint venture with Pfizer known for brands such as Sensodyne toothpaste and Advil painkillers, becoming a separately listed company. Headquarters for the new business, including research facilities, will be built in Weybridge, southwest of London, to house 1,400 staff from the end of 2024. However, staff will first relocate from GSK's current corporate headquarters in Brentford, west London, to temporary facilities in Weybridge when the split takes place in mid-2022. Weybridge is already home to a GSK oral health research and development (R&D) site and Procter & Gamble has an operation in the area.. The rest of GSK's Brentford staff, working for the pharmaceuticals and vaccines business, will move to an as-yet-undetermined site in the same area at the end of 2023 or later, with the pharma giant saying it would be "maintaining access to the UK’s world-leading science and innovation hubs". GSK said it planned to provide further updates on that location in mid-2022. GSK House, as the Brentford headquarters are known, was built about 20 years ago after the merger of SmithKline Beecham and GlaxoWellcome in 2000 created GSK. A spokesperson said it was too spacious to house either of the two successor companies. Relocating can be thorny as evidenced by years of delays in building AstraZeneca's new corporate centre and large R&D campus in the English university city of Cambridge. In 2013, when the scheme was first unveiled, costs were put at 330 million pounds and the aim was to inaugurate the centre by 2016 but construction took until 2020 and costs ballooned to about 1 billion pounds. The listing of the GSK's consumer healthcare business will deliver an 8 billion pound ($11 billion) windfall and other financial benefits to bolster drug development at the pharmaceuticals business. https://finance.yahoo.com/news/gsk-cement-split-two-headquarters-110633657.html
Since the first report of AIDS in 1981, the scientific community has been working tirelessly to develop therapies for AIDS, as well as preventative treatments for the initial stages, HIV. HIV specialist ViiV Healthcare is majority-owned by GlaxoSmithKline (NYSE:GSK) with Pfizer (NYSEFE) and Shionogi as fellow shareholders. ViiV Healthcare announced last month that the U.S. Food and Drug Administration (FDA) accepted and granted priority review for its injectable, long-acting pre-exposure prophylaxis (PrEP) drug known as cabotegravir. With the FDA targeting a decision on the drug by Jan. 24, 2022, what could this revolutionary prophylactic HIV treatment mean for GlaxoSmithKline? Let's find out by examining the appeal and the efficacy of cabotegravir, as well as the sales potential of the drug. Before articulating the potential of cabotegravir, it would be important to highlight the connection between HIV and AIDS. According to HIV.gov, "HIV is a virus that attacks cells that help the body fight infection," which can put a patient at higher risk of serious infections. If HIV isn't treated, it can progress into the late stage of the infection, which is referred to as AIDS. As a person's immune system becomes significantly compromised as a result of AIDS, they are highly susceptible to other illnesses which adds to the already significant costs for healthcare. Even with a variety of effective HIV treatments on the market to reduce the likelihood of progression to AIDS, the prevention of HIV using prophylactic treatments is a high priority since there is no cure for HIV. Drastically reducing the number of new HIV cases through prophylactic treatments is in the interest of public health because that is more time and resources freed up for the healthcare system to treat other equally serious conditions. This is where cabotegravir could be instrumental in significantly reducing the HIV incidence rate compared to existing prophylactic options. ViiV Healthcare's phase 3 clinical trials examined the impact of an every-other-month injection of cabotegravir versus a combo of a daily oral PrEP pill and a placebo injection. Clinical results demonstrated the former was far more effective in "preventing HIV in at-risk men and transgender women who have sex with men," according to the head of research and development at ViiV Healthcare, Dr. Kimberly Smith. In support of this assertion, only 0.41% of patients receiving the injection of cabotegravir every two months went on to test positive for HIV compared to 1.22% in the daily oral PrEP pill and placebo injection group. A 66% reduction in the incidence of HIV while only requiring six injections a year is a major breakthrough in the prevention of HIV, which is great news for at-risk patients and healthcare systems throughout the world. Blockbuster potential So, now we know that the cabotegravir injection is a meaningful advancement in the prevention of HIV. But what does that mean for GlaxoSmithKline? With GlaxoSmithKline's blockbuster Dolutegravir HIV products ($3 billion in first-half sales) set to experience patent expirations near the end of this decade, the company needs new product launches to maintain and build upon its HIV market share. Aside from the approval of cabotegravir earlier this year as a treatment for those already diagnosed with HIV, the drug is only three months away from an almost certain preventative HIV FDA approval based on its efficacy. GlaxoSmithKline itself is forecasting that cabotegravir will generate peak sales in excess of 2 billion pounds or about $2.3 billion at the current exchange rate. While a portion of that revenue will be derived from the treatment of active HIV with cabotegravir, the larger focus is the HIV prevention market. Research firm Global Data estimates that the HIV PrEP market will grow from $2.6 billion in 2019 to $3.3 billion in revenue by 2029. Global Data further anticipates injectable therapies will account for the majority of the HIV PrEP market in 2029 and that cabotegravir-based therapies will dominate the market with a 79% market share, or annual sales of $1.5 billion by 2029. This makes sense given the efficacy of cabotegravir and the fact that it is positioned to be the first long-acting therapy on the market. A high-yielder to consider Pharma stock GlaxoSmithKline has a number of HIV drugs, and cabotegravir will provide a boost to an already strong HIV portfolio and the company's overall drug portfolio. As Fool.com contributor Keith Speights points out, GlaxoSmithKline also has two rapidly growing respiratory therapeutics, Nucala and Trelegy Ellipta. The one major factor that prevents me from saying GlaxoSmithKline could be a core position in a dividend portfolio is the high payout ratio. GlaxoSmithKline's current 5.8% yield is one that income investors should consider as a secondary position within their portfolio. GlaxoSmithKline's anticipated payout ratio is in the high-70% range for this year and low-70% range for next year, which is admittedly on the high end of what I consider acceptable. But with such a high yield, investors shouldn't expect much dividend growth anyway. As a secondary position within a diversified portfolio, GlaxoSmithKline provides income investors a high yield with a tolerable amount of risk, in my opinion. https://www.fool.com/investing/2021...hoo-host&utm_medium=feed&utm_campaign=article
(Reuters) - UK drugmaker GlaxoSmithKline said its plan to separate its consumer healthcare unit next year were on track, after Bloomberg reported potential buyout interest in the business from private equity firms such as Advent, CVC and KKR. The unit, a venture with Pfizer, could also attract some of the world's biggest pharmaceutical and consumer goods companies, the Bloomberg report, citing sources, said https://www.bloomberg.com/news/arti...-consumer-arm-is-said-to-draw-buyout-interest on Tuesday, adding the business could be valued at 40 billion pounds ($54 billion) or more. A GSK spokesman declined to comment on whether the company had received takeover interest in the consumer healthcare business. "GSK is far advanced with its plan for the separation of Consumer Healthcare. This has been developed according to a clear set of guiding principles," he said, adding the company was firmly on track for the split in mid-2022. The London-listed company in June set out plans to turn the consumer arm into a separately listed company to boost its underperforming drugs business, and has also vehemently defended those plans after activist investor Elliott made some proposals https://www.reuters.com/business/he...vestor-elliotts-five-proposals-gsk-2021-07-01. "The GSK board will fulfil its fiduciary duties to evaluate any alternative options for Consumer Healthcare which may arise that maximise value for all shareholders," the GSK representative said. https://uk.finance.yahoo.com/news/gsks-consumer-arm-draws-private-102615121.html
Drugs and vaccines help pharma giant GSK beat expectations Pharmaceuticals giant GlaxoSmithKline (GSK) has revealed turnover ahead of expectations for the past quarter after strong trading its drugs and vaccine arms. The company revealed that turnover grew by 5% to £9.1 billion in the third quarter, surpassing an analyst consensus of around £8.7 billion. It said pharmaceuticals sales lifted by 5.5% to £4.4 billion on the back of strong growth from new and speciality medicines. Meanwhile, the group’s vaccines business saw sales rise by 7% to £2.2 billion for the period. Elsewhere, chief executive officer Dame Emma Walmsley hailed “increased momentum” across its consumer healthcare business, which is due to be spun off next year. The consumer arm, which operates brands including Sensodyne, saw turnover rise by 3% to £2.5 billion. Ms Walmsley said: “GSK has delivered another quarter of strong business performance, with double-digit sales growth in pharmaceuticals and vaccines, increased momentum in consumer healthcare, and continued discipline on costs. “This has allowed us to improve our full-year guidance and, alongside the progress in strengthening our research and development pipeline, reinforces our confidence in the outlook for a step-change in growth and performance in 2022 and beyond. “We also continue to make excellent progress towards unlocking the value of consumer healthcare through a successful demerger in mid-2022.” Ms Walmsley has come under pressure from hedge funds in recent months as GSK prepares to split its consumer healthcare business from its pharmaceutical arm next year. In September, Bluebell Capital joined fellow hedge fund Elliott Management to call for a change at the top of the drugmaker. https://finance.yahoo.com/news/drugs-vaccines-help-pharma-giant-124648859.html
Nov 5 (Reuters) - GlaxoSmithKline said its anaemia pill for patients with kidney disease was shown to have about the same side effect risk as the current standard treatment in two important patient groups, a key advantage in a tight race with rival drug developers. GSK said on Friday that risk measures to determine whether its drug did not pose a higher risk than versions of the current treatment known as Epo, came in better than the predefined hurdle in two trials treating patients on dialysis and those not yet on dialysis. In the trials, its drug daprodustat also improved or maintained haemoglobin levels, when compared to the standard of care, the company added. Analysts have said that safety from side effects such as heart attack or stroke will be a crucial factor to differentiate daprodustat, which GSK has said could have annual sales of as much as 1 billion pounds ($1.35 billion), from competing pills under development by AstraZeneca and others. Anaemia is characterized by a low count of red blood cells or lack of the oxygen-carrying protein haemoglobin in those cells. Patients with kidney disease - ever growing in number due to a rise in obesity, diabetes and high blood pressure - suffer increasingly from anaemia as renal function declines. In later disease stages, particularly when depending on blood-cleansing dialysis, patients currently receive injections of a synthetic version of hormone erythropoietin, or Epo, to stimulate red-blood cell production. But the treatment raises the risk of dangerous heart attacks and strokes. The new class of more convenient oral drugs, known as HIF-PH inhibitors, has attracted several competing drugmakers. AstraZeneca and Fibrogen in August suffered a major setback with their drug roxadustat, part of the same HIF-PH category, when the U.S. Food and Drug Administration (FDA) in August declined approval, citing the need for an additional clinical study on safety. Another HIF-PH inhibitor, vadadustat by Akebia and its Japanese partner Otsuka Pharmaceutical, has been under review by the U.S. FDA since June. GSK's daprodustat is only cleared for use in Japan and GSK said it would make requests for approval with other regulators worldwide, underpinned by the new data. The company had published a short summary of the positive results in June. The positive results come as a boost for GSK boss Emma Walmsley, whose strategy to separately list its consumer health unit has been criticized by activist investor Elliott. Daprodustat is one of a group of GSK drug candidates in late stages of development where the company sees potential for annual peak sales of more than 20 billion pounds. ($1 = 0.7428 pounds) (Reporting by Yadarisa Shabong, Sachin Ravikumar and Pushkala Aripaka in Bengaluru; Editing by Rashmi Aich, Louise Heavens, Elaine Hardcastle) https://finance.yahoo.com/news/gsk-says-anaemia-drug-shows-173000815.html
