GlaxoSmithKline

UK drugmaker GSK under fresh pressure to sell consumer arm

Hedge fund Bluebell also demands replacement of GlaxoSmithKline chairman Sir Jonathan Symonds The British drugmaker GlaxoSmithKline has come under fresh pressure to sell off its consumer arm and carry out a change of leadership, with a hedge fund demanding the appointment of a new chairman. Bluebell Capital Partners, an activist London-based hedge fund that has …

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GSK’s malaria vaccine gets WHO okay for mass rollout

The WHO has given a green light to widespread use of GlaxoSmithKline’s malaria vaccine in Africa, in what could be a major turning point in the fight against the disease. The RTS,S/AS01 vaccine – also known as Mosquirix – will be administered to children living in sub-Saharan Africa and other regions with moderate to high …

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WHO endorses use of world’s first malaria vaccine in Africa

World Health Organization’s director general hails ‘historic day’ in fight against parasitic disease The World Health Organization has recommended the widespread rollout of the first malaria vaccine, in a move experts hope could save tens of thousands of children’s lives each year across Africa. Hailing “an historic day”, the WHO’s director general, Dr Tedros Adhanom …

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GSK bails on $4.2bn partnership with Merck on cancer drug

GlaxoSmithKline has ended its collaboration with Germany’s Merck KGaA’s cancer treatment bintrafusp alfa, after a trio of failed clinical trials. Given the disappointments the decision to part ways on the programme comes as no surprise, but is nevertheless a setback for GSK which had looked to the drug to revitalise its flagging oncology business. It …

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Sanofi abandons mRNA COVID jab, despite positive trial

Sanofi has said that it won’t develop its mRNA-based vaccine for COVID-19 any further, even though it seemed to work in an early-stage trial, and will focus instead on another candidate partnered with GlaxoSmithKline. The French pharma group said it took the decision because mRNA vaccines from Pfizer/BioNTech and Moderna are already widely available today …

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Life sciences use of digital twins mirrors its application in other industries

Life sciences companies are using “digital twins” for everything from drug discovery to manufacturing. A panel of experts at MedCity News’ INVEST Digital Health conference discussed how this capability to run virtual simulations is changing practices now while also shaping the industry for the years to come.

Second hedge fund applies pressure on GSK after taking stake

Activist hedge fund Bluebell Capital Partners has joined Elliott Investment in taking a stake in GlaxoSmithKline and pushing for change at the drugmaker. In a letter to GSK chair Sir Jonathan Symonds, Bluebell has called on GSK to ask its chief executive Emma Walmsley to reapply for her job, and carry out a “thorough and …

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Second hedge fund pushes for change in leadership of GSK

Bluebell Capital takes stake in pharma giant and puts pressure on Emma Walmsley GSK’s chief executive, Emma Walmsley, has come under pressure from a second activist hedge fund, Bluebell Capital Partners, which has taken a stake in the drugmaker to push for change at the top, including forcing her to reapply for her job. The …

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GSK teams with King’s College to use AI to fight cancer

Artificial intelligence will be used to develop personalised treatments while investigating role of genetics The pharmaceuticals firm GSK has struck a five-year partnership with King’s College London to use artificial intelligence to develop personalised treatments for cancer by investigating the role played by genetics in the disease. The tie-up, which involves 10 of the drug …

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Pfizer raises pressure on GSK, J&J with late-stage RSV vaccine trial

Pfizer has vaulted ahead with its respiratory syncytial virus (RSV) vaccine, closing the gap with GlaxoSmithKline and Johnson & Johnson as the companies strive to bring the first licensed shot to market. The first of an anticipated 30,000 subjects have been vaccinated in Pfizer’s phase 3 RENOIR trial of its vaccine, just behind GSK and …

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Major shareholder’s Rolls-Royce grumble could rumble on

Vague demand for board refresh from Causeway likely a hangover from £2bn rights issue The last time Rolls-Royce had an US activist fund on its tail, the aero-engine manufacturer took the unusual step of inviting one of its representatives onto the board. ValueAct Capital was judged to have constructive ideas and useful industry expertise. The …

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GSK takes SK bio-partnered COVID jab into phase 3

As a top vaccine maker, GlaxoSmithKline has been a laggard in the COVID-19 vaccine race, but has put on a late burst of speed with a start of phase 3 trials of a second candidate that will be compared directly to the AstraZeneca shot. The move follows phase 1/2 results with SK bio’s GBP510, which …

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Third strike for GSK/Merck as bintrafusp alfa flubs again

GlaxoSmithKline’s big gamble on Merck KGaA’s bintrafusp alfa has gone from bad to worse, after the drug failed yet another mid-stage trial. The latest disappointment has come from the phase 2 [email protected] BTC 055 study of the drug alongside chemotherapy as a first-line treatment for patients with locally advanced or metastatic biliary tract cancer (BTC), …

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After FDA snub, EMA backs FibroGen, Astellas’ roxadustat

The EU regulator has approved  FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug in the US. The decision makes Evrenzo (roxadustat) the first oral HIF-PH inhibitor to be cleared for use in the EU, ahead of rival candidates daprodustat from …

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FDA decision for GSK drug opens door to treatment of more cancer patients

GlaxoSmithKline drug Jemperli is now FDA approved for treating solid tumors throughout the body as long as they have a particular genetic signature. Expanding the drug’s approval means the drug can treat more patients who have more types of cancer, and it also gives GSK a way to grow revenue in its thin oncology portfolio.

GSK claims broader ’tissue-agnostic’ label for PD-1 drug Jemperli

The FDA has approved GlaxoSmithKline’s latecomer PD-1 inhibitor Jemperli for a second use that will significantly extend the patient population eligible for treatment with the drug. Jemperli (dostarlimab) can now be used to treat adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours – regardless of where they are located in the body – …

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Pfizer, BioNTech file for FDA approval of COVID booster shot

Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. The two companies have submitted data from a phase 1 trial in support of the booster dose to the US regulator, and …

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FDA rejects FibroGen/AZ’s roxadustat, asking for new trial

The FDA has demanded another clinical trial of FibroGen and AstraZeneca’s roxadustat for anaemia caused by chronic kidney disease (CKD) before it will consider approval, setting up a lengthy delay to the programme. The need for a new trial is something of a worst-case scenario for roxadustat, although a rejection was expected after an FDA …

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GSK names McNamara as CEO of consumer health spinout

GlaxoSmithKline has said that Brian McNamara – currently head of its three-year-old consumer health joint venture with Pfizer – will retain the top job at the business after it is hived off into a separate company next year. The appointment, which had been expected, was confirmed in a statement by GSK’s board today. McNamara has …

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EMA starts review of latecomer GSK/Sanofi COVID-19 vaccine

The EMA has kicked off a rolling review of a COVID-19 vaccine from Sanofi and GlaxoSmithKline, which started a 35,000-patient phase 3 trial in May. The vaccine – now dubbed Vidprevtyn – is based on a recombinant protein antigen developed by Sanofi’s vaccines unit Sanofi Pasteur, and also includes an immune-boosting adjuvant developed by GSK …

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GSK unveils plan for life sciences cluster at Stevenage campus

GlaxoSmithKline wants to sell more than a third of the space at its R&D campus in Stevenage, UK, to a new bioscience cluster that it says could become one of the largest in Europe. The drugmaker says it is seeking a development partner for the project, and hopes to unlock £400 million ($553 million) in …

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GSK plans £400m life sciences campus in Stevenage

Pharmaceuticals firm thinks creating cluster of companies at its site could result in up to 5,000 jobs GlaxoSmithKline is seeking to create a £400m campus in Stevenage for new life sciences companies that it believes could result in up to 5,000 jobs over the next decade. The pharmaceuticals company has kicked off a process to …

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FDA adcomm turns down FibroGen, AZ’s roxadustat for CKD anaemia

Safety concerns seem to have scuppered any hope of a near-term approval for FibroGen and AstraZeneca’s roxadustat for anaemia associated with chronic kidney disease (CKD) in the US, after FDA advisors voted comprehensively against the drug yesterday. Just one of the 14-member panel thought that roxadustat should be approved for non-dialysis-dependent CKD patients, and only …

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GSK cancer head Hoos exits, takes top role at biotech Scorpion

GlaxoSmithKline’s head of oncology Axel Hoos has resigned from the company, and will take up a new role as chief executive of US biotech Scorpion Therapeutics.  Hoos is leaving GSK after nine years, a period that saw a complete revamp of the unit including the wholesale divestment of cancer drugs to Novartis in a $16 …

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GSK adds neuro prospects, paying $700M to share R&D of Alector’s two lead drugs

GlaxoSmithKline is paying Alector $700 million up front to share in the development of the biotech’s two lead drugs, which offer potentially broad application in treating neurological disorders. Alector’s approach addresses the role immune cell dysfunction plays in neurodegenerative disorders such as Alzheimer’s and Parkinson’s disease.

GSK backs CEO Walmsley, rejecting Elliott’s call to change board

GlaxoSmithKline’s board had responded to the broadside attack delivered by activist investor Elliott Management yesterday, saying it stands firmly behind the leadership of chief executive Emma Walmsley. The drugmaker rejected calls by Elliott to change its board and accelerate the complete divestment of its consumer health unit which is due to be split from the …

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GSK firmly rejects Elliott Management’s demands over chief executive

Hedge fund had sought to force Emma Walmsley to reapply for her job ahead of drugmaker’s corporate split The drugmaker GlaxoSmithKline has issued a firm rejection of the main demands made by the activist investor Elliott Management, and insisted its chief executive, Emma Walmsley, would lead the new pharmaceuticals and vaccines company after a corporate …

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Nissan hasn’t put UK ahead in electric race, it’s just got it off the starting grid

The first stage of the Nissan project in Sunderland will deliver 9GWh of capacity but there is a very long way to go in this ‘race’ One can’t grumble too much about ministers’ ra-ra tone over Nissan’s plans to build an electric battery plant, or gigafactory, in Sunderland as part of a £1bn project. The …

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Activist investor Elliott tries to force GSK boss to reapply for her job

US hedge fund ratchets up pressure on Dame Emma Walmsley before company’s demerger next year The US activist investor Elliott Management has in effect demanded Dame Emma Walmsley reapply for her job as chief executive of GlaxoSmithKline before the pharmaceutical company’s demerger of its consumer healthcare division next year. In a 17-page public letter (pdf) …

Activist investor Elliott tries to force GSK boss to reapply for her job Read More »

Elliott fires broadside at GSK in wake of investor update

GlaxoSmithKline chief executive Emma Walmsley was no doubt hoping that an upbeat assessment of the firm’s prospects at an investor meeting last week would deflect criticism of her leadership from activist investor Elliott Management – but finds herself in the firing line once again today. The US hedge fund, run by billionaire Paul Singer, has …

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Elliott fires broadside at GSK in wake of investor update

GlaxoSmithKline chief executive Emma Walmsley was no doubt hoping that an upbeat assessment of the firm’s prospects at an investor meeting last week would deflect criticism of her leadership from activist investor Elliott Management – but finds herself in the firing line once again today. The US hedge fund, run by billionaire Paul Singer, has …

Elliott fires broadside at GSK in wake of investor update Read More »

GSK’s changes leave a long road ahead but CEO Walmsley deserves a hearing

Emma Walmsley still has time to build belief in product pipeline – but clinging onto consumer division hardly shouts confidence “I am a change agent,” declared Emma Walmsley, as she unveiled the biggest overhaul of GlaxoSmithKline in the 20-odd years of the company’s life in its current form. The consumer healthcare division will depart via …

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GSK drugmaker sets ambitious sales target before shake-up

Firm aims to boost pharmaceutical and vaccine business by 5% annually for five years GSK has cut its dividend and set ambitious sales targets as its under-pressure chief executive, Dame Emma Walmsley, pledged to lead Britain’s second-biggest drugmaker through a corporate shake-up next year. GSK is spinning off its consumer healthcare business and aims to …

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Will Emma Walmsley’s radical therapy cure GlaxoSmithKline?

The boss’s plan to divide the pharma giant has support – but her own position may hinge on a crucial presentation this week Dame Emma Walmsley faces the toughest day of her career as chief executive of GlaxoSmithKline on Wednesday. The head of Britain’s second-biggest drugmaker will present a 10-year outlook to shareholders and analysts, …

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GSK joins chase for hot cancer target, paying iTeos $625M in new alliance

GlaxoSmithKline is paying iTeos Therapeutics $625 million up front to share in the development of an antibody that targets the TIGIT protein, a hot target in cancer immunotherapy R&D. The deal comes less than a month after rival Bristol Myers Squibb inked its own deal securing rights to a TIGIT-targeting Agenus drug.

Hospitality firms urgently need clarity from Sunak about £2.5bn of unpaid rent

Giving landlords and tenants six months to work out a deal on arrears could stop an wave of bankruptcies in the sector If it really is a case of “one more heave” on vaccinations before restrictions on the hospitality sector can be eased, what’s the best way to ensure the country’s pubs, restaurants and nightclubs …

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GSK joins ant-TIGIT push with $625m upfront iTeos deal

GlaxoSmithKline has staked a claim to the fast-moving category of cancer therapies targeting the TIGIT immune checkpoint, agreeing a $2 billion plus licensing agreement with iTeos Therapeutics for an antibody candidate in early clinical development. The deal includes $625 million in upfront fees to secure rights to EOS-448, which is currently in a phase 1 …

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FDA authorizes Vir & GSK Covid-19 drug, introducing third antibody option

FDA authorization of the Covid-19 antibody drug from Vir Biotechnology and GlaxoSmithKline adds a third antibody drug for treating early cases of the disease that are at risk of progressing to hospitalization. The companies say they plan to launch the drug, named sotrovimab, “in coming weeks.”

GSK, Sanofi eye Q4 approval as COVID jab starts phase 3

GlaxoSmithKline’s COVID-19 drive has advanced on two fronts, with the start of phase 3 trials of its Sanofi-partnered vaccine candidate as well as an FDA emergency approval for antibody sotrovimab, developed with Vir Biotech. GSK and Sanofi think they could be on track for approval of the recombinant protein-based vaccine – delivered with GSK’s immune-response …

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Under-pressure GSK sells stake in respiratory diseases partner Innoviva

GlaxoSmithKline has sold its entire stake in its respiratory partner Innoviva, raising $392 million and simplifying its business ahead of a split into two. GSK is pushing ahead with a split into an innovative drugs business and a consumer healthcare firm, while the spectre of activist investor Elliott Management hangs over it. The fund run …

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GSK and Medicago report positive Covid vaccine trial data

Announcement follows encouraging news from collaboration with French drugmaker Sanofi Coronavirus – latest updates See all our coronavirus coverage GlaxoSmithKline has unveiled positive interim results from mid-stage trials of a Covid-19 vaccine it is developing with the Canadian biotech firm Medicago, a day after releasing strong data from its vaccine collaboration with the French drugmaker …

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Elliott Management could force out GSK CEO Walmsley, investor warns

Speculation is mounting GlaxoSmithKline’s CEO Emma Walmsley may pay the price for the company’s lacklustre performance, after the dreaded activist investor Elliott Management built a stake in the struggling pharma. GSK is fast becoming thought of as the UK’s other pharma company following Pascal Soriot’s successful turnaround of AstraZeneca – but according to press reports …

Elliott Management could force out GSK CEO Walmsley, investor warns Read More »

Medicago, GSK’s plant-made COVID jab clears phase 2

Canadian biotech Medicago has the data it was hoping for from a phase 2 trial of its COVID-19 vaccine, partnered with GlaxoSmithKline, and is now hoping to have phase 3 data available “by early summer.” The interim phase 2 results show that two doses of the plant-derived jab stimulated neutralising antibody levels that are around …

Medicago, GSK’s plant-made COVID jab clears phase 2 Read More »

GSK’s late entry to the vaccine race will help protect it from aggressive investors | Nils Pratley

Whatever Elliott Management’s intentions, the UK-based pharmaceutical firm will now be seen as a national asset GlaxoSmithKline’s progress on Covid vaccines has been slow, frustrating and surprising. More was expected sooner, because the company remains far bigger in the wider vaccine field than, say, AstraZeneca. But there are now tangible signs the pace is improving. …

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Sanofi & GSK Covid-19 vaccine posts strong clinical data, paves way for Phase 3

Sanofi and GlaxoSmithKline reported positive preliminary Phase 2 data for their Covid-19 vaccine. Though several vaccines have been authorized, the companies say that their vaccine’s foundation in existing influenza vaccines offers advantages, and potentially gives their candidate a place in the market as a booster shot.

Sanofi/GSK move latecomer COVID-19 shot into phase 3

Sanofi and GlaxoSmithKline seem to be getting somewhere with their COVID-19 vaccine at last, announcing plans to move to phase 3 following supportive mid-stage trial results. In a statement the companies said that if the late-stage trial and regulatory reviews go well, the vaccine is expected to be approved in the fourth quarter of this …

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GlaxoSmithKline and Sanofi report strong results in trials of Covid vaccine

News will offer some some relief for GSK chief Emma Walmsley, who has been under pressure from investor GlaxoSmithKline is in the running to bring a new Covid-19 vaccine on to the market by the year end, thanks to positive results from early trials that will allow the formula to enter into late-stage studies within …

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EU starts rolling review of GSK’s antibody for COVID-19

The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its type cleared for early use in the EU.  Sotrovimab (VIR-7831) – also known as GSK4182136 – is being assessed as a treatment for patients with SARS-CoV-2 infection aged 12 and …

EU starts rolling review of GSK’s antibody for COVID-19 Read More »

EU wants to mass produce three ‘course-changing’ Covid drugs from October

Health commissioner says plan is to reduce hospitalisation and tackle long-term impact of Covid Coronavirus – latest updates See all our coronavirus coverage Three Covid medicines with the potential to “change the course” of the pandemic will be authorised for mass production and use in the EU by October under a European Commission plan. Stella …

EU wants to mass produce three ‘course-changing’ Covid drugs from October Read More »

GlaxoSmithKline focuses on split after lacklustre Q1 results

GlaxoSmithKline’s CEO Emma Walmsley said the company is focused on pursuing its strategy to spin off its consumer business after downbeat set of first quarter results. Pharma sales were down 12% compared with last year’s Q1 to £3.9 billion and its vaccines business has also been hit by a 32% slump as people put off …

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Miracles may not be in the pipeline at GSK but it’s too soon to panic | Nils Pratley

The CEO’s best policy is to ignore the noise. The decluttering demerger plan looks solid and is backed by shareholders It was not a knockout quarter to put Elliott Management, the big, aggressive and newly arrived US activist hedge fund, back in its box. GlaxoSmithKline’s revenues fell 18% as patients, sensibly, delayed their GSK shingles …

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GSK’s Emma Walmsley vows to lead drugs firm through corporate split

CEO is under pressure to improve GSK’s performance after profit slump and arrival of activist shareholder GlaxoSmithKline’s chief executive, Emma Walmsley, has vowed to lead the company through next year’s corporate split and beyond, and to keep research spending high, as she came under mounting pressure to improve the drugmaker’s performance after a decline in …

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GlaxoSmithKline faces dose of strong medicine from US investor

This week’s lacklustre results will strengthen boss Emma Walmsley’s case for reform – but also inspire her critics When the American hedge fund Elliott Management took a sizeable stake in GlaxoSmithKline this month, the drugmaker’s shares jumped 5% on speculation of a possible shake-up at the company. GSK’s chief executive, Emma Walmsley, will face questions …

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FDA approves under-pressure GSK’s Jemperli for endometrial cancer

The FDA has approved GlaxoSmithKline’s Jemperli (dostarlimab) immunotherapy, a drug acquired through its $5.1 billion acquisition of Tesaro, for certain patients with endometrial cancer.  With Jemperli, a PD-1 class drug, GSK is a latecomer to the immunotherapy party with a host of other competitors already on the market in various cancers. Merck & Co’s Keytruda …

FDA approves under-pressure GSK’s Jemperli for endometrial cancer Read More »

EMA starts review of GSK/Vir COVID-19 antibody

The EMA has started reviewing the emergency use application for GlaxoSmithKline and Vir Biotech’s COVID-19 antibody VIR-7831, which could become the fourth drug of its type cleared for early use in the EU.  The monoclonal antibody – also known as GSK4182136 – is being evaluated for the treatment of people with mild or moderate COVID-19 …

EMA starts review of GSK/Vir COVID-19 antibody Read More »

Activist investor Elliott builds stake in GSK after fresh trial upset

Activist investor Elliott Management has built a significant stake in GlaxoSmithKline, after a poor run of clinical trial results this year raised questions about management’s strategy to turn around the company’s fortunes. The news follows another trial disappointment this week, where GSK’s feladilimab, combined with Merck & Co’s Keytruda (pembrolizumab), came up short in a …

Activist investor Elliott builds stake in GSK after fresh trial upset Read More »

GlaxoSmithKline shares jump at news of activist hedge fund interest

UK pharmaceutical company has been under pressure to rebuild portfolio of new medicines Shares in GlaxoSmithKline jumped on Thursday, after it emerged that the activist hedge fund Elliott Management has built a sizeable stake in the company, signalling a potential battle over the future of the UK drug maker. New York-based Elliott, which is run …

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AZ aims at Pfizer, GSK with potential new PARP cancer drug

AstraZeneca’s Lynparza (olaparib) blazed a trail for the new class of PARP drugs when it was approved in 2014 to treat ovarian cancer.  The drug has gone on to become a huge success, generating sales of nearly $1.8 billion in 2020 alone as part of a partnership with Merck & Co after expanded use in …

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Race for hepatitis B drug intensifies as Antios raises $96m for phase 2 trial

Antios has raised $96 million in Series B financing to support the ongoing phase 2 development of its hepatitis B drug candidate, ATI-2173. There are several competitors developing treatments for hepatitis B in what could turn out to be a competitive market. Most people infected with the disease, which can be spread sexually or by …

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Top 20 BioPharma Companies based on 2020 Total Revenue

Despite having the global pandemic, the biopharma companies were involved in multiple M&A, licensing deals. The major focus of the year remains the production and distribution of vaccines to combat the COVID-19 globally All the companies on our list are on the front line to combat this global crisis. The top 20 companies on the …

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World leaders call for international pandemic preparedness treaty

More than 20 world leaders have called for an international treaty for pandemic preparedness to protect the world from future health crises. Backed by the World Health Organization, the treaty would “dispel the temptations of isolationism and nationalism” in the event of another crisis such as COVID-19. In a commentary backed by the 24 leaders, …

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Lilly and GSK/Vir antibody pairing offers resistant COVID-19 hope

Two antibodies targeting different parts of the COVID-19 virus spike protein, from Eli Lilly and GlaxoSmithKline/Vir Biotech, can cut viral load dramatically within a week.  The BLAZE-4 trial found that co-administration of Lilly’s bamlanivimab – already granted emergency approval as a COVID-19 treatment – and GSK/Vir’s experimental antibody VIR-7831 reduced virus levels by 70% after …

Lilly and GSK/Vir antibody pairing offers resistant COVID-19 hope Read More »

UK to make up to 60m doses of Novavax Covid vaccine under GSK deal

Deal is intended to boost domestic supply amid fears potential export bans could hit vaccine shipments Coronavirus – latest updates See all our coronavirus coverage The UK will produce up to 60m doses of a Covid-19 vaccine under a new deal struck to boost domestic supply, amid fears over potential export bans hitting shipments of …

UK to make up to 60m doses of Novavax Covid vaccine under GSK deal Read More »

GSK fires former R&D chief Slaoui after sexual harassment allegation

GlaxoSmithKline has fired its former research boss Moncef Slaoui from the board of Galvani Bioelectronics, a company it majority owns, after an internal investigation found he sexually harassed a female employee. Slaoui is noted for his work with Operation Warp Speed, the COVID-19 vaccine project launched by the Trump administration, where he was scientific head …

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GSK fires former US vaccine chief Moncef Slaoui over harassment allegation

Drugmaker dismisses former research boss from role at Galvani Bioelectronics GSK has dismissed its former research boss Moncef Slaoui, who became US national vaccine chief under Donald Trump, after an independent investigation found that he sexually harassed one of its female employees. GSK said it had terminated Slaoui’s role at Galvani Bioelectronics, a joint venture …

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GSK fires ex-Warp Speed chief Moncef Slaoui after sexual harassment inquiry

GSK has terminated Moncef Slaoui as board chair of Galvani Bioelectronics after an investigation substantiated a sexual harassment claim dating to his tenure at the pharmaceutical giant. The company said the inquiry is continuing.

Patrick Vallance: the adviser who spoke scientific truth to power

The UK’s chief scientific adviser loves good food, enjoys a Scandi drama – and has been called ‘the richest civil servant in history’ Sir Patrick Vallance spent his 60th birthday at a podium in Downing Street, flanking Boris Johnson. Whatever plans he had were scrapped. Continue reading…

Patrick Vallance: the adviser who spoke scientific truth to power

The UK’s chief scientific adviser loves good food, enjoys a Scandi drama – and has been called ‘the richest civil servant in history’ Sir Patrick Vallance spent his 60th birthday at a podium in Downing Street, flanking Boris Johnson. Whatever plans he had were scrapped. Continue reading…

Vir Biotechnology, GSK Covid-19 antibody shows ‘profound efficacy’ in Phase 3 study

The positive data for the antibody drug from Vir Biotechnology and GlaxoSmithKline give a clearer picture of how and when these treatments could help. Last week, a different pivotal study testing the same drug in hospitalized patients yielded murkier results.

GSK hits trouble with Trelegy as EU regulators block asthma indication

European regulators have refused to back GlaxoSmithKline’s daily triple therapy Trelegy Ellipta for asthma, denying a label extension because there was no evidence to show a reduction of flare-ups. It’s a blow for GSK, which hopes that Trelegy (fluticasone furoate+umeclidinium+vilanterol) will help to revive the fortunes of its respiratory diseases franchise. The company had been …

GSK hits trouble with Trelegy as EU regulators block asthma indication Read More »

Sanofi/GSK restart COVID-19 vaccine trials after tweaking formulation

Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults. At the time analysts said that this was likely due to an insufficient concentration of the …

Sanofi/GSK restart COVID-19 vaccine trials after tweaking formulation Read More »

Drug companies look to AI to end ‘hit and miss’ research

Technology that speeded the development of Covid vaccines has potential to transform the pharmaceutical industry The hunt for new medicines has often been more like a game of roulette than high-end science. But now the pharmaceutical sector is on the cusp of a transformation, as it delves into cutting-edge technology to come up with new …

Drug companies look to AI to end ‘hit and miss’ research Read More »

GSK expands coronavirus antibody tie-up to include potential flu therapies

GlaxoSmithKline is expanding a coronavirus antibody collaboration with US biotech Vir, to include potential therapies for flu and other respiratory viruses. The big UK pharma is already working with Vir on antibody therapies for coronaviruses, and already have the antibody VIR-7831 in clinical trials including the US National Institutes of Health-backed ACTIV-3 study. Several firms …

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GSK commits $345M to Vir as alliance expands to flu, other respiratory viruses

The amended pact follows a collaboration begun last year when GlaxoSmithKline paid Vir Biotechnology $250 million to team up on potential treatments for Covid-19. The expansion includes an influenza treatment based on Vir’s antibody technology.

Novartis antibiotic retreat doesn’t stop Sandoz buying GSK drugs

Novartis exited novel antibiotics R&D three years ago, but is clearly still interested in the category – its Sandoz unit has just spent $350 million buying GlaxoSmithKline’s cephalosporin franchise.  The deal covers global rights to three brands – Zinnat (cefuroxime axetil), Zinacef (cefuroxime) and Fortum (ceftazidime) – which are sold in more than 100 markets …

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ViiV’s Rukobia cleared in EU as rescue HIV therapy

The European Commission has given a green light to the use of ViiV Healthcare’s Rukobia as a treatment for people with HIV that has developed resistance to other antiretroviral therapy (ART).  The first-in-class HIV attachment inhibitor is cleared for use as an add-on therapy to other ARTs in adults “for whom it is otherwise not …

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AstraZeneca set to weather Covid in better health than rivals

The Anglo-Swedish firm already had a strong lineup of cancer drugs when vaccine success gave it a further boost Before the pandemic, AstraZeneca was highly regarded in the business and pharmaceutical world – seen as one of the UK’s best companies. Now, thanks to Britain’s successful vaccine programme, it is a household name. The Anglo-Swedish …

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Bezos is handing over fronting Amazon, but not his grip on his creation | Nils Pratley

The Amazon founder gains time for other projects, such as space and newspapers, while still making the big decisions Jeff Bezos is stepping aside at Amazon – sort of. In fact, he is merely dropping one of his three job titles at thee online retailer. He will no longer be chief executive but will still …

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GSK/CureVac target new COVID variants with next-gen shot

GlaxoSmithKline and CureVac are to begin developing a next generation vaccine targeting emerging variants of the coronavirus – although it is unlikely to be ready until at least next year. New variants of the coronavirus are emerging around the world and there are concerns about whether the first generation of vaccines will work as effectively …

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GSK and CureVac sign £132m deal to develop multi-variant Covid vaccine

Companies hope to have next generation of vaccines against emerging variants by next year GlaxoSmithKline and Germany’s CureVac have reached a €150m (£132m) agreement to develop a next generation of Covid-19 vaccines targeting new emerging variants in the pandemic. The two companies said they they plan to work jointly to develop a vaccine that can …

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CHMP clears way for EU approval of Novartis’ MS drug

Novartis’ multiple sclerosis drug has been given the green light by the European Medicines Agency’s CHMP scientific committee, paving the way for a likely approval in the coming weeks. Kesimpta (ofatumumab) started life as an oncology drug and was first developed by Genmab and licensed to GlaxoSmithKline who marketed under the brand name Arzerra to …

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GSK suffers another R&D setback, axing ulcerative colitis drug trial

GlaxoSmithKline has suffered another research setback after it axed a phase 2 trial of an anti-LAG3 drug in patients with ulcerative colitis, following a major disappointment with a key lung cancer drug last week. Development partner Immutep had been working with GSK on GSK2831781, an anti-LAG3 cell depleting monoclonal antibody, which was derived from a …

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GSK/Merck & Co’s hopeful bintrafusp alfa fails in key lung cancer trial

GlaxoSmithKline’s big gamble on a cancer drug developed by Germany’s Merck KGaA looks unlikely to pay out, after bintrafusp alfa failed to outperform US-based Merck & Co’s Keytruda in a lung cancer trial. GSK had high hopes in 2019 that Merck KGaA’s bintrafusp alfa could be a substantial addition to a pipeline that was in …

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NICE recommends interim funding for GSK’s Zejula in ovarian cancer

Women with newly-diagnosed advanced ovarian cancer have a new treatment option in England after NICE recommend interim funding for GlaxoSmithKline’s Zejula (niraparib) in final guidance. Zejula competes with AstraZeneca/Merck & Co’s PARP inhibitor class rival Lynparza (olaparib) but in this case it has an advantage in this maintenance therapy use as it can be used …

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Tivicay approved in Europe in new dispersible tablet for children with HIV

ViiV’s Tivicay is to become available in Europe in a new dispersible tablet form to treat children living with HIV. The joint venture, majority-owned by GlaxoSmithKline with Pfizer and Shionogi as shareholders, said the European Commission had granted a marketing authorisation for the new formulation. These tablets are used in combination with other antiretroviral agents …

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Britain could be mass-producing its Covid shot. Shame we junked our industrial base | Aditya Chakrabortty

The dire state of UK manufacturing has left us dependent on other nations. We may soon find out why some call this a ‘national security risk’ Everything now hinges on a vaccine: how many more Britons die, whether the NHS finally breaks, how long the UK stays locked down. All depends on how fast the …

Britain could be mass-producing its Covid shot. Shame we junked our industrial base | Aditya Chakrabortty Read More »

GSK closes 2020 with multi-million deal frenzy to bolster pipeline

GlaxoSmithKline has closed the year with a flurry of deals, leaving its development pipeline bulging like Santa’s sack as chief scientific officer Hal Barron pursues a strategy to develop “transformational medicines”. Barron took over as GSK’s CSO in 2018 under instructions from CEO Emma Walmsley to revamp the company’s flagging R&D effort. Since then Barron …

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GSK’s Benlysta claims first FDA okay for lupus kidney damage

GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis. The US regulator has cleared both intravenous and subcutaneous formulations of Benlysta (belimumab) for the new indication, extending the use of the …

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GSK/Sanofi Covid vaccine delayed until end of next year

Trials reveal vaccine failed to produce a strong immune response in older people Coronavirus – latest updates See all our coronavirus coverage A coronavirus vaccine being developed by GlaxoSmithKline and its French partner, Sanofi, will be delayed until the end of next year after trials revealed it failed to produce a strong immune response in …

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Sanofi on notice as FDA reviews GSK’s Nucala for nasal polyps

Sanofi and Regeneron’s Dupixent has had the US market for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) mainly to itself since June 2019, but GlaxoSmithKline’s Nucala is now breathing down its neck. The FDA has started its review of Nucala (mepolizumab) for the inflammatory condition, which results in the growth of nasal polyps …

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VC firm SR One completes GSK spin-out, raising $500m

Trans-Atlantic biotech venture capital firm SR One has completed its spin-out from GlaxoSmithKline and closed its first fund with $500m in its coffers. The VC built itself a considerable reputation after it was founded in 1985 and works with entrepreneurs and scientists to build biotechnology companies. GSK is the largest investor in the independent fund, …

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Vaccine sales recover at GSK in Q3, but lockdown fears weigh on shares

GlaxoSmithKline saw a recovery in its vaccine sales in the third quarter after a big hit in the second as a result of the COVID-19 pandemic, putting it back on course to meet the lower end of earnings guidance for the year. The bounce-back wasn’t enough to ease investor worries however – with fresh lockdowns …

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Lilly asks FDA for emergency clearance for COVID-19 antibody therapy

Eli Lilly has asked the FDA for an Emergency Use Authorization for its COVID-19 antibody therapy, after announcing new efficacy data from an ongoing trial. It’s been a big week for this class of therapies – Regeneron’s antibody cocktail was famously used to treat president Donald Trump’s illness and GlaxoSmithKline is expanding research into its …

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GSK and Vir expand COVID-19 antibody trial after Trump’s treatment with Regeneron’s rival

GlaxoSmithKline and partner Vir Biotechnology are to expand a trial of an experimental antibody to treat COVID-19, putting heat on Regeneron’s rival that has been famously used to treat president Donald Trump. GSK and Vir began trials of the antibody on early-stage COVID-19 patients in August, with the aim of preventing symptoms from progressing. The …

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GSK tells UK staff: turn off Covid test-and-trace app while at work

Drugs company says infection controls at some of its sites are so secure the app is not needed Coronavirus – latest updates See all our coronavirus coverage The pharmaceuticals firm GlaxoSmithKline has told staff to switch off the contact tracing function that allows the NHS test-and-trace app to monitor the spread of Covid-19 while at …

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GSK and Sanofi to start human trials of potential Covid-19 vaccine

World’s largest vaccine makers to begin testing on people in US with eye on rollout in early 2021 Coronavirus – latest updates See all our coronavirus coverage GlaxoSmithKline and Sanofi are to start testing their protein-based Covid-19 vaccine on humans for the first time, following promising results in earlier studies. GSK, the world’s largest vaccine …

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Ionis deal delivers for GSK as HBV drug hits the mark in phase 2

An antisense drug developed by GlaxoSmithKline has been shown to suppress the hepatitis B virus (HBV) in a phase 2 trial, raising hopes of a “functional cure” for the widespread disease. HBV affects an estimated 260 million people worldwide, according to GSK. While drugs to treat it are available – such as Gilead’s polymerase inhibitor …

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GSK moves further ahead in BCMA with EU okay for Blenrep

GlaxoSmithKline has approval on both sides of the Atlantic for its multiple myeloma drug Blenrep, after getting the nod from the European Commission. Blenrep (belantamab mafodotin) becomes the first BCMA-targeted drug for myeloma to be approved in the EU, and according to its label can be used to treat the blood cancer in adult patients …

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GSK nabs FDA approval for first-in-class multiple myeloma drug

Blenrep, an antibody-drug conjugate, is the first drug approved for multiple myeloma that targets the antigen BCMA. Several other companies are also developing BCMA-targeting therapies for the blood cancer, including CAR-T cells and bispecific antibodies.

US pays $2.1bn to Sanofi/GSK for 100 million doses of COVID-19 vaccine

The US government has selected a potential vaccine from Sanofi and GlaxoSmithKline for its Operation Warp Speed COVID-19 vaccine development initiative, committing up to $2.1 billion for an initial 100 million doses. The collaborative effort with the US government will accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine. Developed by Sanofi in …

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Sanofi, GSK nab $2.1B deal from federal government to provide Covid-19 vaccine

The companies will provide 100 million doses of their jointly developed vaccine. But with a Phase I/II study planned in September, it is behind in development compared with those of Moderna and Pfizer and BioNTech, which have already started late-stage clinical testing.

Return to work: a sector-by-sector look at the plans of England’s major employers

Companies can return to work from 1 August, but many employers are making their own plans Companies ready to defy Boris Johnson’s planned return to work Future shape of offices: proposals to make workplaces safe Major companies in England have been told that, from 1 August, they can discuss with workers whether it is safe …

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AstraZeneca beats expectations in Q2, while GSK struggles during pandemic

AstraZeneca has beaten analysts’ expectations in its second quarter results, outshining its UK counterpart GlaxoSmithKline, which has been hit by disruption caused by the COVID-19 pandemic. AZ’s second quarter sales increased by 8% compared with the same period last year to just under $6.3 billion. While both companies are working on COVID-19 vaccines, it was …

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UK places order for 60m doses of Sanofi/GSK’s COVID-19 vaccine

The UK government has signed its fourth coronavirus vaccine deal, snapping up 60 million doses of an experimental shot being developed by Sanofi and GlaxoSmithKline. The order has come in even before the vaccine has started clinical development, with a phase 1/2 trial not due to get underway until September. Sanofi is providing the vaccine …

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Coronavirus: UK signs deal for 60m doses of potential vaccine

GlaxoSmithKline and Sanofi Pasteur could supply vaccine by early next year if it is successful Coronavirus – latest updates See all our coronavirus coverage The government has signed a deal with the pharmaceutical firms GlaxoSmithKline (GSK) and Sanofi Pasteur for 60m doses of a potential Covid-19 vaccine. If the vaccine proves successful, the UK could …

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CHMP gives nod to GSK’s BCMA drug Blenrep for myeloma

GlaxoSmithKline is closing in on EU approval for its first-in-class BCMA-targeting drug Blenrep, after getting a green light from the EMA’s human medicines committee. Blenrep, based on the antibody-drug conjugate belantamab mafodotin, has been recommended for conditional approval by the CHMP in adult patients with the blood cancer multiple myeloma whose disease has progressed despite …

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Covid-19 is Big Pharma’s chance to impress. But who’ll do best?

AstraZeneca and GSK both release results this week. But picking winners in the sector may be complicated It was the press announcement heard around the world: a potential Covid-19 vaccine from the University of Oxford and pharmaceutical company AstraZeneca had not only been “tolerated” by patients, but “generated robust immune responses against the Sars-CoV-2 virus …

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AZ’s COPD triple therapy approved in the US

AstraZeneca’s triple therapy for chronic obstructive pulmonary disease (COPD), Breztri Aerosphere (budesonide+glycopyrrolate+formoterol fumarate), has been approved in the US following a rejection last year. Approval follows a rejection by the FDA in October last year after the FDA refused to grant a licence based on findings of the KRONOS clinical trial and asked for further …

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GlaxoSmithKline makes bold move with £130m Covid-19 investment | Nils Pratley

GSK’s share price has been left standing by AstraZeneca’s high-risk success in cancer treatments Monday’s most important vaccine news was the promising early data from the Oxford University and AstraZeneca coronavirus trial – “robust immune responses” is encouraging. But let’s not overlook other vaccine developments. The industry has been viewed for years as a dull …

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GSK buys £130m stake in German coronavirus vaccine maker

Stake of 10% in CureVac is part of deal that could eventually be worth more than £800m Coronavirus – latest updates See all our coronavirus coverage The British pharmaceutical company GlaxoSmithKline has bought a 10% stake in a German biotech company that is a key player in the global race for a coronavirus vaccine as …

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UK announces COVID-19 vaccine deals with BioNTech/Pfizer and Valneva

The UK has secured 90 million doses of two different COVID-19 vaccines from BioNTech/Pfizer and Valneva, with an option of 40 million doses if they check out in trials.  There is no approved COVID-19 vaccine, but governments across the world are busy signing deals with developers to gain access should trial results check out.  The announcements came as the scientific community held …

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FDA AdCom votes unanimously in favor of GSK myeloma drug, despite earlier agency skepticism

The Oncologic Drugs Advisory Committee voted 12-0 that the benefit-risk profile of belantamab mafodotin supported the drug. The vote came despite concerns expressed by the FDA in briefing documents ahead of the ODAC meeting, particularly with regard to ocular toxicity.

FDA raises concerns over ocular toxicity from GSK’s potential first-in-class myeloma drug

The FDA’s Oncologic Drugs Advisory Committee will convene Tuesday to discuss the drug, belantamab mafodotin. Despite the drug’s first-in-class potential, the briefing document for the meeting raised concerns about eye toxicity and questions about its risk-benefit profile.

ViiV’s twice-monthly injected PrEP drug superior in HIV prevention to Gilead daily pill, analysis shows

The company said Tuesday that a final analysis of its Phase IIb/III study of cabotegravir showed greater efficacy in HIV prevention than Gilead’s Truvada. The study, among men and transgender women who have sex with men, was stopped in May following an interim analysis.