GlaxoSmithKline

GSK, Sanofi and Haleon ‘facing billions of dollars in Zantac liability’

GSK, its consumer health spin-off Haleon and Sanofi could be on the hook for billions of dollars in potential damages over Zantac, a gastrointestinal drug pulled from the market in 2020 after it was linked to cases of cancer. That’s the conclusion of analysts at Morgan Stanley, Deutsche Bank and UBS, who have all issued …

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The power of digital ecosystems to improve pharma supply chain operations [Sponsored]

A panel discussion from a recent Microsoft summit offered insights on how tech companies are closely collaborating with the pharma industry as they seek to repair and improve manufacturing supply chain issues exposed by the Covid-19 pandemic.

Chinese biotech Sironax raises $200m for RIPK1 pipeline

Beijing biotech Sironax has closed a whopping $200 million second-round financing that shows investors still have a desire to back companies working on RIPK1 inhibitors despite setbacks for GSK in the class. The five-year-old Chinese company – which is developing drugs for age-related degenerative diseases – said it will use the proceeds of the Series …

Chinese biotech Sironax raises $200m for RIPK1 pipeline Read More »

Record Shingrix sales help GSK raise 2022 forecasts

In its first set of financial figures since spinning off its consumer health division, GSK has reported a 19% increase in revenues, driven by burgeoning demand for its shingles vaccine Shingrix, which has helped the company to raise its full-year guidance. Total revenues came in at £6.9 billion ($8.3 billion) – ahead of forecasts – …

Record Shingrix sales help GSK raise 2022 forecasts Read More »

Ex-GSK vaccine chief to lead new UK biotech Vicebio

GSK’s former head of vaccines R&D – Dr Emmanuel Hanon – is heading up a new biotech called Vicebio that will go up against his former employer with a vaccine against respiratory syncytial virus (RSV) infections. The London-based company was founded by venture capital firm Medicxi in 2019, but has now come out of stealth …

Ex-GSK vaccine chief to lead new UK biotech Vicebio Read More »

Haleon’s debut suggests it may not be the jewel in GSK’s medicine cabinet | Nils Pratley

Consumer goods spin-off makes few waves in biggest European listing for more than a decade It’s early days for Haleon, GlaxoSmithKline’s consumer goods spin-off, but the day one valuation of £28.5bn for the Panadol-to-Sensodyne business represented a less than storming debut for the biggest European listing for more than a decade. A par score was …

Haleon’s debut suggests it may not be the jewel in GSK’s medicine cabinet | Nils Pratley Read More »

GSK consumer health spin-off Haleon starts trading

GSK’s consumer health spinout Haleon started trading on the London Stock Exchange this morning, making its debut with a price of 330 pence and a market valuation if around £31 billion ($37 billion). The new company – which has achieved the largest London listing in a decade – has annual sales of around £10 billion …

GSK consumer health spin-off Haleon starts trading Read More »

GSK spin-off Haleon begins trading in biggest European listing in a decade

Consumer health company’s shares open at 330p, giving it a market value of about £31bn GSK’s consumer spin-off Haleon, home to brands from Sensodyne toothpaste to Panadol painkillers, has begun trading on the London Stock Exchange in the biggest European listing in a decade. Haleon shares started trading on Monday morning at 330p, with a …

GSK spin-off Haleon begins trading in biggest European listing in a decade Read More »

Teva asks SCOTUS to overturn “skinny label” verdict on GSK drug

Teva has asked the Supreme Court to look at a judgment in a $235 million patent dispute with GSK that it claims could undermine the ability of generic drugmakers to bring new products to market, and thereby help reduce drug prices. The case hinges around the concept of “skinny labelling” which was introduced to stop …

Teva asks SCOTUS to overturn “skinny label” verdict on GSK drug Read More »

London stock market listing of up to £45bn looms as GSK investors vote for demerger

UK pharmaceutical to spin off brands such as Sensodyne, Voltaren and Panadol into Haleon in largest listing since 2011 Investors in the British pharmaceuticals giant GSK have voted to approve a demerger of its consumer brands into a new company, Haleon, firing the starting gun on the largest London stock market listing in a decade. …

London stock market listing of up to £45bn looms as GSK investors vote for demerger Read More »

Partners come on board GSK’s plan for Stevenage life science hub

GSK’s recently-unveiled plan to develop a bioscience cluster close to its main R&D site in Stevenage, UK, has moved closer to fruition, now that the first partners have joined the initiative. The asset management arm of Swiss back UBS has formed a joint venture with property developer Reef Group that will develop the 33-acre campus …

Partners come on board GSK’s plan for Stevenage life science hub Read More »

Pfizer seeks to overturn three RSV vaccine patents held by GSK

Already competing to bring the first vaccine against respiratory syncytial virus (RSV) to market, Pfizer and GSK are also fighting a patent infringement battle in the courts. Earlier this month, Pfizer filed a lawsuit (HP-2022-000016) in the Royal Courts of Justice in London, seeking to invalidate three GSK patients covering its RSVPreF3 shot, according to …

Pfizer seeks to overturn three RSV vaccine patents held by GSK Read More »

Reimagining The Future of Pharmacovigilance (PV): Regulations, Tech, Public Perceptions

Barry Mulchrone, Senior Director& Head of Pharmacovigilance Oversight and Analytics, IQVIA Annette Williams, VP & Global Head, Lifecycle Safety, IQVIA Monitoring the safe and effective use of medicines has now been an essential part of public health policy for several decades. New advances in technology (e.g., ICH E2B for the electronic exchange of case reports) …

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US panel backs Omicron-targeting vaccines for booster campaigns

Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). After hours of deliberation, the panellists voted by 19 to two in favour of using redesigned booster shots, rather than simply using the currently authorised vaccines …

US panel backs Omicron-targeting vaccines for booster campaigns Read More »

GSK hepatitis B hope bepirovirsen heads for phase 3 test

An antisense drug in development at GSK has shown further activity against hepatitis B virus (HBV) in a mid-stage trial, setting up a phase 3 assessment next year to see if it could offer a “functional cure” for the widespread disease. Interim results from the phase 2b B-Clear showed that bepirovirsen reduced levels of hepatitis …

GSK hepatitis B hope bepirovirsen heads for phase 3 test Read More »

GSK pledges £1bn drive for infectious disease R&D

GSK will invest around £1 billion ($1.2 billion) over a 10-year period to speed up R&D on infectious diseases that mainly impact lower-income countries. The initiative will focus on vaccines and medicines for diseases like malaria, tuberculosis, HIV and neglected tropical diseases (NTDs), which according to the drugmaker account for 60% of the disease burden …

GSK pledges £1bn drive for infectious disease R&D Read More »

FDA clears GSK’s Priorix, first new MMR vaccine in 50 years

With vaccine hesitancy leading to a rise in measles cases, the FDA’s approval of GlaxoSmithKline’s venerable vaccine Priorix for sale in the US looks timely. Priorix was first launched in Europe almost a quarter of a century ago by GSK’s predecessor SmithKline Beecham, and is a combination measles, mumps and rubella (MMR) vaccine now cleared …

FDA clears GSK’s Priorix, first new MMR vaccine in 50 years Read More »

Pfizer will exit GSK consumer health JV after spinout

GlaxoSmithKline is due to complete the split from its consumer health decision – now renamed Haleon – next month, with a listing for the new company on the London Stock Exchange set for 18 July. GSK said it has now filed a prospectus for the submission of Haleon’s ordinary shares to the stock market with the …

Pfizer will exit GSK consumer health JV after spinout Read More »

GSK bolsters vaccines division with $3.3bn swoop on Affinivax

GlaxoSmithKline has agreed a $3.3 billion takeover of US biotech Affinivax, buying a pneumococcal vaccine candidate that is aiming to break into a market that for years has been dominated by Pfizer’s Prevnar franchise. GSK said it is paying $2.1 billion upfront for Cambridge, Massachusetts-based Affinivax, with another $1.2 billion in potential development milestones, to …

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GSK said to be close to finding partner for science cluster in UK

GlaxoSmithKline is reportedly close to finding a development partner for a major new investment project in the UK that will see a new bioscience cluster built near its research centre in Stevenage. The pharma group said last year it was looking for a collaborator to develop a 33-acre block of land in the Hertfordshire town …

GSK said to be close to finding partner for science cluster in UK Read More »

Pay deal averts strike action at GSK’s UK sites

Industrial action at several GlaxoSmithKline manufacturing plants in the UK has been called off, after an improved pay deal was accepted by the Unite union. Unite said last month it was calling for strike by GSK workers for the first time in the company’s history, saying a “derisory” 2.75% pay increase was in fact a …

Pay deal averts strike action at GSK’s UK sites Read More »

GSK, iTeos take stock after Roche’s TIGIT setback

iTeos Therapeutics has said it is evaluating with partner GlaxoSmithKline whether to conduct additional clinical trials of TIGIT drug EOS-448 following the failure of a key trial for Roche’s rival drug. In its first-quarter update, iTeos said it assessing “how best to proceed with additional clinical development” of the anti-TIGIT antibody, although chief executive Michel …

GSK, iTeos take stock after Roche’s TIGIT setback Read More »

Boots, Superdrug and other chemists report hay fever pill shortages

GlaxoSmithKline blames shortage of key ingredient for lack of Piriton and Piriteze tablets Big high street pharmacy chains including Boots and Superdrug have run out of some hay fever medicines, with the manufacturer, GlaxoSmithKline, blaming temporary supply issues. Piriton and Piriteze tablets, made by GSK, are out of stock at Boots and other chains because …

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Fifth scientist convicted in GSK trade secrets case

A scientist working in Switzerland has become the fifth person to be convicted of attempting to steal trade secrets from pharmaceutical group GlaxoSmithKline in a case that stretched back several years. Gongda Xue (52), a Chinese citizen formerly working at the Friedrich Miescher Institute for Biomedical Research in Switzerland, has been found guilty of conspiracy …

Fifth scientist convicted in GSK trade secrets case Read More »

GSK beats forecasts, thanks to COVID antibody and Shingrix sales

GlaxoSmithKline has made a promising start to 2022 with a 32% rise in group sales, albeit measured against a downbeat first-quarter result in 2021. Vir Biotechnology-partnered COVID-19 antibody Xevudy (sotrovimab) was the big contributor to the improved result, adding £1.3 billion ($1.6 billion) to the company’s top-line of £9.8 billion with no sales recorded in …

GSK beats forecasts, thanks to COVID antibody and Shingrix sales Read More »

GSK workers vote for strike action over “derisory” pay offer

Workers at a number of GlaxoSmithKline manufacturing plants in the UK have voted to take industrial action over what the Unite union has described as a “derisory” pay offer. A majority of employees – 86% according to the union – voted yesterday that they would start strike actin within 48 hours unless GSK to raise …

GSK workers vote for strike action over “derisory” pay offer Read More »

GSK goes for gold as FDA starts review of daprodustat

GlaxoSmithKline says the FDA has started its review of daprodustat for anaemia associated with chronic kidney disease (CKD), as it strives to succeed where two other rivals in the HIF-PHI class have failed. GSK has submitted daprodustat base on its ASCEND phase 3 programme, which included five trials across both dialysis and non-dialysis patients and …

GSK goes for gold as FDA starts review of daprodustat Read More »

GlaxoSmithKline expands its cancer scope with $1.9B Sierra Oncology acquisition

GlaxoSmithKline is further building out its cancer drug portfolio by acquiring Sierra Oncology, a biotech whose FDA-ready myelofibrosis drug has clinical data showing advantages over a blockbuster product marketed by Incyte. The deal comes as GSK prepares a spinoff of its consumer products as part of a broader strategy to hone its focus on specialty …

GlaxoSmithKline expands its cancer scope with $1.9B Sierra Oncology acquisition Read More »

GSK to buy US cancer drug developer amid pressure from activist investor

GlaxoSmithKline’s £1.5bn Sierra Oncology deal comes after pressure to boost its pipeline from Elliott The UK drug company GlaxoSmithKline has agreed a £1.5bn deal to buy a US cancer treatment developer as it tries to fend off pressure from activist shareholder Elliott Management. The deal will give Britain’s second-largest pharmaceutical company access to California-based Sierra …

GSK to buy US cancer drug developer amid pressure from activist investor Read More »

GSK bolsters cancer pipeline with $1.9bn Sierra Oncology buy

GlaxoSmithKline has agreed a deal to buy Sierra Oncology and its lead drug momelotinib for anaemia associated with the blood cancer myelofibrosis, sending the US biotech’s shares skywards. GSK is paying $55 per share in cash for Sierra – a 39% premium to its closing share price yesterday – which values the company at around …

GSK bolsters cancer pipeline with $1.9bn Sierra Oncology buy Read More »

PathAI and GlaxoSmithKline Partner to Accelerate Research and Drug Development

What You Should Know: – PathAI and GSK announced a multi-year strategic artificial intelligence (AI) partnership today with a focus on accelerating research and- building drug development programs in oncology and non-alcoholic steatohepatitis (NASH). – As part of the partnership, GSK will leverage both PathAI’s expertise and models to advance GSK’s proprietary AI models and focus on designing better …

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FDA restricts GSK’s Xevudy due to lower efficacy against BA.2

GlaxoSmithKline and Vir’s Xevudy has become the latest COVID-19 antibody therapy to have its use restricted by the FDA as a result of waning activity against new variants of the virus. The US regulator has trimmed back the emergency-use authorisation for Xevudy (sotrovimab), saying that new data suggests the current 500mg dose of the antibody …

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ViiV, J&J get FDA nod for simpler HIV injectable dosing

The FDA has given ViiV healthcare and Johnson & Johnson a boost in the market for long-acting injectable HIV drugs, approving a new regimen for their Cabenuva product that does away with the need for an oral lead-in period. The label update means that people living with HIV who want to trade their daily oral …

ViiV, J&J get FDA nod for simpler HIV injectable dosing Read More »

GSK partners LifeMine on fungi-derived medicines

GlaxoSmithKline has thrown its financial and drug development weight behind LifeMine Therapeutics, a US startup that aims to find new therapeutics from fungi – widely regarded as an underexplored resource of biologically-active compounds. There’s a rich history of finding useful medicines from fungi, from the antibiotic penicillin to immune suppressant cyclosporine and cholesterol drug lovastatin. …

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GSK joins LifeMine’s $175M funding as partners revive fungi as a drug discovery frontier

LifeMine Therapeutics, a company that analyzes fungal genomes to find molecules that have potential as new medicines, has raised $175 million in financing. Among the investors is GlaxoSmithKline, which is teaming up with the biotech startup in a multi-target drug discovery alliance.

Trailing its RSV vaccine rivals, Bavarian Nordic cuts China deal

Bavarian Nordic has licensed rights to its respiratory syncytial virus (RSV) vaccine in China and certain other Asian markets to Shanghai’s Nuance Pharma in a $225 million deal. The agreement, which also covers South Korea, Taiwan and certain markets in Southeast Asia, will see Nuance take the lead on a phase 3 trial of the …

Trailing its RSV vaccine rivals, Bavarian Nordic cuts China deal Read More »

Keytruda encroaches on Jemperli’s endometrial cancer territory

Merck & Co’s KEYNOTE-158 trial of Keytruda has underpinned another FDA approval, this time for the PD-1 inhibitor as a single-agent therapy as a therapy for endometrial cancer with certain genetic mutations. Keytruda (pembrolizumab) has been cleared for patients with advanced endometrial cancer whose tumours have microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) mutations, …

Keytruda encroaches on Jemperli’s endometrial cancer territory Read More »

No room for commercial competition in sustainable pharma

With the healthcare sector accounting for around 4% of global emissions – about the same as a small country – only an ecosystem-wide effort will succeed. From synthesising APIs to producing billions of plastic pre-filled syringes, the pharmaceutical industry has a significant impact on the environment. Achieving net zero, then, will take a whole-system approach …

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Latest ABPI code breaches reveal the risk of ‘likes’ on LinkedIn

AstraZeneca (AZ), GlaxoSmithKline (GSK), Sanofi, Allergan and Britannia Pharma have been reprimanded for running advertisements that breached the Association of British Pharmaceutical Industry (APBI) code of practice. Complaints upheld by the Prescription Medicines Code of Practice Authority (PMCPA) include two against AZ and Allergan – now part of AbbVie – related to promotion of medicines …

Latest ABPI code breaches reveal the risk of ‘likes’ on LinkedIn Read More »

GlaxoSmithKline says it will not start any new clinical trials in Russia

Pharma firm joins AstraZeneca and Pfizer in saying it will not enrol new patients into studies Russia-Ukraine war: latest updates What we know on day 22 of the invasion GlaxoSmithKline has joined other drugmakers in halting new clinical trials in Russia while still providing essential medicines to the country. Like others in the sector, it …

GlaxoSmithKline says it will not start any new clinical trials in Russia Read More »

FDA says no to AZ’s Fasenra for nasal polyp indication

AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic rhinosinusitis in people with nasal polyps, after the FDA rejected its marketing application. The US regulator has asked for additional clinical data, according to AZ, which said it remains committed to brining the drug to …

FDA says no to AZ’s Fasenra for nasal polyp indication Read More »

After GSK stumble, Pfizer moves forward with RSV vaccine

Pfizer has been awarded breakthrough status from the FDA for its respiratory syncytial virus (RSV) vaccine in pregnant women, putting the company in pole position to bring a shot to market that will protect infants from the life-threatening infection. The news comes just days after GlaxoSmithKline called a halt to enrolment and vaccination in three …

After GSK stumble, Pfizer moves forward with RSV vaccine Read More »

BP and Shell lead rush to exit Russia. There can be no going back

Oil is always a political business, and there’s no point pretending otherwise First BP, now Shell. The rush to disinvest from Russia is impressively quick since it’s possible to imagine an alternative script in which the oil companies’ boards tried to buy time by issuing woolly “all options are open” statements. A definitive statement to …

BP and Shell lead rush to exit Russia. There can be no going back Read More »

GSK boss upbeat over spin-off of consumer healthcare unit

Expected to be the biggest London listing in a decade, the Haleon demerger is scheduled for July GlaxoSmithKline boss Emma Walmsley said she was “extremely confident” that it would complete the giant spin-off of its consumer healthcare unit in July, despite the market volatility caused by Russia’s invasion of Ukraine. The FTSE 100 company is …

GSK boss upbeat over spin-off of consumer healthcare unit Read More »

GSK’s halts RSV vaccine trials in pregnant women after pause

It looks like GlaxoSmithKline’s concerns about its respiratory syncytial virus (RSV) vaccine in pregnant women aren’t going to be resolved quickly. After suspending three trials of the much-anticipated vaccine earlier this month to investigate a safety signal, the pharma group has now gone a step further, stopping all enrolment and vaccination in the studies. Shares …

GSK’s halts RSV vaccine trials in pregnant women after pause Read More »

Sanofi, GSK Covid-19 vax is now ready for regulators; its future may be as a booster

Sanofi and GlaxoSmithKline weathered clinical trial delays for their Covid-19 vaccine, but the partners now have data to support filings seeking regulatory authorizations. Key features of the vaccine may be able to persuade the vaccine hesitant; it may also be well-suited for use as a booster.

GSK names its consumer health spinoff Haleon

GlaxoSmithKline’s consumer health business will be named Haleon following its planned spinoff and listing on the London Stock Exchange later this year, according to the drugmaker. The name of the unit – whose brands include Sensodyne toothpaste and Voltaren and Panadol painkillers and Centrum multivitamins – comes from the marriage of the word “hale”, meaning …

GSK names its consumer health spinoff Haleon Read More »

GSK unveils its new consumer brands spin-off name: Haleon

Products such as Voltaren, Sensodyne and Panadol to regroup under new stock market listing in summer GSK has revealed that its consumer healthcare business, whose brands include Sensodyne toothpaste, Voltaren and Panadol painkillers, will be called Haleon following its planned spinoff and London stock market listing this summer. The drugmaker said Haleon (pronounced “Hay-Lee-On”) was …

GSK unveils its new consumer brands spin-off name: Haleon Read More »

Safety probe prompts GSK to halt RSV jab study in pregnant women

GlaxoSmithKline has a lot riding on its respiratory syncytial virus (RSV) vaccine, which it thinks could be a $4 billion product at peak, so investors will be nervous about its decision to pause a trial of the shot while a safety signal is investigated. Shares in the company slipped marginally this morning after the announcement …

Safety probe prompts GSK to halt RSV jab study in pregnant women Read More »

AZ’s Saphnelo is cleared in EU, challenging GSK’s Benlysta

lupusAstraZeneca’s Saphnelo has become the first new drug to be approved to treat the autoimmune disease systemic lupus erythematosus (SLE) in the EU for more than 10 years. The European Commission has cleared the type I interferon receptor antagonist antibody as an add-on therapy to standard treatment for adults with moderate to severe SLE, four …

AZ’s Saphnelo is cleared in EU, challenging GSK’s Benlysta Read More »

Vaccines upstart Curevo has designs on blockbuster GSK franchise

Seattle, US vaccine startup Curevo has raised $60 million in first-round financing that it says will be used to run head-to-head trials of its experimental shingles vaccines CRV-101 and GlaxoSmithKline’s market-leading Shingrix. The cash will fund a phase 2b trial in 678 people aged over 50 that will compare CRV‑101’s immunogenicity and safety profile relative …

Vaccines upstart Curevo has designs on blockbuster GSK franchise Read More »

Lilly bags US okay for rival to GSK’s COVID-19 drug Xevudy

Eli Lilly has been granted an emergency use authorisation from the FDA for bebtelovimab, its second COVID-19 antibody drug and a rival to GlaxoSmithKline and Vir Biotech’s fast-growing Xevudy. The US regulator has cleared bebtelovimab (LY-CoV1404) for mild-to-moderate COVID-19 in patients aged 12 or over who are at high risk of progressing to severe illness, …

Lilly bags US okay for rival to GSK’s COVID-19 drug Xevudy Read More »

Screeching U-turn as Unilever’s shareholders balk at $50bn GSK deal

Riot in ranks sends ‘strong message’ against tilt at GlaxoSmithKline’s consumer division Unilever’s plan A was to make a huge acquisition; plan B is not to make one, or at least not “for the foreseeable future”. Boardroom U-turns do not come much more screeching. Chief executive Alan Jope referenced a “strong message” from shareholders about …

Screeching U-turn as Unilever’s shareholders balk at $50bn GSK deal Read More »

Noisy activists aside, GSK investors backed Walmsley and her strategy

The ‘step-change’ in growth for the core pharma division has barely started, but the CEO is secure for now Emma Walmsley is at the starting line. That may sound a churlish assessment of years of graft to get GlaxoSmithKline’s consumer products division fit for demerger this summer, but it’s roughly accurate. The “step-change in growth”, …

Noisy activists aside, GSK investors backed Walmsley and her strategy Read More »

GSK gets £1.4bn sales lift from COVID-19 products in 2021

GlaxoSmithKline’s COVID-19 products – antibody drug Xevudy and a vaccine adjuvant – helped drive a 5% increase in 2021 revenues to £34 billion ($46 billion), ahead of what chief executive Emma Walmsley says will be a “landmark year” for the company. Xevudy (sotrovimab), which was developed with Vir Biotech and has seen its use rise …

GSK gets £1.4bn sales lift from COVID-19 products in 2021 Read More »

Boost for GSK as it reports earnings at £1.4bn in Covid-related sales

Pharmaceutical company’s boss, Emma Walmsley promised a ‘step-change in growth’ after better than expected results GSK made £1.4bn from Covid-related medicines last year, beating earnings forecasts in its first financial results since rejecting Unilever’s £50bn buyout offer in December, as chief executive Emma Walmsley pledged “step-change in growth” in a landmark year. The company is …

Boost for GSK as it reports earnings at £1.4bn in Covid-related sales Read More »

Deborah Waterhouse: ‘The HIV stigma remains, and this is a battle we’ve got to fight’

The former GSK executive has found her niche at ViiV Healthcare developing HIV drugs, and is optimistic a cure will be found A lot has changed since the devastating 1980s Aids crisis depicted in the Channel 4 TV show It’s a Sin – but the stigma attached to the illness remains, says Deborah Waterhouse. As …

Deborah Waterhouse: ‘The HIV stigma remains, and this is a battle we’ve got to fight’ Read More »

ViiV claims $1.25bn settlement from Gilead in HIV patent dispute

A patent dispute between ViiV Healthcare and Gilead Sciences has been resolved, with Gilead agreeing to pay a $1.25 billion settlement as well as royalties on sales of one of its top HIV products. The litigation extends back to 2018, when ViiV – a joint venture majority owned by GlaxoSmithKline alongside Pfizer and Shionogi – …

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GSK, Verily-backed Galvani starts trials of bioelectronic arthritis therapy

The first patient has been treated with an implantable bioelectronic device developed by Galvani Therapeutics, set up by GlaxoSmithKline and Alphabet’s Verily Life Sciences in 2016. A rheumatoid arthritis patient has become the first of five to be implanted with the wireless device in the UK study – using keyhole surgery at the NHS Greater …

GSK, Verily-backed Galvani starts trials of bioelectronic arthritis therapy Read More »

Big questions for Unilever board after GSK pursuit ends

Delivering a minor heart attack to the share price, however temporarily, is not a good look It was fun while it lasted. Unilever says it won’t bump up its £50bn offer for GlaxoSmithKline’s consumer products division, so one has to assume that’s the end of the saga. GSK’s board, after all, can’t credibly have second …

Big questions for Unilever board after GSK pursuit ends Read More »

Unilever will not increase £50bn offer for GSK consumer arm

Company says data shared by GSK suggests ‘fundamental value’ of business no higher than offer Unilever has said it will not increase its offer for GlaxoSmithKline’s consumer healthcare division above £50bn after investors and analysts balked at the risk of it pulling off a large merger. Data shared by GSK suggested the “fundamental value” of …

Unilever will not increase £50bn offer for GSK consumer arm Read More »

GSK’s top scientist jumps ship in new blow for pharmaceutical firm

Hal Barron to leave just as pressure builds on GSK to come up with new medicines Pharmaceuticals company GSK’s chief scientific officer is jumping ship, dealing a blow to the drugmaker as it seeks to rebuild its pipeline of new medicines and gears up for a corporate split in the summer. Hal Barron, the highly-regarded …

GSK’s top scientist jumps ship in new blow for pharmaceutical firm Read More »

Unilever could lose credit rating with purchase of GSK consumer arm

Deal could swell Unilever’s debt pile says ratings agency Fitch Unilever has been warned that buying GlaxoSmithKline’s consumer products arm is likely to substantially swell its debt pile and could trigger a “multi-notch downgrade” to its credit rating. Ratings agency Fitch said Unilever would not be able to keep hold of its current A rating …

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Unilever’s bid for GSK consumables isn’t quite the shocker it seems | Nils Pratley

This could be a long campaign and, despite all the difficulties, there is a logic to the proposal Even a Marmite reaction – some loving it, some hating it – would have been better from brand owner Unilever’s point of view. Unfortunately, almost everybody seemed to agree: the big idea of offering £50bn for GlaxoSmithKline’s …

Unilever’s bid for GSK consumables isn’t quite the shocker it seems | Nils Pratley Read More »

Two new drugs added to WHO list of COVID-19 therapies

A World Health Organization (WHO) panel has given the green light to two new drugs to treat COVID-19. US-based Eli Lilly’s baricitinib (Olumiant), a Janus kinase inhibitor, and GlaxoSmithKline and Vir Biotechnology’s sotrovimab, a monoclonal antibody, were recommended in new WHO guidelines, published in the British Medical Journal.  Baricitinib, administered with corticosteroids, was strongly recommended as …

Two new drugs added to WHO list of COVID-19 therapies Read More »

GSK rejects $68.4bn Unilever bid for consumer health

GlaxoSmithKline (GSK) claims it has rejected three unsolicited, conditional and non-binding proposals from Unilever to acquire GSK Consumer Healthcare in a deal worth approximately $68.4 billion (£50 billion). The Consumer Healthcare business is a Joint Venture between GSK and Pfizer, with GSK holding a majority controlling interest of 68% and Pfizer 32%. The latest proposal, …

GSK rejects $68.4bn Unilever bid for consumer health Read More »

Unilever to expand health and beauty business after failed GSK approach

Dove soap maker’s shares are biggest faller on FTSE 100 after offer for consumer products arm is rebuffed Unilever has pledged to grow its health, beauty and hygiene business as investors dumped its shares after its failed £50bn approach for GlaxoSmithKline’s consumer products arm. GSK rejected three Unilever bids for the consumer products arm it …

Unilever to expand health and beauty business after failed GSK approach Read More »

Analysts say GSK is right to rebuff £50bn offer for consumer healthcare venture

Unilever’s offer represents only a modest premium to its current value, according to some leading analysts Unilever’s rebuffed £50bn takeover offer for GSK’s consumer healthcare venture, which owns the Panadol and Nicorette brands, represents only a modest premium to its current value, according to some leading analysts, suggesting the drugmaker is right to hold out …

Analysts say GSK is right to rebuff £50bn offer for consumer healthcare venture Read More »

GSK banks on stronger offer for its consumer healthcare business

Analysis: drugmaker appears to be holding out for what would be one of largest ever deals in London after rejecting Unilever bids With typical bravado, GlaxoSmithKline has, we learned on Saturday, dismissed three takeover bids from Unilever for its consumer healthcare venture with Pfizer, including one worth £50bn received just before Christmas. The drugmaker, run …

GSK banks on stronger offer for its consumer healthcare business Read More »

Look out GSK, Pfizer and BioNTech are coming for Shingrix

GlaxoSmithKline places shingles vaccine Shingrix is among its top prospects, with peak sales potential of almost $6 billion. Now, Pfizer and BioNTech are joining forces to try to grab a slice of the market. Having already brought their mRNA-based CVID-19 vaccine Comirnaty to market at breakneck speed, Pfizer and BioNTech are hoping to fast-track a …

Look out GSK, Pfizer and BioNTech are coming for Shingrix Read More »

FDA okays ViiV’s Apretude as first injectable for HIV PrEP

GlaxoSmithKline’ majority-owned HIV unit ViiV has scored a key FDA approval, getting approval for its long-acting drug cabotegravir as the first injectable for pre-exposure prophylaxis (PrEP) –challenging market leader Gilead Sciences. Cabotegravir – given the trade name Apretude – can be dosed just six times a year and showed superior results to daily, oral therapy …

FDA okays ViiV’s Apretude as first injectable for HIV PrEP Read More »

GSK hires ex-Tesco boss Sir Dave Lewis to lead healthcare spin-off

Glaxo’s consumer healthcare business is to demerge from wider group from mid-2022 The pharmaceutical firm GlaxoSmithKline has hired the former Tesco boss Sir Dave Lewis to chair the consumer healthcare business that it plans to spin off next year. GSK told investors on Monday morning that Lewis, who left Tesco in September last year, would …

GSK hires ex-Tesco boss Sir Dave Lewis to lead healthcare spin-off Read More »

CDC eyes safety of J&J COVID jab as EU backs booster

Johnson & Johnson’s also-ran COVID-19 vaccine has been cleared in the EU as a booster shot, although its role in the US could be impacted by new data on rare blood clots. A Centres for Disease and Control Prevention (CDC) advisory committee is scheduled to meet today to discuss the new results, according to a …

CDC eyes safety of J&J COVID jab as EU backs booster Read More »

GSK/Sanofi Covid booster delayed by lack of uninfected people to test it on

Early trials show jab effective in people of all ages who have already received doses of any vaccine Coronavirus – latest updates See all our coronavirus coverage Efforts by the British and French drugmakers GSK and Sanofi Pasteur to produce a Covid-19 vaccine have suffered a further setback, with final clinical data on the jab …

GSK/Sanofi Covid booster delayed by lack of uninfected people to test it on Read More »

MHRA okays GSK’s Xevudy as data suggest it works against Omicron

The UK medicines regulator has approved GlaxoSmithKline and Vir Biotech’s antibody for COVID-19, Xevudy, which has been shown to be effective against the new Omicron strain of SARS-CoV-2 in lab testing. Xevudy (sotrovimab) is the second COVID-19 antibody to be approved by the MHRA after Roche/Regeneron’s Ronapreve (casirivimab and imdevimab), which got a green light …

MHRA okays GSK’s Xevudy as data suggest it works against Omicron Read More »

GSK pumps £30m into a new Oxford University partnership

GlaxoSmithKline has formed a five-year partnership with Oxford University to set up a new institute that will apply machine learning and functional genomics to the discovery of new medicines. The Oxford-GSK Institute of Molecular and Computational Medicine – based at Oxford’s Nuffield Department of Medicine – is being set up with £30 million (around $40 …

GSK pumps £30m into a new Oxford University partnership Read More »

GSK poaches Pfizer exec Dormitzer as new vaccines R&D chief

GlaxoSmithKline has found a replacement for head of vaccines R&D Emmanuel Hanon, who left the company for a US biotech earlier this year, hiring Phil Dormitzer from Pfizer. Phil Dormitzer Dormitzer is due to take up his new role at GSK on Friday, and will report to chief scientific officer and group president of R&D …

GSK poaches Pfizer exec Dormitzer as new vaccines R&D chief Read More »

GSK aims at NASH target with $1bn-plus Arrowhead alliance

GlaxoSmithKline has joined the ranks of drugmakers trying to develop new drugs for non-alcoholic steatohepatitis (NASH) – a condition with no approved therapies and a lengthy list of failed drug candidates – via a deal with Arrowhead Pharmaceuticals. The bolt-on deal comes – which includes an upfront payment of $120 million and up to $910 …

GSK aims at NASH target with $1bn-plus Arrowhead alliance Read More »

GSK joins NASH chase, paying $120M up front for rights to Arrowhead RNAi drug

GlaxoSmithKline sees enough promise in the early clinical data of a novel NASH drug to pay its developer, Arrowhead Pharmaceuticals, $120 million up front for rights to the experimental therapy. The Arrowhead drug uses RNA interference to “silence” an enzyme associated with the progression of the fatty liver disease.

NICE backs ViiV/J&J’s six-per-year injection for HIV

People living with HIV in England and Wales now have an alternative to daily oral tablets, after NICE backed NHS use of two long-acting injectable therapies developed by ViiV Healthcare and Johnson & Johnson’s Janssen pharma unit. The cost-effectiveness watchdog has recommended the use of ViiV’s Vocabria (cabotegravir) with Janssen’s Rekambys (rilpivirine) as a combination …

NICE backs ViiV/J&J’s six-per-year injection for HIV Read More »

US signs $1bn order for GSK, Vir’s COVID-19 antibody

The US has made a sizeable order for GlaxoSmithKline and Vir Biotechnology’s antibody-based COVID-19 treatment sotrovimab said to be worth approximately $1 billion. The deal does not specify the number of doses of sotrovimab ordered by the federal government, but takes the total number to be supplied globally to around 750,000, according to a Reuters …

US signs $1bn order for GSK, Vir’s COVID-19 antibody Read More »

Study shows HPV jab almost 90% effective at preventing cervical cancer

Routine vaccination with human papillomavirus vaccines have resulted in an 87% reduction in cervical cancer cases in England, and could even see the need for smear tests phased out in future, according to a new study. The jabs with have been offered by the NHS to girls between the ages of 12 and 13 since …

Study shows HPV jab almost 90% effective at preventing cervical cancer Read More »

GSK side-lines COVID drug otilimab to focus on Xevudy

GlaxoSmithKline said today it would halt further development of its antibody for severe COVID-19 pneumonia – otilimab – in order to focus its resources on Xevudy for mild-to-moderate disease. The drugmaker said in its third-quarter results update this morning that it had decided to invest more in generating data on Vir BioTech-partnered anti-SARS-CoV-2 antibody Xevudy …

GSK side-lines COVID drug otilimab to focus on Xevudy Read More »

Walmsley needs a fast-acting remedy for GSK’s malaise

With just a few years to turn the group around, the boss could do without a bellicose hedge fund breathing down her neck Few companies fit with the national zeitgeist quite like drugs giant GlaxoSmithKline. But few face the cocktail of pressures Dame Emma Walmsley, chief executive at Britain’s second-biggest drugmaker, is wrestling with. In …

Walmsley needs a fast-acting remedy for GSK’s malaise Read More »

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 …

UK drugmaker GSK under fresh pressure to sell consumer arm Read More »

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 …

GSK’s malaria vaccine gets WHO okay for mass rollout Read More »

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 …

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

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 …

GSK bails on $4.2bn partnership with Merck on cancer drug Read More »

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 …

Sanofi abandons mRNA COVID jab, despite positive trial Read More »

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 …

Second hedge fund applies pressure on GSK after taking stake Read More »

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 …

Second hedge fund pushes for change in leadership of GSK Read More »

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 …

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

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 …

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

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 …

Major shareholder’s Rolls-Royce grumble could rumble on Read More »

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 …

GSK takes SK bio-partnered COVID jab into phase 3 Read More »

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 INTR@PID BTC 055 study of the drug alongside chemotherapy as a first-line treatment for patients with locally advanced or metastatic biliary tract cancer (BTC), …

Third strike for GSK/Merck as bintrafusp alfa flubs again Read More »

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 …

After FDA snub, EMA backs FibroGen, Astellas’ roxadustat Read More »

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 – …

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

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 …

Pfizer, BioNTech file for FDA approval of COVID booster shot Read More »

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 …

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

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 …

GSK names McNamara as CEO of consumer health spinout Read More »

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 …

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

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 …

GSK unveils plan for life sciences cluster at Stevenage campus Read More »

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 …

GSK plans £400m life sciences campus in Stevenage Read More »

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 …

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

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 …

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

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 …

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

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 …

GSK firmly rejects Elliott Management’s demands over chief executive Read More »

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 …

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

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 …

Elliott fires broadside at GSK in wake of investor update 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 …

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 …

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

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 …

GSK drugmaker sets ambitious sales target before shake-up Read More »

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, …

Will Emma Walmsley’s radical therapy cure GlaxoSmithKline? Read More »

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 …

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

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 …

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

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 …

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

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 …

Under-pressure GSK sells stake in respiratory diseases partner Innoviva Read More »

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 …

GSK and Medicago report positive Covid vaccine trial data Read More »

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. …

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

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 …

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

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 …

GlaxoSmithKline and Sanofi report strong results in trials of Covid vaccine Read More »

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 …

GlaxoSmithKline focuses on split after lacklustre Q1 results Read More »

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 …

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

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 …

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

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 …

GlaxoSmithKline faces dose of strong medicine from US investor Read More »

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 …

GlaxoSmithKline shares jump at news of activist hedge fund interest Read More »

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 …

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

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 …

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

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 …

Top 20 BioPharma Companies based on 2020 Total Revenue Read More »

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, …

World leaders call for international pandemic preparedness treaty Read More »

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 …

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

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 …

GSK fires former US vaccine chief Moncef Slaoui over harassment allegation Read More »

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 …

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

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 …

Novartis antibiotic retreat doesn’t stop Sandoz buying GSK drugs Read More »

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 …

ViiV’s Rukobia cleared in EU as rescue HIV therapy Read More »

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 …

AstraZeneca set to weather Covid in better health than rivals Read More »

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 …

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

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 …

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

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 …

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

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 …

CHMP clears way for EU approval of Novartis’ MS drug Read More »

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 …

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

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 …

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

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 …

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

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 …

Tivicay approved in Europe in new dispersible tablet for children with HIV Read More »

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 …

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

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 …

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

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 …

GSK/Sanofi Covid vaccine delayed until end of next year Read More »

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 …

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

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, …

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

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 …

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

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 …

Lilly asks FDA for emergency clearance for COVID-19 antibody therapy Read More »

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 …

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

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 …

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

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 …

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

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 …

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

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 …

GSK moves further ahead in BCMA with EU okay for Blenrep Read More »

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 …

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

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 …

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

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 …

AstraZeneca beats expectations in Q2, while GSK struggles during pandemic Read More »

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 …

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

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 …

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

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 …

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

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 …

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

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 …

AZ’s COPD triple therapy approved in the US Read More »

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 …

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

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 …

GSK buys £130m stake in German coronavirus vaccine maker Read More »

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 …

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

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.