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… Read More »GSK hits trouble with Trelegy as EU regulators block asthma indication
Though GlaxoSmithKline’s drug otilimab missed the main goal of a mid-stage Covid-19 study, the company points to better data in a subgroup of older patients. GSK is expanding the study in patients 70 and older in hopes of replicating those results.
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… Read More »Sanofi/GSK restart COVID-19 vaccine trials after tweaking formulation
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… Read More »Drug companies look to AI to end ‘hit and miss’ research
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… Read More »GSK expands coronavirus antibody tie-up to include potential flu therapies
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 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… Read More »Novartis antibiotic retreat doesn’t stop Sandoz buying GSK drugs
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… Read More »ViiV’s Rukobia cleared in EU as rescue HIV therapy
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… Read More »AstraZeneca set to weather Covid in better health than rivals
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.… Read More »Bezos is handing over fronting Amazon, but not his grip on his creation | Nils Pratley
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… Read More »GSK/CureVac target new COVID variants with next-gen shot
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… Read More »GSK and CureVac sign £132m deal to develop multi-variant Covid vaccine
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… Read More »CHMP clears way for EU approval of Novartis’ MS drug
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… Read More »GSK suffers another R&D setback, axing ulcerative colitis drug 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… Read More »GSK/Merck & Co’s hopeful bintrafusp alfa fails in key lung cancer trial
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… Read More »NICE recommends interim funding for GSK’s Zejula in ovarian cancer
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.… Read More »Tivicay approved in Europe in new dispersible tablet for children with HIV
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… Read More »Britain could be mass-producing its Covid shot. Shame we junked our industrial base | Aditya Chakrabortty
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… Read More »GSK closes 2020 with multi-million deal frenzy to bolster pipeline
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… Read More »GSK’s Benlysta claims first FDA okay for lupus kidney damage
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… Read More »GSK/Sanofi Covid vaccine delayed until end of next year
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… Read More »Sanofi on notice as FDA reviews GSK’s Nucala for nasal polyps
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… Read More »VC firm SR One completes GSK spin-out, raising $500m
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… Read More »Vaccine sales recover at GSK in Q3, but lockdown fears weigh on shares
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… Read More »Lilly asks FDA for emergency clearance for COVID-19 antibody therapy
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… Read More »GSK and Vir expand COVID-19 antibody trial after Trump’s treatment with Regeneron’s rival
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… Read More »GSK tells UK staff: turn off Covid test-and-trace app while at work
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… Read More »GSK and Sanofi to start human trials of potential Covid-19 vaccine
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… Read More »Ionis deal delivers for GSK as HBV drug hits the mark in phase 2
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… Read More »GSK moves further ahead in BCMA with EU okay for Blenrep
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.
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… Read More »US pays $2.1bn to Sanofi/GSK for 100 million doses of 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.
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… Read More »Return to work: a sector-by-sector look at the plans of England’s major employers
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.… Read More »AstraZeneca beats expectations in Q2, while GSK struggles during pandemic
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… Read More »UK places order for 60m doses of Sanofi/GSK’s COVID-19 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… Read More »Coronavirus: UK signs deal for 60m doses of potential vaccine
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… Read More »CHMP gives nod to GSK’s BCMA drug Blenrep for myeloma
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… Read More »Covid-19 is Big Pharma’s chance to impress. But who’ll do best?
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… Read More »AZ’s COPD triple therapy approved in the US
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.… Read More »GlaxoSmithKline makes bold move with £130m Covid-19 investment | Nils Pratley
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… Read More »GSK buys £130m stake in German coronavirus vaccine maker
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… Read More »UK announces COVID-19 vaccine deals with BioNTech/Pfizer and Valneva
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.
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.
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.