As the omicron BA.2 subvariant has spread, FDA has announced that it will further constrain the use of the investigational monoclonal antibody sotrovimab. The agency announced that it would limit the use of the antibody in some U.S. regions last week. GlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) were initially confident that the antibody could…
J&J and Roche named to Clarivate’s Top 100 Global Innovators list
Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT). Two companies in pharma and another in medtech, however, made the cut. Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator. Roche was included for the 11th consecutive year…
GSK and Vir file for EUA for intramuscular administration of sotrovimab to treat COVID-19
GlaxoSmithKline (LSE/NYSE GSK) and Vir Biotechnology (NSDQ:VIR) are seeking to expand the use of the investigational monoclonal antibody sotrovimab. Intravenous sotrovimab is currently authorized to treat mild-to-moderate COVID-19 in patients at least 12 years of age, weighing at least 40 kg (88 pounds). The authorization is constrained to patients who face a high risk of…
Sotrovimab wins EU marketing authorization as an early COVID-19 therapy
GlaxoSmithKline (LSE/NYSE:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have received marketing authorization from the European Commission for the dual-action monoclonal antibody Xevudy (sotrovimab). The marketing authorization covers individuals 12 and older who weigh at least 40 kg who do not need supplemental oxygen. It also requires that such individuals have a heightened risk of developing…
GSK and Vir upbeat about efficacy of sotrovimab against Omicron
GlaxoSmithKline (LON:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have announced that their COVID-19 drug sotrovimab continues to offer protection against the mutations in the spike protein of the Omicron SARS-CoV-2 variant. In March, the two companies received emergency use authorization (EUA) for the drug. The EUA specifically covers the treatment of mild-to-moderate COVID-19 in high-risk adults…
GSK touts DREAMM clinical trial headway in multiple myeloma
GlaxoSmithKline (NYSE:GSK) will present 11 abstracts on Blenrep (belantamab mafodotin blmf) at the American Society of Hematology (ASH) Annual Meeting and Exposition on December 11–14. Presentations will include new data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial program and two collaborative studies focused on Blenrep. The drug won FDA approval…
ACIP votes unanimously backs GSK’s shingles vaccine Shingrix for immunocompromised adults 19 and older
CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended two doses of GlaxoSmithKline’s (NYSE:GSK) Shingrix (a recombinant adjuvanted zoster vaccine) for adults 19 and older with immunodeficiency or immunosuppression as a result of disease or therapy. CDC considers Shingrix to be an adult vaccine, and its recommendation is for the adult immunization schedule, which begins…
WHO endorses first malaria vaccine
The World Health Organization (WHO) has backed the first malaria vaccine, which could be especially beneficial in areas such as sub-Saharan Africa with moderate to high malaria transmission rates. In 2019, malaria caused 409,000 deaths, according to WHO. The vaccine from GlaxoSmithKline (NYSE:GSK) specifically targets plasmodium falciparum, a malaria strain common in sub-Saharan Africa. Plasmodium falciparum…
Janssen begins Phase 3 study for RSV vaccine in adults 60 and older
After recently sharing positive Phase 2b data related to its experimental respiratory syncytial virus (RSV) vaccine in seniors, Janssen (NYSE: JNJ) has launched a Phase 3 study of the vaccine. RSV is common and contributes to serious respiratory illnesses, including pneumonia in the elderly. The virus infects approximately 64 million people annually. The global EVERGREEN…
FDA approves GSK’s Shingrix to prevent shingles in immunocompromised adults
GlaxoSmithKline (NYSE:GSK) received permission from FDA to expand the use of its Shingrinx shingles vaccine to include immunocompromised and immunosuppressed adults 18 years old or older. Having won initial FDA approval in 2017 for individuals 50 and older, the shingles (herpes zoster) vaccine is a non-live, recombinant subunit adjuvanted vaccine. Shingrix is the first shingles…
NVIDIA debuts supercomputer for healthcare and AI research
Santa Clara, Calif.–based NVIDIA has launched the Cambridge-1, which it hails as “the United Kingdom’s most powerful supercomputer.” Developed with healthcare applications in mind, NVIDIA invested some $100 million in the supercomputer. Initial applications of the Cambridge-1 include using AI to improve drug development, explore the causes of dementia and identify genomic-based disease risk factors.…
An inside look at GSK’s digital twin initiative
Digital twins, functional computerized models of physical objects, are a staple of smart manufacturing. Their use in the pharmaceutical industry, however, is still in an early phase. GlaxoSmithKline (LON:GSK) is one of the first pharmaceutical companies to announce a digital twin initiative. Partnering with Siemens (ETR:SIE) and Atos (EPA:ATO), GSK has created a real-time simulation of…
CureVac’s interim vaccine efficacy is 47% in Phase 2b/3 study
Germany-based CureVac (NSDQ:CVAC) announced that its mRNA vaccine was 47% effective against COVID-19 in a second interim analysis of a pivotal study involving approximately 40,000 participants in 10 countries. The rise of COVID-19 variants played a role in the disappointing results. At least 13 COVID-19 variants were present in the study population who contracted the…
CureVac’s COVID-19 vaccine candidate inches forward to Phase 2b/3 efficacy readout
CureVac (NSDQ:CVAC) has announced that its first-generation COVID-19 vaccine has passed its first interim analysis but has chosen not to share efficacy data until a statistically significant efficacy analysis is ready. The Tübingen, Germany–headquartered company is developing two mRNA-based vaccines. The mRNA vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) are currently two of the most popular…
Sanofi and GSK start Phase 3 trial of COVID-19 vaccine
Sanofi and GlaxoSmithKline announced today that they began enrollment in the Phase 3 clinical trial for their COVID-19 vaccine candidate. The companies will evaluate the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in a global, randomized, double-blind, placebo-controlled Phase 3 study of more than 35,000 participants aged 18 and older, according…
CureVac and GSK announce promising preclinical data for next-gen COVID-19 vaccine
As CureVac (NSDQ:CVAC) awaits European authorization for its mRNA COVID-19 vaccine, it is conducting preclinical research on a second-generation vaccine candidate known as CV2CoV, which it is developing with GSK. In a study involving rats, the new mRNA vaccine candidate yielded high levels of antigen and strong neutralizing antibody titers after the first vaccination. Tübingen, Germany–based…
Pharma 50: Here’s how the world’s largest pharma companies are doing
The global pharmaceutical industry held up well during the pandemic, with 10 of the largest businesses only seeing a roughly –3% drop in revenue in 2020. Eight of the 10 even came out ahead. That’s one of the big takeaways from Drug Discovery & Development’s inaugural Pharma 50, a compilation of data on the largest…
GSK and Vir Biotechnology seek EUA for COVID-19 monoclonal antibody
GlaxoSmithKline and Vir Biotechnology have filed for emergency use authorization (EUA) for VIR-7831 (GSK4182136), a dual-action SARS-CoV-2 monoclonal antibody. VIR-7831 is designed to stop SARS-CoV-2 viral entry into cells and accelerate the clearing of infected cells. VIR-7831 would have a similar indication to other monoclonal antibodies that have won an EUA. It is intended for…
Former head of Operation Warp Speed leaves two more drug companies
Following allegations of sexual harassment, former head of Operation Warp Speed Moncef Slaoui has left roles at two more companies. Yesterday, Slaoui was terminated as the Galvani board of directors’ chair, GlaxoSmithKline’s board of directors announced. The same day, Vaxcyte confirmed in an SEC filing that it had axed Slaoui as its chairman of the…
Former head of Operation Warp Speed loses board seat over sexual harassment claims
GlaxoSmithKline’s board of directors announced today that it terminated Moncef Slaoui as the chair of the Galvani board of directors. Slaoui, who served as the head of Operation Warp Speed — the Trump administration’s program to accelerate COVID-19 vaccine development — was terminated effective immediately, according to a news release from GSK, the majority…
GSK, Sanofi launch new study for protein-based COVID-19 vaccine
Sanofi (NYSE:SNY) and Glaxo Smith Kline (NYSE:GSK) are moving forward with their development plans of a COVID-19 vaccine. In December, the two companies announced that their vaccine development efforts had been delayed after the product failed to mount a robust immune response in older adults. The two companies believe the setback resulted from an insufficient…
GSK and CureVac team up on COVID-19 vaccine to battle viral variants
Late last year, GlaxoSmithKline (NYSE:GSK) and Sanofi (NYSE:SNY) announced that their joint COVID-19 vaccine was delayed. Now, GlaxoSmithKline is hooking up with Germany-headquartered CureVac (NSDQ:CVAC) to develop a COVID-19 vaccine that can target multiple variants of the virus simultaneously. GSK plans on spending €150 million on the project, paying the first half to CureVac initially and the latter half…
11 COVID-19 therapies you need to know
The pharmaceutical industry launched a herculean effort to battle the COVID-19 pandemic early in 2020, developing an array of vaccines and other therapeutics while also identifying existing drugs suitable for treating patients sick with severe coronavirus infections. FDA recently granted emergency authorization to two SARS-CoV-2 vaccines and several other treatments. Here are 11 of the…
Launch of Sanofi and GSK COVID-19 vaccine could be delayed until late 2021
Sanofi (NYSE:SNY) and Glaxo Smith Kline (NYSE:GSK) have confirmed a delay in their adjuvanted recombinant protein-based COVID-19 vaccine owing to an inadequate immune response in older adults in a Phase 1/2 trial. Sanofi and GSK now plan to launch a Phase 2b study in February 2021 to investigate a new vaccine formulation. If that study reaches primary endpoints,…
Appeals court nixes GSK’s petition for new trial in Vectura patent spat
The Federal Circuit Court has rejected Glaxo Smith Kline’s (NYSE:GSK) petition for a new trial in a patent case brought by British inhaler company Vectura. The circuit court upheld a May 2019 jury verdict in U.S. District Court for the District of Delaware, awarding Ventura $89.7 million damages for the period from August 2016 through December 2018 for an…