GSK

Approximately two-thirds of Americans have received at least one dose of a COVID-19 vaccine.  But COVID-19 cases remain elevated following the spread of a series of omicron sublineages, which pose a threat to those vaccinated and naturally infected with various lineages of the coronavirus.  A variety of companies are developing next-generation COVID-19 vaccines that could potentially…

Cancer treatment has been a critical point for clinical diagnostics. Over the years, various treatment approaches- from naked nucleic acid-based therapy, targeting microRNAs, oncolytic virotherapy, and suicide-gene-based therapy to CRISPR/Cas-9-based therapy. More recently, drug-based therapy has also emerged as a promising area for cancer therapeutics. Regarding drug administration, a major buzz has been created around…

GSK plc (LSE/NYSE:GSK) and Sanofi (EPA:SAN) have announced that their adjuvanted bivalent vaccine candidate had 72% efficacy against omicron in adults in stage 2 of a Phase 3 study. For those with SARS-CoV-2 seropositivity, the vaccine was 93.2% effective against omicron. The vaccine is based on the original D614 virus and the beta (B.1.351) strain.…

Sanofi (Nasdaq:SNY) and GSK (NYSE:GSK) have announced that their next-generation COVID-19 booster vaccine candidate based on the beta variant yielded a substantial immune boost in adults previously primed with mRNA vaccines. The novel vaccine yielded a strong increase in antibody titers above baseline against various variants of concern, including a 40-fold increase against the BA.1 omicron subvariant 15…

Immuno-oncology firm Agenus (Nasdaq:AGEN) and its partner GSK (NYSE:GSK) have announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 Phase 3 trial of an experimental respiratory syncytial virus (RSV) vaccine. RSV infects most children before the age of 2. Some 75,000 to 125,000 children are hospitalized as a result of…

GSK plc (LSE/NYSE:GSK) has announced that the FDA has approved the Priorix measles, mumps and rubella (MMR) vaccine for individuals at least 12 months old. Before the FDA approval, Merck & Co.’s M-M-R II was the only MMR vaccine currently FDA approved in the U.S. Merck also has an FDA-approved measles, mumps, rubella and varicella…

SK Bioscience (KRX:302440) and GSK (NYSE:GSK) have filed a biologics license application with the Korean Ministry of Food and Drug Safety for their SKYCovione, a recombinant protein-based COVID-19 vaccine candidate. The self-assembled nanoparticle vaccine candidate is adjuvanted with GSK’s pandemic adjuvant. SKYCovione fared well in a Phase 3 study involving more than 4,000 adults in…

Tübingen, Germany–based CureVac N.V. (Nasdaq:CVAC) and its partner GSK (NYSE:GSK) have announced positive preclinical data about their second-generation COVID-19 vaccine candidate that combines mRNAs for the beta and delta variants. The companies conducted the preclinical research in conjunction with the Friedrich-Loeffler-Institut, Germany. The research pitted the bivalent candidate against monovalent COVID-19 vaccine candidates. The bivalent…

GlaxoSmithKline plc (LSE/NYSE:GSK) has reached a deal to acquire Sierra Oncology (Nasdaq:SRRA) to bolster its oncology pipeline. Under the terms of the proposed deal, GSK would pay $44 per share for a total value of approximately $1.9 billion. GSK shares were mostly flat in mid-day trading, dipping 0.032% to $46.52. SRRA shares surged 38.31% to…

Quillaja saponin-based adjuvant specialist Q-VANT Biosciences announced that Kansas University College of Veterinary Medicine will test its adjuvants in several of its veterinary vaccines. The project’s first focus will test Q-VANT’s sustainable saponin-based adjuvants against other adjuvants using K-State’s subunit classic swine fever (CSF) vaccine. The Kansas University researchers will also validate the safety and…

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…

CureVac N.V. (Nasdaq:CVAC) and its partner GSK (NYSE:GSK) have launched a Phase 1 dose-escalation study to test the performance of CV2CoV, a COVID-19 vaccine candidate based on CureVac’s second-generation mRNA backbone. In late morning trading, CureVac’s stock ticked up 0.10% to $19.22. CVAC shares were trading above $100 before announcing in mid-June 2021 that the…

GlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) have announced that FDA has concluded that the investigational monoclonal antibody sotrovimab is unlikely to be effective against the omicron BA.2 subvariant, which will soon dominate the U.S. FDA has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab and its website to exclude the antibody in…

Pharmaceutical and biotechnology organizations have made significant progress enabling accelerated drug discovery with traditional laboratory and computing methods. However, they have only just begun to harness the potential of artificial intelligence (AI) to develop more effective therapeutics faster. This article looks at recent work from researchers at GlaxoSmithKline (GSK) with Cerebras Systems as an example…

GlaxoSmithKline plc (LSE/NYSE:GSK) has announced that it has chosen to stop enrollment and vaccination of studies testing its respiratory syncytial virus (RSV) maternal vaccine candidate in women. The company had announced a voluntary pause of the trials NCT04605159, NCT04980391 and NCT05229068 on February 18. GSK did not elaborate on the reason for halting the trials.…

GlaxoSmith Kline (NYSE:GSK) and Sanofi (NYSE:SNY) recently announced their intent to seek regulatory authorization for an adjuvanted recombinant protein-based COVID-19 vaccine. Now, GSK and its partner Medicago have received approval from Health Canada for another COVID-19 vaccine, which combines the former’s adjuvant technology with the latter’s plant-derived vaccine.  Known as Covifenz, the vaccine makes use of plant-based virus-like…

In the U.S., Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE) continue to dominate the COVID-19 landscape while demand for Johnson & Johnson’s (NYSE:JNJ) vaccine remains limited. Now, Sanofi (NASDAQ:SNY) and GSK (NYSE:GSK) are preparing to get into the game by preparing their regulatory submissions for their COVID-19 vaccine. The companies are currently communicating with the FDA and…

GlaxoSmithKline plc (LSE/NYSE:GSK) has announced that China’s National Medical Products Administration (NMPA) has approved Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN), a type of kidney disease affecting more than half of those with systemic lupus erythematosus (SLE). Benlysta is the only biologic approved to treat SLE and lupus nephritis…

CureVac (NSDQ:CVAC) and GSK (NYSE:GSK) have announced the dosing of the first participant in a Phase 1 study of a multivalent influenza vaccine built on a second-generation mRNA backbone. The study is based in Panama and will enroll approximately 240 subjects. CVAC shares increased 2.27% to $19.34 in mid-day trading. At various points last year,…

The biotech Altos Labs has exited stealth mode with top-tier talent and $3 billion in funding with a broad mission of promoting homeostasis in cells to reverse disease, injury and disability. In other words, the company aims to use biotechnology to fight aging and disease, as early media reports have suggested. In a press release, Altos…

​​Vir Biotechnology (NSDQ:VIR) with its partner GSK (LSE/NYSE:GSK) recently announced growing traction for the investigational COVID-19 monoclonal antibody sotrovimab. Now, San Francisco–based Vir has expanded its partnership with the Bill & Melinda Gates Foundation to focus on developing broadly neutralizing antibodies intended to provide a “vaccinal effect” for treating HIV and preventing malaria. Vir Biotechnology…

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…

Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory. Researchers are now exploring dozens of new possibilities for the mRNA platform. Here, we summarize several areas where…

A large retrospective study found that a recombinant adjuvanted zoster vaccine was associated with a 32% reduced risk of COVID-19-associated hospitalization. The study, published in The Journal of Infectious Diseases, also found that individuals who received at least one dose of the Shingrix vaccine were 16% less likely to be diagnosed with COVID-19 during the trial…

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…