The European Commission has approved the VidPrevtyn Beta COVID-19 vaccine as a booster for individuals who are at least 18. The vaccine is the first next-gen protein-based adjuvanted COVID-19 booster to win European approval. Sanofi (Nasdaq:SNY) developed the vaccine based on the beta variant using GSK’s (NYSE:GSK) pandemic adjuvant. After announcing the news, Sanofi shares…
GSK stops two Phase 3 studies for novel antibiotic gepotidacin stopped early
GSK (LSE/NYSE:GSK) has announced that it would stop enrolling the pivotal EAGLE-2 and EAGLE-3 studies of the antibiotic gepotidacin based on advice from the independent data monitoring committee. Gepotidacin is a topoisomerase type II inhibitor. The EAGLE-2 and EAGLE-3 trials met the primary efficacy endpoint related to combined clinical and microbiological resolution. The EAGLE-2 and EAGLE-3…
GSK’s RSV vaccine candidate for older adults wins priority review from FDA
On the heels of winning an EU nod for its RSV vaccine marketing authorization application, GSK (LSE/NYSE:GSK) has announced that FDA has accepted a Biologics License Application for its RSV vaccine candidate for older adults. The agency also granted priority review to the vaccine, which will clip four months off the vaccine candidate’s biologics license application (BLA)…
GSK shares positive headline results from Phase 2 study of dostarlimab with chemotherapy in non-small cell lung cancer
GSK (LSE/NYSE:GSK) said that the PERLA Phase 2 study of dostarlimab met its endpoint of objective response rate in non-small cell lung cancer patients. The study used Response Evaluation Criteria in Solid Tumors (RECIST) criteria to compare dostarlimab against Merck’s Keytruda (pembrolizumab) in patients with metastatic non-squamous non-small cell lung cancer who also received chemotherapy.…
Niraparib promoted long-term progression-free survival benefit in Phase 3 advanced ovarian cancer study
Brentford, UK–headquartered GSK (LSE/NYSE:GSK) reported long-term data from the phase 3 PRIMA study indicating that the PARP inhibitor Zejula (niraparib) promoted a sustained and clinically meaningful progression-free survival (PFS) benefit in ovarian cancer patients. The survival benefit was evident across biomarker subgroups, including BRCAm, HRd and HRp. Patients in the HRd subgroup had a 48%…
WHO decision clears path for GSK’s Mosquirix malaria vaccine
The World Health Organization (WHO) has awarded prequalification to GSK’s (LSE/NYSE:GSK) Mosquirix. The move marks the first time that a malaria vaccine has won prequalification. The WHO decision regarding the Mosquirix malaria vaccine is a prerequisite for United Nations (UN) agencies like UNICEF to procure the vaccine in regions with moderate to high P. falciparum malaria transmission. Malaria…
Fall 2022 COVID-19 vaccine candidate tracker
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…
Dostarlimab drug trials: The science behind cancer and the therapy’s future
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…
Sanofi-GSK COVID-19 vaccine effective against omicron
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-GSK COVID-19 booster could compete against updated Moderna and Pfizer offerings
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…
Agenus and GSK tout positive Phase 3 data for RSV vaccine
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 wins FDA approval for Priorix MMR vaccine
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 and GSK seek regulatory nod for COVID-19 vaccine in South Korea
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…
CureVac and GSK announce positive preclinical data for next-gen bivalent mRNA vaccine candidate
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…
GSK to purchase biopharma Sierra Oncology for $1.9 billion
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…
Q-VANT Biosciences signs master agreement with the Kansas State University College of Veterinary Medicine
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…
FDA further limits use of GSK’s and Vir’s SARS-CoV-2 antibody sotrovimab
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 launches Phase 1 study for next-gen mRNA COVID-19 vaccine
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…
FDA amends EUA for SARS-CoV-2 antibody sotrovimab
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…
How high-performance AI computing is accelerating drug discovery
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…
GSK halts Phase 3 RSV maternal vaccine candidate program
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.…
Medicago and GSK win approval from Health Canada for adjuvanted plant-based COVID-19 vaccine
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…
Sanofi and GSK aim to commercialize COVID-19 vaccine
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…
Chinese regulators approve GSK’s Benlysta for lupus nephritis
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 and GSK launch Phase 1 trial of mRNA-based flu vaccine
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,…