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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 $54.66.

Sierra Oncology’s differentiated momelotinib, which inhibits JAK1 and JAK2, offers potential for patients with myelofibrosis, a rare bone marrow cancer. Myelofibrosis can lead to scarring in the bone marrow, thus causing severe anemia.

GSK expects to benefit from sales of momelotinib starting in 2023, with growth ramping up after that.

There is a significant unmet need for patients with myelofibrosis. Roughly 40% of patients diagnosed with myelofibrosis are already anemic, with the majority developing anemia eventually.

Momelotinib has been the subject of 22 clinical trials to date. Read more

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 efficacy of other Quillaja saponin-based adjuvants from Q-VANT.

[Related: Q-VANT aims to rewrite the narrative for Quillaja saponin-based adjuvants.]

Kansas University is also home to the Biosecurity Research Institute, a comprehensive infectious disease high-security research facility.

The CSF vaccine that will be the initial focus of the research was developed by professor Jishu Shi, a professor within the school’s College of Veterinary Medicine who focuses on developing strategies to protect against s…

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 hold up to the first omicron subvariant, but the companies have concluded that it is probably ineffective against the BA.2 subvariant.

The FDA has announced that sotrovimab is not currently authorized in areas where the BA.2 subvariant makes up the majority of COVID-19 infections. These areas include the Northeast, much of the Western part of the country and a portion of the Midwest.

The FDA has also withdrawn authorization for sotrovimab in Alaska and major U.S. territories, including Puerto Rico.

Last year, FDA similarly limited the use of Lilly’s bamlanivimab (LY-CoV555)…

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 interim vaccine efficacy of its first mRNA COVID-19 vaccine candidate was 47% in a Phase 2b/3 study.

Tübingen, Germany–based CureVac believes that its second-generation mRNA could prove to be broadly efficacious against SARS-CoV-2 variants and other pathogens.

Nature published a preclinical study involving cynomolgus macaques last year, indicating that the immunogenicity of CV2CoV was superior to its first-generation vaccine candidate, CVnCoV. The paper concluded that CV2CoV was “comparably immunogenic to the BNT162b2 (Pfizer) vaccine in macaques.”

The dose of the CV2CoV vaccine…

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 certain areas.

GSK and Vir were initially optimistic about the antibody’s ability to target the mutations in the spike protein of the original omicron SARS-CoV-2 variant.

Vir shares dropped 13.56% to $21.81. GSK shares were mostly flat, falling 0.046% to $43.28.

The market for SARS-CoV-2 antibodies has been competitive, but emerging variants have limited use of the therapies.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently recommended marketing authorization for AstraZeneca’s (LON:AZN) Evushe…

How high-performance AI computing is accelerating drug discovery

Image courtesy of GSK.

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 of how the right AI computing platform can enable new research and new methods and potentially transform the future of drug discovery.

Inside the GSK and Cerebras partnership

GSK and Cerebras Systems have a partnership that uses AI computing from Cerebras to accelerate pharmacological and life sciences research at GSK. As a recent example of the power of this partnership, GSK researchers worked with Cerebras Systems to develop a new AI model of cell-type-specific gene re…

How high-performance AI computing is accelerating drug discovery

Image courtesy of GSK.

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 of how the right AI computing platform can enable new research and new methods and potentially transform the future of drug discovery.

Inside the GSK and Cerebras partnership

GSK and Cerebras Systems have a partnership that uses AI computing from Cerebras to accelerate pharmacological and life sciences research at GSK. As a recent example of the power of this partnership, GSK researchers worked with Cerebras Systems to develop a new AI model of cell-type-specific gene re…

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.

GSK’s AReSVi 006 Phase 3 trial (NCT04886596) for RSV older adults 60 years and older is ongoing.

GSK shares were down 2.25% to $41.72 in mid-day trading.

Vaccine makers have attempted in vain to create a vaccine for RSV, which CDC links to 14,000 deaths in adults aged 65 years or older annually.

Several companies have RSV vaccine candidates, including Moderna (NASDAQ:MRNA) and Janssen (NYSE:JNJ).

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 particles.

The Health Canada approval covers adults between the ages of 18 to 64.

The agency approved the Novavax COVID-19 vaccine last week.

GSK is also working with K Bioscience in South Korea on an adjuvanted COVID-19 vaccine and with CureVac on a next-generation mRNA vaccine.

“This first approval is an important milestone in our approach of pairing GSK’s well-established pandemic adjuvant with promising antigens to develop protein-based, refrigerator-stable COVID-19 vaccines to help protect peopl…

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 European Medicines Agency (EMA).

In a Phase 3 efficacy trial, two doses of the vaccine in seronegative individuals were 100% effective against severe COVID-19 disease and hospitalization. Protection against moderate or severe COVID-19 was 75%, while protection against symptomatic COVID-19 was 57.9%.

A booster dose of the vaccine increased neutralizing antibodies 18- to 30-fold in recipients of mRNA and adenovirus vaccines.

The companies note that the research was carried out while challenging variants of concern were circulating. “No other global Phase 3 efficacy study…

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 in China.

The recent indication is constrained to patients receiving standard of care for LN.

The indication for SLE, the most common form of lupus, covers adults and children at least five years old.

FDA approved Benlysta as a lupus treatment in 2011. Approval extended to children at least five years old in 2019. In December 2020, FDA approved an indication of the drug for adults with lupus nephritis.

NMPA approved the new indication after reviewing data from the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) Phase stu…

CueVac 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, however, the company’s stock was trading over $100 per share on enthusiasm about the company’s first-generation COVID-19 vaccine. However, the shares later tanked after the company announced that interim vaccine efficacy was 47% in the Phase 2b/3 study.

The company’s second-generation COVID-19 vaccine remains in pre-clinical development.

Its influenza vaccine candidate has multiple non-chemically modified mRNA constructs related to four different influenza strains.

Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are also developing mRNA-based influenza vaccines.

Investors were dis…