41.13 +0.43 (1.06%)
Before hours: 4:26AM EDT
Commodity Channel Index
|Bid||0.00 x 3200|
|Ask||0.00 x 1200|
|Day's Range||40.05 - 40.76|
|52 Week Range||31.43 - 48.25|
|Beta (5Y Monthly)||0.42|
|PE Ratio (TTM)||41.03|
|Earnings Date||Feb 01, 2017 - Feb 06, 2017|
|Forward Dividend & Yield||1.89 (4.71%)|
|Ex-Dividend Date||May 14, 2020|
|1y Target Est||47.70|
An independent panel to the U.S. Food and Drug Administration on Tuesday voted in favor of approving GlaxoSmithKline's experimental treatment for a common form of blood cancer, saying the benefits of the treatment outweigh the risks. Approval for belantamab mafodotin as a treatment for multiple myeloma is seen as important for GSK's growing oncology portfolio. The drug is a rival to Johnson & Johnson and Genmab's Darzalex treatment.
(Bloomberg) -- Medicago Inc. has been using plants to develop potential vaccines for more than two decades. A new partnership with GlaxoSmithKline Plc. putting its unproven technology to the test against the novel coronavirus is pushing the Canadian biotech into the limelight.The Quebec City-based company dosed the first humans with its experimental Covid-19 vaccine on Monday, making it one of 23 candidates that have reached phase 1 clinical trials in the race to curb the pandemic, according to the World Health Organization.Medicago, which is backed by large investors like Mitsubishi Tanabe Pharma and Philip Morris International Inc., last week clinched a deal with Glaxo to pair the vaccine with the U.K. giant’s adjuvants -- boosters that can help any brand of shot.“It’s a bit of a coup for a company like ours, because I had to convince them about the robustness of our technology,” Chief Executive Officer Bruce Clark said of the plant platform, which has yet to produce an approved vaccine. “It’s a real watershed moment for us as the new kid in town.”Read More: Glaxo Teams With Philip Morris-Backed Biotech on Covid VaccineMedicago relies on an Australian plant that’s a close relative to tobacco, known as nicotiana benthamiana, to develop vaccines. The plant has a weakened immune system that allows it to easily host genetic material and develop particles that mimic a virus. As Clark put it in an interview, the plants serve as “bioreactors” that can harvest clinical-grade material in a matter of weeks.The Canadian trial of Medicago’s Covid-19 candidate will involve 180 healthy patients aged 18 to 55, and will test various doses of the vaccine alone and coupled with two different adjuvants: one from Glaxo, and another from Dynavax Technologies Corp.Pre-clinical results of its vaccine candidate both with and without a booster demonstrated a high level of neutralizing antibodies following a single dose, according to the company. Should the early-stage study prove successful, Medicago aims to enter later-stage trials in October, and manufacture 100 million doses by the end of 2021.Medicago, like many companies behind the 160 coronavirus vaccines currently in development, is seeking to earn investors’ trust by validating their new platforms amid the pandemic.It’s “at once exciting, and extremely frustrating” to be a small vaccine player vying to be taken seriously, Clark said. “If we’re going to show the world how this works, we have to take Covid on. The skepticism for new technology is there. The plant skepticism is there.”Budding TechnologyMedicago launched in 1999 out of a partnership between Canada’s agriculture department and Laval University. After focusing on the tobacco-adjacent plant, Medicago went public in 2006. In 2009 it began using the technology to develop a shot to counter the H1N1 pandemic. In 2013, Medicago was taken private by Mitsubishi Tanabe Pharma and Philip Morris.Clark, who has spent his career at a range of large pharmaceutical companies including Glaxo and Sanofi, was a vice president at Philip Morris when that acquisition occurred. He’s helped the company usher a seasonal flu vaccine through late-stage clinical trials. That program is currently under review by Canadian health authorities.Medicago is not alone in pursuing a plant-based approach to the novel coronavirus. Cigarette maker British American Tobacco Plc has been working on a similar vaccine through its biotech subsidiary Kentucky BioProcessing.Medicago sees itself as confronting a similar challenge as high-profile vaccine makers like Moderna Inc., Pfizer Inc. and Sanofi, which are relying on so-called messenger RNA technology to prompt the body to make a key protein from the virus, sparking an immune response. The mRNA technology also has yet to generate a vaccine approved by regulators in the U.S. or beyond.“We really think we’ll need more than one type of vaccine,” said Nathalie Landry, Medicago executive vice president of scientific and medical affairs, noting that various populations could respond differently to certain technologies.So, Clark said, “the data has to speak for itself.”For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.
Medicago said on Tuesday it has begun testing its plant-based coronavirus vaccine in an early-stage clinical trial as the Canadian company, backed by tobacco company Phillip Morris, races against larger drugmakers to develop a treatment option to battle the COVID-19 pandemic. Medicago said it dosed the first healthy volunteers on Monday in a 180-person study, making it the first vaccine from Canada among the more than 20 experimental coronavirus vaccines being tested in humans. Experts have cautioned that more than one vaccine may be necessary to combat the COVID-19 pandemic, with drugmakers such as AstraZeneca Plc and Moderna Inc ahead in the race and gearing up to test their vaccine candidates in large trials.
GlaxoSmithKline plc has been drifting lower since early May but buyers are showing us signs they are interested and bullish. Depends on your perspective. Let's check out the charts. In the daily bar chart of GSK, below, we can see that prices declined from January into late March.
Pharmaceutical companies, including GlaxoSmithKline, are pulling out all the stops to tackle coronavirus through new treatments and vaccines, but we are playing catch-up. Antimicrobial resistance, or AMR, is just such a threat, but, unlike Covid-19, AMR is predictable. Scientists already track increasing rates of antibiotic resistance and the World Health Organization and the US Centers for Disease Control and Prevention have identified the bacteria that pose the greatest risks to human health.
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12-0 in favour of the demonstrated benefit of monotherapy treatment with belantamab mafodotin outweighing the risks for patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Two committee members could not participate in the final vote.
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The U.S. Food and Drug Administration on Friday said it would review GlaxoSmithKline's experimental treatment for multiple myeloma, a common form of blood cancer, for a reported side-effect which affects the eyes of patients. The FDA on Friday published submissions ahead of a meeting of the Oncologic Drugs Advisory Committee (ODAC) on July 14, where they will evaluate how belantamab mafodotin can cause keratopathy, a side-effect where deposits gather on the cornea of the eye. "The concerns and uncertainties regarding the ocular toxicities raises questions about the overall benefit-risk profile of the belantamab mafodotin in the proposed patient population," a briefing document published on the FDA's website said.
GlaxoSmithKline (NYSE: GSK) announced Tuesday that Medicago -- a private company owned by Mitsubishi Tanabe Pharma (OTC: MTZXF) and Philip Morris International (NYSE: PM) -- will use GlaxoSmithKline's adjuvant in a COVID-19 vaccine it expects to enter phase 1 trials this month. Medicago's recombinant coronavirus "Virus-Like Particles" will be combined with Glaxo's pandemic adjuvant system to boost immune response, potentially allowing for less antigen per dose and thus, more available vaccine doses.
Britain's GSK said on Tuesday that an injection of its cabotegravir drug given every two months was found to be 66% more effective in preventing HIV infections than Gilead's Truvada daily oral pills. HIV incidence rate - or the number of people who contract the infection in a period - was 0.41% with the injection, compared with 1.22% with Gilead's Truvada, final data from a study presented at the virtual AIDS conference showed. Truvada is currently the standard of care for preventing HIV, but GSK hopes to challenge its dominance by making shorter, long-lasting regimens and less toxic alternatives through its ViiV Healthcare unit.
A GlaxoSmithKline anti-HIV drug given every two months is significantly better at preventing infection than the current standard of care, an international trial has found. The drug, called cabotegravir, is given by injection as “pre-exposure prophylaxis” or PrEP, a regimen that aims to prevent infection in people who are exposed to HIV. It is made by ViiV Healthcare, a company that is majority-owned by GSK and also backed by Pfizer and Shionogi.
Britain is close to a 500 million pound ($624 million) supply deal with Sanofi and GlaxoSmithKline for 60 million doses of a potential COVID-19 vaccine, the Sunday Times reported. Clinical trials are due to start in September and Sanofi has said it expects to get approval by the first half of next year, sooner than previously anticipated. More than 100 vaccines are being developed and tested around the world to stop the COVID-19 pandemic and governments are racing to secure supplies of vaccines even before their efficacy is proven.
GlaxoSmithKline's HIV business ViiV is within weeks of resubmitting its request for approval of its long-acting injection Cabenuva to U.S. drug regulators, ViiV's head of research said on Thursday. ViiV executive Kimberly Smith told a media briefing that the company would stick to its previous guidance of refiling the request around mid-year and that this would happen "within weeks".
Sanofi SA (NASDAQ: SNY), which is in the race to develop a vaccine for SARS-CoV-2, which causes COVID-19, is unveiling an accelerated timeline for the vaccine program it is pursuing with GlaxoSmithKline plc (NYSE: GSK).Sanofi has also expanded its collaboration with mRNA vaccine company Translate Bio Inc (NASDAQ: TBIO).Sanofi Moves Up Vaccine Rollout Timeline: Sanofi said it expects to begin a Phase 1/2 study of the recombinant protein vaccine candidate it is co-developing with GlaxoSmithKline in September, and full approval is likely to be obtained at the earliest by the first half of 2021, the company said at its Virtual R&D Investor Day.GlaxoSmithKline is contributing its adjuvant AS03.In mid-April, when the companies announced the collaboration, they gave a timeline of the second half of 2021 for the probable commercial launch of the vaccine."Sanofi is advancing the only vaccine in the race that's off a proven platform that works at scale," Fierce Pharma reported, quoting Sanofi CEO Paul Hudson.Hudson expressed skepticism regarding the efficacy and the ability to scale manufacturing of the new breed of vaccines being developed by frontrunners working on the coronavirus. Translate Bio Pact: Sanofi is also strengthening its vaccine partnership with Translate Bio.The proposed expanded relationship is a collaboration and licensing agreement with the smaller biopharma to develop mRNA vaccines for infectious diseases, including COVID-19.Sanofi and Translate Bio are in the process of shortlisting a coronavirus mRNA vaccine candidate from animal studies and intend to start human trials in the fourth quarter of 2020.SNY Price Action: At last check, Sanofi shares were up 0.53% at $52.78.Related Links:The Week Ahead In Biotech: Karyopharm, Zogenix, Heron, Chiasma On The Radar Ahead Of FDA Decisions The Daily Biotech Pulse: Sanofi Expedites COVID-19 Vaccine Timeline, Apyx Cleared For Market Expansion, Miragen's Positive Readout See more from Benzinga * The Daily Biotech Pulse: Sanofi Expedites COVID-19 Vaccine Timeline, Apyx Cleared For Market Expansion, Miragen's Positive Readout * The Daily Biotech Pulse: Eloxx Resumes Cystic Fibrosis Study, Rexahn's Reverse Merger, Ultragenyx, Epizyme Await FDA Decisions(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Sanofi said Tuesday (June 23) it expects to get approval for a potential coronavirus vaccine by the first half of next year - faster than was previously thought. The French drugmaker is developing the medicine with Britain's GlaxoSmithKline. In April, they had said the vaccine would be available in the second half of 2021. Many drugmakers are racing to come up with a safe and effective vaccine that can be produced on a large scale. Moderna, AstraZeneca and Pfizer all moved to human trials as early as March. But Sanofi CEO Paul Hudson said their rivals were not assured of securing victory - and claimed moving at speed could lead to less effective results. He said the probability of success for his company is 'higher than anybody else'. Sanofi is currently working on two vaccine projects. Clinical trials of the drug developed with GSK are due to start in September. Sanofi said trials of a separate vaccine should begin around the end of 2020. The drugmaker said it had capacity to produce up to 1 billion doses a year of the vaccine it is working on with GSK.
French drugmaker Sanofi SA said on Tuesday it expects to get approval for the potential COVID-19 vaccine it is developing with Britain's GlaxoSmithKline Plc by the first half of next year, faster than previously anticipated. Sanofi, which is hosting a virtual research and development event, and GSK had said in April the vaccine, if successful, would be available in the second half of 2021. "We are being guided by our dialogue with regulatory authorities," Sanofi research chief John Reed told reporters, when asked about the accelerated time frame.