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SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.
Sanofi announced data from a real-world clinical trial that demonstrated its RSV antibody nirsevimab delivered an 83% reduction in hospitalisations in infants with respiratory syncytial virus (RSV)-related lower respiratory tract disease (LRTD). Nirsevimab is being jointly developed between Sanofi and AstraZeneca.
The US government is reportedly investing more than $5bn in a programme to accelerate the development of new Covid-19 vaccines and treatments. Health experts have lent their support to the new programme as the existing vaccines may not be as effective against future virus threats.
The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator.
The immuno-oncology market continues to evolve as treatments establish their presence across different types of cancer, having seen approvals in multiple indications in the past decade. GlobalData separates immuno-oncology treatments into six broad classes, which include bispecific antibodies, cancer vaccines, and cell therapies.
The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March.
The top 20 companies in the global biopharma industry saw 5.4%* aggregate market capitalization from $3.43 The 13 top players experienced significant growth over 2022 despite the decline in demand for COVID-19 vaccines and therapeutics, as well as uncertainty surrounding pricing due to the newly passed Inflation Reduction Act in the US.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca ’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU). Additionally, in the trial, the antibody cocktail was found to be well-tolerated.
IN BRIEF: As a marketer, most of us, like a Jungian archetype, are true Communicators. As a pharma marketer who has worked in many other therapeutic categories and recently on a Covid launch, I have become acutely aware of the interaction between national poles and the on-the-ground sentiment I have observed.
QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Based on the virus a number of vaccines targeting the spike protein were designed, tested in animal models and found to be quite promising against SARS and other coronavirus illnesses like Middle East respiratory syndrome.
RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 1273.214, a bivalent Omicron-targeting Covid-19 vaccine of the company. 5), mRNA-1273. 5), mRNA-1273.
It will also be used for the treatment of people who are not likely to have an adequate immune response to Covid-19 vaccination or for people who are not recommended for Covid-19 vaccination. Evusheld (formerly AZD7442) is a combination of two long-acting antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061).
Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus.
The top 20 global biopharmaceutical companies exhibited a downward trend in aggregate market capitalisation by 9.1% This downturn in market cap was attributed to a decline in the demand for Covid-19 vaccines and therapies. Bayer recorded a negative market capitalization growth of 22.3% trillion in Q2 2022 to $3.14
Syncromune and Biocytogen Pharmaceuticals’ wholly owned subsidiary Eucure Biopharma have entered an exclusive global licence agreement for OX40 antibody YH002 and two other active ingredients. . Eucure will oversee the production and delivery of the drug, while Syncromune will handle the clinical development and marketing.
AstraZeneca’s antibody cocktail for COVID-19, now called Evushield, has become the first drug in the class to be authorised for prevention of infection by the US FDA. The emergency use authorisation (EUA) for Evushield activates a 700,000 order for the antibody from the US government, worth upwards of $726 million.
Half a million people in the UK with conditions like blood cancer that prevents them being protected from COVID-19 vaccines are facing another winter shielding, because the government has shelved plans to offer treatment with AstraZeneca’s antibody therapy Evusheld. — Kidney Care UK (@kidneycareuk) August 12, 2022.
Moderna today highlighted the publication of antibody persistence data out to six months following the second dose of its COVID-19 vaccine in The New England Journal of Medicine.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting expanded conditional marketing authorization (CMA) for Novavax ’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), as a booster in adults aged 18 years and above.
The Korean Ministry of Food and Drug Safety (KMFDS) has granted expanded approval to Novavax partner SK bioscience for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use as a booster dose in adults aged 18 and above. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.
A single dose of the COVID-19 monoclonal antibody therapy developing Regeneron reduced the risk of contracting the virus by around 82% for up to eight months, according to new trial data. The rate of COVID-19 vaccination was balanced between the two groups. The rate of COVID-19 vaccination was balanced between the two groups.
A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial. ” The anti-HER2 market is advancing rapidly however, with a new generation of drugs coming through the industry pipeline.
Pfizer/BioNTech’s mRNA vaccine against COVID is a technical marvel – but the ultra-cool temperatures required for storage and stability has been tricky to handle. The company announced a phase 1 trial is beginning of its nasal spray vaccine just as scientists in the UK said they are considering a similar approach.
The programme is still in the early stages of development, but if it works in trials would provide another approach to prevent transmission of SARS-CoV-2, the virus that causes COVID-19, alongside vaccines and prophylactic antibodies. The post Non-vaccine nasal spray could protect against COVID-19 appeared first on.
AstraZeneca has sought emergency use authorisation for its antibody combination AZD7442, following trial results indicating it can prevent symptomatic COVID-19 infection when given to healthy patients. The post AZ files for emergency use of COVID-19 antibody combo in US appeared first on. Initial results from that study were negative.
Find the leading API biologics companies in contract marketing. Pharmaceutical Technology has listed some of the top API biologics companies in contract marketing based on our intel, insights and decades-long experience in the sector.
Lecanemab by Eisai Co Ltd, a monoclonal antibody therapy marketed for Alzheimer’s disease, is predicted to achieve the most significant commercial debut. Epcoritamab is set to be launched globally as the first and only bispecific antibody for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma.
Preliminary data from an ongoing trial of AstraZeneca’s COVID-19 vaccine Vaxzevria has shown that a booster dose stimulates an increase in antibodies against Omicron, as well as other variants of the virus, including Alpha, Beta, Delta, and Gamma. billion doses administered. billion doses administered.
Pharmaceutical companies have been working on developing vaccines and other prophylactics for respiratory syncytial virus (RSV) since its discovery in 1956. Despite strong efforts and scientific advances, a safe and effective vaccine for RSV has yet to be approved for any patient population.
Valneva has moved a step closer to its goal of becoming the first company to file for approval of a vaccine against chikungunya virus in the US after reporting new clinical data today. Valneva estimates that the global market for vaccines against chikungunya could exceed $500 million annually by 2032.
5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 5-adapted bivalent vaccine will be made readily available for shipping. 5-adapted bivalent vaccine.
Last year, Belgium’s ExeVir Bio raised 23 million euros ($27 million) to finance development of llama antibodies – and now it is ready to begin clinical development of a potential treatment that could be effective against emerging COVID-19 variants. ExeVir is not the first company to spin out of VIB to focus on camelid antibodies.
COVID-19 vaccine makers Pfizer/BioNTech and Moderna have both commenced trials for their new variant-specific vaccines targeting omicron. Pfizer and BioNTech have started to enroll participants in a study that will evaluate the new version of their COVID-19 vaccine that targets the omicron variant of SARS-CoV-2.
AstraZeneca meanwhile has also just reported results with its antibody-based therapy AZD7442 ((tixagevimab and cilgavimab) in mild to moderate COVID-19, also reducing the risk of developing severe disease or death by 50% compared to placebo in the phase 3 TACKLE trial.
Daiichi Sankyo has stepped up its efforts to bring a Japanese COVID-19 vaccine to patients, starting a new clinical trial of its mRNA-based candidate DS-5670 that focuses on its use as a booster dose. The Japanese group says it hopes to complete clinical development of the vaccine and bring it to market in Japan before the end of the year.
An antibody cytokine fusion protein, N-803 is a new interleukin-15 (IL-15) superagonist complex. In January, ImmunityBio and Amyris have concluded a joint venture (JV) agreement announced previously to accelerate the marketing of a Covid-19 vaccine.
European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.
Vir Biotechnology-partnered COVID-19 antibody Xevudy (sotrovimab) was the big contributor to the improved result, adding £1.3 Turnover of the antibody is likely to fall sharply however as the drug has lower efficacy against the prevailing Omicron BA.2 billion ($1.6 billion) to the company’s top-line of £9.8
Prospects for Valneva’s COVID-19 vaccine are up in the air, but another candidate partnered with Pfizer looks increasingly like it could fill the void of an effective shot for Lyme disease. billion contract to supply up to 100 million doses of its COVID-19 vaccine VLA2001.
AstraZeneca may have exited the COVID-19 vaccinemarket, but it is still hoping to protect vulnerable patients with its antibody sipavibart for pre-exposure prophylaxis (PrEP).The
The increase in the production of biological drugs such as vaccines, gene and cell therapies, and monoclonal antibodies, is increasing the volume of injectable drug products in the global healthcare market. Discover the top commercial dose injectables companies in contract marketing.
As we reported this morning, the deal gives Pfizer already-approved SCD therapy Oxbryta (voxelator) – which industry watchers reckon could see a dramatic uptick in sales with Pfizer’s marketing muscle – plus a phase 3 antibody candidate, a phase 1 follow-up to Oxbryta that could offer improved dosing.
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