Pharmaceutical Technology

MARCH 20, 2023

RVAC Medicines has announced a research collaboration with the University of Pennsylvania (Penn) for the discovery and development of mRNA vaccines. The mRNA vaccine candidates will help reduce the chances of autoimmune responses that might lead to allergic conditions or serious autoimmune diseases.

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Pharmaceutical Technology

JULY 6, 2022

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. In April this year, the company sought CMA expansion from the EC for the vaccine use in adolescents.

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Vaccination Vaccine Protein Clinical Trials 264

Pharmaceutical Technology

MAY 25, 2023

A new vaccine developed by the Serum Institute of India to fight meningococcal disease could help eliminate meningitis across Africa. The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile. for serogroup W to 20.5

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Vaccination Vaccine Immune Response Bacteria 195

Pharmaceutical Technology

FEBRUARY 23, 2023

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. GenScript ProBio CEO Dr Brian Min said: “We are delighted to enter into this strategic partnership with RVAC Medicines.

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Vaccination Vaccine Gene Therapy Manufacturing 289

Pharmaceutical Technology

NOVEMBER 21, 2022

RVAC Medicines has signed a master research partnership agreement with the Agency for Science, Technology and Research (A*STAR) for analysing and developing solutions to build messenger ribonucleic acid (mRNA) manufacturing and analytics expertise in Singapore. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

JUNE 20, 2023

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.

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Vaccination Vaccine Protein Clinical Trials 363

Pharmaceutical Technology

MAY 29, 2023

Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373) , in the European Union (EU).

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Vaccination Vaccine Protein Immune Response 130

Pharmaceutical Technology

SEPTEMBER 14, 2022

Novavax and Serum Institute of India (SII) have reported that the former’s Covid-19 vaccine, NVX-CoV2373, has received full product registration from the South African Health Products Regulatory Authority (SAHPRA), with conditions. It is marketed under the brand name Covovax in the country.

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Vaccination Vaccine Clinical Trials Clinical Trials 147

BioPharma Reporter

NOVEMBER 18, 2021

The European Medicines Agency (EMA) could issue an opinion on Novavaxâ Conditional Marketing Authorization for its COVID-19 vaccine âwithin weeksâ.

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Vaccination Vaccine Medicine Marketing 145

Pharmaceutical Technology

JUNE 2, 2023

The European Commission (EC) and Pfizer/BioNTech have agreed to amend their current supply contract to deliver Covid-19 vaccines to the EU. More significantly, the revised contract secures about 70 million vaccine doses every year from 2023 to 2026 for member states, leaving little space in the market for competitors.

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Vaccination Vaccine Marketing Manufacturing 130

Pharmaceutical Technology

MAY 24, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Recombinant viral vector-based medicinal preparations. However, not all innovations are equal and nor do they follow a constant upward trend.

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Medicine Vaccination Vaccine Gene 130

Pharmaceutical Technology

MARCH 31, 2023

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.

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Vaccination Vaccine Immune Response Antibody 277

Pharmaceutical Technology

SEPTEMBER 29, 2022

The European Medicines Agency (EMA) has accepted Moderna ’s submission seeking a variation to the Conditional Marketing Authorization (CMA) for assessing a 50µg dose of the Omicron-based bivalent Covid-19 booster candidate, mRNA-1273.222, for adults aged 12 years and above. 1 targeting vaccine in Europe, our BA.4/BA5

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Vaccination Vaccine Gene Therapy Clinical Trials 147

BioTech 365

DECEMBER 23, 2020

VBI Vaccines Announces European Medicines Agency Acceptance of Marketing Authorization Application (MAA) for 3-Antigen Prophylactic Hepatitis B Vaccine VBI Vaccines Announces European Medicines Agency Acceptance of Marketing Authorization Application (MAA) for 3-Antigen Prophylactic Hepatitis B Vaccine CAMBRIDGE, Mass.–(BUSINESS

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pharmaphorum

NOVEMBER 23, 2022

The US regulator has started a priority, six-month review of Takeda’s dengue fever vaccine TAK-003 – tipped as a potential blockbuster product – making a decision likely in the first half of 2023. The vaccine has already been approved as Qdenga in Indonesia – where the disease is endemic – to protect people in the six to 45 age bracket.

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Vaccination Vaccine Marketing Sales 122

Pharmaceutical Technology

JANUARY 30, 2023

According to GlobalData’s Drugs database, there were 22 prophylactic vaccines in development for COVID-19 with sales forecasts available in H2 2022. Of these 22 vaccines, mRNA-derived vaccines dominate, with Comirnaty and Moderna’s Spikvax accounting for 88% of 2022 sales, with 58% and 30%, respectively.

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Vaccination Vaccine Sales RNA 130

Pharmaceutical Technology

AUGUST 17, 2022

Merck (MSD outside North America) has entered a partnership agreement with Orna Therapeutics for discovering, developing and marketing various programmes based on next-generation RNA technology. These programmes will include therapies and vaccines in infectious disease and oncology areas.

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RNA Vaccination Vaccine In-Vivo 147

Pharmaceutical Technology

AUGUST 23, 2022

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.

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BioPharma Reporter

SEPTEMBER 18, 2023

Moderna has revealed that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Spikevax, its updated COVID-19 vaccine.

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pharmaphorum

JANUARY 27, 2023

So, here are three “best guesses” for what 2023 will hold for the off-patent medicines segment — which accounts for roughly 70% of medicines prescribed worldwide (including the vast majority of system-critical antibiotics and ICU therapies), but only about 20% of the total cost.

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Medicine Production Marketing Packaging 105

Fierce Pharma

MARCH 27, 2024

For various reasons, pharma firms often favor distribution pacts rather than relying on local subsidiaries to market their drugs. |

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Drugs Vaccination Vaccine Marketing 114

Drug Discovery World

JULY 24, 2023

The EU’s Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorisation for 14 new medicines in its July meeting. Degarelix Accord (degarelix acetate), a generic medicine for the treatment of prostate cancer.

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Medicine Marketing Protein Vaccination 52

Pharmaceutical Technology

DECEMBER 18, 2022

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.

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Gene Therapy Vaccination Vaccine Clinical Trials 304

XTalks

OCTOBER 4, 2023

Health economics and outcomes research (HEOR) and market access strategies play a critical role in ensuring that newly approved therapies are made available to patients. Professionals in these roles are facing new challenges when it comes to negotiating coverage for many of the new, innovative treatments that are coming to market.

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Marketing Development Drugs Gene Therapy 105

pharmaphorum

OCTOBER 12, 2022

David Del Bourgo (CEO and co-founder, Whitelab Genomics) has always been passionate about introducing disruptive, innovative technologies to markets. We thought, there has to be something to help use data to make [drug developers] more efficient in bringing therapies to market faster, and at a lower price,” Del Bourgo explains.

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Genome Genomics Medicine Development 105

pharmaphorum

JANUARY 31, 2022

It is becoming increasingly important for people all over the world to understand the importance of vaccines and to have access to the vaccines they need – especially with digital innovation driving new vaccine development. Pfizer’s Josh Raysman, Saad Saeed, and Shanaya Deboo discuss vaccine awareness, access, and innovation.

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Vaccination Vaccine Development Marketing 97

Drug Discovery World

MAY 8, 2023

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a series of reports about the availability of new medicines throughout Europe. EFPIA’s 2022 Patient WAIT Indicator tracks the availability of new medicines and length of time it takes patients to get them in 37 countries in the EU and EEA.

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Medicine Marketing Vaccination Vaccine 52

pharmaphorum

DECEMBER 22, 2022

Construction will start early next year of a new manufacturing centre in the UK with the capacity to produce 250 million vaccine doses per year, the centrepiece of a 10-year alliance between the government and US biotech Moderna. The first vaccines are due to be produced at the new facility in 2025.

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Vaccination Vaccine Life Science Manufacturing 122

pharmaphorum

JANUARY 7, 2021

The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules. As things stand, the two rival mRNA-based vaccines from Pfizer/BioNTech and Moderna are now approved for use in the EU.

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Drug Discovery World

OCTOBER 24, 2023

This free summit, sponsored by Taconic, will offer expert thought leadership on cancer research, precision medicine and immunotherapy. Dr Ahmad will present on ‘The age of therapeutic cancer vaccines – the next frontier in immuno-oncology’. Register for free to secure your place!

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Vaccination Vaccine Research Clinical Development 52

Pharmaceutical Technology

APRIL 10, 2023

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. Dr Noor Hisham was quoted as saying: “The use of Evusheld was based on clinical guidelines issued by the health ministry.”

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Pharmaceutical Technology

SEPTEMBER 19, 2022

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). These antibodies are obtained from B-cells of convalescent Covid-19 patients.

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Pharmaceutical Technology

SEPTEMBER 22, 2022

It could be that you are lucky, and there is already a cancer vaccine on the market that you will get priority for. Alternatively, there are vaccines ready to enter decentralised third-phase clinical trials, so you can enrol quickly.

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Genome Genomics Clinical Trials Clinical Trials 342

pharmaphorum

NOVEMBER 16, 2022

The 2022 edition of the Access to Medicine Index (ATMI) – which places the top 20 pharma companies for their efforts to improve delivery of medicines to lower income countries – sees GSK retain the number one position, newly joined by Johnson & Johnson in second and AstraZeneca in third. Jayasree Iyer.

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Medicine Production Pharma Companies Licensing 106

BioPharma Reporter

DECEMBER 1, 2020

Pfizer/BioNTech and Moderna have each submitted formal applications for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their COVID-19 vaccines: completing the rolling review process.

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Vaccination Vaccine Medicine Marketing 87

Pharma Mirror

SEPTEMBER 2, 2020

HK), a leading company engaged in the research, development, production, marketing and sale of essential medicines and branded healthcare products in Hong Kong, announced the signing of a letter of intent (“Letter of Intent”) with Fosun Industrial Co. a wholly-owned subsidiary of Shanghai.

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Pharmaceutical Technology

NOVEMBER 23, 2022

Innovations in biotechnology are advancing the biopharmaceutical market, enabling the treatment of complex diseases with next-generation therapeutics synthesised or extracted from a biological source. Lifted by increased interest after the onset of the Covid-19 pandemic, the sector is expected to balloon to US$853 billion by 2030.

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