GSK and Flagship Pioneering link for new medicines and vaccines
Pharmaceutical Technology
JULY 30, 2024
GSK has announced a strategic collaboration with Flagship Pioneering for the discovery and development of medicines and vaccines.
Medicine Vaccination Vaccine 
European regulator recommends Bavarian Nordic's vaccine for monkeypox
Bio Pharma Dive
JULY 22, 2022
The positive decision comes as governments aim to expand supply and quicken distribution of the vaccine to combat a widening global outbreak. Separately, the EMA backed approvals of 11 other medicines.
Regulation 
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FDA approves IND application for Everest’s cancer vaccine
Pharmaceutical Technology
MARCH 24, 2025
The FDA has granted approval for the IND application of Everest Medicines tumour-associated antigen (TAA) vaccine, EVM14.
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SK Bioscience gains UK authorisation for SKYCovion Covid-19 vaccine
Pharmaceutical Technology
MAY 30, 2023
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.
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HIV vaccines suffer setbacks but new approaches could turn the tide
Pharmaceutical Technology
FEBRUARY 3, 2023
Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections.
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Valneva’s Lyme disease vaccine faces final clinical test in a sparse landscape
Pharmaceutical Technology
AUGUST 17, 2022
On August 8, Pfizer and Valneva announced the initiation of a Phase III study with their Lyme disease vaccine , bringing the prospect of an injection to prevent the condition disease one step closer to reality. This means that the vaccine works against multiple serotypes of the disease, she explains. A one-size-fits-all approach.
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UK MHRA approves Takeda’s dengue vaccine Qdenga
Pharmaceutical Technology
FEBRUARY 7, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). The vaccine candidate has been approved for active immunisation against the infection in people from four years of age.
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Ghana becomes first country to approve Oxford’s malaria vaccine
Pharmaceutical Technology
APRIL 14, 2023
Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Children between the ages of five and 36 months are at highest risk of death from malaria.
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EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents
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. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain.
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Nobel Prize awarded for research that paved the way for Covid-19 mRNA vaccines
Pharmaceutical Technology
OCTOBER 2, 2023
The Physiology and Medicine Prize has gone to two researchers whose work laid the foundation for Pfizer and Moderna’s Covid-19 vaccines.
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GenScript ProBio and RVAC partner for Covid-19 vaccine pDNA
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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RVAC and University of Pennsylvania to develop mRNA vaccines
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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Covid-19 vaccines targeting Omicron variants expected to be ready for this autumn
Pharmaceutical Technology
JUNE 24, 2022
As regulatory agencies gear up for another round of Covid-19 vaccine deliberations centered on emerging variants, Moderna has released data on its booster’s efficacy against Omicron subvariants. The mRNA-1273.214 booster contains the original Spikevax vaccine and a candidate targeting Omicron BA.1 1 variant of concern.
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Pfizer forecasts $15B sales boost from coronavirus vaccine orders
Bio Pharma Dive
FEBRUARY 2, 2021
The estimate for 2021 sales, which Pfizer splits with partner BioNTech, would make the vaccine one of the highest-selling medicines in the industry.
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WHO grants emergency use listing to SK bioscience’s SKYCovione
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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Pfizer’s Covid-19 vaccine sales forecasts upgraded with sales of $37bn in 2022
Pharmaceutical Technology
FEBRUARY 21, 2023
Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, had a phenomenal year with forecast sales of $37bn in 2022. Comirnaty is the leading prophylactic vaccine for Covid-19 and is expected to generate an additional $2.8bn in sales in 2022 compared to GlobalData’s H1 2022 forecast. Comirnaty is the first globally approved Covid-19 vaccine.
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UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine
Pharmaceutical Technology
AUGUST 15, 2022
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. In addition, no serious safety concerns linked to the vaccine were observed.
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Moderna’s mRNA vaccine along with Keytruda obtains PRIME designation
Pharmaceutical Technology
APRIL 6, 2023
Moderna has announced that its cancer vaccine mRNA-4157/V940 along with Keytruda secured the European Medicines Agency (EMA) Priority Medicines (PRIME) scheme designation for the adjuvant treatment of high-risk stage III/IV melanoma patients after complete resection.
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Pfizer pledges not-for-profit sale of medicines in low-income countries
Bio Pharma Dive
MAY 25, 2022
The pharma has been criticized for not doing enough to make its COVID-19 vaccine and pill available globally. The new initiative commits Pfizer to supplying current and future branded medicines at lower cost to 45 countries.
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Moderna reports ‘encouraging’ early data for one of its rare disease medicines
Bio Pharma Dive
MAY 19, 2023
The biotech, best known for its vaccine research, said its clinical trial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.
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Ten key clinical trials to watch in the first half of 2021
Bio Pharma Dive
JANUARY 11, 2021
Study results could come soon for several coronavirus vaccines, as well as experimental medicines from Amgen, Vertex and Sage Therapeutics.
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Meningitis vaccine comes to the forefront with impressive study results
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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5 FDA decisions to watch in the third quarter
Bio Pharma Dive
JULY 2, 2021
The agency is under pressure to grant full approvals to two coronavirus vaccines and faces important questions on how to handle the next Alzheimer's drugs after Aduhelm. A safety review of several arthritis medicines, meanwhile, is ongoing.
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CHMP recommends approval for GSK’s RSV vaccine candidate
Pharmaceutical Technology
APRIL 28, 2023
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of GSK’s respiratory syncytial virus (RSV) vaccine candidate for use in older adults. This is the first time a vaccine candidate for the potential treatment of adult RSV patients has received a positive opinion.
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Merck, in latest COVID-19 setback, scraps one drug and pins hopes on another
Bio Pharma Dive
APRIL 15, 2021
The decision to end development of a medicine acquired in a $425 million deal last November is another disappointment for Merck's coronavirus effort, which once involved multiple drugs and vaccines.
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EC’s HERA signs Covid-19 vaccine procurement deal with HIPRA
Pharmaceutical Technology
AUGUST 2, 2022
The Health Emergency Preparedness and Response Authority (HERA) of the European Commission (EC) has entered a co-procurement framework contract for HIPRA HUMAN HEALTH’s bivalent recombinant protein Covid-19 vaccine. A total of 14 member states and countries are participating in this deal and can procure up to 250 million vaccine doses. .
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GSK stays optimistic on vaccines amidst US and China woes
Pharmaceutical Technology
FEBRUARY 5, 2025
While vaccine sales dropped, GSK raised its revenue guidance for 2031 with speciality medicines expected to drive that growth.
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UK MHRA approves Pfizer-BioNTech’s bivalent Covid-19 booster
Pharmaceutical Technology
NOVEMBER 9, 2022
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 1 vaccine as well as the safety results from a clinical trial underway. 5 sub-variants.
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Health Canada accepts Pfizer Canada’s bivalent RSV vaccine for review
Pharmaceutical Technology
APRIL 17, 2023
Health Canada has accepted Pfizer Canada’s new drug submission for a bivalent respiratory syncytial virus (RSV) vaccine for review. The vaccine will be used to prevent lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in adults aged 60 and above.
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Hipra’s Covid-19 booster gets EMA nod and enters an uncertain landscape
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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Panel recommends programme for uniform high standard drug regulation nationwide
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 20, 2025
A Parliamentary Panel has recommended implementation of a comprehensive, nationwide and phased Medicines Regulatory Maturity Enhancement Programme on the lines of World Health Organisation’s (WHO) vaccine benchmarking process to ensure a consistently high standard of drug regulation across the country.
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EC grants marketing authorisation for Takeda’s dengue vaccine
Pharmaceutical Technology
DECEMBER 9, 2022
The European Commission (EC) has granted marketing authorisation for Takeda ’s Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) to prevent dengue in people aged four years and above. According to the results, the trial met the primary endpoint of overall vaccine efficacy by averting 80.2%
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EC grants marketing authorisation for GSK’s RSV vaccine Arexvy
Pharmaceutical Technology
JUNE 8, 2023
The European Commission (EC) has granted marketing authorisation for GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, for adults aged 60 years and above. The vaccine is indicated for active immunisation to prevent RSV-related lower respiratory tract disease (LRTD) in older adults.
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EU nears decision on Novavax COVID-19 vaccine
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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EMA grants full marketing authorisation for AstraZeneca’s Covid-19 vaccine
Pharmaceutical Technology
NOVEMBER 2, 2022
The European Medicines Agency (EMA) has granted full marketing authorisation (MA) for AstraZeneca ’s Covid-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]). The vaccine initially received a conditional marketing authorisation (cMA) for use in the European Union (EU).
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EMA CHMP recommends expanded CMA for Novavax’s Covid-19 vaccine as booster
Pharmaceutical Technology
SEPTEMBER 2, 2022
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.
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Novavax and SII receive registration for Covid-19 vaccine in South Africa
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. The vaccine showed efficacy, with an encouraging safety and tolerability profile, in the trials. .
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Precision and personalized medicine: the leading companies in personalized cancer vaccines revealed
Pharmaceutical Technology
NOVEMBER 6, 2023
GlobalData uncovers the leading innovators in personalized cancer vaccines for the pharmaceutical industry.
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EC grants approval for Sanofi-GSK’s Covid-19 booster
Pharmaceutical Technology
NOVEMBER 11, 2022
The European Commission (EC) has granted approval for Sanofi and GSK ’s monovalent, recombinant-protein-based, adjuvanted Covid-19 vaccine, VidPrevtyn Beta, as a booster in adults aged 18 years and above. It is indicated as a booster in people of this age group who were earlier inoculated with a Covid-19 vaccine.
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EMA accepts Moderna’s CMA submission for Covid-19 vaccine
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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EMA CHMP recommends Moderna’s Covid-19 booster for children
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. 5), mRNA-1273.
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Race to the finish: pharma edges closer to approval with RSV vaccines
Pharmaceutical Technology
FEBRUARY 1, 2023
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.
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MHRA looks to AI to hunt for COVID-19 vaccine side effects
pharmaphorum
NOVEMBER 2, 2020
million tender to a software company for an artificial intelligence tool that will be used to process “the expected high volume of COVID-19 vaccine adverse drug reactions (ADRs).”. The post MHRA looks to AI to hunt for COVID-19 vaccine side effects appeared first on. The UK drugs regulator has awarded a £1.5
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‘A very worrying scenario’: Internal documents on India Covid-19 vaccine raise troubling questions about approval process
STAT News
NOVEMBER 15, 2022
As the Covid-19 pandemic spread across the world two years ago, one of India’s leading biotech companies was racing to develop a vaccine with crucial backing from the Indian government. Read the rest…
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