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.
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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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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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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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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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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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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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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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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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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 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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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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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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Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show
pharmaphorum
MARCH 16, 2021
European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. As it conducted its analysis of the vaccine in December, the European Medicines Agency’s systems were targeted by unknown hackers.
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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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At request of AstraZeneca, Europe suspends marketing authorization of COVID vaccine Vaxzevria
Fierce Pharma
MAY 8, 2024
On Tuesday, the EMA said it had accepted a request from AZ and withdrawn the company’s marketing authorization for its COVID-19 shot Vaxzevria.
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FDA grants GSK first-ever approval for RSV vaccine
Pharmaceutical Technology
MAY 4, 2023
After a winter marked by a rise in hospitalisations due to the RSV, the FDA has granted its first approval for an Respiratory Syncytial Virus (RSV) vaccine to GSK’s Arexvy for adults ages 60 years and above. This vaccine specifically prevents RSV-related lower respiratory tract disease (LRTD).
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Valneva seeks Health Canada approval for chikungunya vaccine
Pharmaceutical Technology
MAY 30, 2023
Valneva has submitted a regulatory application to Health Canada, seeking marketing approval for its chikungunya vaccine candidate, VLA1553. The vaccine is designed to be administered as a single shot and is intended for individuals aged 18 years and older. Valneva plans to make further regulatory submissions.
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Indonesia grants EUA for US-developed Covid-19 vaccine
Pharmaceutical Technology
OCTOBER 3, 2022
Indonesia has granted Emergency Use Authorization (EUA) for the patent-free Covid-19 vaccine, IndoVac, developed by the Texas Children’s Hospital Center for Vaccine Development (CVD) and Baylor College of Medicine, US. PT Bio Farma will manufacture 20 million doses of the vaccine this year.
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EC extends marketing authorisation for Bavarian Nordic’s smallpox vaccine
Pharmaceutical Technology
JULY 25, 2022
The European Commission (EC) has extended Bavarian Nordic ’s smallpox vaccine Imvanex (MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic) marketing authorisation to offer protection from monkeypox. A non-replicating smallpox vaccine, Imvanex was developed in partnership with the US Government.
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EU agencies back Covid-19 vaccine update ahead of autumn campaign
Pharmaceutical Technology
JUNE 7, 2023
Covid-19 vaccine compositions should be updated to provide protection against XBB Omicron variant strains in preparation for the autumn vaccination campaign, say EU agencies in a joint 6 June statement. There, organisations determined that the compositions of Covid-19 vaccines need to be updated to reflect the evolution of the virus.
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Pfizer cut vaccine production targets because of raw material shortage – reports
pharmaphorum
DECEMBER 4, 2020
Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses.
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CanSinoBIO developed a highly effective COVID vaccine with an inhalant version
pharmaphorum
JULY 18, 2022
MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Morgon, PharmD, LL.M, How it works. Regarding the BA.4
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Merck and Orna partner for RNA technology-based vaccines and therapies
Pharmaceutical Technology
AUGUST 17, 2022
These programmes will include therapies and vaccines in infectious disease and oncology areas. Preclinical data showed the potential of oRNA expression and delivery as a method for advanced development in various areas, including vaccines and oncology treatments. Topic sponsors are not involved in the creation of editorial content.
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Indonesian pharmaceutical Bio Farma ready to produce IndoVac Covid-19 vaccines
Pharma Mirror
SEPTEMBER 11, 2022
Bandung, W Java, Indonesia, PT Bio Farma, the holding company for state-owned pharmaceutical companies in Indonesia, announced a new milestone in the manufacturing of IndoVac, a Covid-19 vaccine brand it has developed since November 2021.
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Johnson & Johnson starts rolling review for COVID-19 vaccine in Europe
BioPharma Reporter
DECEMBER 1, 2020
Johnson & Johnson has started a rolling submission with the European Medicines Agency (EMA) for its single-dose COVID-19 vaccine candidate.
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FDA and doctors warn against extending COVID-19 vaccine dose gap
pharmaphorum
JANUARY 5, 2021
Tinkering with the dosing schedule of COVID-19 vaccines runs a “significant risk” to public health, the FDA has warned in a statement after the UK announced plans to prioritise the first doses of two approved shots. Several million more doses of the vaccine are understood to have been manufactured but have not yet been bottled in vials.
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UK prepares for decision on AZ/Oxford vaccine as COVID cases soar
pharmaphorum
DECEMBER 24, 2020
The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days. Just how this will be viewed by regulators is unclear, as are the plans to distribute the vaccine.
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Clearing Up a Misconception: COVID-19 Vaccines and Infertility/Pregnancy Loss
BioSpace
MAY 14, 2021
A study, published recently in the New England Journal of Medicine, demonstrated no obvious safety signals among pregnant persons who received the mRNA vaccines.
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Moderna seeks FDA EUA for Covid-19 booster vaccine
Pharmaceutical Technology
AUGUST 24, 2022
5 Omicron-targeting bivalent booster vaccine for Covid-19. The submission is made for a 50µg booster dose of the vaccine for usage in adults aged 18 years and above. Irrespective of previous infection or age, the vaccine also showed neutralising antibody responses against the BA.4 1 subvariant.
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J&J single-shot COVID-19 vaccine shows early promise
pharmaphorum
JANUARY 15, 2021
J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month. Both of these vaccines require two doses, as does the most recently approved shot from Moderna, which is due to arrive in the UK in the spring.
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