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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Pharma Mirror

MAY 31, 2023

In the face of increasing global health challenges, the development and production of vaccines have become paramount. One critical aspect is the ability to scale up manufacturing processes to meet the growing demand for viral vector-based vaccines.

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Pharmaceutical Technology

APRIL 3, 2023

The World Health Organisation (WHO) has revised its recommendations regarding the use of Covid-19 vaccines following a meeting of the agency’s Strategic Advisory Group of Experts on Immunisation (SAGE). The panel emphasised that the extra booster dose recommendation only pertains to one shot and is not for continued annual booster vaccines.

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Pharmaceutical Technology

APRIL 11, 2023

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.

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Pharmaceutical Technology

MARCH 14, 2023

The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The vaccine has received approval for preventing dengue disease in people aged four years to 60 years.

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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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Bio Pharma Dive

MAY 19, 2023

The vaccine could be the first for protecting infants by maternal immunization. The panel voted 14-0 that Pfizer’s data showed its shot to be effective.

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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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Pharmaceutical Technology

DECEMBER 13, 2022

CSL subsidiary CSL Seqirus has closed the international partnership and licence agreement with Arcturus Therapeutics for research, development, production and international marketing of self-amplifying messenger ribonucleic acid (sa-mRNA) vaccines. Under the deal, CSL will gain access to Arcturus’ sa-mRNA vaccine platform technology.

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Bio Pharma Dive

JANUARY 23, 2023

Agency scientists are proposing to update COVID shots once a year to match circulating coronavirus strains, as well as simplifying current vaccination regimens.

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Bio Pharma Dive

APRIL 11, 2023

The shot appears to generate an immune response that matches or exceeds existing vaccines, but investigators aren’t yet sure how well it can prevent illness.

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Bio Pharma Dive

FEBRUARY 10, 2023

The pharma and partner BioNTech have kicked off the first human trial of a messenger RNA shot for shingles, believing there’s room to clear the high bar set by GSK’s rival vaccine.

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Pharmaceutical Technology

APRIL 13, 2023

The expanded licence will include the development of vaccines and therapeutic proteins beyond Covid-19 for human and animal health markets in Africa. During the Covid-19 pandemic, vaccination rates of many countries in Africa were significantly trailing the rest of the world.

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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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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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Bio Pharma Dive

MARCH 29, 2023

The pharma, once a frontrunner in the race to develop the first vaccine for the respiratory virus, said it will end a 23,000-person study of its experimental shot amid a restructuring of its infectious disease division.

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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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Pharmaceutical Technology

MAY 1, 2023

After a long period of inactivity in RSV vaccine development , two pharmaceutical companies are now approaching regulatory decisions for their RSV vaccines. Both Pfizer and GSK have major approval decisions regarding the use of their RSV vaccines for older adults this May. What incentivises a country to cover a vaccine?

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Pharmaceutical Technology

DECEMBER 7, 2022

Health Canada has granted approval for a supplement to a New Drug Submission (sNDS) of Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted), Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. The trial is designed to analyse the safety and effectiveness of the vaccine.

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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. The vaccine candidate will be used to prevent lower respiratory tract diseases (LRTD) caused by RSV in adult patients aged 60 and above.

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Pharmaceutical Technology

OCTOBER 5, 2022

Vaccines are critical to global health security, being the most effective form of prevention and control of the spread of communicable diseases, some of which are particularly serious and potentially life-threatening. Vaccines’ crucial role and high-priority nature become even more evident in cases of pandemic, endemic or epidemic events.

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Pharmaceutical Technology

DECEMBER 11, 2022

The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza. The vaccine is intended to prevent two respiratory ailments through a single injection. 5 Omicron sublineages spike proteins.

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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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Bio Pharma Dive

FEBRUARY 1, 2023

The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults.

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Pharmaceutical Technology

MAY 16, 2023

Bavarian Nordic has completed the acquisition of Emergent BioSolutions ’ travel vaccine portfolio for an upfront payment of $274m, with the potential for the total value to rise to $384m. Following the completion of the deal, Bavarian Nordic now boasts the only oral vaccine licensed by the U.S.

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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. percentage points (96% CI, −0.3

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World of DTC Marketing

JULY 20, 2021

29 percent of Americans said they were unlikely to get vaccinated — up from 24 percent three months earlier. Most workers do not want their own employer to require vaccination, including the vast majority of unvaccinated workers (92%). Yet even as evidence grows that vaccines are safe and effective, resistance to them is also growing.

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Bio Pharma Dive

OCTOBER 21, 2022

The company is considering charging as much as between $110 and $130 per dose — roughly four times the vaccine’s current price — once sales transition to the private market.

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Pharmaceutical Technology

JANUARY 13, 2023

The Biomedical Advanced Research and Development Authority (BARDA) has awarded a multi-year contract to the Sabin Vaccine Institute for developing and producing single-dose vaccine candidates for Ebola Sudan and Marburg virus diseases. Currently, there are no licensed vaccines against these viruses.

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Pharmaceutical Technology

MAY 30, 2023

million government grant from the Flanders Innovation & Entrepreneurship (VLAIO) agency that will be used to fuel the company’s vaccine platform, per a 30 May announcement. The company’s prophylactic yellow fever vaccine is part of its plasmid-launched live attenuated virus (PLLAV) platform. AstriVax has received a €2.5

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Pharmaceutical Technology

APRIL 25, 2023

As the prophylactic landscape for malaria has changed in recent years with vaccine approvals, major issues still remain with ensuring access in remote communities. However, making sure the vaccine reaches everyone can be challenging due to the storage requirements. The Mosquirix vaccine contains two vials.

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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. The post GenScript ProBio and RVAC partner for Covid-19 vaccine pDNA appeared first on Pharmaceutical Technology.

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Bio Pharma Dive

APRIL 17, 2023

The company reported positive results from a second Phase 2 study of a shot that’s meant to challenge vaccines from Pfizer, Merck and GSK.

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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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Pharmaceutical Technology

MAY 18, 2023

International non-profit research organisation IAVI and Zendal Group’s subsidiary Biofabri have signed an expanded deal to develop MTBVAC, a tuberculosis (TB) vaccine candidate. The organisation and the company initially collaborated in 2021 to advance the vaccine candidate into efficacy trials.

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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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Bio Pharma Dive

OCTOBER 12, 2022

The drugmaker’s decision to grab rights to the shot deepens its ties with the COVID-19 vaccine developer and comes weeks before a key data release.

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