XTalks

NOVEMBER 15, 2023

France-based biotech Valneva has won approval from the US Food and Drug Administration (FDA) for its chikungunya vaccine Ixchiq for the prevention of infection from the chikungunya virus. The vaccine is approved for adults 18 years of age and older who are at increased risk of exposure to the virus. The data showed a 98.9

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XTalks

NOVEMBER 4, 2022

Pfizer announced positive top-line data from a Phase III trial evaluating its respiratory syncytial virus (RSV) prefusion vaccine candidate, RSVpreF (or PF-06928316) for pregnant individuals to help protect their infants from RSV disease after birth. Related: Pfizer to Acquire RSV Antiviral Developer ReViral in $525 Million Deal.

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pharmaphorum

FEBRUARY 3, 2022

Moderna has kicked off a clinical trial of an HIV vaccine based on the same mRNA platform that underpins its COVID-19 shot – seeking to succeed where traditional vaccine technologies have failed. Results are due next year, but the current trial is only seen as the first step in developing a potential HIV vaccine.

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pharmaphorum

SEPTEMBER 4, 2020

Sanofi and GlaxoSmithKline have begun clinical trials of their coronavirus vaccine, as AstraZeneca expanded studies of its rival into Japan. The French pharma in April joined forces with the UK’s GSK to produce the vaccine, with Sanofi contributing an antigen that produces the immune reaction.

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BioPharma Reporter

JULY 12, 2021

Antibody responses against the SARS-CoV-2 spike protein were found in 99% of volunteers after the second dose of ReiTheraâs COVID-19 vaccine candidate, according to Phase 2 preliminary data.

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pharmaphorum

SEPTEMBER 28, 2021

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.

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XTalks

MARCH 1, 2021

(NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. Related: Could Pfizer and BioNTech’s COVID-19 Vaccine be Stored at Standard Freezer Temperatures?

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pharmaphorum

OCTOBER 7, 2020

GlaxoSmithKline and partner Vir Biotechnology are to expand a trial of an experimental antibody to treat COVID-19, putting heat on Regeneron’s rival that has been famously used to treat president Donald Trump. The antibody in question, VIR-7831 has already been shown to neutralise the SARS-CoV-2 live virus in the lab and in animals.

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pharmaphorum

MARCH 3, 2022

Pfizer has been awarded breakthrough status from the FDA for its respiratory syncytial virus (RSV) vaccine in pregnant women, putting the company in pole position to bring a shot to market that will protect infants from the life-threatening infection. AZ, Sanofi antibody aces phase 3 trial.

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pharmaphorum

MARCH 7, 2022

The World Health Organization (WHO) announced the opening of a global biomanufacturing hub located in South Korea to provide training to low- and middle-income countries seeking to produce vaccines and other biologics, such as insulin and monoclonal antibodies. . of individuals in low-income countries have received their first dose.

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pharmaphorum

NOVEMBER 17, 2020

Pfizer has begun a pilot delivery programme in the US for its experimental COVID-19 vaccine, as the company seeks to overcome logistical challenges caused by its ultra-cold storage requirements. The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials.

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pharmaphorum

NOVEMBER 9, 2020

As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering the disease in an interim analysis. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

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Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef.

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pharmaphorum

AUGUST 21, 2020

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. The latest data from a phase 1 study in the US showed that seven days after a second dose at 30 micrograms, the vaccine produced 3.8

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Pharmaceutical Technology

JUNE 6, 2023

The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress. MRNA-0184 Overview mRNA-0184 is under development for the treatment decompensated heart failure. The therapeutic candidate consists of messenger RNA (mRNA) encoding for relaxin.

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Pharmaceutical Technology

MAY 26, 2023

GlobalData separates immuno-oncology treatments into six broad classes, which include bispecific antibodies, cancer vaccines, and cell therapies. There are currently over 700 immuno-oncology products in Phase I-III of development in the eight major markets, said Chalk. PD1, BCMA and PDL1 follow as the most common targets.

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Pharmaceutical Technology

MAY 30, 2023

Lecanemab by Eisai Co Ltd, a monoclonal antibody therapy marketed for Alzheimer’s disease, is predicted to achieve the most significant commercial debut. which is the licensee of lebrikizumab, recently reported favourable outcomes for lebrikizumab through a novel secondary analysis of the Phase III clinical development programme.

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pharmaphorum

FEBRUARY 10, 2022

AstraZeneca confirmed today that it has discontinued clinical development of a follow-up to its COVID-19 vaccine Vaxzevria targeted at the Beta variant of the virus, which started development before the emergence of the Delta and Omicron strains.

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The Pharma Data

AUGUST 10, 2020

Novavax is partnering up with the Serum Institute of India Private Limited (SIIPL) in a licensing deal to development and marketing of up to one billion doses of its potential recombinant COVID-19 vaccine candidate, NVX?CoV2373. Negotiations are currently ongoing to have SIIPL manufacture the candidate within India. M adjuvant.

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The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.

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The Pharma Data

MARCH 1, 2022

Astellas”) today announced that they have entered into an agreement whereby Affinivax has reacquired the exclusive worldwide rights to ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae. We believe ASP3772 has significant potential to address unmet needs in this important vaccine category.

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The Pharma Data

SEPTEMBER 2, 2020

. Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology.

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pharmaphorum

OCTOBER 16, 2020

Sanofi will shortly start human trials of a second coronavirus vaccine, developed with US biotech Translate Bio, after reporting that it stimulated antibodies against SARS-CoV-2 in preclinical testing. It started human testing of a protein subunit vaccine with partner GlaxoSmithKline last month.

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The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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Pharmaceutical Technology

JUNE 5, 2023

Kid EDV is under clinical development by ImmunityBio and currently in Phase I for Pediatric Diffuse Intrinsic Pontine Glioma. Kid EDV overview Kid EDV is under development for the treatment of recurrent or refractory solid or CNS tumors including diffuse intrinsic pontine gliomas of children. It is administered intravenously.

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Pharmaceutical Technology

NOVEMBER 7, 2022

The latest approval in the EU is based on findings from Beyfortus's clinical development programme, including the Phase III MELODY, Phase II/III MEDLEY and Phase IIb clinical trials. Beyfortus is a long-acting antibody. compared with placebo through day 151.

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Pfizer

JULY 19, 2022

1 Adapted Bivalent Vaccine Candidate. 1 Adapted Bivalent Vaccine Candidate. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 Tue, 07/19/2022 - 11:22. Booster Series.

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pharmaphorum

OCTOBER 6, 2020

The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University. The post Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab appeared first on.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The joint development team is working on improving the temperature stability of the mRNA vaccine candidate and targeting a -20°C storage temperature for late-stage clinical trials and at launch.

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The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.

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The Pharma Data

AUGUST 6, 2020

We pointed out last week that China was a notable missing element in AstraZeneca’s COVID-19 vaccine strategy, despite being the drugmaker’s second-largest market. The pair will also explore the possibility of producing the vaccine for other markets. The vaccine was moved into phase 2/3 in May. That has changed.

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Vaccination Vaccine Antibody Licensing 52

Pfizer

NOVEMBER 2, 2022

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Wed, 11/02/2022 - 15:44. Thursday, November 03, 2022 - 06:45am. Ugur Sahin, M.D.,

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The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. President of Research and Development, Novavax.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. The vaccine was previously made available to this age group in the U.S. Fri, 07/08/2022 - 11:48. Pfizer and BioNTech Announce U.S.

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Roots Analysis

OCTOBER 30, 2023

The next generation RNA therapeutics and RNA vaccines pipeline currently features the presence of more than 20 circular RNA therapeutics and vaccines, being developed across initial stages of drug development (discovery and preclinical).

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Pfizer

FEBRUARY 16, 2023

who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15. OspA is a surface protein expressed by the bacteria when present in a tick.

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Clinical Trials Clinical Trials Vaccination Vaccine 76

Pfizer

DECEMBER 8, 2022

FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza. INDICATION & AUTHORIZED USE Pfizer-BioNTech COVID-19 Vaccine, Bivalent, (Original and Omicron BA.4/BA.5) AUTHORIZED USE .

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