The Pharma Data

AUGUST 16, 2021

The antiviral agent incorporates RNA-like building blocks into the RNA genome of the virus. If this genetic material is further replicated, defective RNA copies are produced and the pathogen can no longer spread. Molnupiravir is currently being tested in clinical trials. ” Mutations in the genome stop the virus.

RNA 52

RNA Drugs Genome Genomics 52

Drug Discovery World

JANUARY 11, 2024

Researchers have used messenger RNA (mRNA) to create an effective therapy for a rare liver disease in preclinical studies, demonstrating the technology’s potential therapeutic use in people. mRNA contains instructions that direct the cells to make proteins.

Research 59

Research Gene Therapy RNA Gene 59

XTalks

JANUARY 3, 2024

Amvuttra: Alnylam’s Similar Treatment on the Market In 2022, Alnylam, a US-based biopharma company with expertise in RNA interference therapeutics for genetically defined diseases, received FDA approval for its drug Amvuttra (vutrisiran) for the treatment of hATTR.

FDA Approval 105

FDA Approval Protein RNA Clinical Trials 105

The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.

Vaccination 52

Vaccination Vaccine Trials Protein 52

XTalks

JUNE 14, 2023

The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. The solution of Vevye does not contain water, anti-microbial preservatives, oils or surfactants. Vevye (cyclosporine ophthalmic solution) 0.1

Gene Silencing 97

Gene Silencing Drug Delivery FDA Approval RNA 97

pharmaphorum

SEPTEMBER 14, 2021

The Cambridge, Massachusetts biotech is focusing specifically on the 60% of DNA sequences that repeat themselves hundreds or thousands of times in the genome, known as the ‘repeatome’, that could contain targets for cancer and autoimmune disorders. That muffles the immune system response and allows the cancer to grow.

DNA 52

DNA Immune Response Genome Genomics 52

XTalks

JANUARY 25, 2021

The injectable treatment is called Cabenuva and contains two drugs in its injectable formulation — cabotegravir, an integrase inhibitor, and rilpivirine, a second-generation non-nucleoside reverse transcriptase inhibitor. ATLAS and FLAIR Phase III Trials. Updated data from the trial showed 86.6 Opening up Options.

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical Trials 52

XTalks

AUGUST 18, 2023

Izervay is the only approved treatment for geographic atrophy that has demonstrated a significant decrease in the rate of geographic atrophy progression at the 12-month primary endpoint, based on results from two rigorous Phase III clinical trials. Izervay contains avacincaptad pegol sodium, an effective complement C5 inhibitor.

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

pharmaphorum

DECEMBER 7, 2020

Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a clinical trial. On top of this is the requirement for the cutting-edge RNA-based vaccines to be stored at ultra-low temperatures.

Vaccination 79

Vaccination Vaccine Clinical Trials Clinical Trials 79

XTalks

DECEMBER 1, 2021

The country of South Africa has a particularly sophisticated infectious disease monitoring, surveillance and research infrastructure, which is why the country has been at the forefront in both the identification of coronavirus variants as well as COVID-19 vaccine trials. 1.1.529 variant to South Africa and the world.”.

Gene 105

Gene Genome Genomics Genetics 105

The Pharma Data

OCTOBER 25, 2020

mRNA-1273 is currently being studied in a Phase 3 randomized, 1:1 placebo-controlled trial of 30,000 participants at the 100 µg dose level in the U.S. Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. 26, 2020 11:00 UTC. CAMBRIDGE, Mass.–( About Moderna.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Development 52

The Pharma Data

AUGUST 30, 2021

Overall, Leqvio was well-tolerated, with a safety profile similar to placebo and consistent with the overall pooled population from the combined trials 1 – 3. As the first and only small interfering RNA to provide effective and sustained LDL-C reduction, Leqvio helps manage a critical cardiovascular risk factor for ASCVD.

RNA 52

RNA Trials Production Containment 52

Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. IPs containing engineered genetic materials may pose risks potentially not anticipated by the clinic’s standard infection control policies.

Engineer 52

Engineer Genetics Clinical Research Research 52

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. For biosimilars, however, this process is slightly more complex.

Bioequivalency 130

Bioequivalency Production Branding Contamination 130

The Pharma Data

JANUARY 10, 2021

The new year began with a fairly low level of clinical trial news. Arcturus Therapeutics got the FDA go-ahead for its Phase II trial of its COVID-19 vaccine candidate ARCT-021. The trial will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Here’s a look. COVID-19-Related. Non-COVID-19-Related.

Gene Therapy 52

Gene Therapy Trials Gene Clinical Trials 52

The Pharma Data

OCTOBER 28, 2020

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co., 29, 2020 06:00 UTC. CAMBRIDGE, Mass.–(

Vaccination 40

Vaccination Vaccine Manufacturing Clinical Trials 40

The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Dec. million to 7.5

Vaccination 40

Vaccination Vaccine Manufacturing Containment 40

The Pharma Data

MARCH 23, 2022

Back in 2018, researchers tested a broad-spectrum antiviral candidate called remdesivir/VEKLURY, which acts as a nucleotide decoy to get incorporated into the viral RNA genome and stop viral polymerase. who could carry out experiments with live Ebola virus in a high containment research facility.

Protein 52

Protein Genome Genomics Research 52

The Pharma Data

MARCH 28, 2022

We designed BIIB078 to test the prevailing hypothesis that the mechanisms of disease for C9orf72-associated ALS were caused by toxicity associated with the repeat containing RNA and corresponding dipeptides. Unfortunately, this Phase 1 study did not support the hypothesis, suggesting that the disease mechanism is much more complex.

Drugs 52

Drugs Genetics RNA Development 52

The Pharma Data

JULY 18, 2021

Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted. pneumoniae serotypes contained in the vaccine. 50 cells per microliter and plasma HIV RNA value <50,000 copies/mL (V114-018/PNEU- WAY [NCT03480802]). In January 2021, it received Priority Review designation.

Immune Response 52

Immune Response Vaccination Vaccine FDA Approval 52

The Pharma Data

MARCH 4, 2021

Together we generated positive Phase 2 ELEKTRA study data, and as a result, soticlestat is poised to enter two pivotal trials,” said Andy Plump, M.D., “I would like to thank Ovid for their thoughtful and productive collaboration. President of Research and Development at Takeda. For more information, visit [link].

Development 52

Development Containment Medicine Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Sanofi, Empowering Life.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

AUGUST 29, 2020

Basel , August 30, 2020 — Novartis today announced results from a post-hoc analysis of pooled data from the Phase III ORION-10 and -11 trials evaluating the individual responses of patients on low-density lipoprotein cholesterol (LDL-C) reduction with inclisiran, a first-in-class investigational treatment for hyperlipidemia in adults.

Medicine 52

Medicine Containment Trials Production 52

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. For more information, visit.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

DECEMBER 19, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. 20, 2020 02:44 UTC. CAMBRIDGE, Mass.–( –( BUSINESS WIRE )– Moderna, Inc.,

Vaccination 52

Vaccination Vaccine Licensing Licensing 52

The Pharma Data

NOVEMBER 16, 2020

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company’s development of a potential vaccine (mRNA-1273) against the novel coronavirus, the conditions under which mRNA-1273 can be shipped, stored and administered, and the U.S.

Vaccination 52

Vaccination Vaccine Containment Pharmacy 52

pharmaphorum

JANUARY 5, 2022

The year 2020 ended on a note of hope, with the 8th December vaccination of 91-year-old Margaret Keenan, the world’s first person to receive a COVID-19 vaccine outside clinical trials. Lilly also plans an H2H trial of donanemab vs Aduhelm to start enrolling by the end of 2021. Despite an estimated 9.25 CNS’s moment of truth.

Vaccination 93

Vaccination Vaccine Antibody FDA Approval 93

The Pharma Data

DECEMBER 10, 2020

Both vaccination regimens resulted in complete protection from subsequent viral ‘challenge’ as reflected by reductions in viral RNA levels that were below the level of detection by day seven post-challenge compared to controls. Additional safety and neutralizing data are currently being collected/analyzed.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

NOVEMBER 16, 2020

I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. The Phase 3 COVE trial is a randomized, 1:1 placebo-controlled study testing mRNA-1273 at the 100 µg dose level in 30,000 participants in the U.S.,

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 18, 2020

The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. The vaccine was 94.1%

Vaccination 52

Vaccination Vaccine Production Manufacturing 52

Pharmaceutical Technology

NOVEMBER 22, 2022

According to CEPI: “Achieving the 100 Days Mission would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic.”. Messenger RNA vaccines contain nucleic acids that code for a specific protein, or target antigen, related to a virus or disease.

Manufacturing 130

Manufacturing Vaccination Vaccine RNA 130

Pfizer

JANUARY 27, 2023

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

Marketing 75

Marketing Production Drugs Licensing 75

The Pharma Data

NOVEMBER 18, 2021

At the recommendation of the eDMC, Merck is stopping dosing in the trial, with continued monitoring of study participants. In light of the findings from the MK-8507-013 study, Merck conducted a review of trends in total lymphocyte and CD4+ T-cell counts in company-sponsored clinical trials of ISL across all indications and dosing regimens.

Clinical Trials 52

Clinical Trials Clinical Trials Trials RNA 52

Drug Discovery World

DECEMBER 26, 2023

The open-label, single patient cohort ascending dose trial followed promising preclinical data for LEU011 in a spectrum of solid tumour models. Read the story: Potentially game-changing schizophrenia drug enters trials Psychedelic antidepressant trial Psychedelics were big news in 2023. Of the trial participants, 53.3%

Development 64

Development Clinical Trials Clinical Trials Drugs 64

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

JANUARY 6, 2021

About CureVac CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. ak (2021-0003E).

Vaccination 52

Vaccination Vaccine Development Marketing 52

The Pharma Data

SEPTEMBER 1, 2020

COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus. Roche has an ongoing clinical trial program evaluating the role of Actemra©/RoActemra© (tocilizumab) in COVID-19 pneumonia.

In-Vitro 52

In-Vitro Antibody Medicine Clinical Trials 52