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.

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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.

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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.

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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. The long-acting injection can help relieve HIV patients from having to take a daily cocktail of pills. Opening up Options.

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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.

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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.–(

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The Pharma Data

OCTOBER 25, 2020

The investments in this proprietary platform have enabled Moderna to expeditiously create, manufacture and clinically develop mRNA-1273 to potentially address the current COVID-19 pandemic. Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. 26, 2020 11:00 UTC.

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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.

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pharmaphorum

MARCH 29, 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,” said C.

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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

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The Pharma Data

JANUARY 31, 2021

The Coalition for Epidemic Preparedness Innovations (CEPI) will continue to support the development of Clover’s COVID-19 vaccine candidate and will fund the development, including the Phase 2/3 trial, through licensure. Dynavax Forward-Looking Statements.

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The Pharma Data

AUGUST 30, 2021

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. Leqvio is the first and only approved small interfering RNA (siRNA) LDL-C-lowering treatment in Europe 6,7. It is currently under review by the U.S. Disclaimer.

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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.

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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.

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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.

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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.

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The Pharma Data

MARCH 4, 2021

Under the 2017 collaboration agreement, Takeda received equity in Ovid and was eligible to receive up to $85 million in payments for regulatory milestones, including the initiation of Phase 3 clinical trials. You can identify forward-looking statements because they contain words such as “will,” “appears,” “believes” and “expects.”

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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.

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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.,

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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. Th e first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines. The two formulations differ in the lipid nanoparticle (LNP) that contains the mRNA.

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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% ModernaTX, Inc.

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The Pharma Data

NOVEMBER 18, 2021

All clinical studies provide important learnings to help us in the fight against HIV, and we are grateful to the patients and investigators for their contributions.”. Merck recently announced positive topline results from the ILLUMINATE SWITCH A and ILLUMINATE SWITCH B Phase 3 clinical trials. About IMAGINE-DR.

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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. Despite an estimated 9.25 CNS’s moment of truth.

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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.

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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. CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Nov. 16, 2020– Moderna, Inc. They are an inspiration to us all.

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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.

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Drug Discovery World

DECEMBER 26, 2023

Read the story: CAR-T therapy targets over 80% of human tumours Stanford false data accusations In the biggest research ethics scandal of the year, the president of Stanford University in the US announced in July that he would resign after the university found that scientific papers he had published contained manipulated research data.

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Delveinsight

DECEMBER 13, 2020

Even though clinical trial results were promising, adverse events and serious complications were observed. Vosevi) to treat adult chronic hepatitis C of all genotypes previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.

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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.

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The Pharma Data

AUGUST 29, 2020

This analysis confirms that as a small interfering RNA (siRNA), inclisiran provides a remarkably consistent treatment profile. Inclisiran will potentially be the first and only LDL-C-lowering small-interfering RNA (siRNA) treatment. 30% reduction of their LDL-C levels with a mean reduction of 54.1% from baseline (observed values) 2­.

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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).

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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.

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The Pharma Data

SEPTEMBER 9, 2020

Immunization of non-human primates (rhesus macaques) with BNT162b2, a nucleoside-modified messenger RNA (modRNA) candidate that expresses the SARS-CoV-2 spike glycoprotein, resulted in strong anti-viral effects against an infectious SARS-CoV-2 challenge. The study is an event-driven trial. Pfizer Disclosure Notice.

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The Pharma Data

DECEMBER 21, 2020

Nasdaq:BCRX) today announced that data from part 1 of a clinical trial of its broad-spectrum antiviral, galidesivir, showed that galidesivir was safe and generally well tolerated in patients infected with SARS-CoV-2, the virus that causes COVID-19. RESEARCH TRIANGLE PARK, N.C., Post-marketing commitments for RAPIVAB are ongoing.

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The Pharma Data

JANUARY 21, 2021

In the ATLAS study, CABENUVA met the primary endpoint for noninferiority (the proportion of participants with plasma HIV-1 RNA ?50 50 copies per milliliter [c/mL] at Week 48), with a comparable number of patients receiving either CABENUVA or their daily current antiretroviral regimen (CAR) having an HIV-1 RNA level ?50

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Pharmaceutical Technology

FEBRUARY 1, 2023

As an RNA virus, like SARS-CoV-2, RSV is highly prone to mutations. Since RSV has not yet circulated through large populations of vaccinated individuals, except those controlled in clinical trials, the overall widespread viral response of RSV to vaccines remains unpredictable.

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The Pharma Data

OCTOBER 25, 2021

At 48 weeks, both trials met their primary efficacity endpoint of chance of actors with HIV-1 RNA situations ? We’ll continue to study doravirine/ islatravir in different populations of people living with HIV and look forward to participating data from these trials.”. PIFELTRO and DELSTRIGO.

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