Delveinsight

SEPTEMBER 23, 2021

The biotech has evolved a T-cell receptor-like antibody to damage a selected immune checkpoint in oncology. 858 Therapeutics closes USD 60 Million series A round to drug RNA modulation. Now, they are ready for their next venture, which is launching RNA biotech 858 Therapeutics with a USD 60 million Series A fundraising.

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RNA Gene Therapy Gene Protein 61

pharmaphorum

DECEMBER 1, 2020

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. The EMA has also confirmed it has received a filing from Moderna, which is producing a rival vaccine based on similar RNA technology.

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Vaccination Vaccine RNA Clinical Trials 88

pharmaphorum

JANUARY 5, 2022

The results of the CORAL-BOOST are only in a few patients, but showed strong increases in neutralising antibody levels when Gritstone’s shot given as a booster after two doses of AstraZeneca’s Vaxzevria given as a primary course. “With new variants – like Omicron and B.1.640.2

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Protein Vaccination Vaccine Immune Response 126

pharmaphorum

DECEMBER 23, 2021

The US regulator issued Novartis with a complete response letter (CRL) for inclisiran a year ago, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy. It will be launched in the US in January, said Novartis.

Drugs 105

Drugs Sales Antibody FDA Approval 105

Pharmaceutical Technology

DECEMBER 9, 2022

Beyond our expertise in small molecules, we have built a solid reputation with biopharmaceutical companies for the characterisation and analysis of monoclonal antibodies, therapeutic proteins and biosimilars. Ribonucleic acid (RNA) based technologies are among many innovative approaches explored to tackle the Covid-19 pandemic.

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Development Production Manufacturing Vaccine 130

Pharmaceutical Technology

JUNE 4, 2023

Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin-1, which are now well established in the industry.

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Genetics Gene Expression DNA Antibody 130

pharmaphorum

NOVEMBER 17, 2020

Pfizer is poised to file the vaccine with the FDA in the coming days, seeking an Emergency Use Authorization (EUA) after gathering enough safety data required by the regulator. Both Pfizer and Moderna vaccines use synthetic messenger RNA to activate the immune system against the virus. Pfizer and BioNTech have a $1.95

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Vaccination Vaccine RNA Clinical Trials 77

pharmaphorum

MARCH 9, 2022

Sanofi and Sobi’s haemophilia partnership has been under competitive pressure from new therapies like Roche’s antibody Hemlibra, so the two companies are hoping a new long-acting drug candidate can revitalise the franchise.

Protein 98

Protein Gene Therapy Sales Regulation 98

pharmaphorum

NOVEMBER 9, 2020

Results will be discussed with regulators worldwide and the European Medicines Agency has already begun its rolling review of data to hasten a decision on the clinical trial dossier. These cause the body to produce antibodies that neutralise the SARS-CoV-2 virus in the event of an infection.

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Vaccination Vaccine Clinical Trials Clinical Trials 98

pharmaphorum

OCTOBER 6, 2020

The announcement comes just days after the regulator said its CHMP scientific committee had begun to look at the first batch of data from AZ’s rival. These studies suggest BNT162b2 triggers the production of neutralising antibodies and T-cells that target SARS-CoV-2, the coronavirus that causes COVID-19.

Vaccination 59

Vaccination Vaccine RNA Immune Response 59

pharmaphorum

FEBRUARY 9, 2021

InteRNA is focusing on the development of gene-silencing drugs based on microRNA, naturally occurring, non-coding strands of RNA that are thought to regulate gene expression in cells.

Trials 59

Trials Gene Silencing RNA Gene Expression 59

pharmaphorum

OCTOBER 22, 2020

AT-527 works by blocking the viral RNA polymerase enzyme needed for viral replication. But the findings of the latest phase 3 study , EMPACTA, could change that after Roche said it plans to share results with the FDA and other regulators to get its label expanded on the basis of the latest results.

Development 66

Development Branding RNA Manufacturing 66

pharmaphorum

DECEMBER 21, 2020

But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge. Their technology is based on synthetic messenger RNA – short for ribose nucleic acid – which is a short transcript of a longer DNA code.

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Vaccination Vaccine Doctors Doctor 111

pharmaphorum

JULY 19, 2021

Drugs harnessing the potential of modified RNA, antisense and siRNA oligonucleotides, antibody–drug conjugates and nanomedicines will become as important as today’s ‘small molecule’ drugs, reaching potential market values into the hundreds of billions – if the potential can be realised through innovation support and industry collaboration.

Life Science 52

Life Science Medicine RNA Vaccination 52

The Pharma Data

JANUARY 21, 2021

” But the Pfizer and Moderna vaccines are designed to not only target the spike protein, but to promote the creation of antibodies that will attack it in several different ways, Salvatore said. “The height of the antibody response may be somewhat proportional to how sick you are in the beginning.

Vaccination 52

Vaccination Vaccine Protein Immune Response 52

The Pharma Data

MAY 17, 2021

But the companies said their refined antigen formulation induced a strong immune response in individuals agesd18 to 95, with neutralizing antibodies comparable to those found in patients after recovery from SARS?CoV?2 And if the results are positive, the companies expect to seek approval from regulators in the fourth quarter.

Vaccination 40

Vaccination Vaccine Immune Response RNA 40

pharmaphorum

JANUARY 20, 2021

The variant that originated in South Africa carries a mutation in the Spike protein that has been shown to reduce antibody recognition and could therefore affect efficacy of new vaccines. These will be encoded in messenger RNA (mRNA) formulated with the laboratory’s NLP technology before injection.

Vaccination 52

Vaccination Vaccine Protein RNA 52

pharmaphorum

JANUARY 5, 2022

New oral therapies join the existing monoclonal antibody cocktails and include molnupiravir (Lagevrio, Merck) and a combination of the new antiviral nirmatrelvir with the HIV antiviral ritonavir (Paxlovid, Pfizer). New COVID-19 treatments will also be available in 2022, but they are not a panacea.

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Vaccination Vaccine Antibody FDA Approval 98

pharmaphorum

JULY 21, 2021

Novartis has revealed that the FDA has accepted its resubmission for cholesterol-lowering drug Leqvio – rejected unexpectedly by the US regulator last year – and has set a new action date of 1 January 2022.

Sales 52

Sales Gene Therapy RNA Production 52

The Pharma Data

MAY 7, 2021

Despite PRAC’s ongoing surveillance and review, no safety signal is being found for the low platelet and clotting syndrome with either of the two authorized messenger RNA (mRNA) vaccines. The regulator has asked AstraZeneca for a detailed analysis of these cases when the firm submits its next required monthly safety report. .

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Vaccination Vaccine Filler Antibody 40

XTalks

NOVEMBER 7, 2022

Another method to isolate CTCs is by antibody targeting of white blood cells for removal, followed by collection of untagged CTCs. Also, exosomes are mostly being used for the detection of circulating RNA and microRNA. “An Regulators may ask at some point to provide that documentation, so it’s important to track that across the study.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

WCG Clinical

MAY 28, 2024

When properly regulated these cellular features—proliferative capacity and receptor-directed specificity—largely account for the effectiveness of our adaptive immune system in protecting us from infectious disease. If circulating antibody levels become too low, they may be supplemented with immunoglobulin therapy.

In-Vivo 40

In-Vivo Clinical Trials Clinical Trials FDA Approval 40

XTalks

AUGUST 2, 2023

2) Darzalex (daratumumab) Darzalex is a targeted monoclonal antibody that slows or stops the progression of multiple myeloma (a blood cancer) by binding to the CD38 protein on multiple myeloma cells. In September 2022, Roche acquired Good Therapeutics for an upfront payment of $250 million, and has access to their PD-1-regulated IL-2 program.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

JANUARY 4, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Israel’s Ministry of Health (MOH) has given authorization to import the COVID-19 Vaccine Moderna in Israel. Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients.

Vaccination 40

Vaccination Vaccine Medicine Containment 40

pharmaphorum

APRIL 28, 2022

Additionally, regulators recognise the inherent difficulties of finding sufficient populations to study rare diseases, so requirements for clinical rigour can actually be lighter, which can also lead to savings. But they also don’t have to invest in mass market advertising.

Pharma Companies 59

Pharma Companies Branding Development Marketing 59

The Pharma Data

AUGUST 3, 2021

Revenue growth was 12 percent when excluding effects of 2020 COVID-related stocking patterns, revenue from COVID-19 antibodies and recent business development. million in the second quarter of 2021 for its COVID-19 antibodies. million of revenue in the second quarter of 2021 from COVID-19 antibodies, $170.0 Excluding $148.9

Antibody 52

Antibody Sales Development Production 52

XTalks

AUGUST 30, 2022

Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies. What About Small Proteins and Antibodies Reaching Extracellular CNS Targets? Vornov, nusinersen is driving much of what is being currently seen in drug development.

Trials 83

Trials Drug Delivery Drugs Gene 83

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.

Vaccination 52

Vaccination Vaccine Development Production 52

The Pharma Data

SEPTEMBER 8, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. For more information, visit. www.merck.com. and connect with us on. the United States.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

APRIL 30, 2021

Under the multi-year agreement, AbbVie will utilize Caribou’s next-generation Cas12a CRISPR hybrid RNA-DNA genome editing and cell therapy technologies to research and develop two new CAR-T cell therapies directed to targets specified by AbbVie. AbbVie and Caribou Biosciences, Inc., Full-Year 2021 Outlook.

Botox 40

Botox Production Development Cosmetics 40

XTalks

DECEMBER 24, 2020

Most antibody drugs and vaccines have been developed to target parts of the spike protein. These include remdesivir, baricitinib, dexamethasone and three antibody drugs. Antibody drugs were also developed as targeted COVID-19 treatments. Drug Approvals.

Life Science 111

Life Science Vaccination Vaccine Gene 111

Pharmaceutical Technology

APRIL 24, 2023

Since then, the field of nanomedicine has steadily progressed to reach high points such as the successful use of nanotechnology to deliver messenger RNA (mRNA)-based Covid-19 vaccines. This design protects antibodies from the innate immune system. And the issue is that antibodies are too big to go directly inside the cell,” he says.

Drug Delivery 147

Drug Delivery Vaccination Vaccine Research 147

The Pharma Data

NOVEMBER 10, 2020

10, 2020 — Eli Lilly’s experimental antibody treatment for COVID-19 was given emergency approval by the U.S. Employing a single powerful antibody that is believed to keep the infection in check, the treatment is similar to one that President Trump received when he was diagnosed with COVID-19. TUESDAY, Nov.

Antibody 52

Antibody Vaccination Vaccine RNA 52

XTalks

SEPTEMBER 14, 2020

Moderna, for one, recently reported positive results in older adults between 56 and 71, as well as those 71 years of age and older, who reportedly mounted levels of neutralizing antibodies against the SARS-CoV-2 virus after two doses of its vaccine that were comparable to those seen in younger adults. Johnson & Johnson’s COVID-19 Vaccine.

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Vaccine Vaccination Antibody Life Science 92