Pharmaceutical Technology

OCTOBER 5, 2022

miRecule and Sanofi have entered a strategic partnership and exclusive licence agreement for the development and commercialisation of an antibody-RNA conjugate (ARC) to treat facioscapulohumeral muscular dystrophy (FSHD). The anti-DUX4 RNA therapy was discovered using the DREAmiR platform of miRecule.

Development 130

Development RNA Gene Therapy Sales 130

XTalks

JANUARY 21, 2025

The liquid portion of the blood (serum or plasma) containing antibodies is separated and tested using the Liason Biotrin parvovirus B19 IgG plus test on a Liason XL analyzer. If parvovirus B19 antibodies are present, they bind to the chemicals and particular particles in the test, producing a light signal. Photo courtesy of Lumicell.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

Pharmaceutical Technology

AUGUST 24, 2022

Mode rna has submitted an application to the US Food and Drug Administration (FDA) to obtain emergency use authorization (EUA) for mRNA-1273.222, its BA.4/BA.5 As against a 50µg booster dose of mRNA-1273 in priorly uninfected subjects, mRNA-1273.214 demonstrated superior neutralising antibody response against Omicron BA.1 1 subvariant.

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Vaccine Vaccination Gene Therapy Antibody 130

Pharmaceutical Technology

FEBRUARY 1, 2023

Since the FDA approved AstraZeneca’s monoclonal antibody therapy Synagis (palivizumab) 25 years ago, drug development successes for RSV have been few and far between. The two types of candidates currently in the pipeline can be categorised as monoclonal antibodies and vaccines.

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Vaccine Vaccination Antibody Development 162

pharmaphorum

OCTOBER 5, 2022

Sanofi has added to its rare disease pipeline by licensing an antibody-RNA conjugate (ARC) for facioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorder, from US biotech miRecule. billion deal in 2018.

RNA 105

RNA Genetics Dermatology Antibody 105

Pharmaceutical Technology

DECEMBER 9, 2022

M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. The company is ranked in the M&A, PRODUCT LAUNCHES and RESEARCH AND DEVELOPMENT categories in the 2022 Pharmaceutical Technology Excellence Rankings. Pharmaceutical Technology Excellence Rankings – The Verdict.

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Development Production Manufacturing Vaccination 130

Pharmaceutical Technology

FEBRUARY 1, 2023

AstraZeneca’s Synagis (palivizumab), which was approved in 1998, was the only monoclonal antibody (mAb) available for use to prevent RSV in high-risk infants for the past two decades. As an RNA virus, like SARS-CoV-2, RSV is highly prone to mutations.

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Vaccination Vaccine Antibody Protein 162

Roots Analysis

OCTOBER 22, 2023

RNA therapeutics are a novel class of biopharmaceuticals that harness the power of RNA molecules for the treatment and prevention of a wide range of disorders, including oncological, and genetic disorders as well as infectious diseases. Non-coding RNAs include antisense oligonucleotides (ASOs) and RNA aptamers.

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RNA Protein Genetics Gene Expression 40

Roots Analysis

OCTOBER 30, 2023

In the past few years, Next Generation RNA therapeutics have emerged as one of the key therapeutic modalities in the modern healthcare industry. These RNA based therapeutics play a crucial role in protein production and regulation of gene functions.

RNA 40

RNA Vaccine Vaccination Development 40

pharmaphorum

JANUARY 7, 2022

NI006 is an antibody that binds to the misfolded forms of the transthyretin protein that form the fibrils, and cause them to be cleared away by immune cells like macrophages. Antisense drug eplontersen – which is forecast to become a $1 billion-plus product if approved – is being developed for both ATTR cardiomyopathy and polyneuropathy.

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Antibody Licensing Licensing Protein 116

pharmaphorum

DECEMBER 13, 2021

In June, BioNTech started the first phase II trial of BNT111, an mRNA vaccine candidate for skin cancer and later announced plans to move mRNA therapeutics against malaria and tuberculosis into the clinic in 2022 as well as plans to set up a sustainable vaccine production and supply network in Africa. It may have sold its 7.7%

RNA 105

RNA Vaccination Vaccine Development 105

pharmaphorum

JULY 6, 2021

The resubmission to the FDA now lists one of its own sites in Austria as the manufacturing location for the final finished product, which it hopes will sidestep the issue and allow inclisiran to be approved in the US.

RNA 105

RNA Manufacturing Sales Drugs 105

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. Antibody levels were lower in older recipients, however.

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Trials Vaccination Vaccine Antibody 98

Delveinsight

AUGUST 26, 2021

Shape’s RNA editing technologies can modify the RNA sequence, which makes the body’s protein building blocks. This system is designed to deliver RNA editing technology or other payloads directly to particular body areas, such as the nervous system or muscle. The study is set to conclude in the fall.

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Vaccine Vaccination Gene Therapy RNA 98

pharmaphorum

DECEMBER 1, 2020

The FDA and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have already begun their reviews and similar rolling submissions have begun in countries including Australia, Canada and Japan. 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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Vaccine Vaccination RNA Clinical Trials 88

Worldwide Clinical Trials

MAY 30, 2024

was withdrawn, rendering it unapproved for patient use, based on negative review comments by the Committee for Medicinal Products for Human Use. Other researchers are investigating approaches that use AAV-mediated trophic support and antibody-based therapies, such as vaccines and small molecule drugs, to modify various protein expressions.

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Gene Clinical Trials Clinical Trials Gene Therapy 204

pharmaphorum

DECEMBER 23, 2021

Novartis resubmitted its marketing application in the US earlier this year, after swapping fill-and-finish production to one of its own facilities in Schaftenau, Austria.

Drugs 105

Drugs Sales Antibody FDA Approval 105

pharmaphorum

NOVEMBER 23, 2020

The AZ vaccine also has a considerable convenience advantage over RNA-based vaccines from Pfizer and Moderna. The body produces antibodies against the protein, which neutralise the coronavirus in the event of an infection. AZ announced the news as reports suggested the UK could approve Pfizer’s rival by the end of the week.

Vaccination 105

Vaccination Vaccine Regulation Protein 105

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.

Genetics 130

Genetics Gene Expression DNA Antibody 130

XTalks

JULY 10, 2024

Unlike traditional testing methods that require samples to be sent to central laboratories, this test utilizes a blood sample from the fingertip to detect HCV RNA, delivering results in approximately one hour. “This is the first HCV RNA detection technology sensitive enough for active case finding at the point of care.

RNA 97

RNA In-Vitro Genotype Marketing 97

XTalks

MARCH 10, 2021

The products encompass molecular, antigen and T cell-based testing approaches. While molecular PCR-based tests remain the gold standard for the detection of SARS-CoV-2 viral RNA, rapid antigen tests are useful for screening purposes. T cells generally confer longer lasting immunity than antibodies, which more readily wane over time.

Protein 98

Protein RNA Antibody Production 98

XTalks

FEBRUARY 3, 2022

billion into building new manufacturing plants in the US and Ireland to help boost production capacities. The state-of-the-art plant will be dedicated to the manufacture of parenteral (injectable) products and devices using cutting-edge technologies. Related: Eli Lilly Pursues RNA Editing in New Partnership with ProQR.

Manufacturing 52

Manufacturing RNA Life Science Antibody 52

XTalks

OCTOBER 26, 2023

The Flu versus COVID-19: Virology and Vaccines SARS-CoV-2 versus Influenza Virology Viruses contain genetic material that can either be RNA or DNA. Both influenza and SARS-CoV-2 have RNA as their genetic material. An RNA genome enables the genetic material to mutate more rapidly. For COVID, it is much the same case.

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Vaccine Vaccination RNA Manufacturing 105

pharmaphorum

AUGUST 22, 2022

Improving efficiency in care will translate to a much more productive system for healthcare providers and patients. Health Innovation Fund concentrates its investments on highly productive technologies, hoping to create more personalised care that will lead to better outcomes. Investment strategies.

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Gene Therapy Antibody Gene Medicine 102

The Pharma Data

DECEMBER 8, 2020

Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. Laying down a new track for RNA processing, Remix launched with $81 million in financing. Reduce cost. Nuance Pharma .

RNA 52

RNA Antibody Life Science Protein 52

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

OCTOBER 6, 2020

These studies suggest BNT162b2 triggers the production of neutralising antibodies and T-cells that target SARS-CoV-2, the coronavirus that causes COVID-19.

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Vaccine Vaccination RNA Immune Response 59

XTalks

NOVEMBER 30, 2023

Over 26 weeks of Sunlenca combined with other antiretroviral drugs, 81 percent of participants achieved HIV RNA suppression, reaching levels low enough to be considered undetectable. to 10-fold relative to baseline within 28 days after the cell product infusion. percent in the placebo group. In November 2023, Hookipa Pharma Inc.,

FDA Approval 111

FDA Approval Gene Therapy Gene Clinical Trials 111

The Pharma Data

AUGUST 16, 2021

Better activation of innate and adaptive immune responses was achieved with CV2CoV, resulting in faster response onset, higher titers of antibodies, and stronger memory B and T cell activation as compared to the first-generation candidate, CVnCoV. The full manuscript of the preclinical data is available on the pre-print server bioRxiv. “In

Immune Response 52

Immune Response Vaccine Vaccination Antibody 52

The Pharma Data

JUNE 26, 2021

BNT111 is the lead product candidate from BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer and is fully owned by BioNTech. These results were published in Nature in July 2020.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Immune Response 52

Roots Analysis

AUGUST 15, 2023

These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products. Such systems provide control over the components used for the synthesis of target products making it easier to manipulate the contents according to specific needs.

Protein 52

Protein In-Vitro Production Reagent 52

BioSpace

NOVEMBER 20, 2022

Former Theranos CEO Elizabeth Holmes will serve 11 years in prison on four counts of fraud, according to her sentencing by a federal judge in a California courtroom on Friday afternoon.

Antibody 51

Antibody Medicine Research Clinical Trials 51

The Pharma Data

JANUARY 31, 2021

Both vaccines induced high levels of neutralizing antibodies comparable to or exceeding levels in human convalescent sera as well as a strong Th1-biased cell-mediated immunity. Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccine Vaccination 52

Roots Analysis

SEPTEMBER 9, 2024

The rising demand for protein therapeutics, such as monoclonal antibodies and vaccines , is driving advancements in protein expression technology to ensure efficient and scalable production. This process initially involves transcription of DNA to messenger RNA (mRNA). Further, it is not sustainable for large scale production.

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Protein Gene Production DNA 40

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. BNT162b2 vaccination elicited a high frequency of CD4+ T cells that produced IFN-?

Vaccine 52

Vaccine Vaccination RNA Clinical Trials 52

Delveinsight

JULY 29, 2021

billion in biobucks on the table to buy Teneobio and its suite of bispecific and multispecific antibody technologies focused on cancer and other disease targets. An antisense treatment, BIIB080 potentially aims at microtubule-linked protein tau (MAPT) messenger RNA (mRNA) and impedes tau protein production.

Drugs 98

Drugs Protein Life Science Development 98

The Pharma Data

DECEMBER 3, 2020

S-Trimer adjuvanted with GSK’s pandemic adjuvant system induced neutralizing antibody titers (seroconversion) in 100% of participants at the selected 9 µg S-Trimer dose in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800. For more information, please visit our website: www.cloverbiopharma.com.

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Vaccine Vaccination Immune Response Protein 52