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.

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Drugs Sales Antibody FDA Approval 105

pharmaphorum

NOVEMBER 17, 2020

The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials. The company has picked four US states – Rhode Island, Texas, New Mexico and Tennessee, to trial a delivery programme that aims to overcome this challenge. Pfizer and BioNTech have a $1.95

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Vaccination Vaccine RNA Clinical Trials 77

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. In the case of a rolling review, the EMA evaluates trial data as they become available before a complete filing is submitted.

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Vaccination Vaccine RNA Immune Response 59

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.

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Protein Sales Gene Therapy Regulation 98

The Pharma Data

MAY 17, 2021

The adjuvanted vaccine suffered a serious setback in December when a phase 1/2 trial showed the candidate delivered only a weak response in older adults ( DID , Dec. And if the results are positive, the companies expect to seek approval from regulators in the fourth quarter. 14, 2020 ). Although wealthy territories like the U.S.,

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Vaccination Vaccine Immune Response RNA 40

pharmaphorum

NOVEMBER 9, 2020

The companies said they will be ready to file the vaccine with the FDA in the third week of November once they have enough safety data to meet the regulator’s requirements. Top-line results come from a phase 3 trial of the candidate known as BNT162b2 and an evaluation of 94 cases from the trial of 43,538 patients.

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Vaccination Vaccine Clinical Trials Clinical Trials 98

pharmaphorum

OCTOBER 22, 2020

AT-527 works by blocking the viral RNA polymerase enzyme needed for viral replication. It is currently being studied in a phase 2 clinical trial for hospitalised patients with moderate COVID-19. Phase 3 trials are expected to start in Q1 2021, and will test the drug outside of the hospital setting. It’s a disaster.

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Development Branding Manufacturing RNA 66

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.

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Sales Gene Therapy RNA Production 52

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

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

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Vaccination Vaccine Antibody FDA Approval 98

XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies.

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Trials Drug Delivery Drugs Gene 83

pharmaphorum

APRIL 28, 2022

Although they have, by definition, small addressable markets, the treatments cost just as many resources to develop as therapies for more common diseases – sometimes more, because of the added difficulty of finding sufficiently large patient populations for trials and finding disease experts to run them.

Pharma Companies 59

Pharma Companies Branding Development Marketing 59

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

Drug Discovery World

JULY 11, 2023

Now, with the growth of publicly available genomics, transcriptomics, and proteomics databases, the ability to quickly carry out large-scale DNA, RNA, and protein screenings, and the availability of massive sets of de-identified patient data, the amount of high-value, analysable data has reached enormous proportions.

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Big Data Development Life Science Drugs 40

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. The trial compared tirzepatide to insulin glargine in adults with type 2 diabetes and increased cardiovascular risk. Business Development/Other Developments.

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Antibody Sales Production Development 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.

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Vaccination Vaccine Development Marketing 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.

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Vaccination Vaccine Containment 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. For more information, visit.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

Drug Discovery World

AUGUST 10, 2022

Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Later, scientists took advantage of antibodies’ natural tendency to seek out specific antigens and created antibody therapies that guide T cells towards the cells they are supposed to destroy. Training T cells to target tumours.

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Manufacturing Gene Genome Genomics 98

Drug Discovery World

JULY 18, 2023

Current research is focused on designing CRISPR-enhanced CAR T cells that are resistant to immunosuppressive cytokines such as transforming growth factor-β (TGF-β) 2 , programmed cell death protein (PD-1) 3 , or other negative T cell regulators 4 (CTLA-4, LAG-3, and TIM-3), thus improving anti-tumour functions.

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DNA Genome Genomics RNA 98

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.

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Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

APRIL 30, 2021

The positive CHMP opinion is based on data from the VIALE-A and M14-358 trials and represents the third positive CHMP opinion for an extension of indications for Venclyxto. If approved by the European Commission (EC), Venclyxto in combination with hypomethylating agents would be a new regimen for patients with AML. Full-Year 2021 Outlook.

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Botox Production Development Cosmetics 40

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.

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Vaccination Vaccine Medicine Containment 52

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.

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Life Science Vaccination Vaccine Gene 111

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

By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. The company’s candidate vaccine, mRNA-1273, is a synthetic messenger RNA that encodes the stabilized SARS-CoV-2 spike protein. The price of that prize is incalculable. Merck’s COVID-19 Vaccine.

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Vaccination Vaccine Antibody Life Science 92