pharmaphorum

NOVEMBER 23, 2020

AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective. AZ made the announcemen t as the UK regulator reportedly gears up to make a decision on the rival vaccine from Pfizer and BioNTech, ahead of counterparts in the US and Europe.

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pharmaphorum

DECEMBER 24, 2020

The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days. Just how this will be viewed by regulators is unclear, as are the plans to distribute the vaccine.

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pharmaphorum

MAY 11, 2021

The vaccine could play an important role in the next stage of the pandemic as phase 3 trials have shown encouraging safety and efficacy data. Importantly the vaccine can be stored in a fridge, unlike the rivals from Pfizer/BioNTech and Moderna, which require storage at ultra-cool temperatures to maintain their delicate RNA structure.

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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. Patients affected by the disease are found to also experience an imbalance of glutathione regulation, which is important for liver detoxification.

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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 companies initially filed the nonclinical data and other technical data, followed by emerging clinical trial results.

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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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pharmaphorum

DECEMBER 2, 2020

Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it. Pfizer and BioNTech have an agreement to supply the UK with 40 million doses of the vaccine, which is called BNT162b2 and was shown to be 95% effective in a phase 3 trial.

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pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial. “With new variants – like Omicron and B.1.640.2

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pharmaphorum

NOVEMBER 18, 2021

The two companies have been working together since 2019 to develop multiple RNA interference (RNAi) candidates for disorders such as non-alcoholic steatohepatitis (NASH), type 2 diabetes, obesity and rare diseases. billion in cash. The transaction is expected to close in the fourth quarter of this year.

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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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pharmaphorum

MARCH 9, 2022

The XTEND-1 trial also showed that BIVV001 was better at reducing the annualised rate of bleeding episodes than patients’ previous therapies, according to Sanofi and Sobi, which said they will now talk to regulators to chart a path forward to approval.

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pharmaphorum

DECEMBER 16, 2020

Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its efficacy at 94.5%. The overall 94.5% Very encouraging! pic.twitter.com/6IVSj8E3F0. — Eric Topol (@EricTopol) December 15, 2020.

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Drug Discovery World

JANUARY 23, 2023

Additionally, the clinical trial period will be considerably shorter than that required for new drug development. As an FDA-approved oral drug, the side-effects of cladribine are quite manageable and it has been well evaluated for pharmacokinetics.

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pharmaphorum

NOVEMBER 25, 2020

AZ originally planned for trial participants in the UK to receive two full doses but researchers found that certain side effects such as fatigue, headaches or arm aches were milder than predicted. Mene Pangalos, executive vice-president of biopharmaceuticals R&D at AZ, said: “The reason we had the half dose is serendipity.

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Drug Discovery World

APRIL 11, 2023

The molecule, known as lissodendoric acid A, appears to counteract other molecules that can damage DNA, RNA and proteins and even destroy whole cells. USP30 is a (de)ubiquitylation (DUB) implicated in neurodegenerative diseases that regulates the clearance of damaged mitochondria in a process called mitophagy.

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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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Delveinsight

JULY 24, 2021

Ovid Therapeutics is running Phase III clinical trials for its drug, Gaboxadol ( OV101 ). Another therapy by the same company named GTX-102 is also an antisense therapy; however, it silences gene expression by binding to the RNA molecule that regulates its expression.

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pharmaphorum

FEBRUARY 19, 2021

billion cumulative doses of its NVX-CoV2373 recombinant protein-based vaccine candidate, which is yet to be approved by regulators. NVX-CoV2373 is being studied in two ongoing pivotal phase 3 clinical trials: in the United States and Mexico, as well as in the UK for the prevention of COVID-19. The post Novavax provides 1.1

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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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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

DECEMBER 7, 2020

Sinovac has a coronavirus vaccine in late-stage development, which is undergoing large-scale trials in Brazil, Pakistan, Indonesia and Chile. This means they do not require the ultra-cool temperatures needed to store the RNA-based vaccines from Pfizer/BioNTech and Moderna. According to the state-run Indonesian news agency Antara, 1.2

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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. WCG has many ways to support cell and gene therapy clinical trials for lupus.

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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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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.

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VirTrial

OCTOBER 25, 2023

Members of the science and medicine team have additionally worked on hundreds of other vaccine trials involving hundreds of thousands more volunteers. Despite well-constructed and rigorous clinical trials looking at the vaccines, there were those that would not be immunized leading to further death and spread of the disease.

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Drug Discovery World

AUGUST 1, 2023

1 August was first chosen as World RNA Day in 2018 as a play on AUG (adenine, uracil and guanine), a triple sequence of RNA (called a codon) that initiates protein synthesis by the cell. Since then, it has been observed to publicise the importance of this molecule in the generation of proteins in the body.

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XTalks

APRIL 6, 2022

XTALKS WEBINAR: Using CRISPR interference (CRISPRi) Viability Screens to Map Long Noncoding RNA Dependencies in Tumor Cells. Register for this webinar to get an overview of the role of long non-protein coding RNAs (lncRNAs) in gene regulations. Live and On-Demand: Thursday, April 21, 2022, at 11am EDT (4pm BST/UK).

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The Pharma Data

MARCH 3, 2022

In 2014, Shalev’s UAB research lab reported that verapamil completely reversed diabetes in animal models, and she announced plans to test the effects of the drug in a human clinical trial. The United States Food and Drug Administration approved verapamil for the treatment of high blood pressure in 1981.

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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.

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STAT News

MARCH 6, 2023

Cambridge-based Moderna recently reported encouraging results from a study of another type of personalized cancer vaccine it developed with the pharmaceutical giant Merck; it uses messenger RNA technology to target advanced melanoma. But more work remains before personalized vaccines  can be greenlighted.

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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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Drug Discovery World

APRIL 30, 2024

Messenger RNA (mRNA) has come into focus within the drug discovery and development as an exciting tool to deliver genetic information. mRNA is a molecule made up of a single strand of ribonucleic acid (RNA). At the start of 2024, the first patients in a clinical trial investigating an mRNA cancer therapy were dosed.

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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 more information, please download our white paper.

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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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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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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. The major challenge in developing drugs directly against Ebola virus polymerase is that scientists have not solved its atomic structure. .

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Drug Discovery World

JANUARY 2, 2024

As for Infinitopes, the company’s trials will begin in 2024. Looking forward, he said: “If we can solve these problems of targeting, delivery and selecting the optimal patients for trials, we’ll enjoy a greater chance of success. He said: “Between now and 2030, we’re going to see a range of vaccines using various technologies.

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