Broad Institute

JUNE 25, 2024

In T2D, the body gradually loses its ability to regulate blood sugar effectively. This could mean that the virus infects the bacteria and changes its function in a way that increases or decreases type 2 diabetes risk, but more work is needed to understand this connection."

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The Pharma Data

AUGUST 17, 2020

The CCDE also said companies would have to prove their vaccines could provide immunity from the virus for a minimum of six months and be effective for 70 percent of the population. . The regulatory body also has stated that vaccines must be free of the risk of antibody dependent enhancement.

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Drug Target Review

SEPTEMBER 25, 2024

BRAF and downstream mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors are combined to treat BRAF-mutated melanoma, for example. Inhibiting KDM5A, a regulator of cell proliferation, poses another interesting approach.

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Broad Institute

JUNE 10, 2024

Not only could this potentially treat many patients regardless of which mutation they have in a disease-causing gene, but it would also preserve the surrounding DNA sequences, which would increase the likelihood that the newly installed gene is properly regulated, rather than expressed too much, too little, or at the wrong time.

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The Pharma Data

SEPTEMBER 14, 2020

On September 6 the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators, after one trial volunteer experienced an unexplained illness. Source link. Source link.

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The Pharma Data

SEPTEMBER 21, 2020

The agency says that a significant amount of the people exposed fell ill with the virus, but there could be more cases due to incomplete contact tracing information and the virus incubating over several days. This follows other studies in Asia and Europe where scientists believe the virus has spread on commercial flights.

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The Pharma Data

MARCH 18, 2021

The UK regulator confirmed that the benefits of the vaccine in preventing COVID-19 far outweigh the risks, and people should continue to get vaccinated when asked to do so. We trust that, after the regulators’ careful decisions, vaccinations can once again resume across Europe.”.

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The Pharma Data

SEPTEMBER 12, 2020

Children are included in new social distancing regulations in England. But Mr Gove said the England rules were “absolutely right” It comes as one scientist warned UK could lose control of the virus. “We do not want to see a further acceleration of the virus,” he stressed. . Image copyright.

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Codon

OCTOBER 13, 2024

Through genetic engineering, researchers have developed Golden Rice which can help address the problem of vitamin A deficiency , cotton that produces its own insecticide , virus-resistant papayas , and more. In some cases, a combination of technological challenges and regulation impedes the innovation previewed on Farma’s menu.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

However, with this most recent approval, FDA did not leave the question of durability as something to be answered postapproval, which signals to us that this issue looms large in FDA’s preapproval regulation of gene therapies.

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The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. Pascal Soriot, CEO of AstraZeneca, pictured above.

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Drug Target Review

DECEMBER 5, 2024

Challenges of viral capsids in gene therapy efficiency A widely used production method of rAAV vectors requires co-transfection of host cell lines with three plasmids, including one carrying the transgene of interest, one carrying the capsid and replication sequences, and a helper virus to circumvent the inability of rAAV to self-amplify.

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The Pharma Data

MARCH 21, 2022

April 6, to discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants. Along with the independent experts of the advisory committee, representatives from the U.S. Source link: [link].

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The Pharma Data

DECEMBER 14, 2020

The design principle of RT-PCR means that for patients with high levels of circulating virus (viral load), relatively few cycles will be needed to detect virus and so the Ct value will be low. Conversely, when specimens return a high Ct value, it means that many cycles were required to detect virus. Source link.

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The Pharma Data

DECEMBER 3, 2020

The phosphorylation of proteins has a major role in regulating protein function inside cells—these processes are typically highly controlled in normal, healthy cells. The changes help the virus to multiply and eventually destroy the cells. This insight may potentially lead to new drug targets.

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The Pharma Data

JANUARY 19, 2021

The authors suggest natural tracr-L regulates autoimmunity. In particular, Editas is known to be exploring tunable CRISPR-Cas9 systems for therapies has developed self-inactivating Cas9 adeno-associated virus vectors. But altering the tracr-L with genetic engineering to make it function more like a guide RNA increased CRISPR-Cas9 cuts.

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Agency IQ

JULY 26, 2024

reference laboratories for high-risk diagnostics The newly available May 2024 meetings of the Medical Device Coordination Group provide insight into the European Commission’s efforts to fully implement the European medical device and diagnostic regulations. Top IVDR Notified Body concern: Lack of E.U. Some news on E.U.

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The Pharma Data

MARCH 14, 2021

All tests need to meet stringent criteria for quality control and this data is submitted to regulators within each country or region for independent review before any batch can be released to countries. The safety of the public will always come first.

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The Pharma Data

JANUARY 21, 2021

Researchers randomized patients to either 4,200 mg of IV-administered bamlanivimab or placebo and saw that after eight weeks of participant follow-up, the 965 participants who tested negative for the virus at baseline saw a 57 percent lower frequency of symptomatic COVID-19 in the drug arm compared to the placebo arm. James Miessler.

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The Pharma Data

SEPTEMBER 23, 2020

Regulators in each individual country determine when trials can start and they do this in their own timeframe,” AZ said in a statement. Companies provide the information to the regulators to enable them to make this determination. So far, there has been no word from either AZ or the FDA on why the study had not resumed in the US.

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The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. “These regulations aren’t fit for purpose and don’t protect the public from bad tests,” he said. Image copyright. Getty Images. Source link.

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DrugBank

JUNE 13, 2024

  For instance, in the case of cystic fibrosis, a debilitating genetic disorder, Tezacaftor aims to introduce a healthy copy of the CFTR gene to regulate mucus production.    A key part of gene therapy is efficiently delivering the therapeutic genetic material directly into target cells.

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The Pharma Data

DECEMBER 11, 2020

11, 2020 — More than 15 million Americans have been infected by the COVID-19 virus, and many may be questioning whether they need to receive one of the two coronavirus vaccines now on the verge of approval from U.S. regulators. FRIDAY, Dec. Short answer: Yes.

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The Pharma Data

JANUARY 29, 2021

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.

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The Pharma Data

JANUARY 29, 2021

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.

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The Pharma Data

SEPTEMBER 3, 2020

S, prevented severe clinical disease in Syrian golden hamsters, upon challenge with SARS-CoV-2, the virus that causes COVID-19 in people. Four weeks later, the animals were exposed to a high dose of SARS-CoV-2 virus. Janssen’s lead SARS-CoV-2 investigational vaccine candidate, Ad26.COV2.S, Mortalities were absent in vaccinated animals.

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The Pharma Data

DECEMBER 30, 2020

The decision to approve the vaccine was taken under Regulation 174 of the Human Medicine Regulations 2012, which enables rapid emergency regulatory approvals to address significant public health issues such as a pandemic. This is the first authorisation for this vaccine.

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The Pharma Data

AUGUST 24, 2020

The news comes after China said that companies and organisations must prove to regulators that vaccines have 50% efficacy. Conor Kavanagh. Source link.

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The Pharma Data

AUGUST 18, 2020

REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic. and Roche will be responsible for distribution outside the U.S. “We

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Clinical Trials Virus Trials Treatment 52

New Drug Approvals

SEPTEMBER 6, 2024

Toll/IL-1 receptor family members are important regulators of inflammation and host resistance. The Toll-like receptor family recognizes molecular patterns derived from infectious organisms including bacteria, fungi, parasites, and viruses (reviewed in Kawai, T. Nature Immunol., 11:373-384 (2010)).

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RNA Clinical Trials Disease DNA 62

The Pharma Data

MAY 4, 2021

. Big three drug distributors blame doctors, regulators in trial over opioid epidemic ( Reuters ). EU regulator begins real-time review of first Chinese COVID-19 vaccine ( Reuters ) ( EMA ). WHO is closely monitoring 10 Covid variants as virus mutates around the world ( CNBC ) .

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The Pharma Data

AUGUST 28, 2020

UK signs deals for 90 million virus vaccine doses. In addition, the consultation – which seeks to amend the Human Medicine Regulations 2012 – will look into ways to protect companies that manufacture and distribute the vaccine, should it cause any harm. Oxford coronavirus vaccine triggers immune response.

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The Pharma Data

DECEMBER 21, 2020

The path forward through this pandemic must include identifying, treating and tracing as many cases of COVID-19 as possible as we work to suppress this virus.” It will apply for all dates of service from April 1 through March 31, 2021, or as long as the ongoing public health emergency lasts.

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The Pharma Data

AUGUST 17, 2020

The UK government is imposing stricter regulations on the sale of laxatives, to help prevent their misuse. SURVIVING THE VIRUS: ‘Our medical science is struggling to catch-up’ COVID-19: How are dentists coping? Image copyright. Getty Images. People will need to be 18 or older to buy them from pharmacies and supermarkets.

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The Pharma Data

MAY 17, 2021

2 virus and the variant first identified in South Africa. And if the results are positive, the companies expect to seek approval from regulators in the fourth quarter. Sanofi and GSK now plan to enroll more than 35,000 participants I a phase 3 study to evaluate the vaccine’s efficacy against the original SARS?CoV?2

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NIH Director's Blog: Drug Development

APRIL 2, 2020

ACE2 is the receptor that the virus uses to gain entry. The protein is known to play a prominent role in the body’s complex system of regulating blood pressure. What makes this image such a big deal is that it shows—in exquisite detail—how the coronavirus attaches to human cells before infecting them and making people sick.

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The Pharma Data

SEPTEMBER 28, 2020

A former Conservative chief whip Mark Harper said: “I think actually ministers coming to Parliament, marshalling the arguments and laying out the evidence means that we get better decisions that are likely to be more effective in dealing with the virus and protecting our economy.”

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