pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . The post Altimmune ditches nasal COVID vaccine on weak trial data appeared first on.

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Advarra

JANUARY 11, 2024

After injection of such a vaccine, the mRNA instructs cells to produce proteins designed to stimulate an immune response against these same protein targets when they show up in viruses or in tumor cells. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

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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

DECEMBER 11, 2020

Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months.

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Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. Expanded access to experimental biologics. BLA process (CBER).

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The Pharma Data

SEPTEMBER 14, 2020

AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). The move follows a green light by the UK's MHRA. Source link.

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pharmaphorum

APRIL 14, 2022

billion alliance with Genmab to find new cancer therapies, AbbVie has said it is ready to start talking to regulators about filing for approval of the lead drug in the partnership – epcoritamab for large B-cell lymphoma (LBCL). Two years after signing a $3.9 Analysts at Jefferies have previously said they think epcoritamab could become a $1.5

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pharmaphorum

FEBRUARY 8, 2021

China’s national regulator has approved Sinovac Biotech’s COVID-19 vaccine for use by the general public. Brazilian clinical trial results published last month showed the vaccine, dubbed Coronavac, is just over 50% effective. This is the second vaccine approved by China’s National Medical Products Administration (NMPA).

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XTalks

APRIL 26, 2021

Moreover, a very strong immune response is needed to fend off the disease. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax. Malaria Vaccine Phase II Trial. At six months, 29.5 Changing the Face of Malaria.

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pharmaphorum

APRIL 22, 2022

Ampio Pharma’s candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the drug before it will consider a review.

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The Pharma Data

JUNE 17, 2022

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S.

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pharmaphorum

MARCH 4, 2021

Sunak pledged £28 million towards the UK’s capacity for vaccine testing, support for clinical trials and to improve the ability to acquire samples of new COVID-19 variants. The guidance comes from the ACCESS Consortium of regulators from the UK, Australia, Canada, Singapore and Switzerland.

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The Pharma Data

NOVEMBER 10, 2020

Oral administration of anti-CD3 monoclonal antibody is a novel approach to induce an anti-inflammatory immune response to suppress inflammation by inducing T regulatory (Tregs) cells in animal studies 3 ,4. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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pharmaphorum

SEPTEMBER 7, 2022

The Swiss pharma group has agreed to buy Seattle-based biotech Good Therapeutics and its preclinical-stage PD-1-regulated IL-2 receptor agonist programme for $250 million upfront, with undisclosed milestone payments on offer tied to development, regulatory, and commercial objectives.

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pharmaphorum

DECEMBER 14, 2020

Armed with new data from a randomised clinical trial, one company is hoping to change that mindset. The company is FriendsLearn – based in India and with an R&D office in San Francisco – which recently reported results from a trial showing that its fooya!

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Find Me Cure

APRIL 23, 2020

For example, if you become immune but this immunity only lasts for a few weeks, this is not long enough to allow for a good proportion of the population to become infected and then immune as well. Thus, herd immunity wouldn’t work in this scenario. Enter ‘Covid-19′ and start searching. .

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pharmaphorum

FEBRUARY 9, 2021

million ($22 million) in second-round financing as it prepares to start clinical trials of its lead drug candidate INT-1B3 for solid tumours. 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.

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Delveinsight

FEBRUARY 11, 2021

Verily collaborates with Janssen to launch COVID-19 immune response study. Verily is partnering with Johnson & Johnson’s Janssen division to witness the body’s earliest immune responses to a coronavirus infection, with people participating in the research from within their homes. .

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The Pharma Data

OCTOBER 23, 2020

A solidarity clinical trial “is one of the largest international randomized trials for Covid-19 treatments, enrolling almost 12,000 patients in 500 hospital sites in over 30 countries”, according to the World Health Organization (WHO), which launched the trail with a number of partners.

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Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. The city is host to many innovative biotech companies, including relative newcomers Orexa, a company that recently launched its first Phase II clinical trial.

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pharmaphorum

DECEMBER 1, 2021

BeyondSpring’s hopes of an early Christmas gift from the FDA were dashed today after the regulator said it was unable to approve the company’s lead drug plinabulin as a treatment for low white blood cell counts caused by cancer chemotherapy.

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VirTrial

OCTOBER 25, 2023

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. The studies reported the outcomes of thousands of volunteers who participated in the clinical trials which showed safety and efficacy of the vaccine.

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pharmaphorum

OCTOBER 26, 2021

The advisors could also be called on to consider Moderna’s COVID-19 as well for younger children in the coming weeks, as the biotech has just reported positive interim results from a phase 2/3 trial of its mRNA-1273 shot in kids aged six to 11.

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Drug Discovery World

APRIL 20, 2023

SARS-CoV-2 particles spread through the respiratory mucosa and other infected cells, causing changes in peripheral immune cells and eliciting a cascade of immune responses, resulting in a detrimental cytokine storm. Alzheimer’s disease), or by initiating a new one. depression).

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Drug Discovery World

JULY 5, 2023

Protein therapeutics have been developed which bind to the checkpoint protein and “blockade” it, to prevent the moderation of the T-cell response, thus “turning up” the immune response dramatically. Of course, if a patient’s tumour does not have this protein, then this type of treatment won’t be effective.

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The Pharma Data

MARCH 25, 2021

“The results of this study suggest that targeting the LAG-3 pathway in combination with PD-1 inhibition may be a key strategy to enhance the immune response and help improve outcomes for these patients.”. Bristol Myers Squibb thanks the patients and investigators who were involved in the RELATIVITY-047 clinical trial.

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STAT News

MARCH 6, 2023

Unlike most people who receive medications yet to be cleared by the Food and Drug Administration, none of these patients is getting the vaccines as part of a clinical trial. The problem, he said, is that many patients can’t get into a trial. Thirteen patients are waiting for their vaccine to be made.

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XTalks

JULY 2, 2021

This is because the processes that maintain the uterine lining, including the placenta, during pregnancy are different than those that regulate the normal menstrual cycle. Vaccines could cause an inflammatory response as part of the overall immune response.

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The Pharma Data

DECEMBER 11, 2020

regulators. ” Coronaviruses are notorious for prompting a flawed and incomplete immune response in humans, infectious disease experts say. . ” Coronaviruses are notorious for prompting a flawed and incomplete immune response in humans, infectious disease experts say. FRIDAY, Dec. Short answer: Yes.

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The Pharma Data

MARCH 8, 2021

, preliminary evidence suggests that canakinumab inhibits pro-tumor inflammation (PTI) to 1) enhance anti-tumor immune response; 2) reduce tumor cell proliferation, survival and invasiveness; and 3) impair angiogenesis 8. Canakinumab is a first-in-class interleukin-1beta (IL-1?)

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The Pharma Data

NOVEMBER 9, 2020

Combining ICIs with radiation therapy is emerging as a valuable strategy to “prime” an immune response and thereby increase the response rate, however the efficacy of radiation therapy is limited by toxicities related to the exposure of healthy tissues. NBTXR3 is injected one time, directly into solid tumors.

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XTalks

MARCH 13, 2023

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases. All except for Adstiladrin were cleared for rare disease indications.

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XTalks

APRIL 2, 2021

Pfizer’s newest and updated COVID-19 vaccine trial results from its ongoing Phase III clinical trial confirms that protection lasts at least six months after administration of the second dose. 1.351 variant, which may have the potential to evade the immune response.

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The Pharma Data

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies.

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The Pharma Data

SEPTEMBER 9, 2020

“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As billion doses by the end of 2021.

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The Pharma Data

OCTOBER 19, 2020

The physical and universal mode of action (MoA) of NBTXR3 is designed to trigger cellular destruction death and adaptive immune response. Promising results have been observed in the phase I trial regarding local control. Nanobiotix is also running an Immuno-Oncology development program.

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The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

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