Drug Discovery World

AUGUST 24, 2022

A new study investigating a potential treatment for people who have been diagnosed with monkeypox has been launched by the same team who helped develop Covid-19 treatments. . The trial will see participants receive either a 14-day course of 600 mg tecovirimat twice daily or a matched placebo treatment.

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Drug Target Review

FEBRUARY 21, 2024

This is a time when several promising treatments – including mRNA vaccines, BiTE therapies and CAR-T cell therapy, are essentially in competition with each other – they all have a common goal of treating the same disease, but they are approaching the objective from different angles.

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Drug Discovery World

FEBRUARY 9, 2023

Why data from a Phase III clinical trial offers promise for patients with a deadly form of brain cancer. A Phase III clinical trial has produced promising results for a cancer vaccine targeting patients with a new or recurrent glioblastoma. receiving existing treatments.

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Drug Discovery World

SEPTEMBER 13, 2023

27% of patients with non-vaccinal SARS-COV-2 positive serology corresponded to the previously described psychotic disorder subgroup associating HERV-W expression. The first months of the trial have already confirmed that the W-ENV protein is present in the blood of over 25% of patients with persistent syndromes who suffered from Long Covid.

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The Pharma Data

SEPTEMBER 1, 2020

Sanofi is halting clinical trials treating serious COVID-19 patients with its Kevzara drug after the data proved inconclusive. The Phase 3 trial did not meet the primary or secondary endpoints compared with placebo and established hospital care. Conor Kavanagh. Source link.

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Drug Discovery World

JANUARY 11, 2024

Messenger RNA therapies are also currently being investigated in other rare inherited metabolic diseases – propionic and methylmalonic acidaemias – in global clinical trials sponsored by Moderna, including at Great Ormond Street Hospital for Children. We believe it can now do the same for rare diseases.”

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The Pharma Data

DECEMBER 17, 2020

COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could hinder the collection of meaningful trial data. Pfizer, which has received emergency approvals in the U.S.

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H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. When it comes to developing new treatments and vaccines, the development timeline is often long and arduous, especially outside of the U.S. First let’s look at some challenges and then opportunities.

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Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Why are challenge trials becoming more popular?

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The Pharma Data

JANUARY 17, 2021

The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. BARCELONA, Spain , Jan. BARCELONA, Spain , Jan.

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The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov.

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The Pharma Data

OCTOBER 18, 2021

Food and Drug Administration announced it has awarded 11 new clinical trial research grants, equaling more than $25 million of funding over the next four years. “Supporting the development and evaluation of new treatments for rare diseases is a critical part of the FDA’s mission,” said Acting FDA Commissioner Janet Woodcock, M.D.

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The Pharma Data

OCTOBER 30, 2020

More recently, the FDA announced regulatory approval for the first treatment for Covid-19. FDA approves first treatment for Covid-19. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.

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The Pharma Data

DECEMBER 21, 2020

The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We Mascha Binder, M.D.,

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The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * efficacy against any symptomatic COVID-19 disease, in line with expected vaccine effectiveness in today’s environment dominated by variants of concern.

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The Pharma Data

SEPTEMBER 14, 2020

A new antibody treatment is to be trialled on Covid-19 patients in UK hospitals. It forms part of the UK Recovery Trial, which found that a cheap steroid called dexamethasone could save lives. We need to know, and the way to know is to do the trials that will tell us whether that hope turns into reality.”.

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The Pharma Data

DECEMBER 12, 2020

Food and Drug Administration approved Pfizer’s coronavirus vaccine for emergency use on Friday, clearing the way for the launch of a national campaign to inoculate enough Americans to stem the spread of COVID-19. ” Who is first in line to be vaccinated? SATURDAY, Dec. 12, 2020 – The U.S.

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The Pharma Data

DECEMBER 11, 2020

Food and Drug Administration is expected to approve emergency use of Pfizer’s coronavirus vaccine as early as Saturday after its advisory panel cleared the way for the start of a national campaign to inoculate Americans and stem the spread of COVID-19. Who is first in line? Centers for Disease Control and Prevention.

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The Pharma Data

MARCH 14, 2023

QDENGA is the only dengue vaccine approved in Brazil for use in individuals regardless of previous exposure to dengue and without the need for pre-vaccination testing. QDENGA is the only dengue vaccine approved in Brazil for use in individuals regardless of previous exposure to dengue and without the need for pre-vaccination testing.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. The study findings have been submitted to a peer-reviewed journal for future print publication.

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The Pharma Data

SEPTEMBER 15, 2020

Biopharma and pharmaceutical companies developing treatments and vaccines have long faced operational challenges that cost time and money while draining resources from the important work of changing lives. In spring 2020, Avantor’s clinical services team provided treatment developers with support for a fast-track study.

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The Pharma Data

FEBRUARY 24, 2022

Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Today’s approval will provide a treatment option for a wider range of patients with heart failure,” said Norman Stockbridge, M.D., Today, the U.S. The FDA, an agency within the U.S.

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The Pharma Data

MARCH 2, 2021

Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. The terms of the EUA allow use of the vaccine while more data are gathered.

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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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The Pharma Data

DECEMBER 8, 2020

AstraZeneca (AZ) and the University of Oxford have presented new data from a “pooled analysis” of phase 3 trials evaluating COVID-19 vaccine AZD1222 at two different dose regimens, demonstrating an average efficacy of 70.4 percent effective “at least 14 days” following the second injection.

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The Pharma Data

OCTOBER 6, 2021

GlaxoSmithKline (GSK) plc welcomes and applauds the WHO recommendation for the broader deployment of GSK’s RTS,S malaria vaccine to reduce childhood illness and deaths from malaria in children living in sub-Saharan Africa and other regions with moderate to high transmission as defined by WHO.

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Drug Discovery World

DECEMBER 22, 2022

The AI programme, part of a collaboration between Poolbeg Pharma and OneThree, uses Poolbeg’s RSV human challenge trial data to identify disease-relevant biological pathways and potential drug targets. . Compounds with existing Phase I clinical data will be prioritised.

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The Pharma Data

MAY 7, 2021

Pfizer-BioNTech files for US approval of COVID-19 vaccine ( Reuters ) ( NYTimes ) ( Politico ) ( Press ). Covid-19 Vaccines Are Wasted as Special Syringes Run Short ( WSJ ). The US opened pandora’s box on IP waivers for Covid-19 vaccines. . In Focus: US. What happens now?

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The Pharma Data

FEBRUARY 12, 2022

“With the emergence of variants such as Omicron, treatment options remain limited. Lilly is pleased to provide another treatment option to help address the ongoing needs of patients and health care providers who continue to battle this pandemic.” About BLAZE-4.

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The Pharma Data

JANUARY 19, 2021

20, 2021 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced today the submission of an Investigational New Drug (IND) to FDA for the investigational use of Tempol for the treatment of Coronavirus (COVID-19). SAN DIEGO, Jan. Dr. Dennis J. About Adamis Pharmaceuticals. The company’s subsidiary, U.S.

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The Pharma Data

MAY 27, 2022

Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical need. Senior Vice President and Chief Development Officer, Internal Medicine and Hospital, Pfizer. 1,2 Approximately 17 million patients in the U.S.

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NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

hospitals are stretched to the limit trying to help people battling serious cases of COVID-19. Yet the quest to save more lives from COVID-19 isn’t even close to being finished, and researchers continue to work intensively to develop new and better treatments. Vaccines Working Group : Accelerates the evaluation of vaccine candidates.

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The Pharma Data

NOVEMBER 18, 2020

These results will be presented by the lead investigators of OBI Pharma’s novel anti-Globo H therapeutic cancer vaccine, OBI-833. ” Ming-Tain Lai, PhD, Chief Scientific Officer at OBI Pharma stated, “In the trial, OBI-833 demonstrated a favorable safety profile and generated detectable anti-Globo H IgM/IgG responses. .”

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Drug Discovery World

APRIL 20, 2023

There is a clear opportunity to repurpose some of these candidates for preventative/ prophylactic treatment for post-Covid-19 cognitive impairment. Symptoms affect the brain, heart, lungs, GI tract and pancreas, are seen equally in vaccinated populations, and sometimes newly emerge after the acute infection has resolved.

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The Pharma Data

NOVEMBER 12, 2020

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. No new safety signal for Calquence was observed in the trials. No new safety signal for Calquence was observed in the trials.

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Agency IQ

DECEMBER 1, 2023

That guidance, first issued in May 2020 , was released at a time when there were no FDA-approved drugs to treat Covid-19, and the standard-of-care for treatment relied on clinical management of symptoms and supportive care (e.g., Lastly, the revised guidance briefly discussed trials meant to assess drugs intended for prevention of Covid-19.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

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