Drug Discovery World

APRIL 20, 2023

To date, it seems that the likely mechanism of post- Covid-19 cognitive impairment is neuroinflammation triggered by the peripheral / systemic inflammation caused by the virus. Acute and persistent symptoms in non-hospitalized PCR- confirmed COVID-19 patients,” Sci Rep, vol. F Ceban et al., Academic Press Inc., 93–135, Mar.

Drug Development 246

Drug Development Clinical Trials Drugs Virus 246

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36

Virus 40

Virus Trials Clinical Trials Production 40

Codon

JANUARY 21, 2024

Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.

Vaccine 132

Vaccine Trials Disease Virus 132

The Pharma Data

DECEMBER 17, 2020

(NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. “The investigational cocktail is now available to indicated high-risk U.S.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

OCTOBER 30, 2020

30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic. Ricks , Lilly chairman and CEO.

Licensing 40

Licensing Licensing Therapies Laboratories 40

The Pharma Data

AUGUST 16, 2021

Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable. We continuously strive to stay at least one step ahead of the virus. adult participants from the Phase 1 trial of the two-dose series. In the U.S.,

Vaccine 52

Vaccine FDA Virus Immune Response 52

The Pharma Data

SEPTEMBER 1, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the initiation of the Phase 3 MOVe-AHEAD clinical trial to evaluate molnupiravir, an investigational oral antiviral therapeutic, for the prevention of COVID-19 infection.

Laboratories 52

Laboratories Virus Clinical Trials Research Laboratories 52

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic. About Molnupiravir.

Clinical Trials 52

Clinical Trials Laboratories Research Laboratories RNA 52

The Pharma Data

FEBRUARY 12, 2022

” The data supporting this EUA are primarily based on analyses from the Phase 2 BLAZE-4 trial (NCT04634409), treatment arms 9-14. Pseudovirus and authentic virus testing demonstrate that bebtelovimab retains full neutralizing activity against Omicron – currently the predominant variant in the U.S. About BLAZE-4.

Treatment 40

Treatment Hospitals FDA Clinical Trials 40

The Pharma Data

OCTOBER 26, 2020

Hasan Jafri , Chief Medical Officer of Aridis Pharmaceuticals, will be a speaker on a panel entitled “Direct Antivirals and Other Agents Against SARS-CoV2 Virus.” ” Panel: Direct Antivirals and Other Agents Against SARS-CoV2 Virus Date: Wednesday, October 28, 2020 Time: 10:30AM- 11:50AM ET.

Pharmaceuticals 52

Pharmaceuticals Virus Hospitals Small Molecule 52

The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 1-3 Evusheld was generally well-tolerated in the trial. 2 subvariant, now the dominant strain in Europe. Christoph D.

Vaccine 52

Vaccine Virus Immune Response Government 52

The Pharma Data

JANUARY 12, 2021

Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. To date, nearly 15,000 people have participated in casirivimab and imdevimab clinical trials. Yancopoulos , M.D.,

Government 52

Government Hospitals Virus Production 52

The Pharma Data

MARCH 22, 2021

Companion dose-ranging phase II trial showed significant and comparable viral reductions for a range of doses of casirivimab and imdevimab. Casirivimab and imdevimab also met all key secondary endpoints in the phase III REGN-COV 2067 trial, including the ability to reduce symptom duration from 14 to 10 days (median numbers).

Virus 52

Virus Clinical Trials Trials FDA 52

The Pharma Data

JULY 23, 2021

Ronapreve is a combination of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process.

Treatment 52

Treatment Virus Clinical Trials Government 52

The Pharma Data

APRIL 14, 2021

Bamlanivimab and etesevimab together and bamlanivimab alone are not authorized for use in patients: who are hospitalized due to COVID-19, OR. Treatment with bamlanivimab and etesevimab together has not been studied in patients hospitalized due to COVID-19. Some of these events required hospitalization. Adverse Events.

Government 52

Government Long-Term Care Facilities Hospitals Treatment 52

The Pharma Data

APRIL 16, 2021

1.429 California strain that currently accounts for 50 percent of the virus in California and over 10 percent across a number of additional states. Due to the rapidly evolving and geographically diverse nature of the SARS-CoV-2 virus, continued scientific innovation remains critical to develop additional treatments. In the U.S.,

Treatment 52

Treatment Hospitals Long-Term Care Facilities Virus 52

The Pharma Data

AUGUST 20, 2020

What information has been released about how kits were assessed shows most were tested on small numbers of patients only – just a few dozen, all of whom had been admitted to hospital. “For drug licensing the onus is on the companies to go through clinical trials. “There have been a number of arrests.

Clinical Trials 52

Clinical Trials Doctors Regulations Government 52

The Pharma Data

MAY 4, 2021

Direct Relief will allocate donations of baricitinib to low- and lower-middle-income countries (based on World Bank classification) for the treatment of hospitalized COVID-19 patients requiring supplemental oxygen, based on requests from these governments to Direct Relief. It is approved in the U.S. It is approved in the U.S.

Therapies 52

Therapies Hospitals FDA Approval Long-Term Care Facilities 52

Codon

MAY 11, 2023

It is used to prevent respiratory syncytial virus, or RSV, which causes about 60,000 hospitalizations in this age group each year. percent effective in preventing lower respiratory tract illness this age group in a randomized, controlled trial with 250,000 participants. Read more in WIRED. The vaccine was 82.6 Beautiful stuff.

Vaccine 52

Vaccine Engineering Licensing Licensing 52

Codon

MAY 11, 2023

It is used to prevent respiratory syncytial virus, or RSV, which causes about 60,000 hospitalizations in this age group each year. percent effective in preventing lower respiratory tract illness this age group in a randomized, controlled trial with 250,000 participants. Read more in WIRED. The vaccine was 82.6 Beautiful stuff.

Vaccine 52

Vaccine Engineering Licensing Licensing 52

The Pharma Data

APRIL 6, 2021

Ongoing research for baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, in adult and pediatric AD, alopecia areata (AA), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), COVID-19 and for its approved indication for rheumatoid arthritis (RA) continues.

Treatment 52

Treatment Clinical Trials Therapies Drugs 52

The Pharma Data

OCTOBER 26, 2020

I am confident in our ability to advance our promising pipeline and clinical trials despite the challenging environment, and I believe that our leadership and track record of solid commercial execution will continue to drive long-term growth.”. billion related to certain license and collaboration agreements, and certain other items.

Vaccine 40

Vaccine Trials Licensing Licensing 40

The Pharma Data

NOVEMBER 20, 2020

The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. We are extremely grateful to all the children, young adults and their families who have made this possible through participation in the Zokinvy clinical trials.”

FDA Approval 52

FDA Approval FDA Clinical Trials Disease 52

The Pharma Data

NOVEMBER 5, 2020

REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. In October 2020 , the Company and Sanofi announced that a Phase 3 trial met its primary and all key secondary endpoints in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. billion versus third quarter 2019.

Production 52

Production FDA FDA Approval Trials 52

The Pharma Data

NOVEMBER 29, 2020

HB-101, a non-replicating arenavirus vaccine, is being investigated in a double-blind Phase 2 clinical trial (NCT03629080) to assess safety, immunogenicity and efficacy in individuals receiving a kidney transplant from a living donor. Safety and tolerability were evaluated in 69 participants who were enrolled in the trial by the cut-off date.

Vaccine 52

Vaccine Clinical Trials Disease Therapies 52

Agency IQ

FEBRUARY 2, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires.

FDA 40

FDA Science Clinical Trials Regulations 40

The Pharma Data

OCTOBER 29, 2020

Based on the interim results of the Phase 2 part of the study, the Phase 3 portion of BRAVE-AA1 and an additional Phase 3 trial (BRAVE-AA2) were initiated and are ongoing to assess the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo. WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS.

Therapies 52

Therapies Treatment Disease Clinical Trials 52

Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

Therapies 138

Therapies DNA Virus Clinical Trials 138

The Pharma Data

JANUARY 26, 2021

“The death toll from COVID-19 continues to rise around the world and hospitalizations, particularly in the U.S., These data further support our belief that bamlanivimab and etesevimab together have the potential to be an important treatment that significantly reduces hospitalizations and death in high-risk COVID-19 patients.

Hospitals 52

Hospitals Treatment Long-Term Care Facilities Trials 52

Drug Discovery World

SEPTEMBER 16, 2022

In 2021, the Cell and Gene Therapy Catapult estimated that there 168 ongoing clinical trials for advanced therapy medicinal products (ATMPs) taking place – representing 9% of all global trials in the space. The UK stands as one of the key markets for cell and gene therapies. billion in funding. . “In

Therapies 130

Therapies Clinical Trials Production Trials 130

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Yancopoulos, M.D.,

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

FDA 40

FDA Clinical Trials Hospitals Government 40

The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

Trials 52

Trials Production Clinical Trials Government 52

Agency IQ

NOVEMBER 3, 2023

In fact, the FDA has even developed a guidance document for “early clinical trials with live biotherapeutic products [LBPs].” The next day, the FDA published a news release regarding the issues with probiotic products being sold for use in hospitalized preterm infants. What’s next?

Therapies 40

Therapies Science FDA Production 40

The Pharma Data

SEPTEMBER 7, 2021

Bristol Myers Squibb has a global exclusive license to develop, manufacture and commercialize the Rockefeller University’s novel monoclonal antibody (“mAb”) duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. Our Clinical Trials and Research. All of our U.S.

Clinical Trials 52

Clinical Trials Vaccine Virus Trials 52