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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The Pharma Data

APRIL 29, 2022

SK bioscience and GSK announced submission of a biologics license application for SKYCovione™ a recombinant protein-based COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety (KMFDS) following positive Phase III clinical data.

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The Pharma Data

APRIL 27, 2023

This is the first time an RSV vaccine candidate for adults has gained a positive opinion, one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. There are no RSV vaccines or specific treatments currently available for older adults. Efficacy was 94.6% (95% CI, 65.9–99.9,

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The Pharma Data

OCTOBER 26, 2020

FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). Testing Therapies, Antivirals and Vaccines. Eli Lilly halted a separate study of its LY-COV555 antibody against COVID-19 in hospitalized patients.

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Drug Discovery World

APRIL 20, 2023

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. 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. 2021.12.020.

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OCTOBER 19, 2020

.–( BUSINESS WIRE )– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from two additional Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. among adults 65 years of age or older.

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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.

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The Pharma Data

DECEMBER 1, 2020

has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. The distribution of the vaccine in the U.K.

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The Pharma Data

NOVEMBER 9, 2020

Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. Analysis evaluated 94 confirmed cases of COVID-19 in trial participants. Pfizer Inc.

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The Pharma Data

DECEMBER 23, 2020

Joseph Kim , President and CEO of INOVIO, said, “We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet’s EClinicalMedicine , and are grateful for the support of all participants and investigator staff involved in the clinical trial.” . PLYMOUTH MEETING, Pa. ,

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The Pharma Data

NOVEMBER 29, 2020

Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease. 21 participants were vaccinated with HB-101 and 12 received placebo. NEW YORK and VIENNA, Austria, Nov.

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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. MOVe-AHEAD Study.

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The Pharma Data

NOVEMBER 5, 2021

The first global authorization of molnupiravir is a major achievement in Merck’s singular heritage of bringing forward advance drugs and vaccines to address the world’s topmost health challenges. As an oral remedial, molnupiravir offers an important addition to the vaccines and drugs stationed so far to fight the COVID-19 epidemic,” saidDr.

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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.

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The Pharma Data

AUGUST 3, 2021

announced today results from an additional cohort of 101 adult patients from the COV-BARRIER trial. “These new data add to the growing body of evidence demonstrating the important role baricitinib has and may continue to play for certain hospitalized patients with COVID-19.”

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Drug Discovery World

MARCH 29, 2023

Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). Will this be a viable solution? Clinical trials The draft outlines the requirement for clinical trials in children where a drug is approved in adults for a different disease.

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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. Lilly has licensed and developed bebtelovimab after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.

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Codon

MAY 11, 2023

3/ A Vaccine for RSV A vaccine called Arexvy, and marketed by GlaxoSmithKline, has been approved by the FDA for adults aged 60 and older. It is used to prevent respiratory syncytial virus, or RSV, which causes about 60,000 hospitalizations in this age group each year. The vaccine was 82.6 The vaccine was 82.6

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Codon

MAY 11, 2023

3/ A Vaccine for RSV A vaccine called Arexvy, and marketed by GlaxoSmithKline, has been approved by the FDA for adults aged 60 and older. It is used to prevent respiratory syncytial virus, or RSV, which causes about 60,000 hospitalizations in this age group each year. The vaccine was 82.6 The vaccine was 82.6

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The Pharma Data

JUNE 7, 2022

The MITT population included all participants who were randomly assigned, received at least one dose of study drug, and were not hospitalized before the first dose of study drug. Since licensed by Ridgeback, all funds used for the development of LAGEVRIO have been provided by Merck and Ridgeback. to 51.7%]; 6.6% to 51.7%]; 6.6%

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The Pharma Data

NOVEMBER 19, 2021

“We were thrilled with the recent results of our Phase2/3 interim analysis, which showed inviting efficacity of PAXLOVID in reducing the threat of hospitalization among high- threat cases treated within three days of symptom onset by nearly 90 and with no deaths, and are pleased theU.S.

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The Pharma Data

OCTOBER 26, 2020

Demand for our products remains robust, and production, supply and distribution of our medicines, vaccines and animal health products are moving forward with minimal disruption,” said Kenneth C. billion related to certain license and collaboration agreements, and certain other items. Non-GAAP EPS of $1.74 COVID-19 Research Highlights.

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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.

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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. Ricks , Lilly chairman and CEO. It is approved in the U.S.

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The Pharma Data

NOVEMBER 9, 2021

government has chosen to buy further than 3 million courses of molnupiravir, our promising oral antiviral, so that molnupiravir, if authorized, will be among the vaccines and drugs available to fight COVID-19 as part of our collaborative sweats to bring this epidemic to an end. We ’re recognized that theU.S.

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The Pharma Data

DECEMBER 20, 2020

Food and Drug Administration (FDA) is plenty busy with COVID-19 vaccine Emergency Use Authorizations (EUAs) this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. The submission included data from two positive pivotal Phase III trials. Here’s a look. It was approved on December 15, 2020.

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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. “Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics.

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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. Increases of ALT ?5x

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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).

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The Pharma Data

APRIL 16, 2021

More than 400,000 patients have been treated with bamlanivimab – more than any other neutralizing antibody – potentially preventing more than 20,000 hospitalizations and at least 10,000 deaths during the worst of the pandemic in the U.S. Some of these events required hospitalization. Limitations of Authorized Use. Adverse Events.

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The Pharma Data

JULY 23, 2021

In addition to the REGN-COV 2067 trial in non-hospitalised patients, Ronapreve is currently being assessed in a phase II/III clinical trial for the treatment of COVID-19 in hospitalised patients (REGN-COV 2066). On 16 March 2021 the SARS-CoV-2 variant test was launched, designed to detect key spike mutations.

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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.

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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.

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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. 10x ULN were observed in patients in Olumiant clinical trials.

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The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Senior Vice President and Head of Vaccine Research & Development, Pfizer.

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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.

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Codon

JULY 14, 2024

However, the subsequent death of another patient thrust Denys into a contentious trial. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial. The results of the trial are expected at the end of 2024. Data from Rousseau G.F.

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