The Pharma Data

NOVEMBER 2, 2020

GWACHEON, KOREA, November 02, 2020 /24-7PressRelease/ — The trial of Shincheonji Church of Jesus Chairman Man Hee Lee continued on October 21st as the court discussed the alleged violation of the Infectious Disease Prevention Act earlier this year. When in court, he has attended using a wheelchair.

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The Pharma Data

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).

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The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

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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

MARCH 25, 2022

2-4 Evusheld was generally well-tolerated in the trial.(2-4). Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein(10) and were optimised by AstraZeneca with half-life extension and reduction of Fc effector function.

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The Pharma Data

APRIL 18, 2022

Novavax licensed and transferred its manufacturing technologies to enable Takeda to develop and manufacture the vaccine at its facility in Hikari. Takeda will begin distribution of Nuvaxovid doses purchased by the Government of Japan as soon as possible. TAK-019 Clinical Trial. ml dose of TAK-019 at both vaccinations.

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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.

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The Pharma Data

JULY 23, 2021

In December 2020, Chugai obtained development and exclusive commercialisation rights in Japan from Roche, and is working with the Japanese government to ensure an appropriate and timely supply of Ronapreve. As soon as the novel SARS-CoV-2 virus was sequenced in early 2020, we got to work. About Ronapreve (casirivimab and imdevimab).

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The Pharma Data

NOVEMBER 17, 2021

2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7). 2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7). 3,4,5,6,7). .” 3,4,5,6,7).

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The Pharma Data

OCTOBER 25, 2020

It was another busy week for clinical trial updates and news. Army Medical Research and Development (USAMRDC ) initiated a Phase I clinical trial of its novel vaccine against COVID-19. The trials won’t begin until early 2021 and are expected to finish in May 2021. The trial has already restarted in the UK and elsewhere.

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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

JANUARY 22, 2021

iosBio , a UK-based biotechnology company, has announced an exclusive worldwide licensing agreement with ImmunityBio , a clinical-stage immunotherapy company, for rights to use iosBio’s OraPro vaccine platform technology to test the oral administration of ImmunityBio’s vaccine candidate.

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The Pharma Data

AUGUST 20, 2020

“For drug licensing the onus is on the companies to go through clinical trials. “In the long term, evaluations of tests should be added to the existing pre-registers for clinical trials. Across government, action is being taken to enforce these tough regulations. ” Image copyright. .

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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.

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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. 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.

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The Pharma Data

MAY 6, 2021

Under the MoU framework, NOCs and their local governments are expected to coordinate the administration of vaccinations to eligible Games participants. Doses provided under this MoU would be in addition to doses provided under supply agreements with governments worldwide.

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The Pharma Data

JULY 29, 2021

Takeda has granted a license to HilleVax for the exclusive development and commercialization rights to its norovirus vaccine candidate, HIL-214 (formerly TAK-214), worldwide outside of Japan, in exchange for upfront consideration, as well as future cash milestones and royalties on net sales. About HilleVax.

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The Pharma Data

MAY 13, 2021

NIH trial seeks answers. ( UK trial points to mixed vaccines raising risk of side-effects ( FT ). Biogen licenses a stroke drug from Japanese drugmaker TMS ( BioPharmaDive ). UK trial points to mixed vaccines raising risk of side-effects ( FT ). In Focus: International.

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The Pharma Data

JULY 21, 2021

The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments as well as global health partners with the aim to provide 2 billion doses to low and middle income countries in 2021 and 2022 – 1 billion each year.

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The Pharma Data

DECEMBER 10, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

APRIL 27, 2021

We remain committed to moving as quickly and safely as possible to bring this vaccine to more people in Europe, as the deadly virus continues to wreak havoc across the continent.” This brings the total number of doses to be delivered to the EU to 600 million. “We said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “To

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The Pharma Data

DECEMBER 19, 2020

Healthcare workers have been on the front lines of the fight against the virus and are an inspiration to us all. Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021. government by the end of December 2020. W911QY-20-C-0100.

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The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. immediately.

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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 About the Phase 2/3 Study. billion doses by the end of 2021. billion doses by the end of 2021.

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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. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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The Pharma Data

JUNE 24, 2021

“This is a meaningful moment for adolescents, parents and entire families who are seeking protection from this virus and a return to normalcy,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We The EU decision is based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years.

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The Pharma Data

APRIL 16, 2021

government to ensure adequate supply of etesevimab to be used together with bamlanivimab. 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. All sites in the U.S. than bamlanivimab alone, including the rapidly growing B.1.427/B.1.429

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The Pharma Data

JANUARY 13, 2021

we determined the crystal structure of CD40-ligand 2 , developed a humanized version of our antibody (hu5c8, ruplizumab, or Antova®) and tested it in human trials for preventing organ transplant rejection and autoimmunity. Collaborating with a team at Biogen Inc., Tonix Pharmaceuticals Holding Corp.

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The Pharma Data

DECEMBER 5, 2020

Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients. NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. Regeneron Pharmaceuticals, Inc.

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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.

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Agency IQ

FEBRUARY 2, 2024

Government shutdown: At present, the FDA has appropriated funding March 1. 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

AUGUST 20, 2020

Phase 1 trial for the BNT162b2 vaccine candidate, which at 30 ?g The companies are continuing to analyze data from the Phase 1 trials in the U.S. The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials. and Germany.

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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. It is approved in the U.S.

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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

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The Pharma Data

JUNE 25, 2021

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

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