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.

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The Pharma Data

OCTOBER 30, 2020

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. About the REGN-COV2 Trial in Hospitalized Patients. Regeneron Pharmaceuticals, Inc.

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The Pharma Data

SEPTEMBER 30, 2020

image caption Independent hospital group Circle Health Group said it was taking the issues “incredibly seriously” Claims a surgeon kept the bones of more than 5,000 patients he operated on have led to a police inquiry. image copyright Google. Circle Health Group said the “historic issues.

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The Pharma Data

MARCH 8, 2021

Phase 2a study enrolled 202 non-hospitalized adults who had signs or symptoms of COVID-19 within 7 days and confirmed active SARS-CoV-2 infection. At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data.”. This press release features multimedia. This multi-center U.S.

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The Pharma Data

JULY 12, 2021

The Phase 3 portion of the global MOVe-OUT trial studying molnupiravir in non-hospitalized adult patients with laboratory-confirmed COVID-19 and at least one risk factor associated with poor disease outcomes is underway. This press release features multimedia. View the full release here: [link]. “It

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The Pharma Data

OCTOBER 26, 2020

AR-711 was previously shown to be effective in prophylactic as well as therapeutic treatment modes in a SARS-CoV-2 viral challenge study. AR-711 is currently being developed as an inhaled, self-administered treatment for non-hospitalized patients suffering from mild to moderate COVID-19. About Aridis Pharmaceuticals, Inc.

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The Pharma Data

OCTOBER 6, 2021

It is also licensed under the brand name Efluelda ® in Europe where it is indicated for adults aged 60 and older. It is also licensed under the brand name Efluelda® in Europe where it is indicated for adults aged 60 and older. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering.

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Drug Target Review

FEBRUARY 1, 2024

What challenges has the industry faced in developing and commercialising treatments for neurological diseases, including rare diseases? In a roughly $14 billion deal, Bristol Myers Squibb acquired Karuna, a developer of treatments for schizophrenia and other forms of psychosis associated with neurodegenerative diseases.

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The Pharma Data

SEPTEMBER 2, 2021

Interim analysis of patient engagement and adherence assessment indicates ability of Enerzair Breezhaler optional digital companion (sensor and app) in supporting patient engagement and treatment adherence 6. MF is exclusively licensed to Novartis from a subsidiary of Merck & Co., Woehrle et al. g) and medium-dose (150/50/80?g)

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The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. The product is designed for the prevention and treatment of COVID-19, along with related coronaviruses. Kate Krav-Rude/Shutterstock.

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The Pharma Data

NOVEMBER 18, 2020

Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan. Title: OBI-833 was safe and immunogenic, without treatment-related SAEs, in a Phase 1 dose-escalation trial. Title: OBI-833 was safe and immunogenic, without treatment-related SAEs, in a Phase 1 dose-escalation trial. 9:00 – 20:00 Eastern Time.

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The Pharma Data

OCTOBER 15, 2020

The naxitamab data was presented by Dr. Jaume Mora from SJD Barcelona Children’s Hospital, and the omburtamab data was presented by Dr. Kim Kramer from Memorial Sloan Kettering Cancer Center (“MSK”). Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs. About Y-mAbs.

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The Pharma Data

NOVEMBER 29, 2020

Y-mAbs Therapeutics has a target action date of November 30 for its Biologics License Application (BLA) for Danyelza (naxitamab) for patients with relapsed/refractory high-risk neuroblastoma. The drug was developed by researchers at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs. and Europe.

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The Pharma Data

SEPTEMBER 8, 2020

The decisions bring a raft of new treatment options for conditions including epilepsy, depression and cancer. It means eligible children and adults in Scotland will now be able to access this treatment for free on the NHS alongside the rest of the UK.”. days for eyes given treated control).

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New Drug Approvals

APRIL 19, 2025

This has a positive impact on the treatment of patients when reduction of heart rate without decrease in arterial blood pressure is desired. [9] Treatment of phenol 143 with bromo epoxide 144 in the present of K2CO3 afforded ether 145 in 76% yield. 9] It is used as landiolol hydrochloride.

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The Pharma Data

NOVEMBER 5, 2020

It also maintained that effect through 52 weeks of active treatment. Humanigen announced positive interim Phase III data of lenzilumab in hospitalized COVID-19 patients. Food and Drug Administration (FDA) to explore expedited regulatory pathways to advance itolizumab for the first-line treatment of aGVHD.”. Source link.

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The Pharma Data

OCTOBER 18, 2020

DUBLIN–( BUSINESS WIRE )– Inflection Biosciences Ltd , a company developing innovative therapeutics for the treatment of cancer, today announced the appointment of industry veteran Gregory I. Inflection Biosciences Ltd is developing small molecule therapeutics for the treatment of cancer. 19, 2020 08:02 UTC.

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The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. In the U.S., Dupixent is approved in the U.S. Outside of the U.S.,

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The Pharma Data

JUNE 26, 2021

In line with our global leadership and our 7 0-year history of pro tecting people with influenza v accine s , w e will always focus on developing product s that demonstrate protection beyond flu , as we believe it is critical to demonstrate protecting patients from hospitalizations due to cardiovascular events and pneumonia.

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The Pharma Data

MARCH 27, 2022

OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. Marketing authorization for the treatment of hospitalized patients with COVID-19 has been granted for OLUMIANT in multiple countries. It is approved in the U.S. It is approved in the U.S.

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The Pharma Data

JANUARY 18, 2021

At the same time, we continue to prepare for the filing of the Biologics License Application with the U.S. million in 2020 despite a very limited access of patients to hospitals due to the COVID-19 crisis. “We Patients have been scheduled for treatment in January 2021. Cash position and financing runway.

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The Pharma Data

OCTOBER 27, 2020

Nick Colangelo, President and CEO of Vericel added, “Completing the enrollment stage of the CIDS study is an important step toward our goal of providing NexoBrid as a treatment option for pediatric patients with severe burns given NexoBrid’s potential to address the unique challenges in treating children with severe burns.”. and up to 30 U.S.

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The Pharma Data

MARCH 2, 2021

The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021. The Company will ship the vaccine using the same cold chain technologies it uses today to transport treatments for cancer, immunological disorders and other medicines. Johnson & Johnson’s COVID-19 Vaccine Candidate.

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The Pharma Data

JANUARY 5, 2021

“Benuvia is excited to partner with the leadership of Radius Health to progress the late-stage development and commercialization of our synthetic cannabidiol oral solution for the treatment of rare and underserved diseases. We look forward to supporting Radius through our U.S.

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The Pharma Data

OCTOBER 28, 2020

REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits). Clinical results in the overall population (n=799): On the key clinical endpoint, treatment with REGN-COV2 reduced COVID-19 related medical visits by 57% through day 29 (2.8%

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The Pharma Data

NOVEMBER 9, 2020

NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose ICS plus at least one additional controller medication with or without OCS.

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The Pharma Data

DECEMBER 23, 2020

The lead Principal Investigator for the INNOVATE trial is Dr. Pablo Tebas , Professor of Medicine at the Hospital of the University of Pennsylvania. . About the INO-4800 “INNOVATE” Phase 2/3 Clinical Trial.

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The Pharma Data

OCTOBER 29, 2020

Treatment compliance rates across all our medicines have remained strong and continue to be slightly above expectations. We have also seen the predicted slowing of new patient initiations and delays in treatment starts, and we are continuing to closely monitor this environment as the pandemic continues.

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The Pharma Data

NOVEMBER 9, 2020

We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. Albert Bourla, Pfizer Chairman and CEO. “We

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Agency IQ

SEPTEMBER 29, 2023

Essential requirements for interoperability of data spaces: The participants of the data space must sufficiently describe (in machine-readable format where applicable) the dataset content, use restrictions, licenses, data collection methodology and quality. Hospitals can control data, while manufacturers process data.

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The Pharma Data

DECEMBER 1, 2020

will reduce the number of people in the high-risk population being hospitalized. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. “The Emergency Use Authorization in the U.K.

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Agency IQ

SEPTEMBER 1, 2023

occurrence of stroke or other discrete events, hospitalization, survival) in a randomized controlled trial” or serving as the comparator in an externally controlled trial, including historically controlled trials. Thus, the majority of the draft guidance was dedicated to RWD use in non-interventional studies.

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Broad Institute

FEBRUARY 29, 2024

By Leah Eisenstadt February 29, 2024 Credit: Courtesy of (clockwise, from top left) National Park Service; Rainer Zenz, Creative Commons license; Len Charnoff/Flickr, public domain; Riki7, public domain; National Park Service; Rufus46, Creative Commons. The work appears in Proceedings of the National Academy of Sciences (PNAS).

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The Pharma Data

NOVEMBER 8, 2020

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. About Sesquient.

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The Pharma Data

APRIL 8, 2021

“There remains a driving unmet need for treatments with the potential to further decrease mortality for COVID-19 patients,” said co-primary investigator E. These important findings advance our pursuit of treatment options to save lives in hospitalized COVID-19 patients.” Baricitinib-treated patients were 2.7

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The Pharma Data

APRIL 26, 2022

— Approval is Supported by Phase 2/3 Data Demonstrating the Safety and Tolerability Profile and Clinical Improvement Outcome in Hospitalized Pediatric Patients Treated with Veklury — Gilead Sciences, Inc. Nasdaq: GILD) today announced that the U.S.

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The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.

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