The Pharma Data

SEPTEMBER 8, 2020

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Roche’s Chief Medical Officer and Head of Global Product Development. “We

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Drug Discovery World

APRIL 11, 2024

On the final day of AACR, the plenary session of the Annual Meeting put artificial intelligence at the forefront and featured a stellar lineup of AI and data science experts who discussed AI and topics such as imaging, precision medicine, and drug development. And thanks to the city of San Diego for its hospitality.”

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The Pharma Data

APRIL 29, 2022

About Evrysdi® (risdiplam) Evrysdi is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is designed to treat SMA by increasing and sustaining the production of the SMN protein in the central nervous system (CNS) and peripheral tissues.

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Protein In-Vitro Medicine Development 52

Drug Discovery World

JANUARY 23, 2023

This action sensitised GBM cells to radiotherapy both in vitro and in vivo (in mouse models). “Our research has revealed cladribine as a radiosensitiser for GBM treatment by drug repurposing, which can offer multiple advantages,” says Prof Youn. “As GBM is a WHO grade IV brain tumour with dismal prognosis.

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The Pharma Data

MAY 31, 2022

More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings. About Evrysdi® (risdiplam) Evrysdi is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency.

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The Pharma Data

MARCH 25, 2022

This includes about three million people in the EU who are immunocompromised or being treated with immunosuppressive medicines.(1). 2-4 Evusheld was generally well-tolerated in the trial.(2-4). 2-4 Evusheld was generally well-tolerated in the trial.(2-4). 2 Omicron SARS-CoV-2 subvariants in circulation around the world.(5-7)

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The Pharma Data

JANUARY 27, 2021

We look forward to working with Eurofins Discovery to bring this treatment to patients as quickly as possible as we prepare for our IND and trials,” said BetterLife’s Chief Executive Officer, Dr. Ahmad Doroudian. FDA Investigational New Drug (“IND”)-enabling pharmacology studies. About BetterLife Pharma: BetterLife Pharma Inc.

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pharmaphorum

NOVEMBER 9, 2022

for the purpose of advancing disease-modifying oral medicines for debilitating chronic neurodegenerative disorders, by enabling investigational new drugs (IND) studies. In ALS , the protein TDP-43 triggers neuroinflammation via activation of the innate immune sensor STING. It has been supporting NRG’s work since 2019.

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The Pharma Data

MARCH 20, 2023

This trial included people with Type 2 and 3 SMA, including patients with advanced disease. Roche is currently investigating Evrysdi in combination with an anti-myostatin molecule targeting muscle growth in the Ph II/III trial Manatee for the treatment of SMA. Evrysdi was well-tolerated over the four-year time period.

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pharmaphorum

JANUARY 16, 2023

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. And all are predominantly prevented or treated with medicines that are decades old.

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The Pharma Data

SEPTEMBER 17, 2020

The test targets antibodies against the spike protein. 1 Specifically, the test targets antibodies which are directed against the particular region of the viral spike protein responsible for binding to the host cell receptor, which is required for the virus to enter the host cell. said Thomas Schinecker, CEO Roche Diagnostics.

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The Pharma Data

FEBRUARY 25, 2021

Roche announces results from Evrysdi (risdiplam) study in infants with Type 1 spinal muscular atrophy (SMA) published in New England Journal of Medicine. The study also found that treatment with Evrysdi increased the levels of survival of motor neuron (SMN) protein by a median 1.9-fold

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FDA Approval Protein Medicine In-Vitro 52

The Pharma Data

NOVEMBER 17, 2021

Streamlined in vitro data, published in bioRxiv, demonstrate that sotrovimab retains exertion against all current variants of concern and interest of the SARS-CoV-2 contagion as defined by the World Health Organization, plus others, including, but not limited to, Delta (B.1.617.2), 1.617.2), Delta Plus (AY.1 2) and Mu (B.1.621).

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The Pharma Data

SEPTEMBER 27, 2020

These results build on the efficacy and safety demonstrated by Evrysdi in pivotal trials, and we look forward to continued assessments of both survival and motor function during long-term follow up for this first-of-its-kind treatment.”. 59% of infants were able to sit without support for at least 5 seconds.

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Protein In-Vitro Medicine FDA Approval 52

The Pharma Data

JANUARY 17, 2021

The year is starting to pick up in terms of clinical trial announcements. Johnson & Johnson published interim Phase I/IIa data in the New England Journal of Medicine showing its single-dose COVID-19 vaccine candidate created an immune response that lasted at least 71 days. Here’s a look at last week’s news. COVID-19-Related.

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The Pharma Data

MAY 17, 2023

Additionally, pre-clinical data have shown fenebrutinib to be potent and highly selective, and it is the only reversible inhibitor currently in Phase III trials for MS. “I Fenebrutinib significantly reduced the total number of new gadolinium-enhancing T1 brain lesions compared to placebo, the primary endpoint of the trial (p=0.0022).

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The Pharma Data

MAY 27, 2022

Data from the NP30179 study have been submitted for approval to the European Medicines Agency (EMA), and submissions to additional health authorities worldwide, including to the U.S. Glofitamab is being investigated in several clinical trials and explored in earlier lines of lymphoma treatment. After a median follow-up of 12.6

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Drug Discovery World

FEBRUARY 22, 2024

According to Medicine Discovery Catapult, these include: “Navigating the complexity of the CNS; understanding the disease pathology, and accessing predictable in vitro and in vivo cell models 2 ”. For example, it can take up to it three years to recruit enough participants for a dementia clinical trial. to £104.7m

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The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. About COMET-ICE.

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The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and around the world.

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The Pharma Data

SEPTEMBER 1, 2020

Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions. Antigen test accurately screens individuals with known exposure to infected SARS-CoV-2 patients, providing fast answers regarding their infection status. Food and Drug Administration (FDA).

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Drug Discovery World

OCTOBER 4, 2022

There’s no question that cell and gene therapies have emerged as some of the most promising and innovative medicines on the market. . billion in 2020, according to the Alliance for Regenerative Medicine’s (ARM’s): Disrupting the Status Quo report. In 2021, levels of investment hit an all-time high at $22.7 billion, compared to $19.9

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Gene Therapy Drugs Gene Manufacturing 52

The Pharma Data

AUGUST 3, 2021

Bristol Myers Squibb conducted a subsequent confirmatory Phase 3 study evaluating romidepsin plus CHOP (Ro-CHOP) versus CHOP in first-line PTCL patients, but the trial did not meet the primary efficacy endpoint of progression free survival. senior vice president, Hematology Development, Bristol Myers Squibb.

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The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. “Ronapreve has been shown to improve survival in high-risk, non-hospitalised COVID-19 patients by reducing the risk of hospitalisation and death. About Ronapreve (casirivimab and imdevimab).

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The Pharma Data

MARCH 17, 2021

The data builds on the primary outcome analysis of the positive Phase 3 monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 The detailed data were presented at the virtual 17th St. Gallen International Breast Cancer Conference.

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The Pharma Data

DECEMBER 20, 2020

Elizabeth’s Medical Center and associate professor of Urology at Tufts University School of Medicine, said at the time, “The results of the EMPOUR study over the 52-week period demonstrated the sustained benefits of fibegron. The submission included data from two positive pivotal Phase III trials. and Europe, including Russia.

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Pfizer

DECEMBER 13, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, The additional 3.7

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The Pharma Data

APRIL 23, 2021

These results were published in the New England Journal of Medicine in August 2020. Roche announces positive CHMP opinion for Venclyxto-based combinations in certain patients with acute myeloid leukaemia. The VIALE-A study showed Venclyxto plus azacitidine significantly improved overall survival compared to azacitidine alone.

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The Pharma Data

MAY 18, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. This Phase III trial is the designated PMR for the first-line mUC indication and met its co-primary endpoint of progression-free survival.

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Medicine Containment In-Vitro Development 52

The Pharma Data

SEPTEMBER 16, 2020

Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer. New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers.

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Pfizer

JANUARY 27, 2023

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., It is important to note that these studies are required by U.S.

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Pfizer

JANUARY 27, 2023

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 70 countries to treat COVID-19.

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Delveinsight

DECEMBER 21, 2020

Research has shown that most of the cannabinoids bind to G-protein coupled cannabinoid receptors, CB1 and CB2, and act as agonists or inverse agonists. Thus, there can be a possibility that Cannabis may have the potential to cure Glioblastoma, however, further research, clinical trials are required and underway for a clearer picture.

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In-Vivo Clinical Trials Clinical Trials In-Vitro 52

Pfizer

AUGUST 15, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1

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The Pharma Data

APRIL 27, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

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The Pharma Data

DECEMBER 13, 2020

The STAMP-NAFLD trial was a 12-week, randomized, parallel group study in 120 presumed NASH patients with or without type 2 diabetes (T2DM). The Company additionally announced new preclinical results and plans for a Phase 2b trial focused on patients with noncirrhotic biopsy-proven NASH and coexisting prediabetes or T2DM.

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The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase IIIb OCREVUS higher dose clinical trial programme and Phase IV study evaluating OCREVUS in minority populations. New data further reinforce OCREVUS (ocrelizumab) as a highly effective treatment option offering a favourable and consistent benefit:risk profile, with high treatment persistence and adherence.

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