Advarra

FEBRUARY 24, 2023

How do you know your experimental therapy is working? But what does “working” really mean when efficacy means something subjective, like quality of life, reduced psychiatric events, or less symptoms? In most cases, the results you are really looking for and trying to prove in a trial can be complex.

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Drug Discovery World

APRIL 6, 2023

Her work has impacted tribal, rural, and frontier communities and improved quality of life and access to cancer care. Jane Perlmutter, PhD, MBA, is President and Founder of the Gemini Group.

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The Pharma Data

NOVEMBER 30, 2020

Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists. The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials. About Sosei Heptares.

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LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. Small molecule GLP1s? Additional trials (e.g.,

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Drug Discovery World

MAY 11, 2023

DDW’s Megan Thomas spoke with attendees, and comments on the event. Fundraising and investment Coming out of a global pandemic, in-person events initially added a degree of novelty to networking. At previous events, there has been an air of excitement but uncertainty of how quickly to adopt ‘business as usual’.

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The Pharma Data

JANUARY 13, 2021

PITTSBURGH–( BUSINESS WIRE )– Knopp Biosciences LLC today announced positive top-line results in a Phase 2 dose-ranging trial of the novel oral drug dexpramipexole in patients with moderate-to-severe eosinophilic asthma. The trial was conducted at 28 U.S. 14, 2021 11:00 UTC. President and CEO of Knopp. study centers.

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Drug Discovery World

APRIL 15, 2023

As the theme, Advancing the Frontiers of Cancer Science and Medicine , suggests, a number of announcements, results and presentations will take place at what is widely considered to be a flagship event for the cancer research community. Here are eight anticipated ‘curtain raisers’ in advance of the event: 1.

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Drug Discovery World

APRIL 8, 2024

Bold Therapeutics’ BOLD-100, a ruthenium-based small molecule, acts by targeting GRP78 to modulate the unfolded protein response (UPR) and by generating reactive oxygen species (ROS) leading to DNA damage and cell cycle arrest.

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Drug Discovery World

NOVEMBER 1, 2022

Ground-breaking therapies . In September this year, Aucentra Therapeutics announced that it received regulatory approval to progress to a Phase I/II trial for Auceliciclib in combination with Temozolomide for recurrent/refractory Glioblastoma multiforme (GBM) patients 3. .

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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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Drug Discovery World

OCTOBER 16, 2023

A company within this ecosystem is STORM Therapeutics, a clinical stage biotechnology company creating novel small molecule therapies that inhibit RNA modifying enzymes (RME) for use in oncology and other diseases. billion in funding. Northern Ireland “Northern Ireland is a medtech super-hub,” says Saleko.

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The Pharma Data

NOVEMBER 8, 2021

“HER-MES is the first study that directly compared the therapeutic effects of an antibody and a small molecule in migraine prevention,” said Uwe Reuter, M.D., MBA, trial investigator and managing medical director at Charité Universitätsmedizin in Berlin. Additional study treatment-related adverse events reported by

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Drug Target Review

MAY 6, 2024

The clinical efficacy of BRAF inhibitors, like most other targeted cancer therapies, is inevitably limited by resistance development. We found that, indeed, cancer’s earliest defence mechanisms are triggered almost immediately after exposure to a targeted cancer therapy. What if our science can directly impact patients’ lives?”

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Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). set specific standards and expectations for discrete components of clinical trials (e.g.,

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Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. 2021 – and a robust pipeline that includes 3 AI-designed drugs (for IPF, COVID-19 and cancer) currently in clinical trials.

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Drug Discovery World

APRIL 30, 2024

Reece Armstrong explores the potential and future opportunities for mRNA-based therapies. For instance, consider how at the end of 2018, the mRNA therapies market was valued at $3.43 At the start of 2024, the first patients in a clinical trial investigating an mRNA cancer therapy were dosed.

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The Pharma Data

AUGUST 30, 2021

-JADE DARE trial met co-primary and key secondary endpoints and demonstrated a safety profile consistent with previous studies-. The head-to-head study was designed to directly compare the efficacy of abrocitinib 200mg versus dupilumab 300mg, in adult participants on background topical therapy with moderate to severe atopic dermatitis (AD).

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Dark Matter Blog

JULY 16, 2021

My last stop at Arrakis Therapeutics is with a company targeting RNA with small molecules. I was enticed by Arrakis’ founder Jen Petter to serve in one more operational role, leading the research group at Arrakis as the company launched as one of the first biotechs to target RNA with drug-like small molecules.

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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

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. Rates of serious adverse events were similar between vaccine and placebo groups (0.6%

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The Pharma Data

JANUARY 3, 2021

Sixty-two percent of patients were treated with prior PD(L)-1 containing therapy, and the arms were well balanced. The frequency and severity of adverse events in the telaglenastat-treated population were comparable to that of cabozantinib alone. “We The CANTATA trial enrolled 444 patients at multiple centers globally.

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The Pharma Data

OCTOBER 6, 2021

The positive opinion by the CHMP is based on the clinical trial data shared by the companies, real world evidence as well as literature data. The adverse event profile was generally consistent with other clinical safety data for COMIRNATY. About Pfizer: Breakthroughs That Change Patients’ Lives.

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The Pharma Data

NOVEMBER 29, 2020

1 Meanwhile, these MDM2 inhibitors present some challenges, including dose-limiting hematological toxicities, thus the urgent need to develop new generation of MDM2-targeting therapies in the treatment of cancer. Small-molecule inhibitors of the MDM2-p53 protein-protein interaction (MDM2 inhibitors) in clinical trials for cancer treatment.

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The Pharma Data

JANUARY 17, 2021

The NDA was built on data from the Phase III VICTORIA trial. The study enrolled 5,050 patients who received either vericiguat or placebo in combination with available heart failure therapies. The NDA was supported by results from two pivotal trials, Phase III AURORA and Phase II AURA-LV.

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The Pharma Data

APRIL 23, 2021

European Commission approves GSK’s JEMPERLI (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer. The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe. For media and investors only. Issued: London UK. Serious adverse reactions occurred in 8.7%

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The Pharma Data

AUGUST 16, 2021

Primary and all key secondary endpoints including itch, interference of itch on sleep and quality of life were met at Week 16 in two pivotal Phase 3 trials in lebrikizumab clinical trial program – Safety profile consistent with prior lebrikizumab studies in atopic dermatitis. Almirall S.A.’s

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Drug Discovery World

SEPTEMBER 26, 2024

The Drug Discovery in Scotland Forum showcased how Scotland is shaping drug discovery using approaches including traditional small molecules, therapeutic proteins, CRISPR/ RNAi and cell therapies, as well as how these are being used in 2D and 3D models.

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The Pharma Data

OCTOBER 1, 2021

Pfizer today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved CIBINQO ® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and older with inadequate response to existing therapies.

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The Pharma Data

OCTOBER 27, 2020

Mirati is advancing a novel pipeline to treat large patient populations across multiple programs and tumor types, including two programs, adagrasib and sitravatinib, in registration-enabling studies to treat non-small cell lung cancer (NSCLC). Forward-Looking Statements. View original content to download multimedia: [link]. Source link.

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The Pharma Data

NOVEMBER 10, 2020

11, 2020 (GLOBE NEWSWIRE) — Calithera Biosciences, Inc. , (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, today announced its participation at two upcoming healthcare investor conferences in November.

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The Pharma Data

JANUARY 18, 2021

The fireside chat will be available for 90+ days following the event at: [link] 5 69. Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients.

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The Pharma Data

DECEMBER 13, 2020

RLY-1971 has the potential to serve as a backbone for combination therapy across numerous solid tumors and therefore represents an encouraging approach for cancer patients,” said Sanjiv Patel, M.D., In the event of regulatory approval of both RLY-1971 and GDC-6036 in combination, Relay Therapeutics is eligible to receive additional royalties.

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The Pharma Data

DECEMBER 14, 2020

Many drugs fail in clinical trials because of their low blood brain barrier permeability. The effectiveness of standard therapy with TMZ is limited because the response of GBM to TMZ is dependent upon the expression of the DNA repair enzymatic protein, O 6 -alkylguanine DNA alkyltransferase (MGMT). Lantern’s A.I.

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The Pharma Data

NOVEMBER 22, 2020

Omecamtiv mecarbil is an investigational cardiac myosin activator, developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF), and was recently studied in GALACTIC-HF, a positive Phase 3 cardiovascular outcomes clinical trial. Blum, Cytokinetics’ President and Chief Executive Officer. Terms of Termination.

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The Pharma Data

DECEMBER 9, 2020

About Oncternal Therapeutics Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of cancers with critical unmet medical need. SAN DIEGO, Dec. 09, 2020 (GLOBE NEWSWIRE) — Oncternal Therapeutics, Inc.

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The Pharma Data

APRIL 27, 2021

IMPORTANT SAFETY INFORMATION: Events of anaphylaxis have been reported. The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. A slightly lower frequency of reactogenicity events was associated with greater age.

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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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