The Pharma Data

MARCH 5, 2021

The data in the publication include key findings previously presented at the 2020 American Society of Hematology (ASH) Annual Meeting. Currently available BTK inhibitors irreversibly inhibit BTK and the long-term efficacy of these therapies can be limited by acquired resistance, most commonly through BTK C481 mutations.

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The Pharma Data

NOVEMBER 8, 2020

Supernus Pharmaceuticals has a target action date of November 8, 2020 for SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD). The NDA was resubmitted on May 2020. Carlo, president and chief executive officer of Adamis, in May 2020. Supernus Pharmaceuticals’ SPN-812 for ADHD.

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The Pharma Data

NOVEMBER 11, 2020

12, 2020 14:00 UTC. We now have compelling data showing SLV213 has potent antiviral activity against SARS-CoV-2 as well as data on the safety, tolerability, and pharmacokinetics and pharmacodynamics of SLV213 in several preclinical model systems, including nonhuman primates,” said Felix Frueh, Ph.D.,

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The Pharma Data

DECEMBER 15, 2020

16, 2020 (GLOBE NEWSWIRE) — Arecor Limited (“Arecor” or “the Company”), the biopharmaceutical company advancing today’s therapies to enable healthier lives, today announces that Diabetes Care has published data for the Phase I clinical trial of AT247, its ultra-rapid acting insulin product candidate.

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The Pharma Data

DECEMBER 27, 2020

27, 2020 /PRNewswire/ — Gannex , a wholly owned company of Ascletis Pharma Inc. phase I trial is a randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics (biomarkers – FGF19 and C4) of ASC42 in healthy subjects.

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Drug Target Review

JULY 1, 2024

Could you elaborate on the potential market size for SRP-001 and how it fits into the broader landscape of pain therapies? SRP-001 is a novel non-opioid pain relief candidate that works centrally in the brain, offering robust pharmacokinetics without the adverse effects of current medications. South Rampart Pharma, Inc.

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Drug Target Review

OCTOBER 16, 2024

By fostering the fluid movement between research and clinical practice, we can better contribute to the development of therapies, which has been the most rewarding aspect of my career. In reality, our deep understanding of disease pathology and patient needs is instrumental in shaping both basic and clinical research into viable treatments.

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The Pharma Data

DECEMBER 13, 2020

In May 2020, the FDA notified MacroGenics that it was no longer planning to hold an Oncologic Drugs Advisory Committee (ODAC) meeting, but expected to hit the PDUFA date of December 17. “We That collaboration was to develop and commercialize four oncology antibody biosimilar therapies.

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Drug Target Review

OCTOBER 8, 2024

DOTA’s strong binding affinity to metal ions such as ¹⁷⁷Lu and other medical radioisotopes used for therapeutic or diagnostic purposes, along with its demonstrated safety profile in approved radioligand therapies, has made it the most widely used chelator in pretargeting strategies to date. 2020 Aug 21;48(3):874–82.

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New Drug Approvals

SEPTEMBER 13, 2024

14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 19] As of 2016, aticaprant has reached phase II clinical trials as an augmentation to antidepressant therapy for treatment-resistant depression. [20] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 2] Aticaprant is taken by mouth. [1]

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The Pharma Data

NOVEMBER 18, 2020

19, 2020 09:00 UTC. This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. SEFA-1024 is one of NST’s three SEFA programs. NST’s lead program, icosabutate, is currently in a phase 2b ‘ICONA’ study for the treatment of NASH.

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The Pharma Data

APRIL 27, 2021

Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations. The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). and around the globe.”. About the Phase 1/2 Trial.

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The Pharma Data

SEPTEMBER 15, 2020

On a non-risk adjusted basis, these opportunities collectively represent more than $15 billion (excluding 20vPnC) in potential incremental revenue for Pfizer from 2020 to 2025, as well as aggregate peak annual sales potential of $35 billion to $40 billion (including 20vPnC). Penta was well tolerated.

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The Pharma Data

DECEMBER 29, 2020

30, 2020 /PRNewswire/ — Protalix BioTherapeutics, Inc. Topline results from the BRIDGE study were announced in May 2020. As announced in May 2020 , in the study, the mean annualized eGFR slope of the study participants improved from -5.90 The treatment period of the BRIGHT study was completed in July 2020.

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The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. JERSEY CITY, N.J., 1) L iposomal IV formulation of ibrexafungerp entering Phase 1 study.

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The Pharma Data

NOVEMBER 26, 2020

27, 2020 /PRNewswire/ — Protalix Biotherapeutics, Inc. Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. . CARMIEL, Israel , Nov. Galactosidase-A enzyme.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration (FDA) had granted Breakthrough Therapy designation for donanemab based on the Phase 2 data. Additionally, pharmacokinetic/pharmacodynamic modeling showed that greater relative amyloid plaque clearance was correlated with greater clinical benefit. In June 2021, Lilly announced the U.S.

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The Pharma Data

DECEMBER 21, 2020

22, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), As UNITY reported in its press release, this “Phase I, first-in-human, open-label, single-ascending dose study being conducted by UNITY is designed to evaluate the safety, tolerability, and pharmacokinetics of UBX1325 in patients with advanced DME. Ascentage Pharma (6855.HK)

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

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The Pharma Data

JANUARY 26, 2021

Previous human pharmacokinetic (PK) study showed significantly better PK profile when compared to market leading product. The first patent, US 10,653,690, was issued by the USPTO in the summer of 2020. Patent protection until 2039. UPPSALA, Sweden , Jan. About Orexo.

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The Pharma Data

APRIL 11, 2021

.” In the Phase 1/2 LIBRETTO-001 trial, 32 adult patients with 12 unique RET fusion-positive advanced cancer types were enrolled by the efficacy cutoff date of September 19, 2020 (with follow-up through March 19, 2021). Initiate or adjust anti-hypertensive therapy as appropriate.

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New Drug Approvals

OCTOBER 24, 2023

“Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies” Lancet. April 2020). . | twitter +919321316780 call whatsaapp EMAIL. “Velsipity (etrasimod) tablets, for oral use” (PDF). . 401 (10383): 1132–1133. PMID 36871570.

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The Pharma Data

OCTOBER 25, 2020

26, 2020 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (“BTI” Treatment choices are limited, and commonly used off-label therapies are not always effective or may result in prolonged, deep sedation. NEW HAVEN, Conn., About the Richmond Agitation Sedation Scale (“RASS”). BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc.

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The Pharma Data

OCTOBER 18, 2020

19, 2020 (GLOBE NEWSWIRE) — Aptose Biosciences Inc. Separate from the AML trial, Aptose is conducting a Phase 1 a/b dose escalation study with CG-806 in patients with B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphomas (NHL), who have failed or are intolerant to current therapies.

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The Pharma Data

DECEMBER 9, 2020

EDISON, NJ / ACCESSWIRE / December 10, 2020 / Hepion Pharmaceuticals, Inc. “All patients will now be observed for a 14-day follow-up period, which is scheduled to be completed by December 16, 2020. In parallel with the completion of this dosing cohort, we have now dosed the first NASH patient in the 225 mg cohort.

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The Pharma Data

AUGUST 29, 2020

Oral, investigational complement factor B inhibitor LNP023 substantially improved hematological response as add-on therapy to eculizumab. To date, after at least six months of stable LNP023 add-on therapy, and at the investigators’ discretion, seven patients (70%) have discontinued eculizumab and remained on LNP023 as monotherapy.

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The Pharma Data

FEBRUARY 8, 2021

1 Quality of life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate (FACT-P Total). Accessed December 11, 2020. Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). 10 months. [iv]

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The Pharma Data

JANUARY 10, 2021

2020 was a remarkable year of progress for Ascendis reflecting the dedication and commitment of our employees worldwide as we made meaningful strides to achieve our vision, and meet or accelerate completion of our key milestones,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. .

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The Pharma Data

NOVEMBER 22, 2020

Preclinical data support MP0420’s potential efficacy as both a prophylactic and as an acute therapy. MP0420 is designed to bind the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells. Chief Medical Officer of Molecular Partners.

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The Pharma Data

DECEMBER 15, 2020

In late 2020, the effort received $200,000 in seed funding from the Baker Department of Cardiometabolic Health at the University of Melbourne’s medical school. The clinical responses were sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor. Receptor Inhibitors.

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The Pharma Data

DECEMBER 5, 2020

5, 2020 /PRNewswire/ — 63% response rate in patients treated with the highest reported dose. The results were shared in an oral presentation at the virtual 2020 American Society of Hematology (ASH) Annual Meeting. and the world, respectively, in 2020. TARRYTOWN, N.Y. , With a median follow up of 2.6

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The Pharma Data

JANUARY 3, 2021

The last patients in the trial received their final dose on 21 December 2020. The pharmacokinetics of nasally administered Foralumab will also be evaluated. The topline data from the trial is expected to be available in January 2021.

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Agency IQ

JUNE 9, 2023

The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing. Cell and gene therapy products, adjuvanted vaccines, and blood products all fall outside the scope.

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Agency IQ

SEPTEMBER 22, 2023

An AgencyIQ analysis from May 2020 found that a quarter of all New Molecular Entities (NMEs) approved since 2011 had relied upon a single pivotal trial, and that this reliance had remained relatively stable between 2011-2019 despite some year-to-year variability.

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The Pharma Data

NOVEMBER 6, 2020

06, 2020 (GLOBE NEWSWIRE) — Today, the U.S. Secondary outcomes were: (1) the effect of aducanumab on brain amyloid plaque content as measured by [18F]-florbetapir PET, (2) the pharmacokinetics of aducanumab and (3) the immunogenicity of aducanumab. CAMBRIDGE, Mass. and TOKYO, Nov. About Alzheimer’s Disease. About Biogen.

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Agency IQ

FEBRUARY 2, 2024

million deaths, or 23%, were due to cancer in 2020. million deaths, or 23%, were due to cancer in 2020. Additionally, the plan aims to improve the quality of life for the over 12 million cancer survivors who benefited from earlier detection, effective therapies and supportive care. were from cancer.

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The Pharma Data

DECEMBER 3, 2020

4, 2020 14:57 UTC. December 5, 2020 9:00 AM – 10:30 AM; Track: 4. An initial analysis of data from 17/22 patients who completed one of these assessments showed substantially decreased neurocognitive abilities compared to children of the same age level despite the use of multiple anti-epileptic therapies. BEDFORD, Mass.–(

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