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. Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. chief medical officer of Loxo Oncology at Lilly. The primary endpoint for Phase 2 is ORR.

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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. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. Preclinical data show SLV213 is a potent inhibitor of SARS-CoV-2 infection.

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The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec.

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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. Zai Labs obtained regional development and commercialization rights for the programs in mainland China, Hong Kong, Macau and Taiwan.

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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

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

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. A Phase 2b study was initiated in July 2019 (ICONA) to study the efficacy of icosabutate in NASH.

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Drug Target Review

JULY 1, 2024

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. He is spearheading the scientific and clinical development and fundraising of South Rampart Pharma and technology development efforts.

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The Pharma Data

DECEMBER 29, 2020

30, 2020 /PRNewswire/ — Protalix BioTherapeutics, Inc. an international research-focused healthcare Group (Chiesi Group), today announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease. CARMIEL, Israel and BOSTON , Dec.

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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. “We Pipeline Updates.

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The Pharma Data

MARCH 26, 2021

In October 2020, based on a positive evaluation of safety and tolerability data of VIR-7831 from the lead-in part of the trial by an Independent Data Monitoring Committee, the trial began enrolling patients in North America and additional sites in South America and Europe in the global Phase 3 portion of the trial.

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The Pharma Data

OCTOBER 14, 2020

Priothera will use the funds to progress the clinical development of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogeneic hematopoietic stem cell transplantation (HSCT) for treating AML. 1. -- -->. -- [if lte IE 8]--> .

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PPD

MAY 11, 2023

The Many Considerations of Elderly Vaccine Clinical Trials Vaccine development is just as important at the other end of the age spectrum. According to a report from the World Health Organization the global population of those age 60 and older reached 1 billion in 2020. By 2050, that number is expected to more than double to 2.1

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The Pharma Data

OCTOBER 25, 2020

26, 2020 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (“BTI” In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. NEW HAVEN, Conn.,

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Metabolite Tales Blog

APRIL 4, 2023

The Pharmacokinetics, Metabolism, and Clearance Mechanisms of Abrocitinib, a Selective Janus Kinase Inhibitor, in Humans. Identification of the Clinical Development Candidate MRTX849, a Covalent KRASG12C Inhibitor for the Treatment of Cancer. Acta Pharm Sin B. 2018 Sep;8(5):721-732. link] [3] Bauman et al., J Am Acad Dermatol.

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The Pharma Data

AUGUST 29, 2020

Basel, August 29, 2020 — Novartis today announced new Phase II data for LNP023, an investigational oral treatment for paroxysmal nocturnal hemoglobinuria (PNH), presented at the virtually held 2020 European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting.

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Metabolite Tales Blog

JANUARY 23, 2024

Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development. Pharmacokinetics and Metabolism of Nirmatrelvir. [link] [9] Patent EP1242061B1. link] [10] FDA prescribing information for gepirone. link] [11] Zheng et al., Blood 129(13): 1823-1830.

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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. Safety was consistent with published data.

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The Pharma Data

JANUARY 3, 2021

The clinical study was completed in collaboration with scientific teams at the Harvard Medical School (Boston, USA), Santa Casa de Misericórdia de Santos Hospital (Santos, Brazil) and INTRIALS, a world-class, full-service Latin American CRO based in São Paulo, Brazil.

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The Pharma Data

DECEMBER 13, 2020

14, 2020 07:00 UTC. The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. The Phase 2b trial is expected to begin during the second half of 2021. NASH Investor Event Information.

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The Pharma Data

OCTOBER 18, 2020

19, 2020 (GLOBE NEWSWIRE) — Aptose Biosciences Inc. SAN DIEGO and TORONTO, Oct. This press release contains forward-looking statements within the meaning of Canadian and U.S.

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The Pharma Data

MAY 7, 2021

About the Sotrovimab Clinical Development Program. In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. About the Vir and GSK Collaboration. Vir’s Commitment to COVID-19. Vir Forward-Looking Statements.

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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. ,

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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). Monitor open growth plates in adolescent patients. About Lilly Oncology.

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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 secondary outcome involves pharmacokinetic endpoints. The primary outcome includes safety and tolerability endpoints. Receptor Inhibitors.

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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. When should this occur? at the end-of-phase 2 meeting).

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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. BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development?

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Agency IQ

SEPTEMBER 15, 2023

However, the Coronavirus Aid, Relief, and Economic Security (CARES) Act) of 2020 included provisions to overhaul OTC drug regulation. The committee also made recommendations regarding pharmacokinetic and safety assessments. If no, discuss what additional data, if any, are needed to assess phenylephrine pharmacokinetics or efficacy.

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Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. million deaths, or 23%, were due to cancer in 2020. were from cancer.

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The Pharma Data

SEPTEMBER 27, 2020

Basel, 28 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new 2-year data from Part 1 of the pivotal FIREFISH study of Evrysdi (risdiplam) in infants aged 2-7 months with symptomatic Type 1 spinal muscular atrophy (SMA). 59% of infants were able to sit without support for at least 5 seconds.

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The Pharma Data

MARCH 16, 2021

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Food and Drug Administration (FDA) approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older in August of 2020. and 10%, respectively), nasopharyngitis (21.7%

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FDA Law Blog: Drug Discovery

JULY 9, 2024

DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety.

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The Pharma Data

SEPTEMBER 1, 2020

Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod. Author: Minton. Presentation Number: P1133. Presentation Topic: Reproductive Aspects and Pregnancy.

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Metabolite Tales Blog

NOVEMBER 13, 2024

Aficamten (CK-3773274) is a cardiac myosin inhibitor currently in phase 3 clinical development to treat this inherited disorder. References [1] Pharmacokinetics, disposition, and biotransformation of the cardiac myosin inhibitor aficamten in humans. Drug Metabolism and Disposition April 1, 2020, 48 (4) 317-325; DOI: [link]. [5]

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