The Pharma Data

SEPTEMBER 1, 2021

Approval is backed by nearly two decades of proven efficacy and safety of Janssen’s long-acting injectable portfolio of schizophrenia medicines. The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. About the Clinical Trial. Results found that 92.5 1 The most common adverse reactions (?5%)

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The Pharma Data

NOVEMBER 23, 2021

Livtencity’s safety and efficacy were evaluated in a Phase 3, multicenter, open-label, active-controlled trial that compared Livtencity with a treatment assigned by a researcher running the study, which could include one or two of the following antivirals used to treat CMV: ganciclovir, valganciclovir, foscarnet or cidofovir.

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, Pa.

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Drug Target Review

JANUARY 8, 2024

We hope to initiate the first human clinical trials with our lead indications in 2025, which would represent a monumental step forward for the field of cellular rejuvenation. a commercial stage pharmaceutical company. a clinical-stage private biopharma company developing therapies for neurological and psychiatric diseases.

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The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. . HELLERUP, Denmark , Jan.

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Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Food and Drug Administration (FDA) approval. The FDA Since 1983.

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Drug Target Review

SEPTEMBER 19, 2023

The US FDA Modernisation Act 2.0., puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Pharmaceutical companies adapted the usage of organoids derived from specific patient derived tumours in cancer drug screening process for testing drug toxicities and efficacy.

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The Pharma Data

NOVEMBER 9, 2021

Johnson & Johnson and its Janssen Pharmaceutical Companies moment blazoned they will appeal the$ 572 million civil judgment entered in Cleveland County District Court in the State of Oklahoma’s action against opioid manufacturers. The Company is confident it has strong grounds to appeal this decision.

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The Pharma Data

SEPTEMBER 23, 2020

It will ask manufacturers who seek an emergency authorisation to follow participants in late-stage clinical trials for a median of at least two months, beginning when they received a second vaccine shot, according to two people who spoke to The Post anonymously. . Conor Kavanagh. Source link.

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The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.

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Drug Target Review

AUGUST 3, 2023

Clinical trials are now underway for various genetic subtypes of both rare and common diseases, on the understanding that medications utilising genetic biomarkers have a significantly higher chance of success. There are clinical trials underway for genetic subtypes of rare and common diseases.

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The Pharma Data

APRIL 27, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that that the U.S. The NDA for mobocertinib is primarily based on results from the Phase 1/2 trial , which is evaluating the safety and efficacy of oral mobocertinib in patients with mNSCLC. About the Phase 1/2 Trial.

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The Pharma Data

DECEMBER 8, 2020

OSAKA, Japan–( BUSINESS WIRE )– As part of its Wave 1 Pipeline Market Opportunity Call, Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) provided an update on its pipeline portfolio, which has the potential to contribute significantly to revenue growth for the company over the next decade.

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The Pharma Data

DECEMBER 28, 2020

Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .

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The Pharma Data

MARCH 26, 2021

If approved, ponesimod will be the first therapy by Janssen for patients living with RMS with active disease defined by clinical or imaging features. 1 The Phase 3 study showed superior efficacy of ponesimod 20mg on the primary endpoint, annualised relapse rate (ARR), with a rate reduction of 30.5% (p=0.0003) compared with teriflunomide.

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Codon

NOVEMBER 3, 2024

Still, while these developments provide cause for hope, each drug or vaccine faces a variety of challenges, ranging from financial incentives for clinical trials to the difficulty of discovering new antimicrobials that pass safety and efficacy tests. A phase 3 clinical trial for M72/AS01E, funded by the Gates Foundation, began this year.

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The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx ®.

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The Pharma Data

JANUARY 19, 2021

So far, one patient in the trial experienced a complete remission at a 100 mg dosage, and another patient at the 200 mg dosage, even after failing seven previous therapies. Although that Phase II trial is closed to enrollment, a new trial is now enrolling patients with a goal to generate data to support FDA approval for tipifarnib.

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The Pharma Data

JANUARY 13, 2021

Nasdaq: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders and diseases, today announced that it has priced an underwritten public offering of 5,000,000 shares of its common stock at a price to the public of $2.50 SOLANA BEACH, Calif., 13, 2021 (GLOBE NEWSWIRE) — Evoke Pharma, Inc.

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Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. Also consider CRO oversight, trial management, data handling and record keeping, as well as allocation of responsibilities.

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The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations.

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The Pharma Data

JANUARY 17, 2021

Guardant Health’s liquid biopsy tests have been extensively used in clinical trials with over 200 peer-reviewed publications demonstrating its benefits to patients. Guardant Health has achieved CE mark approval as well as U.S.

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The Pharma Data

MARCH 2, 2021

Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.

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The Pharma Data

DECEMBER 8, 2020

Silverback’s lead candidate is currently in a Phase I trial in adults with HER2-expressing solid tumors. The fully integrated pharmaceutical company creates value through China’s specialty pharmaceutical markets with focus on iron deficiency, pain management and respiratory. Nuance Pharma .

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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. 6] ERLEADA ® is being studied in five Phase 3 registrational clinical trials. About the Janssen Pharmaceutical Companies of Johnson & Johnson. ERLEADA ® received U.S.

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The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. All rights reserved.

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Dark Matter Blog

AUGUST 27, 2020

In addition to the early work of Matt Disney at the Scripps Research Institute and others in the academic community showing that this was even possible, a number of pharmaceutical companies have made important advances towards drugging RNA structures to discover new therapeutics.

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The Pharma Data

NOVEMBER 30, 2020

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

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The Pharma Data

AUGUST 31, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today multiple company-sponsored presentations in prostate and bladder cancers will be highlighted at the virtual 2021 American Urological Association Annual Meeting (AUA 2021), September 10-13. 2] ERLEADA ® received U.S.

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The Pharma Data

DECEMBER 8, 2020

Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. The granting of an orphan drug designation request does not alter the standard regulatory requirements and process for obtaining marketing approval.

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announces new initiatives to help COVID-19 patients in India as part of its commitment to bring the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Increases of ALT ?5x

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The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. Toronto, Ontario–(Newsfile Corp.

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SugarCone Biotech

MAY 28, 2019

Venture capital firms and pharmaceutic companies that perform ‘wet diligence’ have consistently concluded that 2/3rds of the results in the literature are not reproducible (wet diligence refers to the hiring of an independent lab to repeat published experiments).

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The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). TITUSVILLE, N.J. , Global Head, Janssen Research & Development, Johnson & Johnson.

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Codon

MARCH 24, 2024

by the time Bancel made it over to Flagship, where Afeyan delivered his pitch: He wanted Bancel to work on a startup that had so far hired only a single staff scientist and conducted just one mouse trial. To make matters worse, many companies struggled with engineering problems on the path to scale. . “It was about 6 p.m.

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Codon

JUNE 18, 2024

Credit: Mikhail Shapiro Just consider a pharmaceutical company that wants to test whether an engineered immune cell, such as those used for CAR-T therapy , can detect and destroy cancer cells. At least six types of CAR-T cells have already passed through clinical trials and garnered FDA approval.

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Agency IQ

OCTOBER 27, 2023

Date What’s Happening Explanation Source October 31 FDA deadline on Florida drug importation plan The FDA has said in court filings that it plans to make a ruling on Florida’s prescription drug importation plan by October 31. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

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