The Pharma Data

OCTOBER 9, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. FDA is anticipated in late 2022. A decision from the U.S.

FDA Approval 52

FDA Approval FDA Treatment Pharmaceutical Companies 52

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%)

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

Drug Discovery World

MARCH 7, 2023

In 2023, the company revealed data from a Phase III trial which showed that its vaccine candidate DCVax-L more than doubled overall survival in glioblastoma patients. Dr Bouarfa is the founder and CEO of OKRA.ai, an artificial intelligence (AI) company for life sciences. Dr Loubna Bouarfa, Founder and CEO, OKRA.ai

International 246

International Science Pharmaceuticals DNA 246

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.

FDA Approval 52

FDA Approval Treatment FDA DNA 52

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.

Science 145

Science Disease FDA Approval Pharmaceutical Companies 145

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.

FDA Approval 52

FDA Approval FDA Treatment Pharmaceutical Companies 52

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.

FDA Approval 52

FDA Approval FDA Clinical Development Clinical Research 52

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.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

Drug Discovery World

JULY 2, 2024

Then, in 2013, Roche gained FDA approval with breakthrough therapy designation for its chronic lymphocytic leukaemia agent obinutuzumab (Gazyva/Gazyvaro) which was discovered at Roche Glycart, and as a result, the new drug generated CHF 730 ($821) million revenue in 2022.

Science 147

Science Drugs Clinical Trials Licensing 147

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.

Vaccine 52

Vaccine FDA FDA Approval Pharmaceutical Companies 52

Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. With these exceptions, no other cannabis, cannabis-derived, or cannabidiol (CBD) products are FDA-approved and therefore on the market 1. Across the border in Canada, cannabis is legal for both recreational and medicinal purposes.

Clinical Trials 130

Clinical Trials Regulations Production FDA 130

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.

FDA 52

FDA Treatment Pharmaceutical Companies FDA Approval 52

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. .

FDA 52

FDA Clinical Trials Drugs Pharmaceutical Companies 52

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.

Treatment 52

Treatment Pharmaceutical Companies Pharmaceuticals FDA Approval 52

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.

Small Molecule 52

Small Molecule Therapies FDA Approval Trials 52

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.

Pharmaceutical Companies 52

Pharmaceutical Companies FDA Approval Clinical Trials Pharmaceuticals 52

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.

Packaging 52

Packaging FDA Regulations Trials 52

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.

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

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.

Clinical Trials 40

Clinical Trials FDA Approval Pharmaceutical Companies Treatment 40

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.

Vaccine 52

Vaccine Clinical Trials FDA Hospitals 52

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 .

RNA 52

RNA Protein Expression Therapies Disease 52

The Pharma Data

OCTOBER 21, 2020

The pooled analysis examined 1,744 participants across 16 countries currently taking long-acting cabotegravir and rilpivirine as part of the regimen’s ongoing global clinical development programme of six studies, which includes the phase IIb/IIIb LATTE-2, ATLAS, ATLAS-2M, FLAIR, POLAR, and CUSTOMIZE clinical trials. Source: GSK .

Clinical Development 52

Clinical Development Therapies Clinical Trials FDA Approval 52

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.

Treatment 52

Treatment Pharmaceutical Companies Therapies Pharmaceuticals 52

Drug Discovery World

AUGUST 10, 2023

Achieve Life Sciences is a specialty pharmaceutical company committed to addressing the global smoking health and nicotine addiction epidemic through the development and commercialisation of cytisinicline. As such, the company has achieved some key milestones this year. What comes next for Achieve?

FDA Approval 130

FDA Approval Clinical Trials Drugs FDA 130

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.

Small Molecule 52

Small Molecule RNA Clinical Trials Drugs 52

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.

Small Molecule 40

Small Molecule Licensing Licensing Clinical Trials 40

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.

Treatment 52

Treatment Trials FDA Approval Pharmaceutical Companies 52

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.

FDA 40

FDA Treatment FDA Approval Drugs 40

The Pharma Data

FEBRUARY 25, 2022

Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. and Europe.

FDA Approval 52

FDA Approval FDA Hospitals Clinical Trials 52

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

Licensing 40

Licensing Licensing Therapies Laboratories 40

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.

FDA 52

FDA Drugs Clinical Development Pharmaceutical Companies 52

The Pharma Data

MAY 27, 2022

Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah ® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.

FDA Approval 52

FDA Approval Therapies FDA Treatment 52

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.

FDA Approval 52

FDA Approval Treatment RNA FDA 52

Drug Discovery World

JANUARY 11, 2023

Phase III trial results showed superior skin clearance outcomes than existing treatments. Positive data have emerged from early-phase trials, with clinical benefit to patients irrespective of their PIK3CA/AKT1/PTEN mutational status, and several Phase III trials are now underway. . Bimekizumab (BIMZELX) developed by UCB.

Drugs 130

Drugs Pharmaceuticals Trials Treatment 130

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.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

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.

Pharmaceutical Companies 52

Pharmaceutical Companies FDA Approval Pharmaceuticals FDA 52

Drug Discovery World

SEPTEMBER 16, 2022

In 2021, the Cell and Gene Therapy Catapult estimated that there 168 ongoing clinical trials for advanced therapy medicinal products (ATMPs) taking place – representing 9% of all global trials in the space. The UK stands as one of the key markets for cell and gene therapies. billion in funding. .

Therapies 130

Therapies Clinical Trials Production Trials 130