The Pharma Data

DECEMBER 20, 2020

Followed by Russia , Indonesia, and Korea, the second phase of the COVID-19 clinical trial was approved in Italy on Friday, December 18, 2020. Currently, it is smoothly progressing with the approval for Phase 2 clinical trials in four countries, and it is expected to see the results sequentially starting as early as the third quarter of 2021.

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The Pharma Data

DECEMBER 17, 2020

18, 2020 /PRNewswire/ — Camurus AB (NASDAQ STO: CAMX) announced today that the Swiss agency for therapeutic products, Swissmedic, has approved weekly and monthly Buvidal ® prolonged release buprenorphine for the treatment of opioid dependence in adults and adolescents from 16 years of age. LUND, Sweden , Dec. About Buvidal.

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The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. WAKEFIELD, Mass.,

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PPD

MARCH 21, 2024

When participating in clinical trials, pediatric populations require distinct considerations for their safety and well-being — which can present unique challenges for drug developers. Five Strategies to Tailor Your Pediatric Clinical Trials to the Child’s Needs 1.

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The Pharma Data

OCTOBER 19, 2020

(NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that the Company’s U.S. Phase 2 trial for Berubicin during the first quarter of 2021.”

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The Pharma Data

JANUARY 17, 2021

This coverage provides a minimally invasive treatment alternative for eligible patients. “Not being able to breathe really limits the ability of patients to go about their daily lives, and for those who qualify for the treatment, endobronchial valves can make a big difference.” . CENTER VALLEY, Pa. ,

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The Pharma Data

NOVEMBER 15, 2020

16, 2020 /PRNewswire/ –: iSTAR Medical , a medtech company developing minimally invasive ophthalmic implants for treatment of patients with glaucoma, today announced positive one-year results from the European STAR-II clinical trial of its micro-invasive glaucoma surgery (MIGS) device, MINIject TM. WAVRE, Belgium , Nov.

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The Pharma Data

JANUARY 20, 2021

21, 2021 /PRNewswire/ — Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX: CALTX) (NASDAQ: CALT) today announced that all 360 patients have been enrolled for the global Phase 3 clinical trial NefIgArd, which investigates the effect of Nefecon® versus placebo in patients with primary IgA nephropathy (IgAN).

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The Pharma Data

JANUARY 17, 2021

a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, today announced dose administration for the first patient in a Phase 2a clinical study of the company’s lead drug candidate, STP705, for the treatment of cutaneous basal cell carcinoma. GAITHERSBURG, Md.

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The Pharma Data

OCTOBER 16, 2020

As pharma companies search for solutions to avoid cancelling or delaying clinical trials, virtualizing trials are fast becoming commonplace during the Covid-19 pandemic. With many nationwide and regional lockdowns coming into force, virtual clinical trials are proving to be an effective way to monitor patients remotely.

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Conversations in Drug Development Trends

JUNE 13, 2024

Pharmacogenomics (PGx), the study of how genes affect a person’s response to drugs, has brought significant changes to the clinical trial industry. This groundbreaking approach can help tailor medical treatments to an individual’s genetic makeup, considerably enhancing drug efficacy and safety while minimizing adverse drug reactions.

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The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. About Pegunigalsidase Alfa.

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The Pharma Data

OCTOBER 25, 2020

for the treatment of severe vernal keratoconjunctivitis (VKC) in patients ages 4-18. “We look forward to working with the FDA during the review process and are optimistic this treatment could provide much needed symptom relief for those affected so they may better engage in their daily activities.” .

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The Pharma Data

JANUARY 13, 2021

Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA. View original content to download multimedia: [link]. . NEW YORK , Jan. MindMed Co-CEO J.R.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has cleared Armata’s IND to initiate a clinical trial of its lead therapeutic candidate, AP-PA02, in Pseudomonas aeruginosa infections. . “Results from this study, which we are calling SWARM- P.a. The SWARM- P.a. About Armata Pharmaceuticals, Inc.

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The Pharma Data

JANUARY 17, 2021

The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA. The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day.

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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The ChEMBL-og

MARCH 8, 2023

ChEMBL contains information on drugs that have been approved for treatment of a specific disease / diagnosis (an indication) within a region of the world (e.g. FDA drugs are approved for use in the United States), and clinical candidate drugs that are being investigated for an indication during the clinical trials process.

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The Pharma Data

OCTOBER 19, 2020

is pleased to announce approval from Health Canada to proceed to a Phase 1 clinical trial with its lead asset, a long-acting anesthetic formulation for the treatment of post-surgical pain. View original content to download multimedia: [link]. TORONTO , Oct. 20, 2020 /PRNewswire/ – AmacaThera Inc. SOURCE AmacaThera Inc.

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The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. and 2 trials planned by our sublicensee WPD in Poland. . and 2 trials planned by our sublicensee WPD in Poland.

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The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About Cantargia.

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The Pharma Data

JANUARY 9, 2021

(NASDAQ: BMRN) today announced positive topline results from its ongoing global Phase 3 GENEr8-1 study of valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A. 80% of participants were bleed-free starting at week five after treatment. median 2.8) at baseline to 0.8

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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. One step closer to a novel treatment.

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The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

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The Pharma Data

JANUARY 31, 2021

The practice offers standard and advanced therapeutics including chemotherapy, biologic therapy immunotherapies and radiopharmaceuticals along with a total complement of radiation oncology treatment options, including proton therapy, brachytherapy, and radiosurgery. View original content to download multimedia: [link]. Source link.

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The Pharma Data

OCTOBER 19, 2020

Caris’ collaborative network focused on expanding the application of precision medicine in oncology supports Winship’s enterprising approach to research leading to transformative discoveries in cancer care and treatment. The NCTN serves as the NCI’s primary infrastructure to conduct phase II and III clinical trials.

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The Pharma Data

JANUARY 6, 2021

Quantitative imaging of CD8 T cells enables quicker identification of drug efficacy, therefore potentially reducing the length of clinical trials, reducing costs and helping new therapies to advance to market faster, which ultimately will improve treatment and care of cancer patients. SOURCE ImaginAb, Inc. Source link.

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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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Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time.

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The Pharma Data

JANUARY 22, 2021

Food and Drug Administration (FDA) approved the use of Aurinia Pharmaceuticals’ Lupkynis TM (voclosporin) as the first oral treatment developed specifically for adults with active lupus nephritis (LN) in combination with standard of care. NEW YORK , Jan.

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The Pharma Data

JANUARY 27, 2021

“The responses observed in six out of nine patients are very encouraging and clearly suggest that BI-1206 may restore the response to rituximab in patients who have few treatment alternatives. . (Nasdaq: CASI), a U.S. CEO of BioInvent. CEO of BioInvent. Wei-Wu He , Ph.D.,

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PPD

OCTOBER 12, 2023

These treatments use a vector to introduce the desired nucleic acid code to replace or modify protein expression or use cells to alter/restore a specific cell type. There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025.

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The Pharma Data

DECEMBER 16, 2020

Last year, GSK announced positive results from a two-year clinical trial involving several hundred people with active lupus nephritis treated with Benlysta. Effective treatment can greatly improve health outcomes and reduce the long-term costs associated with managing lupus-related kidney disease.”

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The Pharma Data

NOVEMBER 4, 2020

CTP-543: An Investigational Treatment for Moderate to Severe Alopecia Areata. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The trial will evaluate 8 mg and 12 mg twice-daily doses of CTP-543 compared to placebo at sites in the U.S., 692 Phase 2 trial was fully enrolled. Canada and Europe.

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The Pharma Data

DECEMBER 2, 2020

Abemaciclib is a cyclin dependent kinase (CDK) 4 & 6 inhibitor used in the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. View original content to download multimedia: [link]. . PLYMOUTH MEETING, Pa. , .

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The Pharma Data

JANUARY 26, 2021

which is evaluating the Company’s lead phage product candidate, AP-PA02, as a potential treatment for Pseudomonas aeruginosa airway infections in cystic fibrosis patients, as well as for general working capital. trial in late 2021/early 2022. View original content to download multimedia: [link].

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PPD

NOVEMBER 21, 2023

Clinical Development in the Biopharma and Biotech Arenas in 2023 Trial design approaches highlight differing priorities Thanks to the rapid development of novel cell and gene therapy approaches to treat cancer, oncology continues to dominate drug development pipelines.

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