Drug Discovery World

FEBRUARY 9, 2023

Launched in 2020, the Oxford-based business hopes the designation will “open regulatory discussions, supplement funding, increase the viability of drug development and enable quick access to market a treatment.” SynaptixBio CEO and co-founder Dr Dan Williams said the designation was a “monumental step forward” in its bid to treat the disease. “To

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Drug Discovery World

AUGUST 2, 2022

Biotechnology company Calidi Biotherapeutics has announced that a Phase I US clinical trial will use the company’s licensed oncolytic virotherapy platform NeuroNova to deliver an oncolytic adenovirus selectively to tumor sites in patients with recurrent high-grade glioma. . Official comments . Worldwide,?an survival of ?less

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Drug Discovery World

DECEMBER 6, 2022

Myeloma Patients Europe (MPE) has launched an advocacy report on addressing access barriers to myeloma clinical trials in Central and Eastern Europe (CEE). . The MPE report presents clinical trial analytics, looking at the number of clinical trials held in CEE countries between 1 January 2001 and 28 September 2020.

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Drug Discovery World

NOVEMBER 16, 2023

Casgevy (exagamglogene autotemcel, or exa-cel) is the first medicine to be licensed that uses gene editing tool CRISPR, for which its inventors were awarded the Nobel Prize in 2020. To date, a bone marrow transplant – which must come from a closely matched donor and carries a risk of rejection – has been the only permanent treatment option.

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Drug Discovery World

SEPTEMBER 21, 2022

Otsuka Pharmaceutical’s Lupkynis (voclosporin) is the first oral treatment to be approved in Europe for the treatment of active lupus nephritis (LN) in adult patients. The combination treatment for this indication was approved by the US Food and Drug Administration in 2021 and gained a positive opinion from the CHMP earlier this year.

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The Pharma Data

NOVEMBER 30, 2020

The UK-based RECOVERY trial, which is evaluating multiple treatments for COVID-19, will add the inexpensive anti-inflammatory drug colchicine to the list of therapies being tested in hospitalized patients.

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Drug Discovery World

FEBRUARY 28, 2024

According to the American Association of Cancer Research (AACR) 2 , research-driven advances in treatments have resulted in the decline in death rates for melanoma, leukaemia, and kidney cancer. Currently, all antibodies approved for the treatment of cancer belong to a class known as IgG. Research into new cancer drugs remain strong.

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Drug Discovery World

JANUARY 24, 2023

Virtual clinical trials ‘Virtual’ and ‘technology’ are concepts which are readily exchanged in this industry, but these are more than just buzzwords. The overall virtual clinical trials market is currently valued at $7.8 In early November 2022, two Alzheimer’s drugs were tested head-to-head in a first-ever virtual clinical trial 3.

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Eye on FDA

JANUARY 6, 2021

During 2020, FDA was able to approve 53 – not surpassing the 2018 all time record of 59, but certainly an admirable second place. Notably, the 2020 NME approvals included 22 related to oncology, with 2 new GIST treatments, 3 in breast cancer and 2 approvals in prostate cancer. That, however, was not really the case.

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The Pharma Data

NOVEMBER 12, 2020

13, 2020 10:00 UTC. The DETOUR1 trial is the first-in-man trial of the FDA-designated Breakthrough Device, The Detour System, evaluating the safety and effectiveness of the novel procedure and device system for treating long, complex lesions in the superficial femoral artery (SFA). MILPITAS, Calif.–(

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Drug Discovery World

MAY 3, 2024

SynOx Therapeutics has closed a $75m Series B financing round, which will be used to generate registrational Phase III clinical and CMC data for emactuzumab, the company’s potentially best-in-class CSF-1(R) inhibiting monoclonal antibody (mAb) for the treatment of tenosynovial giant cell tumour (TGCT).

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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. Prior to this, the safety of hzVSF-v13 was confirmed in the Phase 1 clinical study in Korea and another Phase 1 clinical trial is under way in Australia. CHUNCHEON, South Korea , Dec.

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Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?

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Drug Discovery World

APRIL 3, 2024

While the age-adjusted overall cancer death rate in the US fell by 33% between 1991 and 2020, cancer remains a significant threat to human health, with more than two million new cases expected to be diagnosed in 2024 and uneven progress across different cancer types 1.

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Drug Discovery World

OCTOBER 18, 2023

We’re beginning to see their potential come to fruition, with the FDA having approved three treatments as of January 2023 — for retinal dystrophy 1 spinal muscular atrophy, 2 and haemophilia B. 4 Unfortunately, many AAV-based gene therapies fail during clinical trials, despite them appearing safe and efficacious in preclinical studies.

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The Pharma Data

DECEMBER 1, 2020

Rapid and substantialimprovement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with long-term treatment. 02, 2020 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. . 02, 2020 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. NEW YORK, Dec.

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The Pharma Data

OCTOBER 26, 2020

The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has halted a clinical trial evaluating Eli Lilly’s investigational monoclonal antibody, LY-CoV555 (bamlanivimab), in combination with remdesivir for the treatment of COVID-19 patients. The trial was paused earlier this month due to a safety issue.

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The Pharma Data

NOVEMBER 4, 2020

5, 2020 11:00 UTC. NASDAQ: CNCE) today reported financial results for the third quarter of 2020. Our team has diligently and effectively executed on our plan, and I’m pleased that we have achieved our stated 2020 pipeline milestones. CTP-543: An Investigational Treatment for Moderate to Severe Alopecia Areata.

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Drug Discovery World

OCTOBER 9, 2023

Despite the size of the market and the global impact, there are currently no effective treatments. The reported MOD framework advances the mechanistic rationale of the clinical benefits on fatigue observed in our clinical trial with AXA1125 in the context of the combination’s mechanism of action. Can you explain how it works?

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The Pharma Data

DECEMBER 14, 2020

Researchers with the UK’s multi-armed RECOVERY trial have determined that the widely used antibiotic azithromycin was not beneficial for patients hospitalized with COVID-19 and are discontinuing their evaluation of the drug. Further results from the other arms of the trial are anticipated “over the next couple of months,” Horby said.

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The Pharma Data

SEPTEMBER 1, 2020

Daiichi Sankyo has unveiled promising new benefit for Nilemdo (bempedoic acid) at the ESC Congress 2020 over the weekend for the management of low-density lipoprotein cholesterol (LDL-C) when added to other standards of care. In this extension trial, 970 participants received Nilemdo and 492 received placebo.

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The Pharma Data

OCTOBER 20, 2020

20, 2020 — British scientists are infecting healthy volunteers with COVID-19, in hopes of speeding up vaccine development, TheWashington Post reported Tuesday. Led by scientists at Imperial College London, people in this challenge trial will be guaranteed treatment if they become ill. © 2020 HealthDay. TUESDAY, Oct.

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The Pharma Data

OCTOBER 22, 2020

CRISPR Therapeutics has reported positive results for a phase 1 study evaluating CTX110, its chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed or refractory nonHodgkin’s lymphoma in patients who have received at least two prior lines of therapy. Source link.

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The Pharma Data

OCTOBER 26, 2020

27, 2020 /PRNewswire/ — Synlogic, Inc. Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced the Company will release its third quarter 2020 financial results before the market opens on Thursday, November 5, 2020. CAMBRIDGE, Mass. ,

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The Pharma Data

JANUARY 17, 2021

The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. In October 2020 , Grifols, together with other companies and various U.S.

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The Pharma Data

NOVEMBER 2, 2020

CHARLOTTESVILLE, VA / ACCESSWIRE / November 3, 2020 / ADial Pharmaceuticals , Inc. NASDAQ:ADIL; ADILW) , a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today provided an update on its landmark ONWARD Phase 3 pivotal trial.

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The Pharma Data

JANUARY 21, 2021

“Silmitasertib’s mechanism of action by CK2 inhibition is a unique pathway to target a SARS-CoV-2 infection which is a promising approach to combating COVID-19,” said Dr. Marilyn Glassberg Csete, the Principle Investigator of this BUMCP IIT trial. Dr. Recknor’s trial enrolled their first patient on December 3, 2020.

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The Pharma Data

DECEMBER 17, 2020

COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could hinder the collection of meaningful trial data. Pfizer, which has received emergency approvals in the U.S.

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The Pharma Data

OCTOBER 26, 2020

British drugmaker Evgen Pharma has won approval to start a late-stage clinical trial in the UK to evaluate its respiratory treatment, SFX-01, for COVID-19 patients.

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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

NOVEMBER 16, 2020

17, 2020 11:00 UTC. has sponsored and funded a new FDA Oversight Trial that seeks to restore respiratory function in adults who have suffered lung damage from the COVID-19 virus. Alexander, MD, DMD, FICS is the Principal Investigator, and his office is recruiting patients for enrollment in the trial. Alexander, MD, DMD, FICS.

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The Pharma Data

DECEMBER 8, 2020

The FDA has issued a clinical hold on Bellicum Pharmaceuticals for its ongoing phase 1/2 trial evaluating CAR-T therapy BPX-601 in patients who received prior treatment for metastatic pancreatic or prostate cancer, following the death of a trial participant. The Houston, Tex., The Houston, Tex., Source link.

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The Pharma Data

DECEMBER 15, 2020

Less Invasive Treatment Feasible for Early-Stage Rectal Cancer. 15, 2020 — Short-course radiotherapy followed by transanal endoscopic microsurgery for early-stage rectal cancer (TREC) achieves a high level of organ preservation and improved quality of life, according to a study published online Dec. © 2020 HealthDay.

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. 22, 2020– Gilead Sciences, Inc. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. FOSTER CITY, Calif.–(BUSINESS

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The Pharma Data

OCTOBER 26, 2020

27, 2020 10:45 UTC. –( BUSINESS WIRE )– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2020. 2020. for the third quarter of 2020. 2020. for the third quarter of 2020. .

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The Pharma Data

OCTOBER 27, 2020

Trial of Antibody Drug for COVID-19 Stopped for Lack of Effectiveness. 27, 2020 — Testing of the Eli Lilly antibody drug for hospitalized COVID-19 patients has been halted because the treatment does not help them recover from their infection. © 2020 HealthDay. Posted: October 2020. Professional. TUESDAY, Oct.

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National Institute on Drug Abuse: Nora's Blog

JULY 22, 2024

People with an opioid use disorder (OUD) urgently need treatment not just to protect them from overdosing but also to help them achieve recovery, but highly effective medications like buprenorphine and methadone remain underused. Almost all (99%) of those retained in treatment achieved remission.

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