The Pharma Data

SEPTEMBER 11, 2021

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction. vice president, Product Development, Lilly.

Therapies 52

Therapies FDA Hospitals FDA Approval 52

The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

Drug Discovery World

OCTOBER 16, 2023

A company within this ecosystem is STORM Therapeutics, a clinical stage biotechnology company creating novel small molecule therapies that inhibit RNA modifying enzymes (RME) for use in oncology and other diseases. billion in funding. Northern Ireland “Northern Ireland is a medtech super-hub,” says Saleko.

Drugs 189

Drugs Science Therapies Targeted Protein Degradation 189

Drug Discovery World

MAY 6, 2024

A more established Amsterdam-based enterprise is gene therapy company uniQure, developer of etranacogene dezaparvovec, the first gene therapy for haemophilia B, which was approved for use in the US in November 2022 and in the EU in February 2023. The CDD will sponsor and manage KWF-supported trials.

Drugs 147

Drugs Molecular Biology Science Clinical Trials 147

Drug Discovery World

JULY 2, 2024

They developed the molecule, which went on to become Tracleer, a blockbuster drug for pulmonary arterial hypertension (PAH), and Actelion was subsequently acquired by Johnson & Johnson for $30 million. In 2005, Glycart was acquired by the Roche Group and integrated in Roche Pharma Research and Early Development (pRED).

Science 147

Science Drugs Clinical Trials Licensing 147

The Pharma Data

JANUARY 20, 2021

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. This patient population is at significant risk of developing cardiovascular complications, which are frequently fatal, during their illness.

Hospitals 52

Hospitals Trials International Clinical Trials 52

The Pharma Data

DECEMBER 17, 2020

(NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. and Roche will develop, manufacture and distribute it outside of the U.S.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

Drug Discovery World

JULY 3, 2023

Dr Agapitos Patakas, CSO, Research & Development, Antibody Analytics, presented in this track on a customisable cell line platform for in vitro assessment of safety and efficacy of immune cell-directed therapies.

Engineering 130

Engineering Virus Therapies Treatment 130

Drug Discovery World

AUGUST 28, 2023

What is the potential for this type of therapy in treating other neurodegenerative disorders? DS: Why do you think there haven’t been any therapies targeting autophagy before? Could therapies like these treat rare genetic conditions? What impact could autophagy inducing therapies have on lifespan? LinkedIn profile.

Disease 130

Disease Science Clinical Trials Therapies 130

Cytel

FEBRUARY 20, 2024

Negative binomial probability distribution can be used to model the number of times a particular outcome occurs during a clinical trial.

Clinical Trials 59

Clinical Trials Hospitals Trials Therapies 59

Drug Target Review

DECEMBER 28, 2023

In most cancers, the tumour evolves by acquiring mutations that confer growth advantages or resistance to therapies. Involving more than 250 investigators based at 19 hospital sites across the UK, the study has analysed genetic signatures in lung tumours, tracking how they have evolved over the past nine years in more than 815 patients.

Bioinformatics 104

Bioinformatics Immune Response DNA Vaccine 104

The Pharma Data

MARCH 17, 2022

Merck has an extensive clinical development program in lung cancer and is advancing multiple registration-enabling studies, with research directed at earlier stages of disease and novel combinations. Key studies in earlier stages of NSCLC include KEYNOTE-091, KEYNOTE-671, KEYNOTE-867 and KEYLYNK-012.

Therapies 52

Therapies Clinical Trials Disease Trials 52

Drug Discovery World

SEPTEMBER 16, 2022

Here, DDW Editor Reece Armstrong explores the global hubs of innovation for cell and gene therapies. Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. .

Therapies 130

Therapies Clinical Trials Production Trials 130

The Pharma Data

DECEMBER 13, 2020

Their extensive experience and proven track record in advancing innovative therapies, in addition to strong leadership skills, will help us to strengthen our portfolio and accelerate technology translation to help patients in need.”. Zhang completed his postdoctoral fellowship at Harvard Medical School/Boston Children’s Hospital.

Medical Schools 40

Medical Schools Clinical Development RNA Hospitals 40

The Pharma Data

JANUARY 26, 2021

Short will be responsible for overseeing the clinical development of VarmX’s pipeline, including progression of its lead product, VMX-C001, into clinical proof of concept and registrational studies. During this time, he grew the medical, clinical, and regulatory groups, and established an in-house pharmacovigilance function.

Clinical Development 40

Clinical Development Medical Schools Therapies Pharmaceuticals 40

The Pharma Data

JANUARY 27, 2021

.–( BUSINESS WIRE )– PlateletBio , a pioneering biotechnology company developing next-generation allogeneic cell therapies for treatment of human diseases, has named Steven M. A recognized gene and cell therapy expert, Dr. Altschuler co-founded Spark Therapeutics, taking it from launch to its $4B acquisition by Roche.

Therapies 52

Therapies Engineering Clinical Development Hospitals 52

Precision for Medicine

JUNE 26, 2023

Unraveling the complexity of manufacturing next-gen biologics is critical to the shared mission of accelerating patient access to new therapies,” said Chad Clark, President of Precision for Medicine. This convergence is driving faster clinical development and approval. For more information, visit PrecisionForMedicine.com.

Science 40

Science Small Molecule Clinical Research Engineering 40

Drug Discovery World

JUNE 5, 2023

She said: “It’s not so much about proving the technology, but it’s more about demonstrating how we take it towards the patient space.

Small Molecule 130

Small Molecule Treatment Science Disease 130

The Pharma Data

JUNE 7, 2023

Rahway, NJ, USA), an anti-PD-1 therapy. The updated results from TROPION-Lung02 signal the potential for datopotamab deruxtecan combinations to improve outcomes for patients with non-small cell lung cancer and are a promising development in the pursuit of a new standard treatment option beyond immunotherapy.”

Trials 40

Trials Protein Expression Therapies Treatment 40

The Pharma Data

NOVEMBER 8, 2021

The data demonstrate that finerenone reduced the threat of the CV compound outgrowth ( time to CV death,non-fatal MI, nonfatal stroke or heart failure hospitalization) and the order compound outgrowth ( time to order failure, sustained ? Compared to FIGARO-DKD, FIDELIO-DKD included further cases with advanced habitual order complaint.

Clinical Trials 52

Clinical Trials Trials Therapies Treatment 52

The Pharma Data

OCTOBER 18, 2020

Berk, commented “I am excited to join the Board of Inflection Biosciences as it advances its novel PIM/PI3K inhibitor, IBL-202, towards clinical development for unmet needs in B-cell malignancies and other cancers.”. Dr. Berk most recently has served as a consultant to several companies developing oncology therapies.

Small Molecule 40

Small Molecule Clinical Development Clinical Trials Licensing 40

Drug Discovery World

OCTOBER 18, 2022

For example, the University of Basel works very closely with partners from both the academic world and industry, and in 1996, it jointly founded the Neuroscience Network Basel along with the University Hospital, the Friedrich Miescher Institute and the local pharmaceutical industry.

International 130

International Engineering Science Pharmaceuticals 130

The Pharma Data

SEPTEMBER 11, 2020

Starpharma strived to release DEP remdesivir to allow for less frequent dosing and for use in non-hospital settings such as care homes. DEP remdesivir enables subcutaneous or under the skin injections rather than intravenous infusion, allowing for outpatient treatments and reducing the burden on hospitals. Saama Technologies, Inc. ,

Clinical Trials 52

Clinical Trials Pharma Companies Hospitals Trials 52

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

Disease 52

Disease Trials Treatment Clinical Trials 52

The Pharma Data

JANUARY 20, 2021

The approval of Verquvo by the FDA, which is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics, is based on the results of the pivotal Phase 3 VICTORIA trial and follows a priority regulatory review. Verquvo (vericiguat) 2.5

FDA Approval 52

FDA Approval FDA Hospitals Treatment 52

The Pharma Data

DECEMBER 9, 2020

The FURI study is evaluating oral ibrexafungerp as a salvage treatment in patients with a variety of difficult-to-treat mucocutaneous and invasive fungal infections that are refractory to, intolerant of current standards of care, or require a non-azole oral step-down therapy for treatment of azole-resistant species. JERSEY CITY, N.J.,

Hospitals 52

Hospitals Pharmacokinetics Clinical Trials Trials 52

The Pharma Data

AUGUST 7, 2020

As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. Regenerative medicine and advanced therapies thriving despite Covid-19 disruption.

Clinical Trials 52

Clinical Trials Trials Packaging Therapies 52

The Pharma Data

DECEMBER 21, 2020

The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

Vaccine 52

Vaccine Trials Clinical Trials Clinical Development 52

The Pharma Data

OCTOBER 25, 2020

Agitation associated with delirium is commonly seen in numerous hospital settings, resulting in serious medical complications and extended hospital stays. Treatment choices are limited, and commonly used off-label therapies are not always effective or may result in prolonged, deep sedation. NEW HAVEN, Conn.,

Treatment 52

Treatment Trials FDA Hospitals 52

The Pharma Data

MAY 27, 2022

of patients refractory to their initial therapy and about one-third (33.1%) having received prior CAR T-cell therapy.¹ The pivotal phase II NP30179 expansion study included patients with heavily pre-treated and highly refractory DLBCL, with 58.3% After a median follow-up of 12.6 months, 39.4%

Treatment 52

Treatment Therapies Clinical Trials Engineering 52

The Pharma Data

OCTOBER 26, 2020

Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, today announced the Company will present at the ROTH Capital Partners 2020 MedTech Innovation Forum on Wednesday, October 28, 2020. SAN JOSE, Calif. , AR-301 (VAP). AR-101 (HAP).

Pharmaceuticals 52

Pharmaceuticals Virus Hospitals Small Molecule 52

The Pharma Data

NOVEMBER 12, 2020

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in more than 20 company-sponsored clinical trials. Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19. CALAVI US). Available online.

Trials 52

Trials Clinical Trials Immune Response FDA Approval 52

The Pharma Data

AUGUST 30, 2021

Finerenone significantly reduced the risk of the composite primary endpoint of time to first occurrence of CV death or non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalization by 13% (relative risk reduction, HR 0.87 [95% CI: 0.76-0.98]; 1.09]) and heart failure hospitalization (HR 0.71 [95% CI: 0.56-0.90])

Hospitals 52

Hospitals Disease Clinical Trials Therapies 52

The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group.

Small Molecule 52

Small Molecule Engineering Pharmaceuticals Clinical Development 52

Drug Discovery World

MARCH 29, 2023

Peter O’Donnell, Applied Clinical Trials’ Brussels Correspondent, summarises this as the EMA being tasked with creating a European network of patient representatives, academics, drug developers, investigators, and centres with expertise in the performance of studies in the paediatric population.

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

Drug Discovery World

FEBRUARY 22, 2023

Sustained and durable effect The European Commission’s decision follows the CHMP’s positive opinion in December 2022, based on findings from the pivotal HOPE-B trial, the largest gene therapy trial in haemophilia B to date. The post EU-approved gene therapy reduced haemophilia bleeds by 64% appeared first on Drug Discovery World (DDW).

Therapies 130

Therapies Clinical Trials Licensing Licensing 130

Drug Discovery World

OCTOBER 2, 2023

Dr Mindy Miller, Lead Research Scientist, Terumo Blood And Cell Technologies Conversations and data shared at the CAR-TCR 8 th Annual Summit highlighted the importance of optimising the science behind the therapies to broaden patient access.

Therapies 264

Therapies Treatment Hospitals Production 264