H1 Blog

DECEMBER 18, 2023

How will AI impact clinical trials? Every year, we take a look at annual predictions to help life sciences, pharmaceutical, and healthcare companies understand larger industry trends and dynamics to prepare for the new year. FinTech will merge with HealthTech to provide more robust patient experiences and aid in treatment plans.

Trials 64

Trials Clinical Trials FDA Pharmaceutical Companies 64

The Pharma Data

SEPTEMBER 15, 2020

Biopharma and pharmaceutical companies developing treatments and vaccines have long faced operational challenges that cost time and money while draining resources from the important work of changing lives. In spring 2020, Avantor’s clinical services team provided treatment developers with support for a fast-track study.

Clinical Trials 52

Clinical Trials Trials Pharmaceutical Companies Vaccine 52

DrugBank

MARCH 7, 2024

Inspired by its success, pharmaceutical companies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options. Key Players and Challenges For pharmaceutical giants like Novo Nordisk and Eli Lilly, 2024 presents both opportunities and challenges.

Pharmaceutical Companies 81

Pharmaceutical Companies Clinical Trials Pharmaceuticals Therapies 81

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. 2 PsA can be a challenging disease to treat especially in younger populations, reinforcing the need for additional treatment options. A decision from the U.S.

FDA Approval 52

FDA Approval Treatment FDA Pharmaceutical Companies 52

Conversations in Drug Development Trends

MAY 14, 2024

As the strategists for Worldwide Clinical Trials’ rare disease sponsors, we design customized solutions that make a difference in achieving successful outcomes. This philosophy is encapsulated in our belief: “If you’ve seen one trial for a rare indication, you’ve seen one trial.”

Disease 81

Disease Clinical Trials Trials Pharmaceutical Companies 81

The Pharma Data

FEBRUARY 25, 2021

Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax’ and Moderna’s COVID-19 Vaccine Candidates in Japan. – Phase 1/2 immunogenicity and safety trials designed to include 200 healthy Japanese adults followed for 12 months after second vaccination. TAK-919 clinical trial. TAK-019 clinical trial.

Clinical Trials 52

Clinical Trials Trials Vaccine Pharmaceutical Companies 52

The Pharma Data

OCTOBER 20, 2020

Led by scientists at Imperial College London, people in this challenge trial will be guaranteed treatment if they become ill. The United States says human challenge trials might be too risky or unnecessary. Challenge trials have a long history, going back to Edward Jenner’s development of a smallpox vaccine in 1796.

Trials 52

Trials Vaccine Virus Pharmaceutical Companies 52

Drug Target Review

AUGUST 6, 2024

Autoimmune diseases : Rheumatoid Arthritis : ADCs targeting specific immune cells or inflammatory mediators can provide more precise treatment options with potentially fewer side effects. Obesity : By targeting adipose tissue or specific metabolic pathways, ADCs could offer new treatments for obesity and related metabolic disorders.

Therapies 117

Therapies Pharmaceutical Companies Disease Treatment 117

Advarra

APRIL 4, 2024

In the realm of pharmaceutical development, ensuring the safety and efficacy of new treatments is paramount. One crucial aspect of this process involves establishing data safety monitoring boards (DSMBs) (also known as data monitoring committees [DMCs]) to oversee clinical trials.

Clinical Trials 52

Clinical Trials Pharmaceutical Companies Trials FDA 52

DrugBank

NOVEMBER 4, 2024

  Pharmaceutical companies are, therefore, exploring innovative approaches. Gepotidacin has shown promising results in clinical trials for uncomplicated urinary tract infections and gonorrhea, demonstrating its potential to address the growing threat of MDR Gram-negative infections. 

Pharmaceutical Companies 72

Pharmaceutical Companies Government Pharmaceuticals DNA 72

The Pharma Data

FEBRUARY 8, 2021

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer. ERLEADA ® is an androgen receptor (AR) inhibitor indicated for the treatment of patients with nmCRPC and for the treatment of patients with mCSPC. 10 months. [5]

Treatment 52

Treatment Pharmaceutical Companies Therapies Pharmaceuticals 52

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.

Treatment 52

Treatment Clinical Trials International Pharmaceutical Companies 52

Broad Institute

DECEMBER 18, 2023

Brain disorders are difficult to study and many drug candidates have failed in clinical trials, causing pharmaceutical companies to reduce their investments or even exit the field entirely. But a new path for bringing treatments to patients is starting to emerge. We all recognize the vast, unmet medical need.

Drug Development 130

Drug Development Clinical Trials Drugs Disease 130

The Pharma Data

OCTOBER 9, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced the U.S. The committee also voted unanimously to recommend use of maribavir for the treatment of refractory CMV infection and disease without genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients.

FDA 52

FDA Treatment Disease Pharmaceutical Companies 52

The Pharma Data

APRIL 16, 2021

Approval based on Phase 3 CheckMate -9ER trial results showing Opdivo in combination with Cabometyx significantly improved overall survival and doubled median progression-free survival and objective response rates compared to sunitinib. PRINCETON, N.J.–(BUSINESS

Treatment 52

Treatment Trials Clinical Trials Immune Response 52

The Pharma Data

JANUARY 12, 2021

a leader in precision medicine and artificial intelligence (AI)-enabled patient-centric oncology clinical trial enrollment, announced today it has launched its SYNERGY-AI Oncology Clinical Trial Command Center (OCTCC) with the mission to disrupt and accelerate the clinical trial enrollment process.

Clinical Trials 52

Clinical Trials Trials Clinical Research Pharmaceutical Companies 52

Conversations in Drug Development Trends

MAY 14, 2024

As the strategists for Worldwide Clinical Trials’ rare disease sponsors, we design customized solutions that make a difference in achieving successful outcomes. This philosophy is encapsulated in our belief: “If you’ve seen one trial for a rare indication, you’ve seen one trial.”

Disease 52

Disease Clinical Trials Trials Pharmaceutical Companies 52

The Pharma Data

MARCH 15, 2022

For the Sarclisa ® subcutaneous formulation delivery, Sanofi has partnered with drug delivery technology innovator company Enable Injections , Inc. to advance the development of a subcutaneous delivery for Sarclisa ® with the goal of offering a unique patient-centric treatment experience. John Reed , MD , Ph. About Multiple M yeloma.

Science 52

Science Treatment Clinical Trials Therapies 52

DrugBank

AUGUST 15, 2024

To effectively navigate this ecosystem and expedite the development of new therapies, collaboration between the pharmaceutical industry and academia is proving increasingly vital. This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks.

Drug Development 81

Drug Development Clinical Trials Drugs Therapies 81

The Pharma Data

NOVEMBER 23, 2021

Today’s approval helps meet a significant unmet medical need by providing a treatment option for this patient population.”. In the study, 352 transplant recipients with CMV infections who did not respond (with or without resistance) to treatment randomly received Livtencity or treatment assigned by a researcher for up to eight weeks.

FDA Approval 52

FDA Approval Treatment FDA DNA 52

DrugBank

MARCH 15, 2024

The weight loss industry has emerged as a major hub for innovative research, groundbreaking treatments, and economic opportunity.   Mounjaro received approval as a treatment for diabetes in 2022, then in late 2023, under the brand name Zepbound (tirzepatide), it was approved for weight loss. With sales soaring to $2.2

Pharmaceutical Companies 68

Pharmaceutical Companies Pharmaceuticals Treatment Clinical Trials 68

The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. galactosidase-A product candidate under development for the treatment of Fabry disease. Twenty of twenty-two patients completed the 12-month treatment duration. CARMIEL, Israel and BOSTON , Dec.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

FEBRUARY 12, 2022

“As a global pharmaceutical company, Lilly has worked hard to fight this pandemic. “With the emergence of variants such as Omicron, treatment options remain limited. . “With the emergence of variants such as Omicron, treatment options remain limited.

Treatment 40

Treatment Hospitals FDA Clinical Trials 40

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).

Trials 52

Trials Clinical Trials Pharmaceutical Companies Treatment 52

The Pharma Data

NOVEMBER 5, 2020

There was a handful of positive clinical trial news reported today. The Janssen Pharmaceutical Companies of Johnson & Johnson announced two Phase III trials, DISCOVER-1 and 2 demonstrated Tremfya (guselkumab) improved fatigue in adults with active psoriatic arthritis (PsA). Here’s a look. Janssen’s Tremfya.

Clinical Trials 40

Clinical Trials Trials Hospitals Pharmaceutical Companies 40

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). ADUHELM is indicated for the treatment of Alzheimer’s disease. ADUHELM is indicated for the treatment of Alzheimer’s disease.

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

The Pharma Data

MARCH 26, 2021

Despite continuous innovations in the treatment landscape, unmet needs remain. Overall, the number of treatment-emergent adverse events reported was similar between the ponesimod and teriflunomide treated groups, and the majority were mild/moderate and did not warrant treatment discontinuation. vs. 9.4%), nasopharyngitis (19.3%

Treatment 52

Treatment Pharmaceutical Companies Pharmaceuticals FDA Approval 52

The Pharma Data

DECEMBER 3, 2020

The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (i.e.,

Treatment 52

Treatment Pharmaceutical Companies Therapies Virus 52

The Pharma Data

JANUARY 25, 2021

agree to place handheld Ceribell Rapid Response EEG systems in hospitals in connection with its Phase 3 RSE clinical trial. –( BUSINESS WIRE )– Marinus Pharmaceuticals, Inc. About the RAISE Trial. Benzodiazepines are the first-line treatment for SE. Marinus and Ceribell, Inc. RADNOR, Pa.–(

Clinical Trials 52

Clinical Trials Trials Hospitals Pharmaceutical Companies 52

Codon

JANUARY 21, 2024

yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October.

Vaccine 111

Vaccine Trials Disease Treatment 111

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. In 2019, the U.S.

FDA 52

FDA Treatment Pharmaceutical Companies Therapies 52

The Pharma Data

JANUARY 15, 2021

January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Comenzo, M.D., Director, John C. Approximately 4,500 people in the U.S.

FDA Approval 52

FDA Approval Treatment FDA Pharmaceutical Companies 52

Vial

APRIL 18, 2024

Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding. Specifically, the global ophthalmic clinical trials market, valued at USD 1.5 from 2023 to 2030.

Clinical Trials 52

Clinical Trials Trials Treatment Clinical Research 52

The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. The ASCO GI presentation slides are available on the company’s website. Wainberg, M.D.,

Trials 52

Trials Treatment Therapies Clinical Trials 52

Vial

FEBRUARY 15, 2024

Clinical trials play a crucial role in advancing medical breakthroughs, but effective management is essential to unlock their full potential. Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. over the forecast period (2022-2030).

Pharma Companies 52

Pharma Companies Clinical Trials Compliance Trials 52

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. The full set of results will be published once the complete Phase 1/2a trial data are available.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

DrugBank

JUNE 27, 2024

Add to that, these drugs have already passed safety tests, meaning they could potentially move through early-phase trials faster if doses are compatible for new uses. These include matching molecular signatures, virtual screening, and analyzing large datasets from health records and clinical trials.

Drugs 72

Drugs Pharma Companies Clinical Trials Computational Chemistry 72