The Pharma Data

APRIL 4, 2022

The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D., Chief Medical Officer and Head of Global Product Development, Roche. Actemra/RoActemra is not U.S.

Treatment 52

Treatment FDA Approval Clinical Trials FDA 52

Fierce BioTech

SEPTEMBER 10, 2024

Further, women’s health issues tend to be deprioritized in clinical development, medical treatment, and online health information. And for treatments for a range of life stages, including menopause, women are at a disadvantage due to lower efficacy, more limited access, or both.

Clinical Development 52

Clinical Development Treatment Marketing Production 52

The Pharma Data

MARCH 2, 2021

Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. iii Current treatment options have limited efficacy in terms of weight loss or are often associated with adverse events. “We

Treatment 52

Treatment Bioinformatics Clinical Development Therapies 52

The Pharma Data

MARCH 28, 2022

mg dose of Ozempic ® (once-weekly semaglutide subcutaneous injection), a glucagon-like peptide-1 (GLP-1) analogue for the treatment of adults with type 2 diabetes. mg doses for the treatment of type 2 diabetes in adults. For more information about the SUSTAIN FORTE trial, please read the headline results he r e. mg and 2.0

Treatment 52

Treatment FDA Approval FDA Trials 52

The Pharma Data

MARCH 15, 2022

to advance the development of a subcutaneous delivery for Sarclisa ® with the goal of offering a unique patient-centric treatment experience. for the treatment of patients with RRMM who have received 1–3 prior lines of therapy and in the European Union for patients with MM who have received at least 1 prior therapy.

Science 52

Science Treatment Clinical Trials Therapies 52

The Pharma Data

OCTOBER 14, 2020

a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, announced today that the U.S. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov. For more information, please visit www.apexigen.com.

Treatment 40

Treatment Immune Response Clinical Trials Clinical Development 40

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. “I About Harpoon Therapeutics.

Treatment 52

Treatment FDA Clinical Trials Trials 52

The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. About Sandoz.

Biosimilars 40

Biosimilars Clinical Development Production Government 40

The Pharma Data

JANUARY 14, 2021

PRA Health Sciences selected for the study which will position Awakn at the Forefront of Psychedelic Research for Addiction Treatment. While there are current treatment methods available, which are effective for some segments of the population, relapse rates are high. For more information, please visit awaknlifesciences.com.

Science 52

Science Treatment Clinical Trials Clinical Development 52

The Pharma Data

MAY 15, 2023

FDA accepts application for Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO) Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Roche’s Chief Medical Officer and Head of Global Product Development. “If 1,2 Vabysmo’s safety profile was consistent with previous trials. mg) or aflibercept (2.0

Treatment 40

Treatment FDA Therapies Clinical Development 40

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. Our approach is informed by our combined 30+ years in rare disease clinical development and our time in various stakeholder roles, such as scientists, CRAs, and project managers.

Disease 81

Disease Clinical Trials Trials Pharmaceutical Companies 81

Drug Target Review

SEPTEMBER 5, 2024

With all this experience, I was very excited to take on the CEO role for Alzinova, a company developing a vaccine and other treatments against Alzheimer’s disease. I have built up this biopharma company from being a university science focused company to a biopharma company with all skills and focused on drug development and partnering.

Pharma Companies 112

Pharma Companies Licensing Licensing Disease 112

The Pharma Data

MAY 2, 2022

The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). Sage Therapeutics, Inc.

Treatment 52

Treatment Clinical Pharmacology Drugs Clinical Development 52

DrugBank

JUNE 6, 2024

In the rapidly evolving landscape of oncology drug development, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development.   What sets RADR ® apart is its robust data-driven approach.

Drug Development 73

Drug Development Clinical Trials Drugs Therapies 73

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. 4] , [5] , [6].

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

DECEMBER 13, 2020

Cancer Research UK has partnered with Hummingbird Bioscience to advance this novel antibody drug into clinical trials for the treatment of HER3-driven cancer. Hummingbird Bioscience is an innovative clinical-stage biotech company focused on developing revolutionary therapies against hard-to-drug targets for improved treatment outcomes.

Clinical Development 52

Clinical Development Clinical Trials Therapies Trials 52

The Pharma Data

JUNE 2, 2023

Additional data to be presented include trials-in-progress on the use of Yescarta in FL versus standard of care (ZUMA-22), as a first-line treatment in high-risk LBCL (ZUMA-23) and in the outpatient setting (ZUMA-24).

Therapies 52

Therapies Clinical Development Treatment Trials 52

Drug Target Review

MAY 7, 2024

For instance, AI algorithms could facilitate patient-trial matching, encompassing medical records, genetic information, demographics, and personal preferences. Furthermore, the incorporation of response biomarkers offers early insight into a drug’s effectiveness, preventing the continuation of a treatment.

Disease 59

Disease Clinical Trials Clinical Pharmacology Trials 59

Advarra

OCTOBER 15, 2024

Risks to CtQs factors should be proactively managed and risk language/monitoring adjusted according to new and changing information during the clinical trial. Sponsors should ensure a diverse multidisciplinary team of stakeholders supports the design of the study and the clinical development plan.

Clinical Trials 52

Clinical Trials Trials Clinical Research International 52

H1 Blog

JUNE 7, 2023

Performance data on principal investigators and clinical trial sites provides invaluable insights to pharma companies, helping them leverage successful sites and patient populations to maximize their clinical development feasibility and operations. There is a tendency to want to measure everything.”

Trials 52

Trials Clinical Trials Pharma Companies Clinical Development 52

The Pharma Data

NOVEMBER 3, 2020

Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). Top-tier capsid candidates from this effort demonstrated significant improvements over benchmark AAVs currently in clinical development. Forward Looking Statements.

FDA 52

FDA Treatment Clinical Trials Clinical Development 52

The Pharma Data

JANUARY 17, 2021

To complement the internal capabilities, Aruvant is partnering with world-leading contract development manufacturing organizations. The strategic long-term manufacturing agreement with Lonza is a critical step to advancing the clinical development of ARU-1801 for sickle cell patients.

Disease 52

Disease Trials Treatment Clinical Trials 52

Drug Target Review

MAY 1, 2024

How have advancements in antibody-drug conjugates (ADCs) expanded treatment options for different types of cancer? The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinical development.

Drugs 69

Drugs FDA Approval Organic Chemistry Small Molecule 69

The Pharma Data

OCTOBER 18, 2020

(Janssen) has announced it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the expanded use of Tremfya (R) (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA) in the European Union (EU). In July 2020, the U.S.

Treatment 40

Treatment Clinical Development Therapies Production 40

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. Our approach is informed by our combined 30+ years in rare disease clinical development and our time in various stakeholder roles, such as scientists, CRAs, and project managers.

Disease 52

Disease Clinical Trials Trials Pharmaceutical Companies 52

The Pharma Data

OCTOBER 18, 2020

Food and Drug Administration (FDA) has granted a rare pediatric disease designation (RPDD) to its lead product candidate VS-01, an ammonia clearance enhancer, for the treatment of Urea Cycle Disorders (UCD). Current treatment options are associated with poor outcomes. For additional information, visit: www.versantis.ch.

FDA 40

FDA Disease Treatment Clinical Development 40

The Pharma Data

JUNE 26, 2021

Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Roche’s Chief Medical Officer and Head of Global Product Development. “If

Treatment 52

Treatment FDA Therapies Clinical Trials 52

Drug Target Review

APRIL 3, 2024

This multi-layered mechanism contributes to the development of immunoresistance against current standard-of-care treatments such as checkpoint inhibitors, chemotherapy, or antibody-drug conjugates (ADCs). Visugromab is a monoclonal antibody – a treatment modality that has been extensively studied and de-risked.

Science 106

Science Clinical Development Treatment DNA 106

The Pharma Data

JANUARY 27, 2021

HK), announced today that China Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), for the treatment of adult patients with Myasthenia Gravis (MG). For more information, please visit: www.harbourbiomed.com. CAMBRIDGE, Mass.

Therapies 52

Therapies Treatment International Licensing 52

The Pharma Data

JANUARY 15, 2021

for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. .–(BUSINESS WIRE) January 15, 2021 — Daiichi Sankyo Company, Ltd. In the U.S., Sammons Cancer Center and the W.W. Caruth, Jr.

Treatment 52

Treatment Trials Disease Therapies 52

The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). IMPORTANT SAFETY INFORMATION FOR TYVASO. SILVER SPRING, Md.

FDA 40

FDA Treatment Drugs FDA Approval 40

Drug Target Review

SEPTEMBER 19, 2024

It has a well-defined and strategically focused R&D pipeline of innovative treatments targeting various stages of Parkinson’s as they worsen over time. The pipeline currently includes five drug candidates, all of which have the potential to revolutionise the treatment of PD.

Disease 52

Disease Drugs Treatment Drug Development 52

The Pharma Data

JUNE 26, 2021

The EUA is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients. Roche’s Chief Medical Officer and Head of Global Product Development. Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S.

FDA 40

FDA Treatment Clinical Trials Virus 40

Drug Target Review

JULY 31, 2023

This targeted approach provides readers interested diseases or applications with tailored information and insights that align with their specific interests. By exploring the latest advancements and potential treatment approaches for their areas of interest, readers can deepen their understanding of disease-specific applications.

Therapies 98

Therapies Disease Clinical Development Hospitals 98

The Pharma Data

OCTOBER 27, 2020

(NASDAQ: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders, today announced that the U.S. More information is available at www.passagebio.com. Passage Bio expects to initiate a Phase 1/2 trial for PBKR03 in the first half of 2021. About PBKR03.

Disease 40

Disease FDA Treatment Clinical Trials 40

Conversations in Drug Development Trends

JANUARY 24, 2024

Many parents are hesitant to pursue testing since it will not affect the patient’s care management, as several of these diseases have no approved treatments, such as Fragile X, a syndromic form of autism. As of July 2023, the American Society of Cell + Gene Therapy stated there were 3,905 therapies in development.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

Drug Target Review

AUGUST 28, 2024

What are the main challenges currently faced in the treatment of chronic liver diseases, and how does Resolution Therapeutics aim to address these challenges? Once a patient develops advanced cirrhosis/end-stage liver disease there are no specific therapies to significantly avoid major decompensations and death in the next few years.

Therapies 115

Therapies Disease Engineering Medical Schools 115