The Pharma Data

JUNE 26, 2021

The Phase 3 AMEERA-6 study will evaluate the efficacy and safety of Sanofi’s amcenestrant vs tamoxifen for women with estrogen receptor-positive (ER+) breast cancer who were unable to continue their adjuvant aromatase inhibitor (AI) therapy. Adjuvant therapy helps prevent and delay the progression of disease into the later setting.

Clinical Trials 52

Clinical Trials International Trials Therapies 52

Agency IQ

FEBRUARY 12, 2024

BY RACHEL COE, MSC | FEB 7, 2024 10:21 PM CST The Bespoke Gene Therapy Consortium A collaborative effort, the Bespoke Gene Therapy Consortium (BGTC) was launched in October 2021 to “accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.”

FDA 40

FDA Therapies Clinical Trials Disease 40

The Pharma Data

JANUARY 24, 2021

This marks the third US clinical site that has obtained both study level and site IRB approval through a central IRB. There are 3 pending US clinical study sites that are expected to receive site IRB approval in 1Q2021. The MU team thrives on pushing the envelope of what’s possible in urological medicine. Dr. Laurence H.

Pharmaceutical Companies 52

Pharmaceutical Companies Virus Clinical Research Pharmaceuticals 52

Conversations in Drug Development Trends

MAY 23, 2024

Accelerating Clinical Trials in the EU (ACT EU) ACT EU is an initiative designed to transform the initiation, development, and running of clinical trials within the EU. Embracing Advanced Therapies The expansion of new cell and gene therapies, particularly CAR-T and TCR cell therapies, is a notable trend in oncology.

Trials 52

Trials Clinical Trials Therapies Treatment 52

The Pharma Data

MARCH 26, 2021

The positive CHMP opinion for ponesimod is testament to nearly a decade of cumulative clinical research which ultimately showed the treatment offers RMS patients superior efficacy on the primary endpoint of reduced annualised relapse rate compared to an established therapy, as well as a proven safety profile.”.

Treatment 52

Treatment Pharmaceutical Companies Pharmaceuticals FDA Approval 52

The Pharma Data

JANUARY 6, 2021

Currently, oral treatment options for plaque psoriasis are limited, and many patients with moderate-to-severe psoriasis are receiving systemic injectable therapies. We confidently believe in the benefits of oral orismilast, and the IND approval marks a significant milestone in our clinical development.”

FDA Approval 52

FDA Approval FDA Clinical Development Clinical Research 52

Vial

MAY 15, 2024

Vial | Pros and Cons The unprecedented consequences of the COVID-19 pandemic gave rise to the advent of decentralized clinical trials (DCTs), which are studies that use telemedicine and remote or local healthcare professionals to enable participants to join from different locations. billion and now functions as a subsidiary.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

Vial

APRIL 18, 2024

The urgency for novel therapeutic approaches makes ophthalmology a rapidly growing domain of clinical research. Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding.

Clinical Trials 52

Clinical Trials Trials Treatment Clinical Research 52

The Pharma Data

JANUARY 17, 2021

The service is expected to become operational in 2021 and will be available for clinical research and clinical care — starting with private patients, followed by expansion into the public healthcare system over time. “We This press release features multimedia. View the full release here: [link].

Clinical Trials 40

Clinical Trials FDA Approval Treatment Trials 40

Drug Target Review

AUGUST 3, 2023

Doctors and other healthcare professionals have very little time to devote to signposting patients to research, so we have to explore other ways to find participants and, crucially, keep them engaged. That needs to change.

DNA 52

DNA Clinical Trials Trials Disease 52

The Pharma Data

MARCH 23, 2022

The only large-scale prospective study in dermatology designed to generate key disease insights among Black, Hispanic, Asian, Indigenous and other people of color Study reinforces Janssen’s commitments to inclusive clinical research and addressing health inequities. 11 TREMFYA is approved in the U.S.,

Pharmaceutical Companies 52

Pharmaceutical Companies Clinical Research Disease Therapies 52

The Pharma Data

APRIL 17, 2021

The collaboration, launched in 2019, has successfully combined MD Anderson’s innovative clinical research infrastructure and the patient-driven drug development capabilities of the Therapeutics Discovery division with Boehringer Ingelheim’s pipeline of innovative cancer medicines and expertise in advancing breakthrough therapies.

Therapies 52

Therapies Drug Development Treatment Clinical Trials 52

Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

Drug Development 52

Drug Development Disease Therapies Engineering 52

The Pharma Data

OCTOBER 14, 2020

AOP Orphan – AOP Orphan Pharmaceuticals took over the Viennese pharmaceutical company Amomed and the Luxembourgish health-tech company SciPharm. AOP anticipates new opportunities in Austria as a hub for research and business. All jobs have been maintained and the workforce has grown from about 220 to 350.

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Therapies 52

The Pharma Data

OCTOBER 27, 2020

The companies will work together to scale-up manufacturing capacity, in collaboration with Sandoz, the generics and biosimilar Novartis division, to provide worldwide supply. The company has compounds in various stages of clinical and preclinical development with a focus on oncology.

Therapies 40

Therapies Virus Treatment Clinical Trials 40

The Pharma Data

JUNE 26, 2021

RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. About EXPLORER The EXPLORER clinical research program is unmatched by any oral anticoagulant in the Factor Xa inhibitor class in its size, scope and ambition.

Doctors 52

Doctors Treatment Hospitals Clinical Trials 52

Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. The company reported a revenue of $11,116 million for the first nine months of 2023, marking a 4.2%

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 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. .–( BUSINESS WIRE )– Five Prime Therapeutics, Inc. Wainberg, M.D.,

Trials 52

Trials Treatment Therapies Clinical Trials 52

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

MAY 27, 2022

In the pivotal clinical study CARTITUDE-1, 98 percent of patients with relapsed or refractory multiple myeloma responded to a one-time treatment with ciltacabtagene autoleucel and 80 percent of patients who responded experienced a stringent complete response . In December 2017, Janssen Biotech, Inc. to develop and commercialise cilta-cel.[1].

Therapies 52

Therapies Treatment Pharmaceutical Companies Nurses 52

PPD

FEBRUARY 18, 2025

As the demand for patient-centric clinical trials increases, understanding and adapting to patients’ preferred communication methods is more important than ever. By fostering stronger engagement and retention, sponsors can achieve faster, more reliable trial outcomes and bring therapies to market sooner.

Clinical Trials 90

Clinical Trials Trials Clinical Research Pharmaceutical Companies 90