Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. This is not an exhaustive list; reference the AI Act for complete details.):

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Vial

JUNE 24, 2024

Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery. As clinical trials grow in complexity, the volume of data being gathered and utilized for these studies is expanding.

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Conversations in Drug Development Trends

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. Increased Transparency : Ensures that information on clinical trials is more accessible.

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Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938.

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DrugBank

MARCH 15, 2024

Mounjaro distinguishes itself from other treatments on the market by being the first to simultaneously activate GIP and GLP-1 pathways, offering a novel approach to regulating blood sugars for people with Type 2 Diabetes. This has caused a great deal of hesitation from pharmaceutical companies in the past.

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The Pharma Data

SEPTEMBER 23, 2020

September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. NEW BRUNSWICK, N.J., In the U.S.,

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DrugBank

OCTOBER 4, 2024

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. Emerging Markets Emerging markets, particularly in Asia and Latin America, have become increasingly attractive destinations for pharmaceutical M&A activity.

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Cytel

OCTOBER 11, 2023

Moving beyond static evidence development to ensure local market access success; responding to recent changes in governmental drug regulations and the role of automation Written by Grammati Sarri and Radek Wasiak The worldwide drug regulation landscape is rapidly changing.

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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.

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The Pharma Data

AUGUST 31, 2020

Company working to ensure broad Canadian access to COVID-19 vaccine candidate, following approval from Health Canada. one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (the Company), has agreed in principle to supply the Government of Canada with doses of its SARS-CoV-2 vaccine candidate, Ad26.COV2.S.

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The Pharma Data

NOVEMBER 14, 2020

November 15, 2020 — The Phase 3 ENSEMBLE study of the single-dose regimen of JNJ-78436735, the investigational vaccine candidate for the prevention of COVID-19 being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, continues to enroll and vaccinate study participants. PHASE 3 ENSEMBLE 2 STUDY.

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The Pharma Data

SEPTEMBER 23, 2020

First participants dosed in Phase 3 trial (ENSEMBLE) evaluating safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.” NEW BRUNSWICK, N.J.

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The Pharma Data

JANUARY 19, 2021

The Phase 1 clinical trial is planned to be conducted in Canada and targeted to recruit up to 48 and 24 healthy volunteers for the single-ascending dose (SAD) and multiple- ascending dose (MAD) cohorts, respectively. About Aptorum Group. This press release is provided “as is” without any representation or warranty of any kind.

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The Pharma Data

JANUARY 4, 2021

Drug discovery and development for these drug products is often carried out by academic investigators rather than by biopharmaceutical or pharmaceutical companies, said Patrizia Cavazzoni, acting director of the Center for Drug Evaluation and Research, in announcing the draft’s release. The draft is open for comment until March 5.

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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).

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Drug Target Review

JULY 18, 2023

Cavlan expressed her optimism for AI applications in the development of new medicines: “It will still take a few more years of us mining data, creating data sets, improving models and validating them through bench work and ultimately clinical trials, to be able to see those gains. Will systems like the NHS be able to deliver it?

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H1 Blog

DECEMBER 11, 2024

In this edition, our CEO and co-founder, Ariel Katz, along with Regional VP of Trial Landscape, Ryan Brown, share their top predictions for 2025. Drug Policy There will be significant changes in clinical trials & drug development due to the Inflation Reduction Act.

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The Pharma Data

AUGUST 5, 2020

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. August 05, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. New Brunswick, N.J.,

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H1 Blog

NOVEMBER 29, 2023

Breaking the Barriers: How Inaccurate Trial Records Are Delaying Drug Development and Limiting Diverse Patient Populations In an October 2023 report , BMC Medicine completed a follow-up on a 10-year effort to understand, report on and track data sharing challenges with big pharma, specifically for clinical trials.

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The Pharma Data

SEPTEMBER 3, 2020

The pre-clinical studies were conducted by researchers from Beth Israel Deaconess Medical Center (BIDMC) in collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson and others as part of its ongoing collaboration to accelerate the development of a SARS-CoV-2 vaccine. Source link.

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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.

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DrugBank

FEBRUARY 19, 2025

The application of Artificial Intelligence (AI) in drug discovery is rapidly transforming the pharmaceutical industry, offering opportunities to accelerate the identification of novel therapeutic targets, optimize molecule design, and enhance clinical trial efficiency. AI is also enabling clinical trial personalization.

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Advarra

DECEMBER 14, 2023

Sponsor study team members and research sites each play a critical role in clinical trial executions. Both inspection findings and inspection failures could reduce the quality of the trial data, with inspection failures being most disruptive. In addition, many research trials are conducted over the course of many years.

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The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. Patients had the option to receive PRX-102 infusions in a home care setting based on infusion tolerability and country regulation. CARMIEL, Israel and BOSTON , Dec. About Fabry Disease.

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Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. Also consider CRO oversight, trial management, data handling and record keeping, as well as allocation of responsibilities.

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The Pharma Data

NOVEMBER 13, 2020

November 14, 2020 – Johnson & Johnson (the Company) announced the expansion to the partnership between its Janssen Pharmaceutical Companies (Janssen) and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S.

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The Pharma Data

AUGUST 5, 2020

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. 5, 2020 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) (the Company) today announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. NEW BRUNSWICK, N.J.,

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The Pharma Data

JANUARY 19, 2021

The Company intends to use the net proceeds from this offering for general corporate purposes, which may include but are not limited to working capital and funding clinical trials. NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology.

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The Pharma Data

JANUARY 5, 2021

RAD011 is a pivotal-trial ready synthetic cannabidiol oral solution with potential utilization in multiple endocrine and metabolic orphan diseases. Acquisition and associated PWS trial costs to be funded from existing operations. Management to host conference call and webcast this morning at 8:15 a.m.

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JANUARY 24, 2021

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).

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The Pharma Data

JANUARY 24, 2021

About Citius Pharmaceuticals, Inc. Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. SOURCE Citius Pharmaceuticals, Inc. .

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Altus Drug Development

JUNE 28, 2022

Ensuring access to safe and effective treatments is the main challenge faced by pharmaceutical companies big and small. Value-added medicines offer an efficient method to meet the needs of patients while stimulating innovation in the pharmaceutical industry. What is a value-added medicine? To comply with the law.

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The Pharma Data

DECEMBER 17, 2020

About Avenue Therapeutics Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S.

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The Pharma Data

OCTOBER 27, 2020

For more information on ASP5354 clinical trials, please visit www.clinicaltrials.gov. is a pharmaceutical company conducting business in more than 70 countries around the world. . In the Phase 1 study ASP5354 was safe and well tolerated at all doses evaluated in healthy volunteers. Dis Colon Rectum.

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The Pharma Data

DECEMBER 15, 2020

As the world’s first PPAR pan agonist that completed two confirmatory phase III clinical trials, Chiglitazar Sodium has shown significant and long-lasting hypoglycemic effects in a series of clinical studies, as well as other comprehensive effects including significant insulin sensitization and blood lipid regulation.

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The Pharma Data

JANUARY 14, 2021

A Review of the Phase 3 NefIgArd Trial Data. The presentations will be made available on the company’s website after the end of the meeting. . Pathophysiology of IgA nephropathy & Nefecon Clinical Biomarker Data. 1:40pm.

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The Pharma Data

JANUARY 25, 2021

At their option, the collaboration with the European affiliate of a global pharmaceutical company has expanded to three active pharmaceutical ingredients (“API”s). ” This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

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