Rethinking Clinical Trials

DECEMBER 6, 2023

        Speaker James P. Hughes, PhD Professor Emeritus of Biostatistics, University of Washington Slides Keywords Design, Analysis, Stepped-Wedge Trial Key Points Stepped-wedge design is typically run by clusters that are randomized. Each of the clusters receive the control and treatment, and each cluster is sequenced to the intervention at different times.

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Trials Clinical Trials Clinical Trials Research 124

Bio Pharma Dive

DECEMBER 6, 2023

The deal hands AbbVie a portfolio of psychiatric medicines that originated within Pfizer, among them a closely watched schizophrenia treatment that’s in late-stage testing.

Medicine 321

Medicine Drugs 321

Pharmaceutical Technology

DECEMBER 6, 2023

Seattle Children's launched BrainChild Bio to focus on expediting the development of CAR T-cell therapies in central nervous system tumours.

Development 312

Development 312

Bio Pharma Dive

DECEMBER 6, 2023

The pharma is developing Fabhalta, now cleared for paroxysmal nocturnal hemoglobinuria, for several other rare, complement-driven diseases.

FDA Approval 306

FDA Approval Drugs Development 306

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Medicine

Pharmaceutical Technology

DECEMBER 6, 2023

IGM will lay off 22% of its staff and suspend four clinical activities to advance autoimmune diseases and colorectal cancer programmes.

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Bio Pharma Dive

DECEMBER 6, 2023

Data collected by the research firm suggests venture funding totals are still sliding amid a "strategic shift" by investors towards fewer, but more substantial deals.

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Research 200

Bio Pharma Dive

DECEMBER 6, 2023

The company moved quickly to capitalize on the stock surge, announcing plans to raise $300 million through a secondary stock offering.

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Drugs 182

Rethinking Clinical Trials

DECEMBER 6, 2023

In this Friday's PCT Grand Rounds, Ruth Engelberg, Erin Kross, and Robert Lee of the University of Washington will present "A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication About Goals of Care for Hospitalized Patients With Serious Illness." The Grand Rounds session will be held on Friday, December 8, 2023, at 1:00 pm eastern.

Clinical Trials 147

Clinical Trials Clinical Trials Medicine Trials 147

Bio Pharma Dive

DECEMBER 6, 2023

The funds are meant to boost Fujifilm’s capacity to manufacture cell therapies, a market it expects to grow substantially in the coming years.

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Production Manufacturing Marketing 182

Pharmaceutical Technology

DECEMBER 6, 2023

Health Canada has granted expanded authorisation for Novavax’s updated Covid-19 vaccine, Nuvaxovid XBB.1.5.

Vaccine 147

Vaccine Vaccination 147

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Clinical Supply

Bio Pharma Dive

DECEMBER 6, 2023

The results dim the outlook of so-called BTK inhibitors as potential autoimmune disease treatments and could have ramifications for Roche, Sanofi and Novartis.

Drugs 173

Drugs 173

Fierce Pharma

DECEMBER 6, 2023

With an FDA approval in PNH, Novartis has gained its first nod for iptacopan, dubbed two months ago “a pipeline in pill," by analysts at ODDO BHF.

FDA Approval 134

FDA Approval 134

Pharma Times

DECEMBER 6, 2023

The commitments will make health systems faster, simpler and fairer for patients - News - PharmaTimes

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Pharmaceutical Technology

DECEMBER 6, 2023

Tislelizumab is under clinical development by BeiGene and currently in Phase III for Gastroesophageal (GE) Junction Carcinomas.

Clinical Development 130

Clinical Development Development 130

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Pharma Mirror

DECEMBER 6, 2023

Oral health is a critical component of overall well-being, and growing research suggests that the health of your mouth is closely connected to your body’s overall health. The mouth serves as a gateway to the body, and any issues or infections that begin in the oral cavity can impact other systems and organs. We will explore the intricate relationship between oral health and overall body health, shedding light on how taking care of your teeth and gums can benefit your well-being.

Research 130

Research 130

Pharmaceutical Technology

DECEMBER 6, 2023

CG Oncology has received fast track designation and breakthrough designation needed to accelerate US FDA submission.

Drugs 130

Drugs 130

Fierce Pharma

DECEMBER 6, 2023

After years of back and forth with Daiichi Sankyo over cancer drug patent claims, Novartis has thrown in the towel with a $182 million settlement. | In 2017, Daiichi's former subsidiary Plexxikon alleged that Novartis stepped on its Zelboraf patents with its GSK-acquired medicine Tafinlar. Many years later, Novartis is settling the case.

Medicine 123

Medicine Drugs 123

Pharmaceutical Technology

DECEMBER 6, 2023

The clinical trial market is in a state of flux; to navigate it, supply chain optimisation will be essential.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Marketing 130

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Clinical Supply

BioSpace

DECEMBER 6, 2023

A combination of Merck’s experimental anti-TIGIT antibody vibostolimab and anti-PD-1 drug Keytruda failed to hit its endpoints in a mid-stage non-small cell lung cancer study.

Antibody 122

Antibody Trials Drugs 122

Pharmaceutical Technology

DECEMBER 6, 2023

The Phase Ib trial will evaluate the combination therapy of Welireg and HC-7366 in patients with clear cell renal cell carcinoma.

Trials 130

Trials 130

pharmaphorum

DECEMBER 6, 2023

The Oxford R21 malaria vaccine and the imperative of continued malaria testing Mike.

Vaccine 116

Vaccine Vaccination 116

Pharmaceutical Technology

DECEMBER 6, 2023

AbbVie will pay $30m upfront and up to approximately $325m in milestone-based payments for treatments in neuroscience and oncology.

Antibody 130

Antibody Development 130

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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

Clinical Trials

pharmaphorum

DECEMBER 6, 2023

Daiichi Sankyo unit claims $182m in Novartis patent dispute Phil.

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Pharmaceutical Technology

DECEMBER 6, 2023

The US FDA has accepted Bristol Myers Squibb’s sBLA for Opdivo plus cisplatin-based chemotherapy as a first-line treatment

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pharmaphorum

DECEMBER 6, 2023

Protecting the immunocompromised: Preventative measures against COVID-19 Mike.

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Pharmaceutical Technology

DECEMBER 6, 2023

Odyssey Therapeutics, a biotechnology company developing immunomodulators and oncology therapy, has secured $101m in a Series C funding round.

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Development 130

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Clinical Research

Fierce Pharma

DECEMBER 6, 2023

Novartis’ Kisqali is getting a leg up in the CDK4/6 breast cancer realm as another rival failed to significantly extend patients’ lives in a pivotal trial. | Novartis’ Kisqali is getting a leg up in the CDK4/6 breast cancer realm as another rival failed to significantly extend patients’ lives in a pivotal trial.

Trials 111

Trials 111

pharmaphorum

DECEMBER 6, 2023

Sanofi has deepened an existing collaboration with artificial intelligence specialist Aqemia in the latest among a flurry of collaborations between pharma companies and generative AI (genAI) companies. The French pharma group has signed a multi-year agreement with Paris-based Aqemia, focused on the discovery of small-molecule drug candidates across multiple therapeutic categories, through the application of genAI and deep physics algorithms that can model molecular interactions.

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Drugs Pharma Companies 110

BioSpace

DECEMBER 6, 2023

The deal, announced late Wednesday, will provide AbbVie with access to Cerevel Therapeutics’ pipeline of clinical-stage and preclinical candidates for psychiatric and neurological diseases.

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pharmaphorum

DECEMBER 6, 2023

Merck pummelled as MS hope fenebrutinib dies in phase 3 Phil.

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials