Rethinking Clinical Trials

JANUARY 8, 2024

In a new article from the NIH Pragmatic Trials Collaboratory, investigators from 6 of the program’s pragmatic clinical trials share case examples of the challenges they encountered in collecting patient-reported outcomes (PROs) in their trials and the strategies they used to address them. The article was published this week in Contemporary Clinical Trials.

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Trials Clinical Trials Clinical Trials Research 286

Bio Pharma Dive

JANUARY 8, 2024

The chip maker struck a new deal with Amgen on Monday, while Sarepta brought news of strong sales to the J.P. Morgan Healthcare Conference.

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Sales 305

Pharmaceutical Technology

JANUARY 8, 2024

With micronisation required for 30% of APIs on the market, there is a need for more sustainable methods of milling these vital drug products.

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Production Marketing Drugs 263

Bio Pharma Dive

JANUARY 8, 2024

At the J.P. Morgan Healthcare Conference Monday, company head Chris Viehbacher said insurance reimbursement is now ‘not an issue’ for treatment.

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Drugs 270

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Clinical Supply

Pharmaceutical Technology

JANUARY 8, 2024

The CureVac and GSK Covid-19 collaboration was first announced in February 2021, with regulatory discussions already in motion.

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Vaccination Vaccine Trials 246

Bio Pharma Dive

JANUARY 8, 2024

The acquisition will build out Merck’s pipeline of immunotherapies as its top-seller Keytruda nears the end of U.S. market exclusivity.

Marketing 264

Marketing 264

Bio Pharma Dive

JANUARY 8, 2024

An unusual FTC challenge could have implications for startups, while industry watchers are waiting to see if the sector’s recent momentum signals an end to a lengthy funding crunch.

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Pharmaceutical Technology

JANUARY 8, 2024

The US FDA has granted authorisation for Florida's drug importation programme under section 804 of the FD&C Act.

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Medicine Drugs 246

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 8, 2024

It’s a familiar start-of-the-year scene. You’ve committed to a healthier lifestyle and are determined that this time is going to be different. Your refrigerator is stocked with fruits and veggies, you’ve tossed out processed foods, and your workout routine is written in pen in your daily planner.

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Clinical Trials Clinical Trials Clinical Research Trials 198

Bio Pharma Dive

JANUARY 8, 2024

Small and mid-sized drugmakers shed at least 10,000 jobs in 2023, according to data compiled by BioPharma Dive, but recent deal, stock market momentum have brought some optimism.

Marketing 171

Marketing 171

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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

Pharmaceutical Technology

JANUARY 8, 2024

The layoffs and scaling back of R&D activities will extend Senti Biosciences' cash runway into Q1 2025, according to a press release.

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Trials 162

Bio Pharma Dive

JANUARY 8, 2024

The proposed takeout follows a spate of dealmaking around antibody-drug conjugates, targeted cancer medicines that have lured AbbVie, Pfizer, Merck and Gilead.

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Drugs Development Antibody Medicine 183

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 8, 2024

The National Pharmaceutical Pricing Authority (NPPA) is looking at fixing the ceiling prices of over 200 scheduled formulations under the Revised Schedule I of the Drugs (Prices Control) Order, 2013 based on the price database for the month of October, 2023.

Marketing 133

Marketing Drugs Clinical Trials Clinical Trials 133

Pharmaceutical Technology

JANUARY 8, 2024

Curevo’s shingles vaccine met all primary endpoints and was non-inferior to GSK’s Shingrix in a head-to-head Phase II trial.

Vaccination 147

Vaccination Vaccine Trials 147

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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

pharmaphorum

JANUARY 8, 2024

Dr Peter Marks, director of the FDA Center for Biologics Evaluation and Research told a packed house in San Francisco for JPM that FDA wants to support gene therapies in 2024.

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Gene Therapy Gene Research 131

Pharmaceutical Technology

JANUARY 8, 2024

Boehringer Ingelheim has signed a licensing agreement with Japan’s Kyowa Kirin to develop a new treatment for fibro-inflammatory diseases.

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Licensing Licensing Development 130

Fierce Pharma

JANUARY 8, 2024

San Francisco—Nearly all top cancer drugmakers have struck deals in the sizzling antibody-drug conjugate field—but not Novartis. | Nearly all top cancer drugmakers have struck deals in the sizzling antibody-drug conjugate field—but not Novartis. On Monday, the Swiss pharma’s CEO Vas Narasimhan explained how he's resisted the temptation.

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Antibody Drugs 119

Pharmaceutical Technology

JANUARY 8, 2024

Novartis has received the US FDA approval to commercially manufacture Pluvicto at its new RLT manufacturing facility.

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FDA Approval Production Manufacturing 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

Drug Patent Watch

JANUARY 8, 2024

The article “Settled: Patent characteristics and litigation outcomes in the pharmaceutical industry,” explores the relationship between Paragraph IV litigation characteristics and the probability of a Paragraph IV settlement in the… The post Unveiling the Secrets of Patent Litigation and Settlements in Pharmaceuticals appeared first on DrugPatentWatch - Make Better Decisions.

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Pharmaceutical Technology

JANUARY 8, 2024

SYD-4228 is under clinical development by Byondis and currently in Phase I for Follicular Lymphoma.

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Clinical Development Development 130

BioPharma Reporter

JANUARY 8, 2024

Healthcare industry professionals scored cell and gene therapy (CGT) as the industry trend to have the greatest impact on the pharmaceutical industry in 2024, in a recent survey launched by data and analytics firm GlobalData.

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Gene Therapy Gene 111

Pharmaceutical Technology

JANUARY 8, 2024

HH-006 is under clinical development by Huahui Health and currently in Phase I for Hepatitis D.

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Clinical Development Development 130

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Clinical Supply

Fierce Pharma

JANUARY 8, 2024

While some Merck & Co. investors may still get the heebie-jeebies when thinking about Keytruda’s patent cliff in 2028, but the company’s CEO Rob Davis now thinks “it’s just another year.” | While some Merck & Co. investors may still get the heebie-jeebies when thinking about Keytruda’s patent cliff in 2028, but the company’s CEO Rob Davis now thinks “it’s just another year.

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Sales Vaccination Vaccine 107

Pharmaceutical Technology

JANUARY 8, 2024

AUR-101 is under clinical development by Aurigene Oncology and currently in Phase II for Ankylosing Spondylitis (Bekhterev's Disease).

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Clinical Development Development 100

Fierce Pharma

JANUARY 8, 2024

It took Bristol Myers Squibb’s new CEO Chris Boerner 16 minutes into his 24-minute presentation to address the big news the company made last month, with its holiday

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110

Pharmaceutical Technology

JANUARY 8, 2024

Berdazimer Sodium is a small molecule commercialized by NVN Liquidation, with a leading Pre-Registration program in Molluscum Contagiosum.

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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

pharmaphorum

JANUARY 8, 2024

Stay up to date with the latest developments in clinical trials, including updates on Vicore, Mundipharma, Agios, Ultragenyx, EG 427, Orion, and MSD. Find out what these companies are working on and their potential impact on healthcare.

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Clinical Trials Clinical Trials Trials Development 107

Pharmaceutical Technology

JANUARY 8, 2024

AUR-101 is under clinical development by Aurigene Oncology and currently in Phase II for Ankylosing Spondylitis (Bekhterev's Disease).

Clinical Development 100

Clinical Development Development 100

BioPharma Reporter

JANUARY 8, 2024

Merck has announced a new licensing agreement with Inspirna for ompenaclid, a first-in-class treatment currently in phase 2 development for RAS-mutated (RASmut) advanced or metastatic colorectal cancer (mCRC).

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Licensing Licensing Development Regulation 105

Pharmaceutical Technology

JANUARY 8, 2024

MASCT is under clinical development by Hengrui Yuanzheng Biotechnology and currently in Phase I for Kidney Cancer (Renal Cell Cancer).

Clinical Development 100

Clinical Development Development 100

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Clinical Supply