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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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 320

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 284

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

JANUARY 8, 2024

The FDA has granted approval for Ligand Pharmaceuticals’ Zelsuvmi (berdazimer topical gel, 10.3%) for molluscum contagiosum.

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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.

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Marketing 276

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 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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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.

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Vaccination Vaccine Trials 147

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Clinical Supply

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.

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Marketing 187

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.

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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 137

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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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

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 117

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

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 115

Pharma Times

JANUARY 8, 2024

Over a three-month period, 57% of patients using the app remained sober

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Clinical Supply

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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pharmaphorum

JANUARY 8, 2024

Alphabet’s AI in drug discovery startup Isomorphic Labs signs collaborations with Eli Lilly and Novartis worth up to $3bn, its first two pharma partnerships

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Drugs 110

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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pharmaphorum

JANUARY 8, 2024

This 12 Questions With Marcus West explores the 60 Seconds remote coaching app founder's journey into corporate coaching and how West realised his clients would improve faster if they dedicated themselves to ongoing microlearning in between coaching sessions.

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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

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

XTalks

JANUARY 8, 2024

Getting a drug to market used to be a relatively simple and straightforward affair. That’s just not the case anymore. Whether it’s for a treatment for a chronic ambulatory condition, precision medicine or cell and gene therapy, there is a massive uptick in clinical trial complexity. Most Phase II and Phase III studies have around 20 endpoints and 263 procedures per patient.

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Clinical Trials Clinical Trials Trials Gene Therapy 105

pharmaphorum

JANUARY 8, 2024

Servier has added a third digital twin project to its collaboration with AI specialist Aitia, trying to identify Parkinson's patients who will respond to its LRRK2 inhibitor in clinical trials.

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Clinical Trials Clinical Trials Drugs Trials 104

Pharma Times

JANUARY 8, 2024

The nine-week DTxl CBT helps to address psychological symptom burdens in PF patients

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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

JPM24 starts with three takeovers including J&J's $2bn bid for Ambrx, Merck’s $680m play for Harpoon Therapeutics and a $425m offer from Novartis for Calypso Biotech

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Fierce Pharma

JANUARY 8, 2024

Johnson & Johnson is starting the year with a new corporate identi | Despite all the recent changes at Johnson & Johnson, the company maintains an aggressive outlook for its pharmaceuticals division. In fact, J&J's sales forecasts for some drugs come in vastly higher than analyst numbers.

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Sales Drugs 102

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

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 99

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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