Mon.Feb 05, 2024

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8 Reasons to Move Your Clinical Trial Imaging to TrialKit Right Now

Crucial Data Soutions

Clinical trial imaging is different. There is a lot of variability involved with data collection. For studies engaging multiple sites, The post 8 Reasons to Move Your Clinical Trial Imaging to TrialKit Right Now appeared first on Crucial Data Solutions.

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J&J says top drug prospect works across autoimmune disorders

Bio Pharma Dive

The pharma disclosed positive results from two studies testing its antibody drug nipocalimab in generalized myasthenia gravis or Sjögren's disease.

Drugs 321
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You May Not Need to Lose as Much Weight as You Think, Expert Reveals

AuroBlog - Aurous Healthcare Clinical Trials blog

If you’re one of the one in three people whose New Year’s resolution involved losing weight, it’s likely you’re now contemplating what weight-loss goal you should actually be working towards. But type “setting a weight loss goal” into any online search engine and you’ll likely be left with more questions than answers.

Engineer 246
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Novo Holdings to buy contract drugmaker Catalent for $16.5B

Bio Pharma Dive

In a related deal, Novo Holdings subsidiary Novo Nordisk will buy three major Catalent factories for $11 billion as it works to keep pace with demand for its obesity and diabetes medicines.

Medicine 290
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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NABL announces transitional changes in lab accreditation procedures

AuroBlog - Aurous Healthcare Clinical Trials blog

In order to ensure the seamless transition of accredited laboratories, the National Accreditation Board for Laboratories (NABL) has announced an extension of the transition period for accredited laboratories from the initial deadline of December 31, 2023 to the revised date of August 31, 2024.

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Regeneron’s linvoseltamab application accepted for review

Pharmaceutical Technology

Regeneron Pharmaceuticals' application for linvoseltamab has received acceptance from the EMA for review to treat multiple myeloma.

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Risk adjusted net present value: What is the current valuation of Merck’s V-116?

Pharmaceutical Technology

V-116 is a conjugate vaccine commercialized by Merck, with a leading Pre-Registration program in Streptococcal Pneumonia.

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Study reveals AI can predict patients’ survival in glioblastoma

Pharma Times

The aggressive brain cancer is responsible for over 3,000 cases in the UK every year

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Risk adjusted net present value: What is the current valuation of AstraZeneca’s Tozorakimab?

Pharmaceutical Technology

Tozorakimab is a monoclonal antibody commercialized by AstraZeneca, with a leading Phase III program in Chronic Obstructive Pulmonary Disease (COPD).

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Data science in healthcare

pharmaphorum

Data science in healthcare is transforming the industry, from drug discovery to patient care. Learn about the role of data, artificial intelligence (AI), and the impact of initiatives like the NHS Datastore in revolutionising healthcare outcomes.

Drugs 129
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Novo Holdings acquires Catalent for $16.5bn

Pharmaceutical Technology

Novo Holdings announced a merger agreement with Catalent, selling three manufacturing facilities to Novo Nordisk.

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New programme shown to help dementia patients live independently

Pharma Times

The neurodegenerative condition currently affects over 944,000 people in the UK

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Contentious Medicare price negotiations underway as US drug prices rise

Pharmaceutical Technology

The HHS released new research that highlights US prescription drug prices are nearly triple those of 33 other OECD countries.

Drugs 130
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Novartis CEO’s 2023 pay rises 21% as Roche's helmsman nets $11M in his first year

Fierce Pharma

After leading Novartis and Roche through pivotal years in 2023, the CEOs of the Swiss drug giants each netted multimillion-dollar compensation packages. | After leading Swiss drug giants Novartis and Roche through pivotal years, their CEOs have each netted multimillion-dollar compensation packages for 2023.

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The New Age of Decentralized Clinical Trials

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

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Valneva sells Ixchiq priority voucher for $103m to fuel R&D

Pharmaceutical Technology

Valneva will use the voucher sale funds for R&D projects, including a Lyme disease vaccine being co-developed with Pfizer.

Sales 130
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GSK details Blenrep combo data that could bring the multiple myeloma ADC back to life

Fierce Pharma

If a new package of pivotal data satisfies the FDA, GSK could have another run at the U.S. | If a new package of pivotal data satisfies the FDA, GSK could have another run at the U.S. multiple myeloma market with its previously withdrawn BMCA-targeted antibody-drug conjugate, Blenrep.

Packaging 122
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AnaMar secures double orphan drug designation for systemic sclerosis drug

Pharmaceutical Technology

AnaMar’s AM1476 received FDA and EMA orphan drug designations, with the Swedish biotech now planning a Phase II trial.

Drugs 130
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Astellas' sales expectations are up for Padcev, down for Veozah

Fierce Pharma

Less than two months after the FDA approved the combination treatment of Astellas and Pfizer’s Padcev and Merck’s Keytruda in first-line bladder cancer, the Japanese company has

Sales 119
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AbbVie’s full year 2023 sees 6.4% net revenue drop

Pharmaceutical Technology

AbbVie has reported a decrease in net revenues to $54.32bn for the FY 2023, marking a 6.4% decline from the previous year's $58.05bn.

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Astellas raises Padcev forecasts on bladder cancer data

pharmaphorum

A bladder cancer study prompts Astellas to lift peak sales prediction for Padcev, although its menopause therapy Veozah isn’t ramping up as hoped.

Sales 116
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Inmagene to secure licence for two HUTCHMED drug candidates

Pharmaceutical Technology

Inmagene has exercised its option to secure a licence for HUTCHMED’s two drug candidates to treat immune and inflammatory ailments.

Drugs 130
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Novo antes up $16.5B to poach CDMO giant Catalent amid Wegovy surge

Fierce Pharma

Late last month, Novo Holdings’ CEO Kasim Kutay hinted that the fund manager was eyeing buyouts as an outlet for its trove of Wegovy cash. Now, a major deal has materialized. | Late last month, Novo Holdings’ CEO Kasim Kutay hinted that the fund manager was eyeing buyouts as an outlet for its trove of Wegovy cash. Now, a major deal has materialized.

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The New Age of Decentralized Clinical Trials

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.

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EMA validates application of Genmab-Pfizer cervical cancer treatment

Pharmaceutical Technology

The EMA has validated the MAA for review of Genmab and Pfizer’s tisotumab vedotin to treat recurrent or metastatic cervical cancer.

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WuXi AppTec defends against 'blanket allegations' as US legislation casts shadow over certain Chinese drugmakers

Fierce Pharma

As new legislation stands to threaten the U.S. business of certain Chinese biopharma companies, CDMO giant WuXi AppTec has stepped in to make a case for itself. | The company's executives inked an open letter after the recent BIOSECURE act flagged WuXi AppTec and other Chinese drugmakers as potential national security threats.

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AbbVie’s new drugs keep post-Humira prospects on track

pharmaphorum

Better-than-expected sales of some of its new products, including Skyrizi and Rinvoq, helped AbbVie handle a sharp decline in sales of former cash-cow product Humira in the last quarter of 2023.

Sales 105
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Which pharmaceutical companies have the most drug patents in Croatia?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Croatia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is… The post Which pharmaceutical companies have the most drug patents in Croatia? appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 104
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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4DMT gene therapy cuts need for Eylea in wet AMD trial

pharmaphorum

4D Molecular Therapeutics' 4D-150 gene therapy for wet AMD has shown efficacy and a reduced need for eye injections with current therapy Eylea in a phase 2 trial.

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Risk adjusted net present value: What is the current valuation of Ironwood Pharmaceuticals’s Apraglutide?

Pharmaceutical Technology

Apraglutide is a synthetic peptide commercialized by Ironwood Pharmaceuticals, with a leading Phase III program in Short Bowel Syndrome.

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Novo Nordisk tackles supply issues with $11bn Catalent deal

pharmaphorum

Novo Nordisk has taken the bold step of buying three manufacturing facilities from contract development and manufacturing organisation Catalent as it tries to meet surging demand for its diabetes and obesity drugs. The deal includes $11 billion upfront to buy the fill-finish sites that Novo Nordisk said will enable “an expansion of the manufacturing capacity at scale and speed while providing future optionality and flexibility for Novo Nordisk’s existing supply network.

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Risk adjusted net present value: What is the current valuation of Gritstone Bio’s GRANITE-001?

Pharmaceutical Technology

GRANITE-001 is a vaccine commercialized by Gritstone Bio, with a leading Phase III program in Metastatic Colorectal Cancer.

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How Machine Learning Drives Clinical Trial Efficiency

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.