Mon.Jun 24, 2024

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Leveraging 505(b)(2) to Innovate Beyond Existing Drug Patents

Drug Patent Watch

The 505(b)(2) regulatory pathway provides an attractive avenue for drug developers to bring new products to market by leveraging existing data on approved drugs. This pathway allows modifications and improvements to be made to existing drugs, while potentially reducing development costs and timelines compared to the traditional new drug application (NDA) route.

Drugs 105
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Osteoporosis market expected to reach $17.9bn across 7MM by 2033

Pharmaceutical Technology

The osteoporosis market is expected to grow at a compound annual growth rate of 5.4% from 2023 to 2032, reaching $17.9bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) by the end of this forecast period, according to leading data and analytics company GlobalData’s recent report: Osteoporosis: Seven-Market Drug Forecast and Market Analysis.

Marketing 264
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The Risk Factors For Long COVID Have Finally Been Revealed

AuroBlog - Aurous Healthcare Clinical Trials blog

For many, catching SARS-CoV-2 means an unpleasant few weeks of aches, coughs, and fatigue. In roughly one in every five cases, however, the discomfort endures for months on end. What puts some individuals at greater risk of an acute infection lingering as long COVID has been far from clear.

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The evolution of contract packagers: delivering sustainability for injectables packaging

Pharmaceutical Technology

Big pharma and their packaging partners are collaborating to cut emissions and deliver more sustainable solutions for injectables.

Packaging 243
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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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Centre forms 5-member panel to examine manufacturing of nutraceuticals within drug production facility

AuroBlog - Aurous Healthcare Clinical Trials blog

Union government has now formed a committee to examine the matter of manufacturing of nutraceuticals within the drug manufacturing facility. This follows the implementation of revised Schedule M mandating dedicated areas for manufacture of nutraceuticals and pharmaceuticals.

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Obesity drugs from Altimmune, Hengrui show potential; Lilly details Zepbound sleep apnea data

Bio Pharma Dive

The American Diabetes Association’s annual meeting provided a forum for early trial results on several would-be weight loss drug competitors.

Drugs 162

More Trending

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Novo fills in positive picture for preventive hemophilia drug

Bio Pharma Dive

Phase 3 trial results should support an approval application for the drug, which analysts view as a potential competitor to Roche’s blockbuster medicine Hemlibra.

Drugs 162
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Alimera Sciences shares jump by 77% after being acquired by ANI  

Pharmaceutical Technology

Alimera Sciences shares have increased following a $5.50 per share buyout offer from ANI Pharmaceuticals.

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Bridging science and humanity: Systems thinking in clinical trial design

Bio Pharma Dive

Benefits of adopting the systems thinking approach in clinical trial design.

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The FDA awarded a record number of review designations to mRNA vaccines in 2023

Pharmaceutical Technology

The success of the Covid-19 messenger ribonucleic acid (mRNA) vaccines highlighted the major advantages of utilising mRNA technology in vaccine development.

Vaccine 147
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Alnylam says heart drug succeeds in closely watched study

Bio Pharma Dive

Positive results from a Phase 3 trial of vutrisiran in transthyretin amyloidosis cardiomyopathy come eight months after the FDA rejected another medicine Alnylam developed for the condition.

Medicine 145
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ADA 2024: Altimmune’s GLP-1 drug shows weight loss potential

Pharmaceutical Technology

As the obesity drug development space gains traction, Altimmune shared positive data from a Phase II trial for pemvidutide.

Drugs 147
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The role of a specialty pharmacy in enhancing patient access to rare and gene therapies

Bio Pharma Dive

Four critical components in which the right specialty pharmacy partner can bring rare and gene therapy manufacturers the scale, expertise and capabilities needed to drive enhanced patient access.

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FDA approves argenx’s VYVGART Hytrulo for CIDP treatment

Pharmaceutical Technology

The US FDA has approved argenx's VYVGART Hytrulo to treat adults with chronic inflammatory demyelinating polyneuropathy (CIDP).

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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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Alnylam CEO touts 'big-win scenario' for Amvuttra in closely watched heart disease trial

Fierce Pharma

In one of the most closely watched biotech trial readouts of the year, Alnylam Pharmaceuticals said its RNA interference drug reduced the risk of death or recurrent cardiovascular events in patient | In one of the most closely watched biotech trial readouts of the year, Alnylam Pharmaceuticals said its RNA interference drug reduced the risk of death or recurrent cardiovascular events.

RNA 127
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Navigating the global epilepsy clinical trial landscape in 2024 

Pharmaceutical Technology

Novotech shines a light on the cutting-edge progress in epilepsy research in its latest in-depth disease analysis.

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Rallying in RSV vaccine race, Pfizer gains contract win over GSK in the UK

Fierce Pharma

After losing round one of its respiratory syncytial virus (RSV) vaccine bout with GSK, Pfizer is rallying. | After losing round one of its respiratory syncytial virus (RSV) vaccine bout with GSK, Pfizer is rallying. And what better way to do it than to win a major contract in your rival’s home country? The U.K. government has selected Pfizer to supply 5 million doses of its RSV shot Abrysvo over the next two years.

Vaccine 126
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Blockbuster deals are shaping key player CMOs despite 31% drop in M&A

Pharmaceutical Technology

Despite a difficult investing environment, major well-capitalised contract manufacturing organisations (CMOs) have been involved in recent acquisitions, as big pharma and private equity alike highly value the manufacturing capabilities and expertise these companies bring to the table.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Digital twins in healthcare and drug discovery: From idea to success stories

pharmaphorum

Explore how digital twins are transforming healthcare and drug discovery, with success stories showcasing their impact in the biopharma industry. Learn about their journey from concept to real-world applications.

Drugs 124
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BMS expands Krazati’s FDA label to include colorectal cancer

Pharmaceutical Technology

The KRAS inhibitor, Krazati, is expected to generate $1.3bn in global sales in 2029, as per GlobalData’s analysis.

Sales 130
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Amid duel with Novo's Wegovy, Lilly's Zepbound homes in on potential FDA sleep apnea nod

Fierce Pharma

Following Novo Nordisk’s recent Wegovy approval to cut heart risks in adults with obesity, Eli Lilly appears to be homing in on the next potential label expansion for its rival GIP/GLP-1 weigh | Late last week, Lilly shared detailed results from its phase 3 SURMOUNT-OSA study, which found that Zepbound at the 10 mg and 15 mg doses aced its primary and secondary endpoints in obese patients with obstructive sleep apnea (OSA).

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Alnylam reveals positive Phase III results for rare heart disease drug vutrisiran

Pharmaceutical Technology

The Phase III HELIOS-B study met its primary and secondary endpoints in the monotherapy and overall study populations.

Drugs 130
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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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UK dementia organisations publish new manifesto ahead of general election

Pharma Times

The manifesto calls on the next UK government to make dementia a key health priority

Research 118
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Pharmaceutical consulting companies, services and solutions 

Pharmaceutical Technology

Discover the key factors in selecting pharmaceutical consulting firms for regulatory compliance, strategic development, and market success.

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BMS gets FDA approval for Krazati in colorectal cancer

pharmaphorum

Bristol-Myers Squibb’s KRAS inhibitor Krazati has been approved for a second indication, colorectal cancer

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Daiichi Sankyo peripheral T-cell lymphoma therapy approved in Japan

Pharmaceutical Technology

Daiichi Sankyo has announced the receipt of approval from the Japan MHLW for EZHARMIA to treat peripheral T-cell lymphoma (PTCL).

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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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Cholesterol drug could find new role in diabetic eye disease

pharmaphorum

Fenofibrate, a decades-old drug used to lower cholesterol levels, has been shown to reduce the progression of diabetic retinopathy in a large-scale trial.

Drugs 111
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EC approves Takeda’s Fruzaqla for metastatic colorectal cancer

Pharmaceutical Technology

The EC has approved Takeda’s Fruzaqla for adults with metastatic colorectal cancer (mCRC) who have exhausted standard therapies.

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Alnylam’s vutrisiran aces ATTR cardiomyopathy readout

pharmaphorum

Alnylam shares spike after vutrisiran aces HELIOS-B trial in ATTR-cardiomyopathy, setting up regulatory filings

Trials 111
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Melodia Therapeutics and Alivexis agree to develop MDI-0151

Pharmaceutical Technology

Melodia Therapeutics has signed an exclusive licence agreement to obtain rights for Alivexis’ MDI-0151, a cathepsin C inhibitor.

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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.