Trending Articles

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These microscopic tunnels are a goldmine for new medicines

Bio Pharma Dive

A growing cohort of biotechs, from Biohaven to Neurocrine to Jazz, hope research on ion channels will bring them new drugs and big business — much like it has done for Vertex.

Medicine 341
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AstraZeneca’s Tagrisso receives approval in Japan for lung cancer

Pharmaceutical Technology

AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).

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Scientists Pinpoint Where Extreme Moods of Bipolar Disorder Exist in Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

Moods and emotions play an important role in our day-to-day life. They even influence how we experience things – for instance, whether we start the day feeling hopeful and energised or grumpy and lethargic. This can affect whether we interpret events in a positive or negative light.

Scientist 179
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June 26, 2024: Using ChatGPT to Facilitate Informed Medical Consent, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Fatima Mirza In this Friday’s PCT Grand Rounds, Fatima Mirza of the Warren Alpert Medical School of Brown University will present “Using ChatGPT to Facilitate Truly Informed Medical Consent.” The Grand Rounds session will be held on Friday, June 28, 2024, at 1:00 pm eastern. Mirza is chief resident in the Department of Dermatology at the Warren Alpert Medical School of Brown University.

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

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Daiichi’s lung cancer ADC rejected by FDA in blow to first project under Merck partnership

Fierce Pharma

In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate (ADC) patritumab deruxtecan. | In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate patritumab deruxtecan.

Antibody 128
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Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help?

Bio Pharma Dive

Obesity drugs like Wegovy are proving useful in many other diseases. Polycystic ovary syndrome, a chronic condition that can cause infertility, may be one.

Hormones 313

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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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June 24, 2024: GGC4H Finds Increase in Depression Among Early Adolescents During COVID-19 Pandemic

Rethinking Clinical Trials

Dr. Margaret Kuklinski and Dr. Stacy Sterling In an analysis of behavioral health data from the GGC4H study, researchers observed a significant increase in the rate of depression among early adolescents during the first year of the COVID-19 pandemic in the United States. The results extend findings on adolescent mental health during the pandemic to younger adolescents, a relatively understudied population.

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Zealand Pharma rakes in $1bn in funding for obesity drugs

pharmaphorum

Fresh from reporting encouraging results with its obesity drug candidate petrelintide, Zealand Pharma has raised an impressive $1 billion from a new share offering.The Danish biotech started the fundraising process earlier this week with an expectation of raising $900 million but easily overshot that target, evidence once again of huge investor interest in companies developing a new generation of obesity drugs.

Drugs 118
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First-of-its-kind Intellia data suggest CRISPR drug could be given more than once

Bio Pharma Dive

The findings provide early proof that multiple doses of a gene editing medicine can be safely administered with additive effects, overcoming a key constraint of the complex therapies.

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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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Novavax seeks EMA approval for updated JN.1 Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought EMA approval for its updated JN.1 Covid-19 vaccine, NVX-CoV2705, for people aged 12 years and above.

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Artificial intelligence transforming healthcare customer experience: VR Munnaluri

AuroBlog - Aurous Healthcare Clinical Trials blog

Artificial intelligence (AI) is transforming healthcare customer experience as healthcare organisations are uniquely challenged to provide great customer service in stressful and highly personal situations, says Vasudeva Rao Munnaluri, regional vice president (RVP) for India & SAARC at Zendesk while discussing the role of AI in healthcare customer experience (CX) and the unique challenges faced […]

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With FDA nod, Verona’s Ohtuvayre is set to Jack up the COPD market

Fierce Pharma

Thirteen years after his passing, Sir David Jack still looms as an innovative force in healthcare. | Verona Pharma has earned an FDA approval for Ohtuvayre, a potential blockbuster with a novel mechanism of action, to treat patients with chronic obstructive pulmonary disorder (COPD). It is the first novel treatment advancement in the indication in more than a decade.

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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 121
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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.

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2seventy slims down with sale of hemophilia assets to Novo

Bio Pharma Dive

Novo will pay $38 million in cash under the deal, which will also see 2seventy employees working on the program transfer to the Danish drugmaker.

Sales 274
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Amylyx ventures into metabolic diseases market with $35.1m deal

Pharmaceutical Technology

On 17 June, Amylyx acquired the rights to Eiger Biopharmaceutical’s experimental GLP-1 receptor antagonist, avexitide, for $35.1m.

Marketing 227
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TN govt appoints M N Sridhar as state licensing authority & controlling authority for DC department

AuroBlog - Aurous Healthcare Clinical Trials blog

The Tamil Nadu government has appointed the incumbent controlling authority (CA) of the drugs control administration, M N Sridhar, as state licensing and controlling authority (SLA and CA) for the department of drugs control from June 18 onwards.

Licensing 154
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Lilly Teams With OpenAI to Tackle Threat of Drug-Resistant Bacteria

BioSpace

Following in the footsteps of Sanofi and Moderna, Eli Lilly on Tuesday inked a collaboration agreement with OpenAI to develop novel antimicrobial agents against drug-resistant pathogens.

Bacteria 109
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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We want your feedback!

pharmaphorum

Take part in the pharmaphorum reader survey 2024 and share your views on the latest trends and developments in the pharmaceutical industry. Your input helps us tailor our publication to meet your needs.

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Exsilio debuts with $82M, pitching a ‘leap’ forward for genetic medicine

Bio Pharma Dive

The company claims it can address some of the field’s limitations with medicines delivered via messenger RNA and lipid nanoparticles.

Medicine 275
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FDA go-ahead for Verona Ohtuvayre transforms US COPD exacerbator market

Pharmaceutical Technology

Data showed that Ohtuvayre significantly improved dyspnea compared to placebo in as little as six weeks and maintained this over 24 weeks.

Marketing 230
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Drinking Coffee May Lower Risk of Death From Too Much Sitting

AuroBlog - Aurous Healthcare Clinical Trials blog

Years of life spent sitting on an office chair or a couch can have deadly health effects in the long run – but curling up with a regular cup of coffee might be a way to offset that harmful lifestyle.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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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.

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Verona Gears Up for First Novel COPD Approval in Over a Decade

BioSpace

If approved, ensifentrine would be the first non-steroidal, anti-inflammatory drug for patients with chronic obstructive pulmonary disease, offering an option with potentially fewer side effects.

Drugs 113
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Novo nixes trial of blood pressure drug it bought in deal worth $1.3B

Bio Pharma Dive

The failure of a Phase 3 trial led the Wegovy maker to take an accounting charge that will hit its operating profit growth this year.

Trials 242
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Novo Nordisk invests $4.1bn in manufacturing facility in NC

Pharmaceutical Technology

Novo Nordisk has unveiled a significant investment plan, committing $4.1bn to construct a second fill and finishing facility in Clayton.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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Best Practices for Drug Patent Portfolio Management

Drug Patent Watch

Introduction Patent portfolios are critical assets for pharmaceutical companies, providing market exclusivity and protecting revenue streams for drug products. Effective management of drug patent portfolios requires strategic planning, ongoing evaluation, and adaptation to the evolving pharmaceutical landscape. This article explores key best practices for optimizing drug patent portfolios to maximize value and maintain competitive advantage.

Drugs 104
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FDA Rejects Rocket’s Gene Therapy, Cites Need for Additional CMC Info

BioSpace

Rocket Pharmaceuticals’ gene therapy Kresladi has been hit with an FDA Complete Response Letter requesting additional chemistry, manufacturing and controls information to complete its review.

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Merck’s pneumococcal vaccine gets CDC panel backing

Bio Pharma Dive

Advisers to the agency unanimously recommended use of Capvaxive in older adults and in certain younger ones, putting it in the same tier as Pfizer's competing Prevnar shot.

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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.