Sat.Jun 22, 2024 - Fri.Jun 28, 2024

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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 345
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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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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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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 125
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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

More Trending

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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 177
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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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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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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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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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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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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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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 241
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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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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 153
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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 112
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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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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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Ayush and herbal products exports grow over 20% in April

AuroBlog - Aurous Healthcare Clinical Trials blog

Exports of Ayush and herbal products have reported a growth of 20.33 per cent during the first month of the current fiscal year, at $51.44 million as compared to $42.75 million during the same month of previous fiscal year.

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Alumis Pushes Through With Smaller IPO, Looks to Raise $250M for Immuno Candidate

BioSpace

Alumis is debuting in an initial public offering Friday on the Nasdaq, though the $250 million IPO is less than its initial targeted raise of $274 million just days ago.

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Supreme Court overturns Chevron doctrine, limiting reach of federal agencies

Bio Pharma Dive

Federal courts will no longer have to defer to agency regulations for interpretation of ambiguous statutes, a ruling that could have significant impact on the FDA and CMS.

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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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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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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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Illumina Reports $1.47B ‘Goodwill’ Impairment Charge After Grail Spinoff

BioSpace

Following the recently completed spinoff of cancer detection company Grail, sequencing giant Illumina said Thursday it expects to absorb a $1.47 billion goodwill impairment charge.

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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’s ocedurenone Phase III flop costs company $816m

Pharmaceutical Technology

NovoNordisk acquired the hypertension and kidney disease drug ocedurenone from KBP Biosciences in 2023 as part of a $1.3bn deal.

Drugs 236
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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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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 119
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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 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 239
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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.