Lilly drug for Alzheimer’s approved by FDA
Bio Pharma Dive
JULY 2, 2024
The drug, which Lilly will sell as Kinsunla, carries a warning for the risk of a certain kind of imaging abnormality that can be serious in rare cases.
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EMA fast-tracks review of AstraZeneca’s sipavibart to stop Covid
Pharmaceutical Technology
JULY 2, 2024
The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.
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These microscopic tunnels are a goldmine for new medicines
Bio Pharma Dive
JUNE 27, 2024
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.
AstraZeneca’s Tagrisso receives approval in Japan for lung cancer
Pharmaceutical Technology
JUNE 26, 2024
AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).
Scientists Pinpoint Where Extreme Moods of Bipolar Disorder Exist in Brain
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 26, 2024
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.
July 1, 2024: Latest Podcast Features Michael Pencina and Brian Anderson of Coalition for Health AI
Rethinking Clinical Trials
JULY 1, 2024
In a new episode of our Rethinking Clinical Trials podcast, Drs. Michael Pencina and Brian Anderson of the Coalition for Health AI speak with host Dr. Adrian Hernandez about public-private partnerships in a trustworthy health AI ecosystem. Pencina and Anderson presented on their experiences during the March 8 session of PCT Grand Rounds. Listen and subscribe to the podcast on SoundCloud or Apple Podcasts , and view the full March 8 PCT Grand Rounds webinar.
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Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help?
Bio Pharma Dive
JUNE 26, 2024
Obesity drugs like Wegovy are proving useful in many other diseases. Polycystic ovary syndrome, a chronic condition that can cause infertility, may be one.
Novavax seeks EMA approval for updated JN.1 Covid-19 vaccine
Pharmaceutical Technology
JUNE 25, 2024
Novavax has sought EMA approval for its updated JN.1 Covid-19 vaccine, NVX-CoV2705, for people aged 12 years and above.
Artificial intelligence transforming healthcare customer experience: VR Munnaluri
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 25, 2024
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 […]
June 26, 2024: Using ChatGPT to Facilitate Informed Medical Consent, in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
JUNE 26, 2024
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.
The New Age of Decentralized Clinical Trials
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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
Merck's Capvaxive gears up to challenge Pfizer's dominant Prevnar with CDC panel backing
Fierce Pharma
JUNE 28, 2024
After scoring approval as the world’s first pneumococcal disease vaccine made specifically for adults earlier this month, Merck’s Capvaxive passed the next test in its bid to take on Pfizer an | The recommendation sets up Merck's new pneumococcal disease vaccine to potentially capture some of Pfizer's market share.
First-of-its-kind Intellia data suggest CRISPR drug could be given more than once
Bio Pharma Dive
JUNE 26, 2024
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.
Amylyx ventures into metabolic diseases market with $35.1m deal
Pharmaceutical Technology
JUNE 28, 2024
On 17 June, Amylyx acquired the rights to Eiger Biopharmaceutical’s experimental GLP-1 receptor antagonist, avexitide, for $35.1m.
TN govt appoints M N Sridhar as state licensing authority & controlling authority for DC department
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 26, 2024
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.
How Machine Learning Drives Clinical Trial Efficiency
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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.
FDA Rejects Rocket’s Gene Therapy, Cites Need for Additional CMC Info
BioSpace
JUNE 27, 2024
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.
With FDA nod, Verona’s Ohtuvayre is set to Jack up the COPD market
Fierce Pharma
JUNE 26, 2024
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.
FDA go-ahead for Verona Ohtuvayre transforms US COPD exacerbator market
Pharmaceutical Technology
JUNE 27, 2024
Data showed that Ohtuvayre significantly improved dyspnea compared to placebo in as little as six weeks and maintained this over 24 weeks.
Ayush and herbal products exports grow over 20% in April
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 27, 2024
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.
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.
Zealand Pharma rakes in $1bn in funding for obesity drugs
pharmaphorum
JUNE 26, 2024
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.
Billionaire Sackler family can't get legal immunity as part of Purdue bankruptcy deal, Supreme Court rules
Fierce Pharma
JUNE 27, 2024
Years of negotiations and legal proceedings surrounding a high-dollar opioid settlement for Purdue Pharma have reached a dead end at the U.S. Supreme Court. | Years of negotiations and legal proceedings surrounding a high-dollar opioid settlement for Purdue Pharma have reached a dead end at the U.S. Supreme Court.
10 clinical trials to watch in the second half of 2024
Bio Pharma Dive
JULY 1, 2024
Study results are expected for a pair of closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.
Novo Nordisk invests $4.1bn in manufacturing facility in NC
Pharmaceutical Technology
JUNE 25, 2024
Novo Nordisk has unveiled a significant investment plan, committing $4.1bn to construct a second fill and finishing facility in Clayton.
2022 Research: The Rapid Rise of Ocean Freight Visibility
Advertiser: FourKites
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.
Drinking Coffee May Lower Risk of Death From Too Much Sitting
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 27, 2024
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.
Verona’s first-in-class COPD drug ‘could transform market’
pharmaphorum
JUNE 27, 2024
Verona Pharma has claimed FDA approval for its chronic obstructive pulmonary disease (COPD) drug ensifentrine, which has been tipped as a future blockbuster.The first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor – now given the somewhat tongue-twisting brand name of Ohtuvayre – is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years, according to Verona.
GSK takes another Zantac personal injury case off its plate with settlement in Illinois
Fierce Pharma
JULY 1, 2024
GSK scratched another Zantac lawsuit off the list with a confidential settlement in Illinois as it continues to work through the mountain of personal injury litigation related to the heartburn pill | Following a win and a separate dismissal in Illinois, GSK agreed to a confidential settlement to resolve prostate cancer claims put forward by plaintiff Martin Gross.
2seventy slims down with sale of hemophilia assets to Novo
Bio Pharma Dive
JUNE 27, 2024
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.
Novo Nordisk’s ocedurenone Phase III flop costs company $816m
Pharmaceutical Technology
JUNE 27, 2024
NovoNordisk acquired the hypertension and kidney disease drug ocedurenone from KBP Biosciences in 2023 as part of a $1.3bn deal.
Alumis Pushes Through With Smaller IPO, Looks to Raise $250M for Immuno Candidate
BioSpace
JUNE 27, 2024
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.
House committee backs some Medicare cover for obesity drugs
pharmaphorum
JUNE 28, 2024
The House Ways and Means Committee in the US voted in favour of a new bill which would end a two-decade-long restriction on the coverage of drugs to treat obesity under Medicare.The Treat and Reduce Obesity Act of 2023 (TROA) was originally intended to overturn the restriction completely, but has been hugely scaled back in its scope.
Regulatory tracker: Sandoz, Samsung Bioepis gain FDA approval for biosimilar to J&J's Stelara
Fierce Pharma
JULY 1, 2024
Welcome to Fierce Pharma's regulatory tracker for the second half of 2024. | In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.
The New Age of Decentralized Clinical Trials
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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.
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