Wed.Jun 26, 2024

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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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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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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 317
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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 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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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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Magazine: UK’s new Netflix-style funding model for antibiotics goes live

Pharmaceutical Technology

In this issue: UK’s new Netflix-style funding model for antibiotics, the Swiss biotech ecosystem recuperates from financial instability of 2023, how patient advocacy can lead to more successful clinical trials, and more.

More Trending

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Lilly joins fellow pharma giants in OpenAI partnership

Pharmaceutical Technology

The collaboration is intended to leverage OpenAI's generative AI-based platform to invent novel antimicrobials to treat drug-resistant pathogens.

Drugs 147
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Zealand hauls in $1B off obesity drug data; Curie.bio zeroes in on Series A’s

Bio Pharma Dive

Zealand capitalized on a stock surge following the release of early study results. Elsewhere, U.S. regulators rejected an AbbVie medicine and another well-funded AI drug discovery startup emerged.

Drugs 147
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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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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 138
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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GLP-1 shortages are not expected to resolve this year, says EMA Director

Pharmaceutical Technology

The EU regulatory agency states that the shortages are due to higher demand and off-label use of GLP-1 receptor agonists.

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After 33 years, Geron’s first approval marks a turn in Nobel-winning science

Bio Pharma Dive

The decades-long story of how a novel type of blood cancer drug went from a scientific idea to an approved product.

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Harnessing the power of eCOA in clinical trials

Pharmaceutical Technology

Electronic clinical outcome assessment (eCOA) solutions are vital for sponsors to capture, manage, and utilize growing volumes of data.

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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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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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Sharp Services announces expansion in Pennsylvania to facilitate growth in sterile injectable market 

Pharmaceutical Technology

Sharp Services announces expansion in Pennsylvania to facilitate growth in sterile injectable market

Marketing 130
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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 124
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Impact and implications of the $35 monthly price cap on asthma inhalers

Pharmaceutical Technology

In the US, an initiative to cap the monthly cost of asthma inhalers at $35 marks a development in healthcare affordability and accessibility.

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Haleon reels in $633M with sale of ex-US nicotine replacement unit to Dr. Reddy's

Fierce Pharma

With U.K. consumer health giant Haleon slimming down and India’s Dr. Reddy’s Laboratories beefing up its over-the-counter offerings, the two have arrived at a deal that makes sense for both. | Haleon has continued its push to divest, selling its nicotine replacement therapy (NRT) business outside of the United States to Dr. Reddy’s for 500 million pounds ($633 million).

Sales 120
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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China NMPA approves Simcere Zaiming’s Enlituo for mCRC treatment

Pharmaceutical Technology

The China National Medical Products Administration (NMPA) has granted marketing approval for Simcere Zaiming’s Enlituo for the treatment of metastatic colorectal cancer (mCRC).

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FNIH’s Dr. Travaglia and ALS Patient Advocate Dr. Sethi Discuss New ALS Program

XTalks

In this episode, Ayesha spoke with Alessio Travaglia, PhD, Director Neuroscience at the Foundation for the National Institutes of Health (FNIH) who also manages FNIH’s new Accelerating Medicines Partnership in Amyotrophic Lateral Sclerosis (AMP ALS) program, and Nadia Sethi, DDS, an ALS patient advocate who formerly served as Director of Community Outreach and Engagement at the ALS Therapy Development Institute.

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Carisma Therapeutics’ solid tumour therapy obtains FDA Fast Track status

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Fast Track designation for Carisma Therapeutics’ CT-0525 for the treatment of solid tumours overexpressing human epidermal growth factor receptor 2 (HER2).

Drugs 130
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Despite J&J's Rybrevant full nod, FDA encourages Dizal to file rival lung cancer drug for accelerated approval

Fierce Pharma

The FDA in March converted Johnson & Johnson’s Rybrevant use in previously treated EGFR exon20 insertion-mutated non-small cell lung cancer into a full nod. | Even after the FDA has converted J&J’s Rybrevant use in previously treated EGFR exon20 insertion-mutated non-small cell lung cancer into a full nod, the door to an accelerated approval in the same indication remains open, according to AstraZeneca spinout Dizal Pharma.

Drugs 118
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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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FDA issues complete response to AbbVie’s NDA for Parkinson’s drug

Pharmaceutical Technology

The US FDA has issued a complete response letter (CRL) for AbbVie’s NDA for ABBV-951 in adult patients with advanced Parkinson's disease.

Drugs 130
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EvolutionaryScale emerges with $142m for AI drug discovery

pharmaphorum

AI in drug discovery start-up EvolutionaryScale raises $142m in seed financing for its LLM-powered platform for designing protein structures.

Drugs 115
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Pharma M&A: The top high value deals in 2023

Pharmaceutical Technology

From Pfizer’s Seagen acquisition to Sanofi’s deal with Provention Bio, Pharmaceutical Technology lists the highest value pharma deals that were completed in 2023.

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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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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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CDC immunization advisers vote to shrink recommendations for RSV vaccination

Fierce Pharma

The respiratory syncytial virus (RSV) vaccine showdown already saw a shakeup last month with a new competitor in Moderna’s mRESVIA. | The vaccines are now recommended for adults aged 75 years and older and those aged 60 to 74 with a higher risk of severe disease. Previously, all adults aged 60 and older were advised for vaccination.

Vaccine 111
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Non-cancer and HST focus are needed to speed up NICE guidance

pharmaphorum

To speed up NICE guidance, a focus on non-cancer and HST areas is essential. Learn more about the importance of these aspects in the NICE process.

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Sanofi asks for private equity bids for its consumer health unit: Bloomberg

Fierce Pharma

It finally appears to be go-time in Sanofi’s continuing effort to separate from its consumer health unit. | Sanofi has told prospective buyers of its consumer health unit to provide bids for its consumer division by the middle of July, Bloomberg reports. Private equity firms Advent International and PAI Partners are believed to be the most serious potential suitors.

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Smith+Nephew takes sports injury message to Wimbledon

pharmaphorum

Smith+Nephew takes sports injury message to Wimbledon Phil.

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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.