Thu.Jun 27, 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 341
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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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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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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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AbbVie expands its IBD prospects with $250M Celsius deal

Bio Pharma Dive

The pharma’s acquisition of Celsius is the latest in a string of deals by major drugmakers hunting anti-inflammatory medicines.

Medicine 196
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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.

More Trending

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2seventy bio completes $40m haemophilia A program deal with Novo Nordisk

Pharmaceutical Technology

US-based 2seventy bio has completed an asset purchase agreement (APA) to divest its haemophilia A candidate to Novo Nordisk.

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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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Biotech fund Curie.Bio augments reserves with $380m to boost startups  

Pharmaceutical Technology

The recent raise will bring the biotech accelerator Curie.Bio’s total funds raised to nearly $1bn since it launched back in February 2023.

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Podcast June 14, 2024: Public-Private Partnerships in the Trustworthy Health AI Ecosystem (Michael Pencina, PhD; Brian Anderson, MD)

Rethinking Clinical Trials

This podcast continues the discussion with Dr. Michael Pencina and Dr. Brian Anderson as they discuss discuss Public-Private Partnerships in the Trustworthy Health AI Ecosystem. Click on the recording below to listen to the podcast. NIH Pragmatic Trials Collaboratory · Podcast 49: Public-Private Partnerships in the Trustworthy Health AI Ecosystem Want to hear more?

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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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Verona scores FDA approval for Ohtuvaye as COPD maintenance therapy

Pharmaceutical Technology

Ohtuvaye is expected to rake in $1.1bn in global sales from the market for COPD patients with moderate to severe exacerbations by 2029.

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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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Formation Bio secures $372m funds for AI-driven drug platform

Pharmaceutical Technology

Formation Bio has secured $372m in Series D funding to bolster its drug pipeline and expand its AI-driven drug development platform.

Drugs 130
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Billionaire Sackler family can't get legal immunity as part of Purdue bankruptcy deal, Supreme Court rules

Fierce Pharma

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.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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US CDC recommends routine RSV vaccination for older adults

Pharmaceutical Technology

The CDC ACIP has recommended the routine use of respiratory syncytial virus (RSV) vaccines for all adults aged 75 years and above.

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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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AI and stable funding environments are catalysts for biotech assets

Pharmaceutical Technology

As the funding market evolves, there is greater emphasis on companies having commercial plans and using AI for drug discovery.

Marketing 130
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A methodological approach in patient insights to discover the emotional patient journey

pharmaphorum

Explore a methodological approach for discovering the emotional patient journey through patient insights. Understand the importance of emotional connections in healthcare.

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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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AbbVie gains FDA approval for EPKINLY in follicular lymphoma

Pharmaceutical Technology

AbbVie has announced the receipt of accelerated approval from the US FDA for EPKINLY to treat adults with follicular lymphoma.

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AbbVie Expands Immuno Portfolio With $250M Celsius Buy as Humira Hits Patent Cliff

BioSpace

AbbVie on Thursday announced it has acquired Celsius Therapeutics to expand its immunology portfolio with a first-in-class TREM1 inhibitor CEL383, following other big players looking to cash in on the hot immuno market.

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FDA issues complete response to Daiichi Sankyo-MSD’s BLA for NSCLC

Pharmaceutical Technology

The US FDA has provided a complete response letter for Daiichi Sankyo and MSD’s BLA for patritumab deruxtecan to treat NSCLC.

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FDA Needs to Step Up As Use of Third-Party Manufacturers Leads to Rejections

BioSpace

AbbVie and Merck/Daiichi Sankyo were hit this week with Complete Response Letters from the FDA, which rejected their respective drugs due to manufacturing issues.

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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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Capturing the genAI boom for drug development

Pharmaceutical Technology

Biotechs with AI-led drug pipelines appear to be enjoying higher investment attraction.

Drugs 147
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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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The top 5 emerging startups fuelling drug discovery with AI

Outsourcing Pharma

Artificial intelligence is showing great promise in the quest to unearth new drug candidates and disease targets faster than ever before.

Drugs 104
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In bispecific rivalry, AbbVie’s Epkinly follows Roche’s Lunsumio into follicular lymphoma

Fierce Pharma

With Regeneron’s treatment delayed, AbbVie is expanding its T-cell engager competition against Roche in blood cancer with a new FDA approval. | With Regeneron's treatment delayed, AbbVie is expanding its T-cell engager competition against Roche in blood cancer with a new FDA approval.

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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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WuXi AppTec - examining the impact of personalized medicine on reproductive health

Outsourcing Pharma

Personalized medicine has evolved to the point where it is transforming areas of healthcare, bringing hope to patients across the world.

Medicine 105
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Verona’s first-in-class COPD drug ‘could transform market’

pharmaphorum

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.

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With Latest Expansion in Ohio, Resilience Can Best Serve Partners and Patients

BioSpace

Expansion across its network will mean hundreds of new employees in Cincinnati, increased ability to get complex medicines to patients and more.

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How are pharma companies addressing sustainability and climate change?

Outsourcing Pharma

The pharmaceutical industry is making significant strides toward sustainability, with companies across the sector implementing various Environmental, Social, and Governance (ESG) initiatives.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.