Thu.May 16, 2024

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Lilly’s once-weekly insulin matches daily shots in late-stage tests

Bio Pharma Dive

The results, which showed Lilly’s drug was as effective at controlling blood sugar as standard injections, come as Novo Nordisk seeks approval for a competing once-weekly insulin.

Insulin 285
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Tracking the opioid lawsuit settlements amidst calls for oversight

Pharmaceutical Technology

The US National Opioid Settlement is distributing more than $54 billion to communities grappling with the opioid crisis.

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Investors put $400M into biotech licensing obesity drugs from China

Bio Pharma Dive

The biotech, tentatively named Hercules CM Newco, has rights to three incretin drugs discovered by Jiangsu Hengrui Pharmaceuticals, two of which are in clinical testing.

Licensing 354
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Docetaxel albumin bound by CSPC Pharmaceutical Group for Hypopharyngeal Cancer: Likelihood of Approval

Pharmaceutical Technology

Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Hypopharyngeal Cancer.

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

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Biogen, Ionis shelve ALS drug following study failure

Bio Pharma Dive

While results indicated the drug works as intended, it didn’t have enough of an effect on a protein that’s become integral to many ALS research programs.

Drugs 302
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Docetaxel albumin bound by CSPC Pharmaceutical Group for Oropharyngeal Cancer: Likelihood of Approval

Pharmaceutical Technology

Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Oropharyngeal Cancer.

More Trending

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Docetaxel albumin bound by CSPC Pharmaceutical Group for Laryngeal Cancer: Likelihood of Approval

Pharmaceutical Technology

Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Laryngeal Cancer.

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Roche keeps pace in obesity drug field with early study data

Bio Pharma Dive

A drug Roche acquired in a buyout of Carmot Therapeutics and that works similarly to Zepbound helped people lose nearly 19% of their body weight in a Phase 1 trial.

Drugs 174
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Chenodiol by Leadiant Biosciences for Cerebrotendinous Xanthomatosis: Likelihood of Approval

Pharmaceutical Technology

Chenodiol is under clinical development by Leadiant Biosciences and currently in Phase II for Cerebrotendinous Xanthomatosis.

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May 16, 2024: Journal Peer Reviewers Are Familiar With Pragmatic Trials, Want More on Implementation

Rethinking Clinical Trials

According to a report from the NIH Pragmatic Trials Collaboratory Coordinating Center, journal editors and peer reviewers were familiar with pragmatic clinical trials and their designs and analytic approaches, but they often asked for more information about intervention implementation. The report was published this week in the Living Textbook of Pragmatic Clinical Trials.

Trials 147
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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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DN-1508052 by Shanghai De Novo Pharmatech for Melanoma: Likelihood of Approval

Pharmaceutical Technology

DN-1508052 is under clinical development by Shanghai De Novo Pharmatech and currently in Phase I for Melanoma.

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Top 10 countries accounted for India’s 63% of Ayush and herbal products export in 2023-24

AuroBlog - Aurous Healthcare Clinical Trials blog

The top 10 destinations led by USA, Germany and Italy accounted for almost 63.3 per cent of India’s Ayush and herbal products during the fiscal year 2023-24. Exports to these 10 countries together stood at $412 million, with a growth of 5.

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INZ-701 by Inozyme Pharma for Pseudoxanthoma Elasticum (PXE or Gronblad Strandberg Syndrome): Likelihood of Approval

Pharmaceutical Technology

INZ-701 is under clinical development by Inozyme Pharma and currently in Phase II for Pseudoxanthoma Elasticum (PXE or Gronblad Strandberg Syndrome).

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A Neuroscientist Explains How Your Brain Actually Thinks

AuroBlog - Aurous Healthcare Clinical Trials blog

Have you ever wondered how your brain creates thoughts or why something randomly popped into your head? It may seem like magic – but actually the brain is like a supercomputer inside your head that helps you think, learn and make decisions. Imagine your brain as a busy city with lots of streets and buildings.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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KRAS inhibitors: The next frontier beckons

Pharmaceutical Technology

There has been several developments in the KRAS inhibitor space, shaping the KRAS inhibitors of the future.

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J&J to buy Proteologix and its dual-targeting antibody drugs for $850M

Bio Pharma Dive

The deal is part of a plan by J&J to build a portfolio of “differentiated” bispecific antibodies, an increasingly popular area of drug development.

Antibody 129
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ABP-671 by Jiangsu Atom Bioscience and Pharmaceutical for Chronic Kidney Disease (Chronic Renal Failure): Likelihood of Approval

Pharmaceutical Technology

ABP-671 is under clinical development by Jiangsu Atom Bioscience and Pharmaceutical and currently in Phase I for Chronic Kidney Disease (Chronic Renal Failure).

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Amgen Wins FDA Approval for Difficult-to-Treat Lung Cancer

BioSpace

Bolstered by promising response data from its Phase II study, Amgen announced Thursday it got the FDA’s green light for its first-in-class bi-specific T-cell engager Imdelltra for extensive-stage small lung cancer.

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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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Food Allergy Awareness Week 2024: How can new treatments target an unmet need?

Pharmaceutical Technology

IgGenix is planning to initiate a clinical trial later this year investigating its peanut allergy monoclonal antibody IGXN001.

Allergies 147
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Biogen Drops Ionis-Partnered Assets in ALS, Angelman Syndrome After Early-Stage Readouts

BioSpace

Disappointed with Phase I/II results for two Ionis-partnered programs, one for amyotrophic lateral sclerosis and another for Angelman syndrome, Biogen has opted to not proceed with their development.

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Ionis and Biogen discontinue experimental ALS drug after Phase I/II flop

Pharmaceutical Technology

The ALS space takes another hit after experimental drug BIIB105 failed to show evidence of benefit in patients in the Phase I/II ALSpire trial.

Drugs 130
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FT US Pharma and Biotech Summit: Live coverage

pharmaphorum

Explore innovation, investment, and policies at the US Pharma and Biotech Summit 2024. Join industry leaders, regulators, and investors to discuss trends shaping healthcare.

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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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Podcast #2: Doing Digital Deals in Life Sciences | Information Governance

Pharmaceutical Technology

In this series, life sciences industry M&A veteran John Easton will discuss how digital deals differ from traditional life science deals

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Bayer’s 1,500 Layoffs Are Latest Salvo in CEO Bill Anderson’s Company Overhaul

BioSpace

Since taking the helm in 2023, Anderson has embarked on a radical departure from the traditional structure of large pharma companies. Will getting rid of management layers fix Bayer?

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Takeda’s dengue vaccine obtains WHO prequalification

Pharmaceutical Technology

Takeda's new dengue vaccine, TAK-003, has received prequalification from the World Health Organization (WHO).

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In Big Pharma's growth rankings, Lilly took top spot from Novo Nordisk in Q1

Fierce Pharma

The momentum the biopharma industry showed in the fourth quarter of 2023 has continued into this year. | The momentum the biopharma industry showed in the fourth quarter of 2023 has continued into this year. With 18 of the industry’s top 25 companies achieving year-over-year revenue gains, Q1 came close to matching the final quarter of last year, when 21 of the top 25 companies showed increases.

Drugs 108
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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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FDA approves Bristol Myers Squibb’s Breyanzi for follicular lymphoma

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted accelerated approval for Bristol Myers Squibb’s Breyanzi for follicular lymphoma (FL).

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GSK to Sell Remaining Stake in Haleon, Looks to Raise $1.52B

BioSpace

GSK said Thursday it plans to divest its remaining 4.2% stake in the consumer health spinout, its fourth and final round of selling off Haleon shares worth approximately $1.52 billion.

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AstraZeneca selects new heart failure target with BenevolentAI

Pharmaceutical Technology

AstraZeneca has incorporated a new target for heart failure into its discovery portfolio, a result of its collaboration with BenevolentAI.

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Oxford BioDynamics and Kings College London to advance rheumatoid arthritis treatment

BioPharma Reporter

Oxford BioDynamics (OBD) and Kingâs College London (KCL) have partnered to use OBDâs EpiSwitch technology to identify patients at risk of rheumatoid arthritis (RA) who can benefit from abatacept treatment.

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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.