Tue.Aug 17, 2021

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Lilly, preparing Alzheimer's drug plans, forms new neuroscience unit in company restructure

Bio Pharma Dive

Lilly Bio-Medicines will be split into separate neuroscience and immunology groups, while the Loxo cancer research division will merge with Lilly Oncology.

Medicine 325
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Small versus big digital agencies for pharma

World of DTC Marketing

SUMMARY: You should never choose an agency based on size. It should be because they are a good fit with your brand team and can take your digital marketing to the next level while ensuring that everything they do is best in class. Debra called me up in a bit of a panic. She had received a proposal from her digital agency to build their product website and a proposal for paid media.

Branding 249
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Private equity dives deeper into biotech with nearly $2B Bain fundraise

Bio Pharma Dive

Bain Capital's latest life sciences fund, its third, is another example of private equity's growing interest in drug development.

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Global regulators seek permanent working group on AI

pharmaphorum

Rapid advances in the use of artificial intelligence (AI) in healthcare and medicines development are at risk of outstripping current regulatory frameworks, according to a new report. The International Coalition of Medicines Regulatory Authorities (ICMRA) has recommended that a new permanent working group be set up to keep tabs on the use of AI and make sure that regulations can accommodate new developments.

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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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Could Aspirin be Key in Unlocking Triple-Negative Breast Cancer?

BioSpace

?Scientists from The Christie NHS Foundation Trust have begun human trials on the use of aspirin and avelumab in treating patients diagnosed with triple-negative breast cancer.

Scientist 106
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Health Innovators: PureTech Health’s Daphne Zohar

pharmaphorum

In latest episode of our Health Innovators video interview series, Dr Paul Tunnah speaks to Daphne Zohar, the co-founder and CEO of PureTech Health. They discuss the publicly-listed biotech’s pipeline projects and focus on the BIG (brain-immune-gut) axis as well as PureTech’s interest in digital therapeutics. Daphne explains how she built an impressive team of board advisors for her company, plus the challenges and experience of fund raising.

Medicine 111

More Trending

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Does Your Wendy’s Burger Need to Be Made in a Wendy’s? The Fast-Food Chain Doesn’t Think So

XTalks

Wendy’s and REEF are developing 700 delivery kitchens in the US, Canada and the UK by 2025. This is after a successful pilot program in Canada that included eight delivery kitchens in 2020. REEF is an operator of parking real estate and delivery kitchens, logistics hubs, and kitchens. This collaboration between REEF and Wendy’s will bring the fast-food franchise to the UK for the first time. “The demand for convenient delivery solutions means we must look for opportunities beyond our

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Verily Folds in SignalPath to Enhance Trial Efficiency and Execution

BioSpace

Google's Verily snapped up N.C.-based SignalPath and its clinical trial management system that is expected to support its own clinical trial and evidence-based platform known as Baseline.

Trials 102
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Novartis says trials back Beovu safety in diabetic eye disease

pharmaphorum

There is plenty of evidence that Novartis’ ophthalmology drug Beovu can match its rivals when it comes to efficacy, with less frequent dosing, but the big question facing the company is whether it is less safe. Data from phase 3 trials of the drug in diabetic macular oedema (DMO) provide some encouragement for Novartis on the safety issue, with Beovu (brolucizumab) found to be roughly equivalent to Bayer and Regeneron’s Eylea (aflibercept) when it came to inflammatory reactions in th

Trials 98
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Life Sciences Companies Expand Their Footprints in the US and Canada

BioSpace

August has been busy with a flurry of life sciences expansion announcements, particularly in the United States and Canada. Here’s a look at a few companies increasing their presence in the two countries.

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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.

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AXON appoints Colette Balaam as its new US Managing Partner

pharmaphorum

New York, United States – 17 August 2021 — AXON is delighted to announce the appointment of Colette Balaam, our new Managing Partner in the US and lead of the AXON New York office. Hiring Colette is a testament of the healthcare communications firm’s long term growth ambition coming to life, with the US being AXON’s fasting growing opportunity. AXON is expecting to make several appointments in the US in the coming months to support existing clients and potential new opportunities, as we expand o

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FDA approval to Keytruda and Lenvima; FibroGen’s Roxadustat; Pfizer’s TICOVAC; Ipsen’s Palovarotene; Jazz Pharma’s Xywav; Seagen-RemeGen’s Cancer Medicine

Delveinsight

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC). The efficacy and safety results were produced from a broad research study, multicenter, open-label, randomized phase 3 trial data from the Keynote-581 trial of the first-line therapy indicated to the patients that r

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Trial complexity, info explosion driving data management evolution

Outsourcing Pharma

A leader from Veeva Systems shares perspective on what factors are impacting clinical trial data management, and how the industry can adapt to the changes.

Trials 105
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GSK, CureVac’s COVID-19 vaccine candidate shows promise in preclinical study

Pharma Times

Preclinical study shows high protective efficacy in primates for Beta, Delta and Lambda variants

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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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Sacklers Threaten to Pull Out of Purdue Pharma Opioids Settlement

NY Times

In a rare court appearance, David Sackler said he and his family would withdraw their pledge to pay $4.5 billion, unless they are granted broad legal immunity.

Drugs 98
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mRNA Looks Beyond COVID-19 Vaccines to Therapeutics and Diagnostics

BioSpace

mRNA has built its reputation as a type of vaccine to fight COVID-19, but its capabilities extend beyond vaccines into therapeutics and even diagnostics.

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FDA fast tracks breast cancer candidate samuraciclib

Pharma Times

Carrick Therapeutics’ oral CDK7 inhibitor may improve patient outcomes

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Why GoodRx—Not Amazon—May Be the True PBM Disrupter

Drug Channels

The generic prescription market is being disrupted—but not by the big, bad spaceman from Seattle. Instead, consider how GoodRx is affecting patients, payers, and PBMs. Below I summarize the latest financial results for GoodRx’s discount card business. We estimate that the company accounted for $4.1 billion in U.S. prescription revenues for 2021. That’s about six times its 2016 figure.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Tips for Overcoming Imposter Syndrome as a Young Professional

BioSpace

While imposter syndrome can be caused by external factors, there are several things you can start doing today to combat it at work.

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Pirfenidone could offer ‘viable’ heart failure treatment

Pharma Times

NIHR trial shows the lung drug could treat heart failure patients

Trials 123
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Diagnostic Face Mask Detects SARS-CoV-2 Quickly, with PCR-Like Accuracy

BioSpace

The prototype offers PCR-like precision without a power-source, and is stable at room temperature for many months.

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Hired and retired: New appointments in the biopharma industry

BioPharma Reporter

Lilly, Sanofi and Catamaran Bio are among the companies making new appointments this month.

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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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Biopharma Companies Raise Millions to Solve Cancer, Neurodegenerative Diseases

BioSpace

?The companies will use their funds to support the development of their lead assets and advance their pipelines.

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The COVIDome online portal can rapidly accelerate coronavirus research worldwide

The Pharma Data

To further accelerate COVID-19 research on a global scale, investigators from the University of Colorado Anschutz Medical Campus have created a multidimensional dataset, known as the COVIDome dataset, derived from hospitalized COVID-19 patients versus negative controls. The team has now launched a public online portal called the COVIDome Explorer to share that data in real time.

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Money on the Move: August 11 – 17

BioSpace

Here’s the shortlist of which life sciences companies took a dip in the money pool this week.

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GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours

The Pharma Data

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% across dMMR solid tumours 95% of responders had a duration of response of ?6 months. GlaxoSmithKline (GSK) plc today announced the US Food and Drug Administration (FDA) approved a new indication for JEMPERLI (dostarlimab-gxly), a programmed cell death receptor-1 (PD-1) blocking antibody, for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced s

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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GSK Wins Big as FDA Expands Checkpoint Inhibitor's Reach

BioSpace

Specifically, the new approval was for adults with dMMR recurrent or advanced solid tumors who have progressed on or after previous treatment and who have no satisfactory alternatives.

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Novartis secures new approval in China for Cosentyx® (secukinumab) in pediatric psoriasis

The Pharma Data

China National Medical Products Administration (NMPA) approval reinforces that Cosentyx ® (secukinumab) is safe and effective for children and adults with psoriasis Moderate-to-severe plaque psoriasis affects more than 350,000 children worldwide 1 , with the physical and psychological burden disrupting important formative years 2 Cosentyx is a proven treatment, supported by long-term five-year sustained efficacy and safety data across several inflammatory conditions 3-5 and with more than 500,

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Years after Pfizer merger, ex-Medivation exec gets insider trading charge

pharmaphorum

A Medivation executive at the heart of the company’s team that sold the company to Pfizer for $14 billion five years ago is facing allegations of insider trading. Matthew Panuwat. A complaint filed by the US Securities and Exchange Commission (SEC) today accuses Matthew Panuwat, the then-head of business development at Medivation, of buying sizeable stock options in rival cancer-focused biotech InCyte Corp in the days before the merger went through in September 2016.

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Lilly Announces Leadership Changes and Formation of Neuroscience and Immunology Business Units

The Pharma Data

Eli Lilly and Company (NYSE: LLY) today announced executive leadership changes and the creation of neuroscience and immunology business units. These changes will increase Lilly’s focus on introducing breakthrough new medicines to millions of people with unmet needs. Effective September 5, Lilly Bio-Medicines will split into two business units: Lilly Neuroscience and Lilly Immunology.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.