Fri.Feb 02, 2024

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FDA sets date for high-profile CAR-T adcomm for Bristol’s Abecma, J&J’s Carvykti

Fierce Pharma

Mark your calendars, oncology drug and CAR-T therapy developers. | Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting for Bristol Myers' Abecma and J&J's Carvykti.

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Simplifying the Maternal Care Network

MedCity News

A new era in maternal care is emerging with the advent of maternity care management platforms. Innovative organizations are centralizing the coordination of all patient care aspects, seamlessly integrating with providers’ electronic health records, existing workflows, and health information exchanges.

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As Humira plummets, AbbVie dials up Rinvoq and Skyrizi estimates to a combined $27B

Fierce Pharma

As AbbVie slogs through sharp revenue declines for Humira, the company is looking to the immunology light at the end of the tunnel. | Sales of Humira—which once sat pretty as the world’s best-selling drug—plunged nearly 41% to $3.3 billion in the third quarter.

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Neuro Biotech Alto Adds $128M in IPO Cash for Biomarker-Based Psych Drugs

MedCity News

Alto Neuroscience will apply the IPO proceeds toward clinical tests of its psychiatric drugs in patients who exhibit certain biomarkers. The company’s two most advanced programs are depression drugs in mid-stage development.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Bristol Myers CEO outlines transition strategy featuring 11 key brands, more dealmaking

Fierce Pharma

In his first earnings call as Bristol Myers Squibb’s CEO, Chris Boerner laid out his plan to quickly navigate the company through a period filled with patent cliffs and new government-man | In his first earnings call as Bristol Myers Squibb’s CEO, Chris Boerner laid out his plan to quickly navigate the company through a transition period filled with patent cliffs and new government-mandated pricing pressure.

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The Path for Prescription Drug Sales

Pharmaceutical Commerce

A dive into this market reveals that the latest numbers yield promising results—a global value of a worldwide $1.6 trillion—but it will continue to be attributed to past, present, and future healthcare spending.

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Staying Competitive With Consumerism in Healthcare

MedCity News

Adapting to healthcare consumerism is vital for providers to stay competitive. Shifting from traditional roles to informed consumers requires embracing transparency, technology, and personalized care.

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Novo, Lilly poised to become first trillion-dollar healthcare companies

PharmaVoice

Explosive demand for weight loss drugs has propelled both companies to new heights. Here’s a look at the staggering growth, by the numbers.

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Metabolic Disorder-Focused Fractyl Health ‘GUTS’ Out a $110 Million IPO

MedCity News

Fractyl Health will use the IPO proceeds for pivotal testing of a medical device and surgical procedure intended to address root causes of diabetes and obesity. The Fractyl pipeline also includes a gene therapy for these conditions.

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Construction of major radioligand therapy manufacturing site begins

European Pharmaceutical Review

Orano Med (a subsidiary of the Orano Group), has begun to build a new manufacturing site for targeted alpha therapies (TAT) for oncology indications. The ATLab (Alpha Therapy Laboratory) Valenciennes in Onnaing, France, will produce lead-212 radioligand therapies. TAT [targeted alpha therapies] is one of the most potent therapeutic payloads against cancer cells” According to Orano Med, TAT is “one of the most potent therapeutic payloads against cancer cells” As such, these trea

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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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Foodsmarts’ New Program Allows Doctors to Prescribe Produce Just as Easily as They Can Medication

MedCity News

Foodsmart is rolling out its new program that enables doctors to refer their patients to Foodsmart’s dieticians and healthy eating platform, as well as write prescriptions for healthy food just as easily as they might a normal pharmacy prescription. The initiative is being rolled out at Advocate Health, Intermountain Health and Memorial Hermann Health System.

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Biosensing technique promising for whole-genome detection

European Pharmaceutical Review

A study has described a multivalent-colloid detection system capable of identifying whole genomes of bacteria without the use of DNA amplification. Data from the paper published in Applied Physical Sciences , showed that the method can detect pathogens at an early stage when the bacterial load is low. Currently, the “gold standard” of pathogen identification is based on the recognition of DNA sequences that are unique for a given pathogen, according to the authors.

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Bridging the Impact Gap in Cancer R&D

MedCity News

It is critical that we rightsize and redistribute available funds based on our knowledge of persistent cancer disparities to help more patients benefit from potentially lifesaving innovations and ensure no one is left behind.

Patients 100
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CCC President & CEO Tracey Armstrong Wins 2024 BIG Innovation Award

Copyright Clearance Center

The post CCC President & CEO Tracey Armstrong Wins 2024 BIG Innovation Award appeared first on Copyright Clearance Center.

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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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Startup Launches To Support Low-Income Patients with Complex Needs

MedCity News

Accompany Health launched Tuesday with $56 million in Series A funding. It offers primary and behavioral care for underserved patients. It also provides social care, such as food, housing and transportation assistance.

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Lonza and Oxford Nanopore Partner on mRNA Analytics

PharmaTech

Under a new collaboration, Lonza and Oxford Nanopore aim to commercialize a CGMP-validated test for advanced analysis of mRNA products.

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Vera prices $$250m offer, and other biotech financings

pharmaphorum

Our round-up of recent biotech financings is headed by a $250 million public offering for late clinical-stage biotech Vera Therapeutics, with an initial public offering (IPO) filed by CAR-T specialist Kyverna and private rounds for Eyconis, COUR Pharmaceuticals, Basking Biosciences, Enterprise Therapeutics, Halia Therapeutics and NeoPhore.

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Peeking Behind the Curtain: The Current State of Pharma 3PLs and Future Outlook

Pharmaceutical Commerce

Leading experts in the sector explore the value of third-party logistics providers when it comes to fortifying pharmaceutical supply chains.

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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.

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Tyra Biosciences’ TYRA-300 gains FDA rare paediatric disease status

Pharmaceutical Technology

The US FDA has granted rare paediatric disease (RPD) designation for Tyra Biosciences’ TYRA-300 for treating achondroplasia.

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Biogen refocuses its Alzheimer’s strategy

European Pharmaceutical Review

Biogen is planning to reprioritise its resources allocated to ADUHELM ® (aducanumab-avwa), to advance its Alzheimer’s treatment LEQEMBI ® (lecanemab-irmb) and to develop new treatment modalities. The company stated that it will discontinue the development and commercialisation of ADUHELM 100 mg/mL intravenous injection and will terminate the corresponding Phase III ENVISION clinical study.

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Hikma will pay $150m in US opioid settlement

pharmaphorum

Indian pharma Hikma has agreed a $150 million settlement to resolve lawsuits claiming that it helped fuel to the opioid crisis in the US

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Study reveals SARS-CoV-2 can infect dopamine neurons causing senescence

PharmaTimes

Dopamine neuron senescence is a hallmark of Parkinson’s disease

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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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The PM Society Careers Conference

pharmaphorum

The PM Society are delighted to be running their fifth Careers Conference that will be taking place on the 21st of February 2024 between 1pm to 6pm at the Royal Society of Medicine. Please share with your colleagues and network, as this is a great opportunity for students to attend and learn more about our industry.

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NHS launches BRCA testing programme for people of Jewish descent

PharmaTimes

Individuals with Jewish ancestry are six times more likely to carry a genetic fault

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Talkspace, Bicycle partner on opioid use and mental health

pharmaphorum

Virtual opioid use disorder (OUD) therapy provider Bicycle Health has teamed up with telemedicine specialist Talkspace to expand access to care for patients battling addiction in the US. Bicycle Health provides medication for OUD treatment, drug screening, behavioural therapy, and peer support via an app that has been used by tens of thousands of people across the US.

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How Employers Can Manage the Rising Costs of Insurance

MedCity News

One new solution that’s becoming an emerging standard is the Health Payment Account (HPA). HPAs offer employees a line of interest-free credit that employees can use to pay for care expenses up-front.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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FDA sets date for Adaptimmune’s sarcoma drug verdict

pharmaphorum

The FDA is due to decide by 4th August whether to approve Adaptimmune’s afami-cel engineered T-cell therapy for advanced synovial sarcoma.

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StartUpdates: New Developments for Healthcare Startups

MedCity News

Check out news from Alpha Sophia, Wisedocs, Swift Medical, and Isaac Health.

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Global cancer burden study reveals ‘striking inequity’

pharmaphorum

The World Health Organization (WHO) has said that the burden of cancer on societies around the world is growing at an alarming rate, with a 77% increase in new cases expected by 2050, along with significant gaps in care.

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Sanofi, AstraZeneca Launch Program to Mitigate Future RSV Vaccine Shortages

Pharmaceutical Commerce

New reservation program for Beyfortus (nirsevimab-alip) seeks to improve access to the monoclonal antibody that is FDA-approved to protect against respiratory syncytial virus-associated lower respiratory tract disease.

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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.