Sat.Jul 01, 2023 - Fri.Jul 07, 2023

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Pfizer backs CRISPR biotech Caribou in latest cell therapy investment

Bio Pharma Dive

Five years after helping launch Allogene Therapeutics, Pfizer is backing another developer of “off-the-shelf” cell therapies in a deal that gives the drugmaker the chance to acquire a multiple myeloma treatment.

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Digital health tech: a solution to substance use disorders?

Pharmaceutical Technology

Substance use disorders leave people with long-term negative mental and physical health implications and can lead to death.

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July 6, 2023: NIH Pragmatic Trials Collaboratory Welcomes 2 New Demonstration Projects: BEST-ICU and Remote Tai Chi

Rethinking Clinical Trials

Dr. Michele Balas and Dr. Eduard Vasilevskis The NIH Pragmatic Trials Collaboratory is excited to add 2 new Demonstration Projects to its portfolio of innovative pragmatic clinical trials embedded in healthcare systems. BEST-ICU (or Behavioral Economic and Staffing Strategies to Increase Adoption of the ABCDEF Bundle in the ICU) is supported by the National Heart, Lung, and Blood Institute (NHLBI).

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Bernie Sanders proposes price caps on drugs developed with federal funds

Fierce Pharma

After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. | After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. Bernie Sanders, I-Vermont—a longtime opponent of Big Pharma—has become even more ubiquitous in his efforts to reduce drug prices.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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With new data, J&J steps forward in growing race for oral autoimmune drugs

Bio Pharma Dive

Phase 2 results show a pill the company is developing is competitive with other oral medicines in testing against psoriasis, among them the TYK2 inhibitors that have drawn significant industry interest.

Medicine 273
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Eli Lilly’s retatrutide sets new record for weight loss in obesity space

Pharmaceutical Technology

Pipeline developments within the obesity space have recently garnered interest following recent results published on Eli Lilly’s retatrutide.

More Trending

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DigitalHealth.London’s Accelerator programme selects Aide

Pharma Times

Project aims to boost the adoption of technology across London’s NHS and help patients manage conditions - News - PharmaTimes

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FDA grants Eisai’s Leqembi full approval, opening door to wider use of Alzheimer’s drug

Bio Pharma Dive

The broader approval is expected to push insurers, namely Medicare, to increase coverage of so-called amyloid-targeting therapies.

Drugs 273
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Rationing strategies proliferate with cancer drugs in short supply

Pharmaceutical Technology

While drug shortages have been a major cause for concern over the past few years, medications to treat cancer are in particularly short supply.

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July 3, 2023: Report Shares Strategies for Addressing Bias and Lack of Generalizability of EHR Data

Rethinking Clinical Trials

Pragmatic research is vulnerable to biases due to differences in data capture and access to care for different subsets of the population, which, if left unaddressed, can propagate inequities in health and the healthcare system. In a new article published online ahead of print in JAMIA , the NIH Pragmatic Trials Collaboratory’s Demonstration Project teams reflect on the health equity challenges encountered by their trials and share the specific strategies they used to mitigate sources of po

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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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Teva weighs sale of $2B API business as CEO Richard Francis embarks on 'Pivot to Growth' strategy: reports

Fierce Pharma

Less than two months into its "Pivot to Growth" strategy under a new CEO, Israeli-American generics giant Teva Pharmaceutical could be weighing a major shake-up of its key drug ingredients business | Teva is looking at strategic options for its active pharmaceutical ingredient unit, with a potential sale on the table, BNN Bloomberg and Benzinga have reported.

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Sarepta sells FDA fast pass earned from Duchenne gene therapy approval

Bio Pharma Dive

The deal enables Sarepta to quickly cash in on the clearance of Elevidys, with $102 million in new funds to help bankroll its drug research.

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Lifera, Sanofi and Arabio boost vaccine manufacture in Saudi Arabia

Pharmaceutical Technology

Lifera, Arabio and Sanofi have signed a memorandum of understanding (MOU) to bolster manufacturing of vaccines in Saudi Arabia.

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Complex road ahead, despite phase 3 progress, for Annovis’ buntanetap in Parkinson’s Disease

Outsourcing Pharma

Drugs like Annovis Bioâs buntanetap and prasinezumab have the potential to ârevolutionize the treatment of Parkinsonâs Diseaseâ says analytics company, GlobalData, an analytics company, but it is a complex road ahead.

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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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Novo Nordisk brings new round of lawsuits against compounded versions of Ozempic and Wegovy

Fierce Pharma

As demand skyrockets for GLP-1 drugs that can trigger significant weight loss, unauthorized versions of the treatments have started to fill pharmacies. | In late May, the FDA warned of illegal knockoffs of Novo Nordisk’s Ozempic and Wegovy. And now, the Danish company has filed its second wave of lawsuits against pharmacies in the U.S. that are producing the copycats.

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What US trial sponsors should know about the GDPR

Bio Pharma Dive

What is the GDPR and why does it matter to your life sciences company. iliomad Health Data can help you maintain GDPR compliance.

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Incyte’s non-segmental vitiligo treatment approved in UK

Pharmaceutical Technology

Following FDA approival and CE marking for Incyte’s JAK-inhibiting cream Opzelura (ruxolitinib), the MHRA has followed suit in the UK.

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CPHI South East Asia visitor numbers expected to double as interest in drug supply chain security booms

Outsourcing Pharma

This yearâs CPHI South East Asia is expecting a surge in international partnering with organizers expecting a record attendance of 8,000 visitors including a significant number from overseas â doubling last yearâs figures.

Drugs 105
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest

Fierce Pharma

It’s official: Roughly half a year after the FDA granted an accelerated nod to Eisai and Biogen’s new Alzheimer’s disease med lecanemab, the companies have converted that green light into a full-fl | With a full approval in hand, Leqembi has become the first treatment shown to reduce the rate of disease progression and slow cognitive and functional decline in adults with Alzheimer’s disease under the FDA's traditional approval pathway.

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‘It’s felt like Groundhog Day’: Biotech IPO slump drags on through 2023

Bio Pharma Dive

Some industry watchers predict activity could soon pick up, as market conditions improve and a mix of cash-strapped startups as well as advanced biotechs test the waters.

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Abeona Therapeutics raises funds to launch cell therapy

Pharmaceutical Technology

Abeona Therapeutics has raised $25m from its current select investors to launch and commercialise its cell therapy, EB-101.

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Women in Science: How Charco Neurotech's Lucy Jung is 'restoring joy' for Parkinson's patients

BioPharma Reporter

Lucy Jung is the CEO and founder at Charco Neurotech, a medtech start-up which has developed the CEU1, a non-invasive wearable device for Parkinson's, that uses vibrotactile stimulation to reduce symptoms of slowness and stiffness resulting in improved movement. We spoke to her about her background, how she got involved in the Parkinson's space and her fascination for problem-solving.

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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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Biosimilar clinical trials and study designs’ considerations

ProRelix Research

Biosimilar clinical trials and study designs’ Considerations The rising prevalence and large market share of biological products emphasize their importance as treatment options for several cancers and autoimmune diseases. In […] The post Biosimilar clinical trials and study designs’ considerations appeared first on ProRelix Research.

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‘Mixed’ results seed doubt about AstraZeneca, Daiichi’s next cancer drug

Bio Pharma Dive

The medicine delayed disease progression compared to chemotherapy in a closely watched lung cancer trial. But analysts questioned its effect size and safety, and AstraZeneca shares fell more than 8%.

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Generative AI – beyond the hype

Pharmaceutical Technology

2023 started with a buzz around ChatGPT, and more generally around the immense potential that generative AI (GenAI) holds.

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Moderna strikes deal worth up to $1B to develop, produce mRNA drugs in China: reports

Fierce Pharma

Despite political tensions between Washington and Beijing, foreign pharmaceutical investments are progressing in China. | In a deal that could be worth up to $1 billion, Massachusetts-based Moderna inked a memorandum of understanding, plus a land collaboration agreement, to research, develop and manufacture mRNA medicines in China.

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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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Do Physician-Owned Hospitals Offer Lower Negotiated, Cash Prices?

XTalks

A recent study in JAMA Network Open analyzed the differences in commercial negotiated prices and cash prices between physician-owned hospitals (POHs) and non-POHs. Data on commercial negotiated prices and cash prices for eight specific services were analyzed from 156 POHs and 1,116 non-POHs in 78 hospital referral regions (HRRs). The eight services included spinal injection, therapeutic physical therapy exercise, magnetic resonance imaging (MRI) scan of the lower spinal canal, computed tomograph

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Brii buys further into VBI therapy, expanding hepatitis B partnership

Bio Pharma Dive

The deal comes three months after VBI cut costs and laid off staff in a restructuring meant to prioritize the two medicines Brii is interested in.

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Chinese NMPA approves Innovent and IASO Bio’s myeloma therapy

Pharmaceutical Technology

China has granted approval for Innovent Biologics and IASO Bio Fucaso for treating relapsed or refractory multiple myeloma (RRMM) in adults.

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Q&A with Mark Garner: The golden age of cancer research  

Drug Discovery World

Mark Garner, PhD., Global Cancer Segment Market Manager at Agilent Technologies, recently sat down with DDW Editor Reece Armstrong to tell us about the developments in the ‘golden age’ of cancer research. RA: Please can you tell us a bit more about your role at Agilent? MG: I am responsible for Agilent’s cancer segment. You could describe my role as being a convener across all our cancer research-related product lines, our Medical Affairs team, and the rest of the organisation.

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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.