Clinical trial disparities and how to build a more inclusive future
pharmaphorum
OCTOBER 30, 2023
Clinical trial disparities and how to build a more inclusive future Mike.
October, 2023
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Opinion: How AI Can Accelerate and Improve Clinical Trial Recruitment
BioSpace
OCTOBER 26, 2023
New platforms are emerging to help biopharma companies fill their human studies more efficiently, but barriers remain to their successful implementation.
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On a journey to diverse, inclusive, and more efficient rare disease trials
pharmaphorum
OCTOBER 27, 2023
On a journey to diverse, inclusive, and more efficient rare disease trials Mike.
FDA Lifts Hold on Mersana’s Antibody-Drug Conjugate Following Patient Death
BioSpace
OCTOBER 31, 2023
The regulator has released Mersana Therapeutics’ antibody-drug conjugate XMT-2056 from its clinical hold, allowing the biotech to proceed with Phase I studies of the candidate with a lower starting dose.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Health Literacy Month: How industry communication can impact patient health literacy
Antidote
OCTOBER 20, 2023
Since 1999, October has been designated as Health Literacy Month , a month dedicated to promoting patient-centricity in healthcare communications across the industry. Health literacy refers to a person’s ability to find, understand, and use health-related services and make informed decisions for themselves and others.
Evolving with the patient: Optimising CAGT post-trial long-term follow-up
pharmaphorum
OCTOBER 27, 2023
Evolving with the patient: Optimising CAGT post-trial long-term follow-up Mike.
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Hyloris wins painkiller approval amidst amplified anti-opioid efforts
Pharmaceutical Technology
OCTOBER 18, 2023
The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.
With COVID sales in free-fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts
Fierce Pharma
OCTOBER 16, 2023
As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. | Pfizer has slashed its 2023 revenue projection by $9 billion because of declining demand for COVID products. The company now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion.
Parkinson’s Research Buoyed by Alzheimer’s Advances
BioSpace
OCTOBER 1, 2023
After a groundbreaking year in the Alzheimer’s space, Parkinson’s disease researchers express renewed hope based on a greater biological understanding of neurodegeneration.
AstronauTx completes £48m series A financing for Alzheimer’s disease
Pharma Times
OCTOBER 12, 2023
The financing will support the biotech’s clinical study of people with AD as a lead programme - News - PharmaTimes
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
LogiPharma USA 2023: Tracy Nasarenko Provides a Synopsis of “DSCSA—Final Checks to Have Before Deadlines.”
Pharmaceutical Commerce
OCTOBER 5, 2023
In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Tracy Nasarenko, Sr. Director of Community Engagement for Pharmaceuticals, GS1 US highlights her “DSCSA—Final Checks to Have Before Deadlines.
A decade later, biotech’s CRISPR revolution is still going strong
Bio Pharma Dive
OCTOBER 11, 2023
Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.
ADDF announces speech database to identify biomarkers for Alzheimer’s
Pharmaceutical Technology
OCTOBER 24, 2023
SpeechDx will contain recorded voice samples and other data, which will be used to develop algorithms for creating new speech biomarkers.
UPDATED: Pfizer plans to shutter New Jersey site, discloses layoffs amid $3.5B cost-cutting drive
Fierce Pharma
OCTOBER 30, 2023
Editor's note: This story has been updated with a comment from Pfizer. An earlier version of the story stated that nearly 800 jobs would be affected. | After plunging COVID revenues prompted Pfizer to embark on a cost-cutting crusade, more details about the company's savings efforts are coming into focus.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Relay Therapeutics Pauses Lirafugratinib Rare Cancer Plans Due to IRA
BioSpace
OCTOBER 12, 2023
The biotech will pause its lirafugratinib program for a rare bile duct cancer to target a larger FGFR2-altered solid tumors population, citing the Inflation Reduction Act as a driving decision factor.
CAR-TCR 2023 – Matt Lakelin
pharmaphorum
OCTOBER 27, 2023
At CAR-TCR in Boston last month, pharmaphorum’s Jonah Comstock caught up with Matt Lakelin, co-founder of TrakCel, a software company that helps makers of advanced therapies manage their supply chain.
Understanding primary sclerosing cholangitis symptoms
Antidote
OCTOBER 30, 2023
Primary sclerosing cholangitis (PSC) is an autoimmune disease that mainly targets bile ducts in the liver. PSC is a rare condition, impacting about 1 in 10,000 people worldwide , and it is diagnosed twice as frequently in men as it is in women.
Verve gets FDA green light to run base editing study in US
Bio Pharma Dive
OCTOBER 23, 2023
The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S. since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease.
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.
Lisata receives orphan drug designation for pancreatic cancer therapy
Pharmaceutical Technology
OCTOBER 18, 2023
Lisata has received orphan drug designation from the EMA's Committee for Orphan Medicinal Products for LSTA1 to treat pancreatic cancer.
Merck’s Keytruda wins coveted FDA nod around surgery for early lung cancer—with a surprise
Fierce Pharma
OCTOBER 16, 2023
Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. | Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. The drug's label already includes an overall survival win from a key trial.
NASH on the Cusp: An Emerging Market Opportunity
BioSpace
OCTOBER 22, 2023
The non-alcoholic steatohepatitis space is still a “big mystery,” analysts tell BioSpace, but its connection to weight loss could provide an additional opportunity for contenders.
UCL study suggests changes to improve MRI scans for prostate cancer
Pharma Times
OCTOBER 16, 2023
The research aims to make MRIs more available to men and improve treatment decisions - News - PharmaTimes
2022 Research: The Rapid Rise of Ocean Freight Visibility
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s
FDA Law Blog
OCTOBER 16, 2023
By Gail H. Javitt & Steven J. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The first article—“Is the Eye the Window to Alzheimer’s?
Pfizer to cut costs, lay off staff on waning demand for COVID products
Bio Pharma Dive
OCTOBER 13, 2023
Sales of Pfizer's antiviral Paxlovid and shot Comirnaty have been slower than it anticipated, while a shift to the commercial market for the antiviral has been delayed.
Podcast: The British start-up taking psychedelic therapy mainstream
BioPharma Reporter
OCTOBER 16, 2023
In our first podcast interview of 2023, BioPharma Reporter spoke with Dr Sarah Bateup, therapy lead at Clerkenwell Health, about the potential of psychedelic medicine and her work within the psychedelic therapy training space.
As COVID sales crater, Pfizer takes $5.6B in inventory write-offs on Paxlovid, Comirnaty
Fierce Pharma
OCTOBER 31, 2023
For Pfizer, several years of pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials. | Pfizer's pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials.
An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
Opinion: The Potential of Neurofilament Light Chain as a Biomarker in Parkinson’s Disease
BioSpace
OCTOBER 22, 2023
While sensitive and specific biomarkers for Alzheimer’s disease have recently taken a leap forward, the Parkinson’s space has lagged behind. Neurofilament Light Chain could change that.
Local authorities in England are failing to meet dementia diagnosis targets
Pharma Times
OCTOBER 25, 2023
The APPG has called for urgent improvements in rural and ethnically diverse-areas - News - PharmaTimes
Empowering patients: How to match to clinical trials
Antidote
OCTOBER 3, 2023
Clinical trials are an integral part of the medical industry, as they are required for any new treatment to be approved. Every medicine used today, whether prescription or over the counter, is a result of the rigorous research process that is a clinical trial — and for these trials to take place, volunteers are vital.
Vertex, CRISPR therapy for sickle cell passes FDA panel test
Bio Pharma Dive
OCTOBER 31, 2023
The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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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