Sat.Jan 20, 2024 - Fri.Jan 26, 2024

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Pharma Horizons: Artificial Intelligence

European Pharmaceutical Review

The first in our inaugural Pharma Horizons report series is dedicated to exploring the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control. AI/ML is predicted to be the top technology investment for 60 percent of life sciences companies over the next two years, according to a recent survey 1 from the Pistoia Alliance.

Pharma 127
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FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe

Fierce Pharma

As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning. | As many have feared, the FDA's investigation into secondary T-cell malignancies following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning.

FDA 338
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Trending Sources

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Return-to-Office Pushes Can Cause a ‘Riot’

Copyright Clearance Center

A growing number of managers want workers in the office more often, citing the connections, collaborations, and innovations that in-person work can bring.

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Inside California’s Free Digital Health Platforms Supporting Child Mental Health

MedCity News

The California Department of Health Care Services launched the Behavioral Health Virtual Services Platform last week. The platform includes two digital health solutions: BrightLife Kids (developed by Brightline) for parents/caregivers and kids ages 0 to 12 and Soluna (developed by Kooth) for teens and young adults ages 13 to 25.

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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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Adverse Event Reports Linked to Counterfeit Ozempic on the Rise

Pharmaceutical Commerce

Concerns regarding hypoglycemia potentially linked to a counterfeit version of Ozempic come at a time in which reports have grown regarding the improper use of GLP-1 receptor agonists for the purpose of cosmetic weight loss.

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Merck's Keytruda extends life for kidney cancer patients after surgery, while Bristol's Opdivo fails again

Fierce Pharma

Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. | Merck’s unique approval for Keytruda as a postsurgerical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives.

Patients 324

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Key Trends from the 2024J.P. Morgan Healthcare Conference

MedCity News

Key trends such as the resilience of the emerging biopharma space, the complexities of Medicare, and the revolutionary role of data and AI are shaping the future of the industry.

Biopharma 119
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KBI Biopharma and Argonaut Manufacturing Services Team Up on Drug Substance and Drug Product Manufacturing Solutions

PharmaTech

Under a new alliance, KBI Biopharma and Argonaut Manufacturing Services will combine their strengths to offer end-to-end biopharma development and CGMP manufacturing solutions.

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Gilead's Trodelvy fails to extend survival in lung cancer study, prompting selloff

Fierce Pharma

Even as Gilead looks to become an oncology powerhouse in the coming years, the company on Monday recorded a major setback for its antibody-drug conjugate (ADC) Trodelvy. | The antibody-drug conjugate did not significantly improve survival outcomes compared with a chemotherapy alone in previously treated patients with metastatic non-small cell lung cancer.

Patients 307
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Sandoz makes its first post-spinout acquisition

pharmaphorum

Sandoz makes its first acquisition since spinning out of Novartis, buying a Lucentis biosimilar from Coherus that will boost its position in the US market.

Marketing 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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ArriVent’s Nasdaq Debut Nabs $175M as Signs Indicate an Opening IPO Window

MedCity News

ArriVent BioPharma will apply the IPO cash toward furmonertinib, which the biotech says could offer advantages over Takeda Pharmaceutical and Johnson & Johnson drugs that address the same lung cancer target. It’s the second biotech IPO of this week, following CG Oncology.

Biopharma 114
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Is AI’s Copyright World Flat, or Will AI Flatten the Copyright World?

Copyright Clearance Center

AI is global, and copyright laws are national. Thus, some countries will have strict laws on making copies of copyrighted content to “train” an AI system while others will be more relaxed. AI companies will use these jurisdictional differences as leverage to lobby for the relaxation of legal standards.

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Eli Lilly's troubled NJ manufacturing site in hot water again over maintenance, quality control lapses

Fierce Pharma

Eli Lilly’s beleaguered manufacturing site in Branchburg, New Jersey, is back in the U.S. Food and Drug Administration’s crosshairs, Reuters first reported. | Following a July inspection, the FDA has uncovered eight new production deficiencies at Eli Lilly's Branchburg production plant. The observations run the gamut from problems in tracking manufacturing processes and quality controls to equipment calibration lapses and poor facility maintenance.

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J&J’s 2024 strategy will focus on newer meds to offset Stelara’s patent cliff

PharmaVoice

Executives on the healthcare giant’s full-year earnings call highlighted a strong cash position and incremental dealmaking as a way to get past incoming competition.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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How Are Payers Approaching Obesity Management?

MedCity News

GLP-1s continue to be in high demand, and the healthcare industry is watching closely to see how payers decide to cover the drugs going forward. During a virtual panel, payer executives noted that it’s important to remember that GLP-1s won’t be able to solve the country’s obesity crisis by themselves.

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Inside the growing precision therapy market and the crucial role of pDNA manufacturing

Pharmaceutical Technology

CDMOs, who cater to the requirements of multiple companies and develop platform processes to achieve the much-needed economy of scale, are being seen as a possible solution.

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J&J, Merck CEOs dodge subpoenas by agreeing to testify at Senate committee's pricing hearing

Fierce Pharma

With the unusual threat of a Senate subpoena hanging over their heads, the CEOs of Johnson & Johnson and Merck & Co. | With the unusual threat of a Senate subpoena hanging over their heads, the CEOs of Johnson & Johnson and Merck & Co. have agreed to join their counterpart at Bristol Myers Squibb in testifying before the Senate Committee on Health, Education, Labor and Pensions (HELP).

Education 284
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NICE backs two AIs for stroke diagnosis in NHS

pharmaphorum

Two artificial intelligence-powered software tools – e-Stroke and RapidAI – have been recommended for use in the NHS to help detect stroke from CT brain scans by NICE. The health technology assessment (HTA) agency said there is some evidence that people admitted to hospital with a suspected had faster or better access to treatment after using the software, although for now it is unclear whether that was a direct consequence of the digital technology.

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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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Bladder Cancer Therapies Developer Raises $380M in the First Biotech IPO of 2024

MedCity News

CG Oncology’s upsized IPO will support pivotal testing of cretostimogene, an oncolytic virus for non-muscle invasive bladder cancer. The clinical program spans tests of the engineered virus as a monotherapy and as part of combination treatments.

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Does Patient Priorities Care Result in Better Outcomes for Patients?

Pharmaceutical Commerce

A non-randomized control trial investigates whether older adults with multiple chronic conditions can benefit by receiving more specialized services.

Patients 103
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Amid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review

Fierce Pharma

Three months after launching an investigation into the risk of patients developing secondary T-cell cancers after receiving a CAR-T drug, the FDA has shared more information on the cases it has see | Three months after launching an investigation into the risk of secondary T-cell cancers after treatment with a CAR-T medicine, the FDA has shared more information on the cases that it has seen.

Safety 277
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Next stage in GSK’s Zantac defense gets underway today

pharmaphorum

A hearing will get underway in Delaware later today in the latest phase of GSK’s attempts to defend itself from allegations that its Zantac drug caused cancer in patients.

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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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This Mom Was Frustrated with the Scarcity of Child Development Specialists — So She Launched a Startup

MedCity News

After experiencing firsthand the shortcomings of existing public and private programs to treat children’s developmental delays, Jen Wirt founded a startup called Coral Care. The company, which announced its official launch on Tuesday, brings pediatric developmental specialty care into families’ homes.

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Using Blockchain to Minimize Consumers’ Risk Aversion Toward Generic Drugs

Pharmaceutical Commerce

Study describes how a game theoretic model can successfully analyze how adoption of blockchain technology can reveal quality information.

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AbbVie pumps $223M into Singapore biologics plant, plots 100 hires

Fierce Pharma

In late 2022, GSK, Sanofi and Takeda signed on with a partnership of local agencies to advance biologic manufacturing in Singapore. | In late 2022, GSK, Sanofi and Takeda signed on with a partnership of local agencies to advance biologic manufacturing in Singapore. Now, a little more than a year later, AbbVie is getting in on the action by starting a major production expansion in the Garden City.

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Will new therapeutic agent replace antibodies for bacterial detection?

European Pharmaceutical Review

As a tool for detecting and identifying bacteria, aptamers are a promising new class of synthetic nucleic acid molecules that can be used to detect and treat of pathogenic bacteria. With the ability to be developed against a whole bacterium, a microbial toxin, or some proteins, for some bacteria, “aptamers against pathogens can not only supplement the deficiency of antibodies but can also enrich the aptamer database to develop efficient analytical regents”, according to a paper published in the

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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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Breaking the Cycle: Telehealth Treatment for People in Custody is Key to Recidivism Disruption

MedCity News

Expanding access to telehealth-based treatment programs that include medications for OUD, like buprenorphine or Sublocade, to patients as they leave custody can upend this cycle of incarceration through seamlessly following patients wherever they go next. The TREATS Act creates a legal pathway for this care to continue.

Medical 112
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Lilly trumpets early success with deafness gene therapy

pharmaphorum

Eli Lilly’s gene therapy for otoferlin-related deafness has restored the hearing of the first child enrolled in its ongoing phase 1/2 trial

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After Padcev combo’s major triumph, Merck’s Keytruda delivers partial win in bladder cancer

Fierce Pharma

The combination of Merck's Keytruda and Pfizer and Astellas' Padcev recently made waves in bladder cancer—and the broader oncology world—by delivering a massive life-extension benefit against | The combination of Merck's Keytruda and Pfizer and Astellas' Padcev recently made waves in bladder cancer—and the broader oncology world—by delivering a massive life-extension benefit.

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Bladder cancer-focused CG Oncology files for IPO

Pharmaceutical Technology

On 18 January 2024, US-based biotech CG Oncology announced it was looking to raise $200m in an upcoming initial public offering (IPO), which will be the first for the biotech sector in 2024.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.