European Pharmaceutical Review

JANUARY 24, 2024

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 130

Pharma Pharmaceutical manufacturing Manufacturing Pharmaceutical 130

Fierce Pharma

JANUARY 22, 2024

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 353

FDA Safety Leads 353

Copyright Clearance Center

JANUARY 23, 2024

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

Management 136

Management 136

MedCity News

JANUARY 25, 2024

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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What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

Sales Management

European Pharmaceutical Review

JANUARY 23, 2024

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

Transportation 116

Transportation Pharmaceutical 116

Fierce Pharma

JANUARY 26, 2024

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 327

Patients 327

MedCity News

JANUARY 25, 2024

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 115

Biopharma Healthcare Healthcare Medicine 115

pharmaphorum

JANUARY 24, 2024

CG Oncology completes the first biotech IPO of 2024, raising $380 million for its oncolytic virus bladder cancer immunotherapy.

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Fierce Pharma

JANUARY 22, 2024

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 338

Patients 338

PharmaTech

JANUARY 24, 2024

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.

Biopharma 98

Biopharma Manufacturing 98

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Patients

MedCity News

JANUARY 25, 2024

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.

Engineering 113

Engineering Biopharma Pharma 113

European Pharmaceutical Review

JANUARY 25, 2024

Eli Lilly and Company’s Executive Vice President of Global Quality, Johna Norton, is ending her lengthy tenure with the company this summer and retiring after 34 years of service. However, she will continue in her current role and remain as part of Eli Lilly’s Executive Committee of until 31 July 2024. “Johna’s career has been built on her commitment to ensuring that our medicines are produced with the highest quality standards.

Manufacturing 98

Manufacturing Medicine Pharmaceutical Patients 98

Fierce Pharma

JANUARY 22, 2024

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.

Manufacturing 309

Manufacturing Food FDA 309

Copyright Clearance Center

JANUARY 23, 2024

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.

Training 98

Training 98

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MedCity News

JANUARY 26, 2024

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 111

Biopharma Pharmaceutical Pharma 111

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023. In addition to approaches evaluating E&L, the draft guidance also discussed evaluation of impurities and degradation products.

FDA 98

FDA Food and Drug Administration Safety Manufacturing 98

Fierce Pharma

JANUARY 26, 2024

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 303

Education 303

Pharmaceutical Technology

JANUARY 21, 2024

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.

Manufacturing 98

Manufacturing Marketing 98

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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.

Safety

MedCity News

JANUARY 26, 2024

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.

Management 111

Management Healthcare Healthcare 111

European Pharmaceutical Review

JANUARY 26, 2024

The US Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) as a treatment for children patients aged one to 11 years, weighing at least 15kg with eosinophilic esophagitis (EoE). This new authorisation by the FDA’s expands its initial approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40kg. “With this approval, Dupixent becomes the first and only treatment option for EoE patients aged one year and older, weighing at least 15kg” “With this

Medicine 98

Medicine Food and Drug Administration FDA Pharmaceutical 98

Fierce Pharma

JANUARY 25, 2024

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 312

Safety FDA Medicine Patients 312

PharmaVoice

JANUARY 24, 2024

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.

Competition 98

Competition Healthcare Healthcare 98

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Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

Sales

MedCity News

JANUARY 24, 2024

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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European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. These standardised documents provide meticulously curated and scientifically approved information. They detail the medication’s intended use, proper administration, potential side effects and precautions. They are vital to ensuring the safe and effective use of medicines, making them an integral part of healthcare in Europe.

Healthcare 98

Healthcare Healthcare Safety Electronics 98

Fierce Pharma

JANUARY 26, 2024

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.

Manufacturing 281

Manufacturing 281

pharmaphorum

JANUARY 22, 2024

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

Marketing 108

Advertiser: ZoomInfo

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

Competition

MedCity News

JANUARY 22, 2024

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 108

Medical Patients 108

European Pharmaceutical Review

JANUARY 22, 2024

Researchers have developed two capillary electrophoresis (CE)-based analytical methods : capillary zone electrophoresis (CZE) and imaged capillary isoelectric focusing (iCIEF) to analyse a broad spectrum of monoclonal antibodies (mAbs) and complex mAb formats. Charge heterogeneity analysis of mAbs and complex formats, such as bispecifics, is “crucial” for therapeutic applications, according to the researchers.

Leads 98

Leads Manufacturing Pharmaceutical 98

Fierce Pharma

JANUARY 26, 2024

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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Pharmaceutical Commerce

JANUARY 23, 2024

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

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