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 350

FDA Safety Leads 350

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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122

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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 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 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 117

Biopharma Healthcare Healthcare Medicine 117

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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132

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 329

Patients 329

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

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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 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

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 115

Marketing 115

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 301

Safety FDA Medicine Patients 301

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

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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 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 112

Biopharma Pharmaceutical Pharma 112

pharmaphorum

JANUARY 23, 2024

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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104

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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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

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.

FDA

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

pharmaphorum

JANUARY 22, 2024

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.

Patients 103

Patients 103

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

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

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Distribution

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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110

pharmaphorum

JANUARY 23, 2024

Study finds evidence that an AlZpath immunoassay for phosphorylated tau could deliver an effective blood test for Alzheimer's, paving the way for screening and early treatment

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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 302

Education 302

European Pharmaceutical Review

JANUARY 26, 2024

A paper, published in Nature Chemical Biology has reported the first ‘free-from ‘tree’ production of a key vaccine ingredient sourced from the soapbark tree. Researchers from the John Innes Centre, a research institute in the UK, have reconstituted the chemical pathway of the potent adjuvant molecule QS-21 in a tobacco plant. Bioengineering vaccine adjuvants The paper explained: “QS-21 is a potent vaccine adjuvant currently sourced by extraction from the Chilean soapbark tree.

Pharmaceutical 98

Pharmaceutical 98

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Safety

MedCity News

JANUARY 22, 2024

No matter the outcome, it’s certain that the cost of drugs will not be an issue easily resolved anytime soon even though several other states also have laws allowing for drug imports.

Healthcare 109

Healthcare Healthcare FDA Biopharma 109

pharmaphorum

JANUARY 24, 2024

BenevolentAI’s search for a new chief executive has concluded with the appointment of industry bigwig Dr Jörg Möller to the role, four months after Joanna Shields stepped down and as the company emerges from a restructuring drive. The UK artificial intelligence specialist said in a statement that Möller is “an accomplished R&D leader and champion of the application of AI to drug discovery.

Pharma 100

Pharma 100

Fierce Pharma

JANUARY 26, 2024

At Sanofi and Regeneron, it’s all about the kids—at least with respect to their recent advancements of anti-inflammatory powerhouse Dupixent. | The FDA has signed off on Sanofi and Regeneron's Dupixent to treat children between the ages of 1 and 11 who weigh at least 33 pounds with eosinophilic esophagitis. Dupixent becomes the first treatment in the U.S. for children in this age group with the disorder.

FDA 268

FDA 268

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

Advertiser: ZoomInfo

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.

Marketing