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 127

Pharma Pharmaceutical manufacturing Manufacturing Pharmaceutical 127

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 320

Patients 320

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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123

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Distribution

Pharmaceutical Commerce

JANUARY 26, 2024

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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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 318

FDA Safety Leads 318

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 118

Biopharma Healthcare Healthcare Medicine 118

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

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 285

Patients 285

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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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 114

Engineering Biopharma Pharma 114

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

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 277

Manufacturing Food FDA 277

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 95

Training 95

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 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 113

Biopharma Pharmaceutical Pharma 113

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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110

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 267

Education 267

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 94

Transportation Pharmaceutical 94

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 112

Management Healthcare Healthcare 112

Pharmaceutical Commerce

JANUARY 26, 2024

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

Patients 103

Patients Specialization 103

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 258

Manufacturing 258

Pharmaceutical Technology

JANUARY 22, 2024

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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94

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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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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 91

Manufacturing Medicine Pharmaceutical Patients 91

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 258

Safety FDA Medicine Patients 258

Pharmaceutical Technology

JANUARY 24, 2024

Accent Therapeutics has raised $75m in a Series C financing round to progress the development of precision cancer therapies.

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109

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Safety

MedCity News

JANUARY 23, 2024

Sanofi is acquiring Inhibrx to get its hands on a drug candidate in pivotal testing for the protein deficiency alpha-1 antitrypsin deficiency, which leads to lung and liver problems. Inhibrx’s remaining assets will be spun out into a new company.

Leads 110

Leads Biopharma Pharma 110

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 90

Leads Manufacturing Pharmaceutical 90

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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246

Pharmaceutical Technology

JANUARY 26, 2024

CAR-T cell therapies can provide durable cancer remission, however, a recent FDA investigation into reports of secondary T-cell malignancies has increased scrutiny of their risk profiles.

FDA 87

FDA 87

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