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 130
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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 354
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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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CG Oncology is first biotech IPO of 2024, raising $380m

pharmaphorum

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

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

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.

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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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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 347

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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 119
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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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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 331
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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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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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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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 124
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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 329
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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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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 124
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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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Sanofi snaps up Inhibrx and its rare disease drug for $2.2bn

pharmaphorum

Sanofi agrees $2.2bn deal to buy California biotech Inhibrx and its long-acting therapy for rare disease AATD, which causes life-threatening emphysema.

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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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Accent Therapeutics secures funding to advance cancer therapies

Pharmaceutical Technology

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

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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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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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Remote Parkinson’s monitoring tech backed by NICE

pharmaphorum

NICE firms up guidance backing NHS use of five digital health wearables for remote monitoring of Parkinson's disease patients

Patients 111
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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

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

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NHS catch up campaign launched for missed MMR vaccines

PharmaTimes

Approximately one in five children will be hospitalised to treat measles

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Sanofi Commits $1.7B to Buy an Entire Company, But Wants Just a Single Drug

MedCity News

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 122
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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 312
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LEO says chronic hand eczema drug bests its only rival

pharmaphorum

LEO Pharma's chronic hand eczema drug delgocitinib has outperformed the only approved drug for the condition in a phase 3 trial.

Pharma 111
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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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Researchers advance blood tests’ ability to detect cancer earlier

PharmaTimes

The advancement could allow earlier detection of cancer in the blood and better treatment

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Eli Lilly Sounds Off as Early Data Show How Gene Therapy Can Restore Hearing

MedCity News

Eli Lilly said its experimental gene therapy restored hearing in a boy born with profound hearing loss. The results for this experimental treatment come three months after Regeneron Pharmaceuticals reported early but encouraging data for its hearing loss gene therapy.

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Sanofi and Regeneron's Dupixent picks up FDA nod to treat kids with eosinophilic esophagitis

Fierce Pharma

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.

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AbbVie invests $223m in Singapore biologics site

pharmaphorum

AbbVie has broken ground on a new $223 million expansion of its biologics manufacturing facility in Singapore, creating around 100 new jobs

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time