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

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Novartis nominates former Bristol Myers CEO Giovanni Caforio as its new chair. Will M&A deals follow?

Fierce Pharma

Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. | Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. The recent Big Pharma CEO, known for steering the $74 billion acquisition of Celgene, has been proposed as the new chair at Novartis for 2025.

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FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

MedCity News

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The novel immunotherapy works by sparking activity from three types of immune cells. The post FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery appeared first on MedCity News.

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Novartis names ex-BMS CEO Caforio as chair amid strong Q1

pharmaphorum

Novartis has proposed ex-BMS CEO Caforio as the successor to chair Joerg Reinhardt when he steps down next year, as it posts a strong set of Q1 results

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LogiPharma Europe 2024: LogiPharma Commercial Director Discusses Themes of the Show

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Nicholas Saraceno, Will Robinson, Commercial Director, LogiPharma, talks themes of this year's event and future plans for the show.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Sanofi's Zantac settlement is worth $100M, or $25K per claimant: Bloomberg

Fierce Pharma

Sanofi will pay $100 million—or approximately $25,000 each—to roughly 4,000 claimants who filed lawsuits saying that the French company failed to warn users that its heartburn medicine Zantac (rani | Sanofi will pay approximately $25,000 per person to roughly 4,000 claimants who filed lawsuits saying that the French company failed to warn users that its heartburn medicine Zantac (ranitidine) can cause cancer, Bloomberg reported.

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Hospital Discharge Backlogs Impacting Patient Outcomes

MedCity News

Hospital readmissions have a two-fold impact. They not only drive up the cost of care, but they also create a glut of surplus patients in hospitals waiting to be discharged to a limited number of beds at a partner skilled nursing facility. The post Hospital Discharge Backlogs Impacting Patient Outcomes appeared first on MedCity News.

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More Trending

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BioMarin Pharmaceutical gets grant for treatment of adolescent PKU patients using AVPAL variant

Pharmaceutical Technology

Discover how BioMarin Pharmaceutical's patent for PAL variants offers a groundbreaking method to treat PKU in adolescents. Administering AvPAL variants weekly over 50 weeks effectively reduces blood phenylalanine levels.

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Soon-Shiong's ImmunityBio bags FDA approval for Anktiva to challenge Merck in bladder cancer

Fierce Pharma

After a merger and an FDA rejection, celebrity businessman and biotech entrepreneur Patrick Soon-Shiong’s ImmunityBio has landed the company’s first U.S. | After a merger and an FDA rejection, celebrity businessman and biotech entrepreneur Patrick Soon-Shiong’s ImmunityBio has landed the company’s first U.S. approval in the cancer immunotherapy Anktiva.

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MedCity FemFwd: What Needs To Happen to Improve Preeclampsia Rates?

MedCity News

In this episode, we’re joined by John Auerbach, senior vice president of federal health at consulting firm ICF. He discusses rising preeclampsia rates and how stakeholders need to act. The post MedCity FemFwd: What Needs To Happen to Improve Preeclampsia Rates? appeared first on MedCity News.

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With $75m cash injection, SynOx plans ph3 rare tumour trial

pharmaphorum

Ireland’s SynOx Therapeutics has completed a second-round financing, raising $75 million, as it prepares to take its drug for tenosynovial giant cell tumour (TGCT) into phase 3 trials. TGCT is a rare disease affecting the joints and tendons caused by overproduction of the protein CSF-1, which stimulates the proliferation of various cell types, inflammation, and destruction of the matrix of the joint.

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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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Health Canada approves Merck’s KEYTRUDA for gastric cancer treatment

Pharmaceutical Technology

Health Canada has approved Merck’s KEYTRUDA (pembrolizumab), an anti-programmed cell death protein 1 (PD-1) therapy for use in combination with fluoropyrimidine- and platinum-containing-chemotherapy as a first-line treatment for adult gastric cancer patients.

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US Supreme Court rejects Vanda's bid to revive patents on sleep disorder drug Hetlioz

Fierce Pharma

The prospects for Vanda Pharmaceuticals’ 10-year-old circadian rhythm drug Hetlioz have grown that much dimmer after the U.S. | The prospects for Vanda Pharmaceuticals’ 10-year-old circadian rhythm drug Hetlioz have grown that much dimmer after the U.S. Supreme Court shot down the company’s attempt to challenge an appeals court decision invalidating several of the drug’s patents in 2023.

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Solera Health Expands Platform To Address Cardiometabolic Conditions

MedCity News

Solera Health added Ciba Health, Digbi Health and Wondr Health to its HALO platform. The companies treat conditions like hypertension and diabetes. The post Solera Health Expands Platform To Address Cardiometabolic Conditions appeared first on MedCity News.

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NICE backs Novartis duo for NHS use in young glioma patients

pharmaphorum

An oral therapy that can allow children and adolescents with an aggressive form of brain cancer to be treated at home rather than in hospital has been recommended for use by the NHS in England and Wales.

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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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GS-6212 by Gilead Sciences for Human Immunodeficiency Virus (HIV) Infections (AIDS): Likelihood of Approval

Pharmaceutical Technology

GS-6212 is under clinical development by Gilead Sciences and currently in Phase I for Human Immunodeficiency Virus (HIV) Infections (AIDS).

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Ahead of Alnylam's key heart disease readout, experts say Pfizer rival would be hard to displace

Fierce Pharma

As a closely watched readout from Alnylam Pharmaceuticals' Amvuttra in the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM) is expected in a few weeks, experts suggested the RNA si | As an all-important readout from Alnylam’s Amvuttra in the rare heart disease ATTR-CM is expected in a few weeks, experts suggested that the RNA silencer may have a hard time challenging Pfizer’s tafamidis franchise despite a last-minute trial design change.

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Which Medtech Startups Will Take Part in the MedCity INVEST Pitch Perfect Contest?

MedCity News

The diagnostics/medical device track focuses on cardiology this year. The post Which Medtech Startups Will Take Part in the MedCity INVEST Pitch Perfect Contest? appeared first on MedCity News.

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Widening adoption of animal-free reagents for endotoxin testing

European Pharmaceutical Review

The USP Microbiology Expert Committee is due to vote on the proposed Chapter <86> to approve bacterial endotoxin testing using non-animal derived reagents between 21 June and 1 July 2024. Jaap Venema , Chief Science Officer, USP shared with EPR that the chapter is helping to guide manufacturers how to the adopt these methods and provides “a path to wider adoption”.

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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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EU approves Pfizer antibiotic for superbug infections

pharmaphorum

Pfizer’s Emblaveo has been approved in the EU with a first-in-class indication in multidrug-resistant (MDR) infections. The drug – a combination of beta-lactam antibiotic aztreonam with beta-lactamase inhibitor avibactam – is the first drug of this type to get a green light from the European Commission to treat serious infections caused by MDR Gram-negative bacteria in adults.

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Novartis 'actively' reviewing relationships with Chinese contractors amid US biosecurity crackdown: CFO

Fierce Pharma

As the BIOSECURE Act threatens to upend relationships with Chinese contractors and western biopharma companies operating in the U.S., Novartis has elected not to adopt a “wait and see” attitude.

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Why the Commonwealth Fund Created a Task Force for Employer-Sponsored Insurance

MedCity News

The Commonwealth Fund recently launched the National Task Force on the Future Role of Employers in the U.S. Health System. In 2025, the task force will release a blueprint of actionable recommendations on how employers can improve their coverage. The post Why the Commonwealth Fund Created a Task Force for Employer-Sponsored Insurance appeared first on MedCity News.

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Vistagen’s on-demand nasal spray could provide a novel option for social anxiety

PharmaVoice

The fast-acting medication is one of a few new approaches being tested for the crippling condition.

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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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AST-001 by Ascentawits Pharmaceuticals for Non-Small Cell Lung Cancer: Likelihood of Approval

Pharmaceutical Technology

AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Non-Small Cell Lung Cancer.

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Day One takes on Novartis with FDA nod for Ojemda in broader common childhood brain tumor use

Fierce Pharma

Another drug is in town for common pediatric brain tumors. Compared with an incumbent offering from Novartis, the newcomer boasts an FDA approval covering a broader patient population. | Another drug is in town for common pediatric brain tumors. Compared with an incumbent offering from Novartis, Day One's newcomer boasts an FDA approval covering a broader patient population.

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Collaboration Now: Maximizing AI’s Potential in the Industry it Matters Most

MedCity News

No passing fad, AI in healthcare is here, and it’s already improving the lives of patients, healthcare workers, and researchers. How can we make a good thing even better? The post Collaboration Now: Maximizing AI’s Potential in the Industry it Matters Most appeared first on MedCity News.

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Shakeup at BenevolentAI continues with job, programme cuts

pharmaphorum

BenevolentAI is embarking on another round of job losses, closing its US office, and shelving its software-as-a-service business to extend its cash reserves into the third quarter of 2025.

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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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AST-001 by Ascentawits Pharmaceuticals for Renal Cell Carcinoma: Likelihood of Approval

Pharmaceutical Technology

AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Renal Cell Carcinoma.

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Orphan drug market to reach $270B by 2028, led by J&J, Vertex and Roche: Evaluate

Fierce Pharma

The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. | The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. But thanks to blockbuster meds across wider disease areas and other challenges, the lucrative market may soon slow down for the first time in years.

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Neurodivergent Masking: A Hidden Contributor to the $2-Trillion Burnout Crisis

MedCity News

It can be tiring pretending to be someone you’re not. For many neurodivergent people at work, this is an everyday reality — and it’s burning them out. The post Neurodivergent Masking: A Hidden Contributor to the $2-Trillion Burnout Crisis appeared first on MedCity News.

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BMS preps for CAR-T growth with $380m Cellares deal

pharmaphorum

Bristol-Myers Squibb has shored up manufacturing of its CAR-T therapies by reserving exclusive capacity wt contract manufacturer Cellares in $380m deal

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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.