Fierce Pharma

APRIL 23, 2024

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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MedCity News

APRIL 23, 2024

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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pharmaphorum

APRIL 23, 2024

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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Pharmaceutical Technology

APRIL 18, 2024

Outrun Therapeutics announced its launch with $10m seed funding to advance a protein stabilisation pipeline focused on E3 ligase inhibitors.

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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

Distribution

Pharmaceutical Commerce

APRIL 23, 2024

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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Fierce Pharma

APRIL 17, 2024

One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.

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pharmaphorum

APRIL 22, 2024

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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Pharmaceutical Technology

APRIL 22, 2024

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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European Pharmaceutical Review

APRIL 22, 2024

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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Fierce Pharma

APRIL 18, 2024

Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year.

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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

APRIL 22, 2024

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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pharmaphorum

APRIL 23, 2024

After rejecting ImmunityBio’s Anktiva last year, the FDA has now cleared the drug as a treatment for bladder cancer, making it the biotech's first commercial-stage product

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Pharmaceutical Technology

APRIL 22, 2024

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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Integrity Solutions

APRIL 19, 2024

Mastering the human side of selling is key to sales success, but what does phrase that mean exactly? At its essence, humanizing the sales experience is really about personalization. It’s about asking questions from a place of genuine curiosity, listening, fully absorbing what you’re hearing and then being willing and able to pivot in whatever direction the customer’s answers take us.

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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

Fierce Pharma

APRIL 18, 2024

During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. | During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. A spokesperson said the company would offer affected employees a chance to apply for new roles, plus "outplacement services.

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MedCity News

APRIL 21, 2024

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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pharmaphorum

APRIL 17, 2024

Sage Therapeutics has suffered another disappointment after deciding that it will have to drop the Parkinson’s programme for key pipeline drug dalzanemdor after it showed no benefit in a phase 2 trial. The oral positive allosteric modulator (PAM) of the NMDA receptor is being investigated to see if it can counteract mild cognitive impairment in neurodegenerative disorders, and the PRECEDENT trial in Parkinson’s is the first major readout from the drug programme.

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Pharmaceutical Technology

APRIL 22, 2024

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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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

Pharmaceutical Commerce

APRIL 19, 2024

In an interview with Pharma Commerce Editor Nicholas Saraceno, Niklas Adamsson, COO, Environtainer, suggests how to improve visibility and risk management for cold chain shipping.

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Fierce Pharma

APRIL 22, 2024

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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MedCity News

APRIL 22, 2024

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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Patients 112

pharmaphorum

APRIL 18, 2024

UK researchers describe an algorithm that is more accurate than current tools at predicting an individual’s risk of developing cardiovascular disease in the next 10 years.

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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.

Specialization

Pharmaceutical Technology

APRIL 19, 2024

The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).

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PharmaVoice

APRIL 19, 2024

Where Amylyx ultimately failed in ALS, it could prevail in a rare disease. The doctor leading this research explains why.

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Fierce Pharma

APRIL 17, 2024

In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. | In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. Now, two trials have shown that Eli Lilly’s weight loss product Zepbound (tirzepatide) can help patients overcome obstructive sleep apnea (OSA).

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MedCity News

APRIL 22, 2024

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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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Management

pharmaphorum

APRIL 24, 2024

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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Patients 79

Pharmaceutical Technology

APRIL 18, 2024

Inflammation, cell metabolism and neuronal health are current key areas of focus for dementia researchers, according to Jane Osbourn, chief scientific officer (CSO) at Alchemab.

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LEVO Health

APRIL 18, 2024

At Levo Health, we’re always on the lookout for opportunities to push the boundaries of healthcare marketing and support innovations that can transform the industry. This year, we’re thrilled to take our commitment a step further by sponsoring the 2024 HealthTech|X Accelerator program hosted by Tampa Bay Wave. Tampa Bay Wave has a proven track record of fostering startup success, having supported 527 startups, collectively raising over $900 million in capital and creating more than 5

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Fierce Pharma

APRIL 22, 2024

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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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Patients