Fierce Pharma

OCTOBER 18, 2024

After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. | Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.2 positive. The drug was rejected earlier this year thanks to observations raised during the agency's inspection of a third-party manufacturing facility.

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pharmaphorum

OCTOBER 18, 2024

Sanofi invests €300m in Orano Med's lead-based radioligandsSanofi has firmed up its position in the red-hot area of radiopharmaceuticals for cancer with the purchase of a €300 million ($325 million) stake in Orano Med, a subsidiary of French nuclear fuel company Orano.The transaction builds on a three-way partnership between Sanofi, Orano Med, and RadioMedix – signed in September with a €100 million upfront payment – to develop a radioligand therapy (RLT) for rare neuroendocrine tumours (NETs) c

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Fierce Pharma

OCTOBER 18, 2024

After falling short in a confirmatory clinical trial, Gilead Sciences has decided to withdraw Trodelvy as a bladder cancer treatment in the U.S. | After falling short in a confirmatory clinical trial, Gilead Sciences has decided to withdraw Trodelvy as a bladder cancer treatment in the U.S.

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MedCity News

OCTOBER 18, 2024

Gilead Sciences’ Trodelvy did not meet the main overall survival goal of its confirmatory Phase 3 test. The antibody drug conjugate was awarded accelerated approval for advanced urothelial carcinoma in 2021. The post Gilead Sciences Voluntarily Pulls Drug for Bladder Cancer After Trial Failure appeared first on MedCity News.

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Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

Sales

Fierce Pharma

OCTOBER 18, 2024

After hitting a wall with the FDA last year, Novo Nordisk has picked up backing from European drug reviewers for its novel hemophilia treatment concizumab. | Novo Nordisk received good news from European drug reviewers on its hemophilia treatment, while PTC Therapeutics' Duchenne Muscular Dystrophy therapy was again recommended for rejection upon a re-examination.

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MedCity News

OCTOBER 18, 2024

New research shows that there are more than 14,000 unique IP addresses across the globe exposing patients’ potentially sensitive medical information on the public internet. Nearly half of these exposures are in the U.S. The post Nearly 7,000 US Healthcare Devices & Records Are Exposed to the Public Internet, Research Shows appeared first on MedCity News.

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pharmaphorum

OCTOBER 18, 2024

MSD reveals the data that could unlock filings for clesrovimab, a rival to Sanofi and AstraZeneca's Beyfortus for preventing infant RSV infections

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Fierce Pharma

OCTOBER 18, 2024

As recovery efforts at the North Carolina plant hit by Hurricane Helene move at an “encouraging pace,” Baxter International is laying out new details on a sweeping importation plan to help critical | Baxter has said the first IV product shipments cleared by the FDA for temporary importation are set to arrive in the U.S. this weekend. By the end of the year, the company expects nearly 18,000 tons of product from Europe and Asia to reach The States.

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MedCity News

OCTOBER 18, 2024

Waymark’s community-based interventions reduce hospital and emergency department visits and improve care quality, according to a new study. The company supports Medicaid patients by connecting them with community health workers, therapists, pharmacists and care coordinators in their area. The post New Study Shows That Waymark Reduces ED, Hospital Visits for Medicaid Patients appeared first on MedCity News.

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Patients 88

PharmaTech

OCTOBER 18, 2024

The agency has reconfirmed its recommendation to not give positive opinion to Translarna (ataluren) after a reexamination of the available data.

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MedCity News

OCTOBER 18, 2024

This technological shift not only boosts efficiency and profitability for pharmaceutical companies but also speeds up the delivery of innovative therapies to patients. The post Overcoming Pharma’s Major Pain Points and Pitfalls With AI appeared first on MedCity News.

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Pharmaceutical Technology

OCTOBER 18, 2024

An 800% increase in licensing deal values indicates growing confidence in mRNA technology, but some vaccine producers are facing lawsuits.

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MedCity News

OCTOBER 18, 2024

Startups will take part in four different competitions at HLTH. There will also be plenty of opportunities to network. The post Which Startups Will Present at HLTH? appeared first on MedCity News.

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pharmaphorum

OCTOBER 18, 2024

AbbVie has finally claimed FDA approval for its 24-hour Parkinson's therapy Vyalev, 18 months after the US regulator turned it down

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FDA 89

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Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A

Sales

MedCity News

OCTOBER 18, 2024

Organizations are delivering digital experiences and content to HCPs on a much larger scale than was previously possible. Integrating digital tools will advance things even further and help marketers and MLR teams maintain brand consistency and ensure compliance across digital and content operations. The post Unify Digital Publishing with MLR Review to Speed Compliant Content to Market appeared first on MedCity News.

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pharmaphorum

OCTOBER 18, 2024

Jörg Möller's sojourn as CEO of BenevolentAI has come to an abrupt end, as the firm names co-founder Ken Mulvany as executive chair

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Pharmaceutical Commerce

OCTOBER 18, 2024

With great power comes great responsibility. In this case, tackling these obstacles is vital to making sure that the positives of GLP-1s are not outweighed by the downfalls of improper waste disposal.

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European Pharmaceutical Review

OCTOBER 18, 2024

A new immunotherapy treatment regimen (nivolumab plus doxorubicin, vinblastine, and dacarbazine (AVD)) provided a significant survival rate in advanced Hodgkin lymphoma patients, Phase III trial data shows. This new treatment could decrease long-term side effects including second cancers later in life and heart and lung conditions, according to the researchers.

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PharmaVoice

OCTOBER 18, 2024

From tech-related challenges to an ongoing staffing crunch, Parexel’s CEO explains what the clinical trials industry is up against.

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PharmaTech

OCTOBER 18, 2024

Xiao-Yan Cai, PhD, co-founder and CEO of Accurant Biotech, discussed collaborative efforts that must be undertaken between companies, and across scientific disciplines, to work together on continuing to develop medicines to save lives.

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Medicine 52

PharmExec

OCTOBER 18, 2024

Priority Review status for GSK’s New Drug Application for gepotidacin was based on promising results from the Phase III EAGLE-2 and EAGLE-3 trials, which demonstrated non-inferiority to nitrofurantoin in uncomplicated urinary tract infections.

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FDA 52

PharmaTech

OCTOBER 18, 2024

Redica Systems has been assisting pharmaceutical companies in determining GMP quality risks at their manufacturing sites, and with AI, it has a relatively new addition to its toolbox.

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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.

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PharmExec

OCTOBER 18, 2024

Expanded approval of Lumryz offers a once-nightly treatment option for younger patients, eliminating the need for traditional narcolepsy treatments that often require multiple doses throughout the night.

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PharmaTech

OCTOBER 18, 2024

Anil Andrade, vice-president of Global Sales at ACG World, shared insights about the growth in demand in the pharma industry and efforts put forth to achieve sustainable operations.

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Pharma Sales 52

PharmExec

OCTOBER 18, 2024

In this part of her video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One and Pharmaceutical Executive Advisory Board Member discusses how CMOs effectively measure the return on investment (ROI) of their marketing efforts in the pharmaceutical industry, particularly in light of the long-term nature of drug development and approval processes.

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Pharmaceutical Technology

OCTOBER 18, 2024

A potential three-year framework agreement between the Greek government and the pharmaceutical industry, starting at the beginning of 2025, has been the focus of recent discussions between the Ministry of Health (MoH) and associations representing the pharmaceutical industry in Greece.

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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

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Scott Burrows

OCTOBER 18, 2024

In today’s rapidly evolving healthcare landscape, physical therapy organizations play a crucial role in patient recovery and rehabilitation. These organizations not only provide essential services but also advocate for the advancement of the profession. As we explore the importance of physical therapy across the country, let’s discuss how these organizations can harness innovation, collaboration, and community engagement to enhance patient care and support their members.

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Pharmaceutical Technology

OCTOBER 18, 2024

Late-stage pipeline products could drive combined sales of approximately $171.4 million by 2033 in the 8MM.

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PharmaTech

OCTOBER 18, 2024

The agency’s CHMP recommended drugs to treatments for hemophilia, two biosimilars for psoriasis, and two flu vaccines at their October meeting.

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Medicine 52

PharmExec

OCTOBER 18, 2024

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Pharma 52

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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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