Fierce Pharma

FEBRUARY 7, 2024

Despite markedly slower cell therapy growth from the third to the fourth quarter of 2023—and a recent setback for Trodelvy—historically HIV-focused Gilead Sciences is not discouraged amid its | Despite a tame level of fourth-quarter growth, recent advances should drive long-term cell therapy sustainability, Gilead execs said. Overall, the company is pushing to generate 30% of its revenues from oncology by 2030.

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MedCity News

FEBRUARY 7, 2024

Strengthening health IT infrastructure is a critical and necessary step toward abating the opioid crisis and evaluating the impact of how opioid settlement dollars are allocated across communities.

Pharma 130

Pharma 130

Fierce Pharma

FEBRUARY 7, 2024

As part of the acquisition of manufacturing giant Catalent, Novo Nordisk will fork over $11 billion for three of the CDMO’s plants. | While Catalent’s Bloomington, Indiana, site is no stranger to FDA reprimands, its latest write-up is notable given that the site forms part of the $16.5 billion deal Novo Holdings struck to acquire Catalent earlier this week.

Manufacturing 219

Manufacturing FDA 219

MedCity News

FEBRUARY 7, 2024

Establishing site-neutral payments for outpatient services is a hot issue in Capitol Hill right now. Advocates say that such policy would lower healthcare costs, saving both patients and taxpayers money. Opponents say that it would put hospitals’ financial security at risk and jeopardize access to care.

Healthcare 117

Healthcare Healthcare Patients 117

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Fierce Pharma

FEBRUARY 7, 2024

Even with Leqembi now sporting a full FDA approval and benefiting from the simpler Medicare coverage that distinction brings, Eisai and Biogen’s latest Alzheimer’s disease med appears to be moving | While Japan’s Eisai had set the goal to reach 10,000 patients with Leqembi by the end of its 2024 fiscal year, which wraps up in March, only 2,000 patients in the U.S. were receiving the amyloid-busting antibody as of Jan. 26, Eisai explained in a third-quarter earnings presentation.

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FDA Patients 218

MedCity News

FEBRUARY 7, 2024

Gilead Sciences said an independent review of interim Phase 3 data found the immunotherapy, magrolimab, led to a higher risk of death. Though Gilead is discontinuing further development of the drug in blood cancers, a review is ongoing in solid tumors.

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Safety Leads FDA Biopharma 102

MedCity News

FEBRUARY 7, 2024

Providing patients with comprehensive patient resource sheets on clinical trials can alleviate worry, support dialog with family members and clinical care providers and empower informed decision-making.

Patients 96

Patients Healthcare Healthcare Education 96

Fierce Pharma

FEBRUARY 7, 2024

Despite reaching new heights in breast cancer, Eli Lilly’s Verzenio has been sent packing in prostate cancer. | Despite reaching new heights in breast cancer, Eli Lilly’s Verzenio has been sent packing in prostate cancer. Meanwhile, the Indianapolis pharma has another phase 3 prostate cancer program in the works.

Pharma 208

Pharma 208

MedCity News

FEBRUARY 7, 2024

Amazon has eliminated “a few hundred” jobs across Amazon Pharmacy and One Medical, the company confirmed to MedCity News Wednesday. While some may believe this could lead to Amazon leaving healthcare, one industry expert said that would be an “overly simplistic” takeaway.

Healthcare 95

Healthcare Healthcare Medical Leads 95

Fierce Pharma

FEBRUARY 7, 2024

After Amgen completed its $27.8 billion buyout of Horizon Therapeutics in October, executives at the California biotech made it a priority to right the course of thyroid eye disease treatment Tepez | After Amgen completed its $27.8 billion buyout of Horizon Therapeutics in October, executives at the California biotech made it a priority to right the course of thyroid eye disease treatment Tepezza—an instant blockbuster that saw a perplexing slide in just its third full year on the market.

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Sales Marketing 197

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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

pharmaphorum

FEBRUARY 7, 2024

Jazz Pharmaceuticals has agreed another pipeline-building deal, this time paying $10 million upfront for rights to a KRAS inhibitor programme from UK biotech Redx Pharma, continuing a move into targeted cancer therapies. Under the terms of the deal, Jazz will acquire Redx’s KRAS inhibitor programme outright, including multiple preclinical-stage drug candidates, and will take responsibility for ushering the most promising compounds through clinical trials and onto the market.

Pharma 92

Pharma Pharmaceutical Marketing 92

Fierce Pharma

FEBRUARY 7, 2024

With an upfront payment of $100 million, Kyowa Kirin has bought into a partnership with BridgeBio to develop and commercialize infigratinib in Japan.

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Pharmaceutical Technology

FEBRUARY 7, 2024

AstraZeneca is investing $300m in a facility in Rockville, US - a significant step in launching its cell therapy platforms in the country.

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pharmaphorum

FEBRUARY 7, 2024

GSK has revealed the data it hopes will allow a return to the US market for Blenrep, which was the first BCMA-targeting drug to launch there but was withdrawn from sale after it failed a confirmatory trial.

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Sales Marketing 83

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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

European Pharmaceutical Review

FEBRUARY 7, 2024

AstraZeneca has announced a $300 million investment in a US-based manufacturing facility in Rockville, Maryland, which will focus initially on T-cell therapies for oncology indications. The site will launch the company’ s cell therapy platforms in the US for critical cancer trials and future commercial supply. The site may widen its focus to support other disease areas, according to AstraZeneca.

Manufacturing 83

Manufacturing Medicine Networking Patients 83

Pharmaceutical Technology

FEBRUARY 7, 2024

Gilead Sciences has announced a 22.9% increase in net income of $5.61bn for FY23 as against $4.56bn in FY22.

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pharmaphorum

FEBRUARY 7, 2024

Eli Lilly has called on financial regulators to look into the antitrust implications of Novo Holdings purchase of Catalent and the sale of three manufacturing facilities to Novo Nordisk.

Manufacturing 72

Manufacturing Sales 72

PharmaTimes

FEBRUARY 7, 2024

The HTA reported that Brainomix 360 improved access to treatment for stroke patients

Patients 104

Patients 104

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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.

Safety

pharmaphorum

FEBRUARY 7, 2024

Jewish people in England are being asked to have gene testing for BRCA mutations that elevate their risk of breast cancer

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Pharmaceutical Technology

FEBRUARY 7, 2024

BCMA-GPRC5D CAR-T Cells is under clinical development by Guangzhou Bio-gene Technology and currently in Phase II for Relapsed Multiple Myeloma.

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PharmaTimes

FEBRUARY 7, 2024

The new products are in the areas of gastrointestinal and respiratory medicines

Medicine 89

Medicine 89

Pharmaceutical Technology

FEBRUARY 7, 2024

Elotuzumab is under clinical development by AbbVie and currently in Phase II for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF).

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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

pharmaphorum

FEBRUARY 7, 2024

Life sciences communications agency Real Chemistry has more than doubled its medical team through the acquisition of Avant Healthcare. The takeover – which was completed earlier this month for an undisclosed sum – will bolster Real Chemistry’s medical education, medical affairs, and healthcare provider (HCP) communications capabilities, said the company in a statement.

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Healthcare Provider Education Healthcare Healthcare 57

Pharmaceutical Technology

FEBRUARY 7, 2024

Avadomide hydrochloride is under clinical development by Bristol-Myers Squibb and currently in Phase I for Follicular Lymphoma.

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PharmaVoice

FEBRUARY 7, 2024

Investment heavyweights BlackRock and Glass Lewis want compensation clawbacks on execs who don’t protect a company’s reputation.

Pharma 64

Pharma 64

Pharmaceutical Technology

FEBRUARY 7, 2024

Enfortumab vedotin is under clinical development by Astellas Pharma and currently in Phase II for Esophageal Squamous Cell Carcinoma (ESCC).

Pharma 71

Pharma 71

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Leads

PharmExec

FEBRUARY 7, 2024

Data from the ENHANCE-3 trial of magrolimab in combination with azacitidine plus Venclexta showed futility and an increased risk of death in patients with acute myeloid leukemia.

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FDA Patients 52

Pharmaceutical Technology

FEBRUARY 7, 2024

(Sacubitril + valsartan) is under clinical development by Novartis and currently in Phase II for Hypertrophic Cardiomyopathy.

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Quantified

FEBRUARY 7, 2024

Traditional sales training is hitting a roadblock. It may still provide sound fundamental skills to sales agents new to the profession or your organization, but it’s not designed for a modern workforce or modern buyers requiring individualized approaches. It’s part of the reason why companies spend millions every year on sales training with varying levels of impact.

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Training Sales Sales Management Management 52

Pharmaceutical Commerce

FEBRUARY 7, 2024

Phase III CheckMate -77T trial data show statistically significant improvements in event-free survival with Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo in the treatment of resectable stage IIA to IIIB non-small cell lung cancer.

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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