Wed.Feb 07, 2024

article thumbnail

Gilead plots long-term cell therapy growth, maintains confidence in Trodelvy despite trial miss

Fierce Pharma

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.

245
245
article thumbnail

Increasing the Impact of Opioid Settlement Funds by Investing in Health IT Infrastructure

MedCity News

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
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Catalent receives another regulatory wrist slap at Indiana plant included in Novo buyout

Fierce Pharma

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.

article thumbnail

Why Are Hospitals Fighting Site-Neutral Payments So Fervently?

MedCity News

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.

article thumbnail

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.

article thumbnail

Eisai, Biogen likely to miss early launch goal for Alzheimer's drug Leqembi

Fierce Pharma

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.

FDA 241
article thumbnail

Jazz buys KRAS inhibitors from Redx in $880m deal

pharmaphorum

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 107

More Trending

article thumbnail

Safety Risks and FDA Hold Lead Gilead to Stop Work on Drug in Blood Cancers

MedCity News

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.

Safety 101
article thumbnail

Eli Lilly’s Verzenio fails prostate cancer test as possible Novartis showdown nears

Fierce Pharma

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 229
article thumbnail

GSK backs up its Blenrep rehab bid with survival data

pharmaphorum

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.

Sales 97
article thumbnail

Amgen makes progress with its Horizon prize Tepezza, but there's much work left to do

Fierce Pharma

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.

Sales 219
article thumbnail

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.

article thumbnail

Empowering Patient Healthcare Decision-Making: How Resource Sheets Support Patient Understanding of Clinical Trial Data

MedCity News

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.

article thumbnail

Kyowa Kirin pays $100M to partner with BridgeBio on potential dwarfism drug

Fierce Pharma

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

200
200
article thumbnail

Believing Amazon’s Job Cuts Signal an Exit From Healthcare Would Be ‘Overly Simplistic,’ Expert Says

MedCity News

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.

article thumbnail

Could Novo-Catalent deal face antitrust hurdles?

pharmaphorum

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.

article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

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.

article thumbnail

AstraZeneca invests $300m to build new facility in US

Pharmaceutical Technology

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

97
article thumbnail

AstraZeneca to boost cell therapy operations with $300m manufacturing investment

European Pharmaceutical Review

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.

article thumbnail

NHS England pushes BRCA testing for Jewish community

pharmaphorum

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

100
100
article thumbnail

Gilead Sciences posts $5.61bn net income in FY 2023

Pharmaceutical Technology

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

98
article thumbnail

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.

article thumbnail

Brainomix’s AI-enabled stroke software endorsed by NICE

PharmaTimes

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

Patients 108
article thumbnail

BCMA-GPRC5D CAR-T Cells by Guangzhou Bio-gene Technology for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

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

75
article thumbnail

ALTURiX acquires exclusive UK rights to three new products

PharmaTimes

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

article thumbnail

Elotuzumab by AbbVie for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF): Likelihood of Approval

Pharmaceutical Technology

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

74
article thumbnail

The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.

article thumbnail

Real Chemistry grows in med comms with Avant buy

pharmaphorum

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.

article thumbnail

Avadomide hydrochloride by Bristol-Myers Squibb for Follicular Lymphoma: Likelihood of Approval

Pharmaceutical Technology

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

75
article thumbnail

Pharma has a misinformation problem — and execs could be on the hook

PharmaVoice

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

Pharma 64
article thumbnail

Enfortumab vedotin by Astellas Pharma for Esophageal Squamous Cell Carcinoma (ESCC): Likelihood of Approval

Pharmaceutical Technology

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

Pharma 71
article thumbnail

Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

article thumbnail

Gilead Discontinuing Development of Magrolimab in Hematologic Cancers Following Full Clinical Hold by FDA for Increased Risk of Death

PharmExec

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.

FDA 52
article thumbnail

(Sacubitril + valsartan) by Novartis for Hypertrophic Cardiomyopathy: Likelihood of Approval

Pharmaceutical Technology

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

74
article thumbnail

The Power of Immersion: Using Sales AI Simulators for Realistic Sales Training

Quantified

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.

article thumbnail

Regulatory Submissions Filed for Opdivo Regimen in Resectable Non-Small Cell Lung Cancer

Pharmaceutical Commerce

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.

52
article thumbnail

Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.