Fierce Pharma

SEPTEMBER 19, 2024

From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it. | Earlier this month, Granules was slapped with a Form 483 following an inspection of its Telangana facility in India that ran from Aug. 26 to Sept. 6. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more.

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Manufacturing FDA 301

MedCity News

SEPTEMBER 19, 2024

During a panel discussion at MedCity News’ INVEST Digital Health conference, three healthcare leaders shared their expert insight on what needs to change in order to improve the industry’s cybersecurity strategy. The post What Will It Take to Improve Healthcare Cybersecurity? appeared first on MedCity News.

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Healthcare Healthcare 117

Fierce Pharma

SEPTEMBER 19, 2024

A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migra | A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migraines than a previous class of medicines.

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Medicine 254

MedCity News

SEPTEMBER 19, 2024

Doctor’s offices are the front door of the American healthcare system. We owe it to them to support H.R. 2474 and put an end to annual Congressional stop-gap spending bills. The post Medicare Reimbursement for Doctors is in Critical Condition appeared first on MedCity News.

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Fierce Pharma

SEPTEMBER 19, 2024

Gilead Sciences’ Kite Pharma will sell its stake in China’s Fosun Kite Biotechnology nearly eight years after forming the 50-50 cell-therapy-focused joint venture with Fosun Pharma. | Gilead Sciences’ Kite Pharma will sell its stake in China’s Fosun Kite Biotechnology nearly eight years after forming the cell therapy-focused joint venture with Fosun Pharma.

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Pharma 203

MedCity News

SEPTEMBER 19, 2024

Months after 23andMe CEO Anne Wojcicki publicly stated she wants to take the company she co-founded private, all of the company’s independent board directors have resigned. The board letter to Wojcicki stated that its members preferred resigning over continuing to have a difference of view over the direction of the company. The post Mass Board Exodus at 23andMe Leaves Company With Tough Decisions Ahead appeared first on MedCity News.

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MedCity News

SEPTEMBER 19, 2024

Real change will come from disrupting the status quo. Advances in AI and a focus on prevention offer a way forward, promising not just financial rewards, but a healthier population, less strain on healthcare, and a future where “healthcare” truly means care. The post Disrupting the U.S. “Sickcare” System appeared first on MedCity News.

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Healthcare Healthcare 97

pharmaphorum

SEPTEMBER 19, 2024

Neuralink gets FDA breakthrough status for an implantable chip called Blindsight that promises to restore eyesight to the blind

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FDA 98

MedCity News

SEPTEMBER 19, 2024

During a panel discussion at the MedCity News INVEST Digital Health Conference, executives shared the top challenges they’re facing in the consumer diagnostic testing space. These challenges include funding and encouraging behavior change. The post What Are the Challenges in Building a Consumer-Focused Diagnostic Testing Startup? appeared first on MedCity News.

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pharmaphorum

SEPTEMBER 19, 2024

FDA turns down Vanda Pharma's tradipitant for gastroparesis, prompting a furious response from the company

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FDA Pharma 107

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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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Pharmaceutical Technology

SEPTEMBER 19, 2024

An innovative approach to healthcare, precision medicine is a new medical model that takes into account individual differences in genes, environments, and lifestyles to drive better outcomes through medicine.

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Medicine Healthcare Healthcare Medical 59

pharmaphorum

SEPTEMBER 19, 2024

Upstream Bio has become the latest biotech to chance its arm with a public listing in the US, seeking funds for its rival to respiratory drug Tezspire.

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PharmExec

SEPTEMBER 19, 2024

Conferences, congresses, and the digital discussions kicked off by those events create a halo effect that amplifies scientific information more so than other scientific activities.

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Medical 52

pharmaphorum

SEPTEMBER 19, 2024

Daiichi Sankyo's FLT3 inhibitor Vanflyta has been recommended for NHS use as a treatment for a specific form of acute myeloid leukaemia (AML) in England and Wales, the first countries in Europe to authorise use of the drug after a health technology assessment (HTA) review.

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Pharmaceutical Commerce

SEPTEMBER 19, 2024

Results of the Phase III CENTERSTONE study demonstrated that when Xofluza is taken by an individual with influenza, it lowers the risk of others in the household contracting it.

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pharmaphorum

SEPTEMBER 19, 2024

ICER will preempt the next Medicare drug pricing round with a 'special report' on two COPD drugs from GSK

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Specialization 66

LEVO Health

SEPTEMBER 19, 2024

Patient engagement is no longer just a buzzword in healthcare — it’s a critical component of delivering effective care and improving outcomes. As healthcare providers and medtech companies aim to provide more personalized and timely care, interactive health technologies are emerging as powerful tools to bridge the gap between patients and their providers.

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PharmExec

SEPTEMBER 19, 2024

Results of the Phase III HERTHENA-Lung02 trial demonstrated the superiority of patritumab deruxtecan over platinum plus pemetrexed induction chemotherapy in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer.

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Patients 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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Copyright Clearance Center

SEPTEMBER 19, 2024

CCC introduced RightFind Curriculum, which is the only all-in-one combined content and licensing solution that enables K–12 educators, EdTech companies, curriculum developers, and custom publishing companies to easily search for, discover, and incorporate high-quality, copyrighted content into curriculum and instructional materials, EdTech applications, and online platforms.

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Education 52

Clarivate

SEPTEMBER 19, 2024

Encountering objections and questions from payers and health technology assessment (HTA) decision-makers is an unavoidable part of bringing a new pharmaceutical or medical technology to market. Payer conversations provide an opportunity to acknowledge potential issues or evidence gaps and alleviate concerns. Yet without careful planning and the development of effective objection handling resources, these concerns can cause delays and disappointment on the road to reimbursement or formulary listi

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Marketing Pharmaceutical Medical Insurance 52

PharmaTech

SEPTEMBER 19, 2024

Lilly has added a $1 billion investment to increase biologics manufacturing at its Limerick, Ireland, site while unveiling its new $800 million facility in Kinsale.

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Manufacturing 52

PharmExec

SEPTEMBER 19, 2024

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

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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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Pharmaceutical Technology

SEPTEMBER 19, 2024

Accord BioPharma received FDA approval for 420mg HERCESSI, a biosimilar to Herceptin to treat various kinds of HER2-overexpressing cancers.

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PharmExec

SEPTEMBER 19, 2024

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

Pharma 52

Pharma 52

Pharmaceutical Technology

SEPTEMBER 19, 2024

Before the FDA approved AstraZeneca’s Fasenra, Nucala was the only therapy for treating eosinophilic granulomatosis with polyangiitis.

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FDA 52

PharmExec

SEPTEMBER 19, 2024

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

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Food Pharma 52

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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

Pharmaceutical Technology

SEPTEMBER 19, 2024

NanoVation will receive $600m in upfront cash and potential milestone payments, as well as tiered royalties on future product sales.

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Sales 52

PharmaTimes

SEPTEMBER 19, 2024

There is currently no national screening programme for the disease in the UK

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Pharmaceutical Technology

SEPTEMBER 19, 2024

Lupin has announced a non-exclusive patent licence agreement with Takeda for the commercialisation of Vonoprazan Tablets in India.

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Pharmaceutical Commerce

SEPTEMBER 19, 2024

The collaboration is centered around meeting track-and-trace requirements.

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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.

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