Fierce Pharma

SEPTEMBER 11, 2024

For Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming. | Ahead of an advisory committee meeting slated for Friday, the FDA unleashed damning briefing documents calling into question the effectiveness and safety of Intercept’s rare liver disease drug Ocaliva. The regulator specifically raised an eyebrow at the post-marketing trials Intercept has used in a bid to keep hold of the accelerated approval it won back in 2016.

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MedCity News

SEPTEMBER 11, 2024

More than 330 provider organizations signed letters this week urging the White House and Congress to extend a pandemic-era telehealth prescribing flexibility. Failure to extend this policy would cause millions of Americans to lose access to treatment, they argued. The post 300+ Provider Organizations Urge Feds to Prevent Leaked DEA Rule From Going into Effect appeared first on MedCity News.

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Fierce Pharma

SEPTEMBER 11, 2024

Johnson & Johnson already has a major presence in the crowded inflammatory bowel disease (IBD) space with its popular Stelara. | Tremfya will enter the UC space as J&J’s older Stelara, which is approved to treat both forms of IBD, nears biosimilar competition and Inflation Reduction Act-mandated price concessions.

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Competition FDA 263

Pharma IQ

SEPTEMBER 11, 2024

Explore how the pharmaceutical industry is addressing its carbon footprint through sustainable sourcing, supply chain decarbonization, and data-driven strategy.

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Pharmaceutical 100

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Fierce Pharma

SEPTEMBER 11, 2024

Last week, Zydus Lifesciences confirmed the receipt of an FDA warning letter at its Waghodia plant in Gujarat, India, marking the latest in a string of production reprimands for the India | Last week, Zydus Lifesciences confirmed the receipt of an FDA Warning Letter at its Waghodia plant in Gujarat, India, marking the latest in a string of production reprimands for the Indian drugmaker.

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FDA 147

MedCity News

SEPTEMBER 11, 2024

More than 4 million Highmark commercial members now have access to AppliedVR’s RelieVRx as a covered therapeutic. The post Highmark Covers AppliedVR’s Product for Chronic Low Back Pain appeared first on MedCity News.

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MedCity News

SEPTEMBER 11, 2024

By surfacing conversational, behavioral, and environmental insights at the point of care — and enabling data-driven operational decisions — AI has the power to transform individual patient experiences and drive systemic improvements in care quality and efficiency. The post The New Role of Engagement: Surfacing Insights at the Point of Care and Beyond appeared first on MedCity News.

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Fierce Pharma

SEPTEMBER 11, 2024

More than two years after an initial FDA approval in melanoma, Bristol Myers Squibb is moving its PD-1/LAG-3 combo Opdualag into registrational testing in one of the most important oncology disease | More than two years after an initial FDA approval in melanoma, Bristol Myers Squibb is moving its PD-1/LAG-3 combo Opdualag into registrational testing in one of the most important disease areas—first-line non-small cell lung cancer.

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Competition FDA 130

pharmaphorum

SEPTEMBER 11, 2024

A machine-learning tool developed by AstraZeneca and trained on UK Biobank data, called MILTON, can predict over 1,000 diseases, before diagnosis

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Training 116

Fierce Pharma

SEPTEMBER 11, 2024

Sanofi and Regeneron’s superstar anti-inflammatory biologic Dupixent is on a roll. | It was a busy day for Sanofi and Regeneron as the Dupixent partners look to expand the reach of Dupixent into several new diseases.

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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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European Pharmaceutical Review

SEPTEMBER 11, 2024

Sanofi has inaugurated a new production unit in France which utilises a world-first modular concept. The site, Modulus, located in Neuville-sur-Saône (Rhône-Alpes), is supported by an investment of nearly €500 million and will produce Sanofi’s next vaccines and biologic drugs. Modulus can adapt to manufacture up to four vaccines simultaneously. Notably, reconfiguration of the technological platform (live attenuated viral vaccines, recombinant protein or messenger RNA vaccines, as well as treatme

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MedCity News

SEPTEMBER 11, 2024

Securities regulators say the role of Ipsen employee Dishant Gupta made him privy to details of the Epizyme acquisition. Gupta allegedly accumulated Epizyme shares while the deal was negotiated, then sold all of them hours after the transaction was announced. The post SEC Charges Ipsen Worker for Insider Trading Tied to $247M Epizyme Acquisition appeared first on MedCity News.

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pharmaphorum

SEPTEMBER 11, 2024

One in two UK doctors would not use GenAI to treat patients, but there was more willingness to use it for diagnostic purposes, survey finds

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Doctors Patients 101

Pharmaceutical Technology

SEPTEMBER 11, 2024

As the approval date for Bristol Myers Squibb’s schizophrenia drug KarXT looms, a prodrug approach emerges to potentially address dosing challenges.

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Side effects 98

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Pharmaceutical Commerce

SEPTEMBER 11, 2024

The parties’ want to provide customers with a “one-stop-shop,” with the hopes that their services will be easier to navigate.

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MedCity News

SEPTEMBER 11, 2024

HLTH 2024, scheduled for October 20-23 at the Venetian Expo Center in Las Vegas, will highlight new programming, a physicians roundtable, generative AI, the shifting landscapes of telemedicine, retail health, women’s health, and lots more. The post Get Ready for HLTH 2024: A Preview Guide appeared first on MedCity News.

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PharmaTech

SEPTEMBER 11, 2024

During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R. Palmer Limited discussed how aging facilities can impact the quality of pharmaceutical products.

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MedCity News

SEPTEMBER 11, 2024

A direct-to-patient model for observational research will ease the participation burden, better incorporate the patient voice, and empower individuals to take control of their health – all while meeting the growing demands for robust evidence in developing new drugs and therapeutics. The post A Tailor-made Approach to Simplify Observational Research appeared first on MedCity News.

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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

SEPTEMBER 11, 2024

Viridian's thyroid eye disease drug veligrotug clears its first phase 3 trial, with data suggesting it could be competitive with Amgen's Tepezza

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Competition 67

Pharmaceutical Technology

SEPTEMBER 11, 2024

EASD 2024 participants are looking for the hottest efficacy data to make predictions on the next trend in the metabolic space.

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PharmaVoice

SEPTEMBER 11, 2024

A handful of potential blockbusters are marching toward FDA review.

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FDA 98

PharmaTimes

SEPTEMBER 11, 2024

New evidence highlights AI’s potential in early lung cancer detection

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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

pharmaphorum

SEPTEMBER 11, 2024

A clinical trial has backed the safety and efficacy of Novo Nordisk's weight-loss drug Saxenda in children as young as six with obesity.

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Safety 62

Pharmaceutical Commerce

SEPTEMBER 11, 2024

The latest news for pharma industry insiders.

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pharmaphorum

SEPTEMBER 11, 2024

Roivant reveals its latest company, Pulmovant, which will develop a pulmonary hypertension drug licensed from Bayer in a $294m deal.

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PharmaTimes

SEPTEMBER 11, 2024

Patients with relapsed multiple myeloma gain access to life-extending therapy

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Patients 81

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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

PharmaTech

SEPTEMBER 11, 2024

Solid form screening (SFS) is highly customizable based on the phase of the drug development life cycle, and collaborating with an expert solid form team will help accelerate your timelines and reduce costs. Not to mention, understanding the solid forms of your API will set you up for regulatory success. In this case study, Lonza’s SFS team collaborated with a drug sponsor to help select their lead form from three polymorphs and design a base crystallization process that met regulatory complianc

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Leads 52

Evolve Your Success

SEPTEMBER 11, 2024

Anne Saulnier, the trailblazing CEO of Hex IQ, joins us to reveal how reimbursement data is revolutionizing healthcare sales. With her unique expertise in both marketing and enterprise software, Anne sheds light on the groundbreaking changes brought about by the 2020 law that mandates insurance companies to disclose negotiated rates. This newfound transparency empowers medical sales reps to showcase ROI compellingly, target the right customers, and accelerate their sales cycles.

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Referral MD

SEPTEMBER 11, 2024

Artificial Intelligence (AI) has the potential to revolutionize the medical industry by improving patient outcomes, streamlining workflows, and enhancing referral processes. Is AI transforming patient outcomes? The Problem with Traditional Referrals Referrals often involve time-consuming paperwork, multiple steps, and inefficiencies, leading to treatment delays and patient frustration.

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Pharmaceutical Commerce

SEPTEMBER 11, 2024

In an interview with Pharma Commerce Editor Nicholas Saraceno, Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Healthcare Distribution Alliance, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar.

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Distribution Pharma Healthcare Healthcare 52

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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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