Fierce Pharma

JANUARY 18, 2024

Six months after England’s National Institute for Health and Care Excellence (NICE) spurned Pfizer’s breast cancer treatment Talzenna (talazoparib) because it was not cost effective, the agency has | Six months after England’s National Institute for Health and Care Excellence spurned Pfizer’s breast cancer treatment Talzenna because it was not cost effective, the agency has reversed course following the company’s offer to slash the price.

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MedCity News

JANUARY 18, 2024

BridgeBio will receive $500 million in exchange for royalties from sales of acoramidis, a drug currently under FDA review for treating heart complications caused by the rare disease transthyretin amyloidosis. The deal also refinances lending agreements, providing BridgeBio with access to additional capital.

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FDA Sales Biopharma Pharma 107

Fierce Pharma

JANUARY 18, 2024

In its efforts to probe high U.S. drug prices, the Senate health committee has already heard from the heads of Moderna, Eli Lilly, Novo Nordisk and Sanofi. | The Senate Committee on Health, Education, Labor, and Pensions will vote on issuing subpoenas at the end of the month after the Johnson & Johnson and Merck CEOs refused to testify at an upcoming hearing.

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Education 230

MedCity News

JANUARY 18, 2024

During a panel discussion at CES 2024, health executives shared safe ways AI can be used to support value-based care. This includes automating tasks and predicting who needs additional care.

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Medical 106

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Fierce Pharma

JANUARY 18, 2024

It took 17 years for Sun Pharmaceutical and Taro Pharmaceutical to finally tie the knot. | It took 17 years for Sun Pharmaceutical and Taro Pharmaceutical to finally tie the knot. On Thursday, the companies revealed their long-awaited merger, with Sun of Mumbai, India, agreeing to purchase outstanding shares in the Israeli drugmaker for $43 each. The deal nets out to $348 million for a 48% premium on Taro's share price of $29.

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Pharmaceutical 201

MedCity News

JANUARY 18, 2024

CEO Bill Anderson said despite prior cost-cutting measures, Bayer still has too many layers of management and bureaucracy. A new restructuring will come with layoffs but the corporate shakeup plan does not yet include a separation of Bayer’s business units.

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MedCity News

JANUARY 18, 2024

This year’s digital health fundraising environment requires startups to focus more on their unit economics and pathway to profitability, according to Ian Wijaya, managing director at Lazard. He predicted that the ability to achieve profitability will be much more important in 2024 than it has been in the past four years or so.

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Management 105

Fierce Pharma

JANUARY 18, 2024

Novartis hopes new data will open a $1 billion market opportunity for its radioligand therapy, Lutathera, as a first-line treatment. | Novartis hopes new data will open a $1 billion market opportunity for its radioligand therapy, Lutathera, as a first-line treatment. Friday, the company's ambition received a boost from the phase 3 readout of the NETTER-2 trial.

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Marketing 161

Pharmaceutical Commerce

JANUARY 18, 2024

In an interview with Pharma Commerce editor Nicholas Saraceno, Bill Roth, General Manager, Managing Partner, Blue Fin Group, discusses changes that will come with the pharma giant's new platform.

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Management Pharma Sales Patients 105

Fierce Pharma

JANUARY 18, 2024

At Fierce Pharma, the arrival of a new year is synonymous with the release of our annual special report on drug approvals. | At Fierce Pharma, the arrival of a new year is synonymous with the release of our annual special report on drug approvals. This week on “The Top Line,” Fierce Pharma’s Eric Sagonowsky and Kevin Dunleavy, both instrumental in creating the special report, are breaking down the numbers and sharing key insights into the landscape of drug approvals in 2023.

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Specialization Pharma 130

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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

JANUARY 18, 2024

An attractive destination for ATMP clinical trials Based on the Cell and Gene Therapy Catapult (CGT Catapult)’s recently published UK 2023 Advanced Therapy Medicinal Product (ATMP) Clinical Trials Database , the UK is an attractive location for ATMP clinical trials. This is largely due to the number of ongoing ATMP clinical trials in the UK remaining “largely stable” over the past three years.

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Distribution Manufacturing Medicine Government 99

Fierce Pharma

JANUARY 18, 2024

AstraZeneca charts new course for Imfinzi in liver cancer, but FDA path remains uncertain aliu Thu, 01/18/2024 - 14:27

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FDA 141

MedCity News

JANUARY 18, 2024

Telehealth is poised to serve as an essential tool to fill an exploding demand for care. Providers and digital health companies need to act now by expanding telehealth offerings that include on-demand care teams knowledgeable and experienced in GLP-1 drugs, but also overall health and wellness strategies.

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Biopharma 96

pharmaphorum

JANUARY 18, 2024

Pfizer’s PARP inhibitor Talzenna has become the first targeted treatment for HER2-negative locally advanced or metastatic breast cancer with BRCA1/2 mutations to be recommended by NICE for routine NHS use.

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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

MedCity News

JANUARY 18, 2024

Increasing innovation in, and consumer demand for, healthcare technology continue to transform the Medtech industry, including in digital health, wearables, diagnostics, telemedicine and other health IT solutions.

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Healthcare Healthcare 93

pharmaphorum

JANUARY 18, 2024

Medtech company DermaSensor gets FDA approval for a handheld device, powered by AI, that can be used to detect skin cancer at the point of care

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FDA 99

MedCity News

JANUARY 18, 2024

TBD Health is moving into the B2B healthcare space by partnering with digital health companies, starting with FOLX Health and Wisp.

Healthcare 96

Healthcare Healthcare 96

pharmaphorum

JANUARY 18, 2024

AI-powered patient risk assessment company C2-Ai and the Sickle Cell Society have won an NHS contest to find solutions that can tackle health inequality

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Healthcare Healthcare Patients 90

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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

European Pharmaceutical Review

JANUARY 18, 2024

US researchers have reported promising outcomes from a Phase I/II trial in cancer patients treated with cord blood-derived CD19-targeted chimeric antigen receptor (CAR) natural killer (NK) cell therapy. Published in Nature Medicine , the findings revealed an overall response (OR) rate of 48.6 percent at 100 days post treatment. The one-year progression-free survival (PFS) and overall survival (OS) rates were reported to be 32 percent and 68 percent, respectively, in patients with relapsed or re

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Manufacturing Patients Safety Medicine 78

pharmaphorum

JANUARY 18, 2024

India’s Sun Pharma has signed an agreement to take full control of Israeli generic drugmaker Taro Pharmaceutical Industries, taking it into private hands.

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Pharma Pharmaceutical 80

Pharmaceutical Technology

JANUARY 18, 2024

The endocannabinoid inhibitor SYT-510 will be investigated in healthy patients to assess its safety, tolerability, and pharmacokinetics.

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Safety Patients 85

PharmaTimes

JANUARY 18, 2024

Green light concerns generalised myasthenia gravis therapy

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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

JANUARY 18, 2024

Bayer has reached a deal with union representatives that will result in a sizeable reduction in managerial roles

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Management 71

PharmExec

JANUARY 18, 2024

Fran Gregory, VP of Emerging Therapies, Cardinal Health discusses her career, how both CAR-T therapies and personalization have been gaining momentum and what kind of progress we expect to see from them, some of the biggest hurdles facing their section of the industry, the importance of patient advocacy and so much more.

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Patients 52

PharmaVoice

JANUARY 18, 2024

Creative thinking is the name of the game as biopharmas seek to overcome a host of challenges — and investing with purpose, building trust and embracing tech could get them there.

Biopharma 52

Biopharma 52

PharmExec

JANUARY 18, 2024

In an interview with Nicholas Saraceno, Bill Roth, General Manager, Managing Partner, Blue Fin Group, discusses changes that will come with the pharma giant's new platform.

Management 52

Management Pharma Sales Patients 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 Commerce

JANUARY 18, 2024

Data show daily oral dosing of NX-5948 in patients with relapsed or refractory B-cell malignancies experienced a clinical benefit across dose ranges from 50 mg to 200 mg.

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FDA Patients 52

PharmaTimes

JANUARY 18, 2024

Company is focused on endocannabinoid system treatments

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Pharmaceutical Commerce

JANUARY 18, 2024

Pivmecillinam (Pivya) has a clinical cure rate of 95% in uncomplicated urinary tract infections and is recommended as a first-line option for treatment in many countries.

FDA 52

FDA 52

Pharmaceutical Technology

JANUARY 18, 2024

The proceeds will fund a clinical trial of Comanche’s siRNA therapy in pregnant preeclamptic women that will start later in the year.

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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