Thu.Dec 14, 2023

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Done deal: Pfizer completes $43B acquisition of Seagen, doubling its oncology pipeline

Fierce Pharma

Pfizer’s $43 billion acquisition of Seagen is in the books, the company said on Thursda | It’s a done deal. Pfizer’s $43 billion acquisition of Seagen is in the books, as it becomes the largest M&A transaction in the biopharma industry since AbbVie snatched up Allergan for $63 billion in 2019. The buyout of the antibody-drug conjugate specialist has doubled Pfizer’s pipeline to 60 programs.

Biopharma 360
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‘I’ll Ask My Wife About This’: The Silly Things Women’s Health Entrepreneurs Hear From Male VCs

MedCity News

There are a lack of women at venture capital firms. This makes it difficult for women’s health startups focused on stigmatized conditions to get funding when pitching to those who don’t always have a good understanding, startups say.

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US WorldMeds' Iwilfin bags FDA nod as 1st oral maintenance treatment for high-risk neuroblastoma

Fierce Pharma

While existing neuroblastoma treatments can help patients achieve remission, sustaining that remission has proven tricky. But now, patients and doctors have a new oral option. | The U.S. FDA has approved US WorldMeds’ Iwilfin—also known as eflornithine—as a new oral maintenance therapy for high-risk neuroblastoma. The drug, cleared in 192 mg tablets, is indicated to cut the risk of relapse in kids and adults with high-risk neuroblastoma who’ve had at least a partial response to prior treatment.

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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

In the ever-evolving landscape of regulatory decisions, the quest for safeguarding public health remains paramount. Decisions to remove medicines from market are not taken lightly and are often based upon all evidence available to inform a benefit/risk balance. This evidence can come from a range of sources, such as randomised controlled trials (RCTs), observational studies, and spontaneous reporting.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Bluebird signs major coverage deal for sickle cell gene therapy Lyfgenia, easing some price concerns

Fierce Pharma

Despite the high list price of Lyfgenia, bluebird has signed a large reimbursement deal for the sickle cell disease (SCD) gene therapy less than a week after its

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What to watch in the life sciences in 2024

Clarivate

It’s the season of predictions and projections. Here are a few trends in life sciences and healthcare our analysts are keeping an eye on – and what they expect to see in 2024: Move over, oncology – metabolic drugs are the new hotness: The successful launches of Novo Nordisk’s Wegovy® and Eli Lilly’s Mounjaro® represent a revolutionary pharmacological breakthrough of rare proportions.

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Atropos Health, Seqster Team Up to Reduce Disparities in Clinical Trials

MedCity News

Atropos Health and Seqster joined forces to address historical diversity and inclusion challenges in clinical trials. The partnership seeks to enable the swift creation of turnkey patient registries that generate real world evidence from existing registries in under 48 hours.

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Fierce Pharma Asia—BMS’ $8.4B ADC bet; China’s reimbursement update; FDA’s CAR-T roadblock

Fierce Pharma

Bristol Myers Squibb inked an antibody-drug conjugate (ADC) licensing deal worth up to $8.4 billion. AstraZeneca and Gilead's ADCs passed on China's national insurance scheme. | Bristol Myers Squibb inked an antibody-drug conjugate (ADC) licensing deal worth up to $8.4 billion. AstraZeneca and Gilead's ADCs passed on China's national insurance scheme.

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Insurers Turn Payment and Compliance Headaches Into Competitive Advantage With Sales Performance Management

MedCity News

Sales performance management (SPM) solutions, also known as distribution management systems, continue to be a competitive differentiator and vital to insurers’ top and bottom lines.

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The Weight Loss Medication Dilemma: A Physician’s Perspective

PM360

Survey any physician if they’ve been asked by a patient about a prescription weight loss medication and you’ll hear a resounding “yes.” The recent Sermo Barometer confirms that 89% of 300+ global practitioners have seen an increase in patients proactively requesting prescription weight loss medications. 1 I predict this number will only steadily increase.

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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.

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Patient Centric Diabetes Care

PharmExec

A discussion of the current standard for diabetes care and how the importance of patient centricity, including addressing patient's mental health, are imperative to the future of the space.

Patients 105
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Talkiatry, Charlie Health Strike Mental Health Partnership for Children, Young Adults

MedCity News

Through a new partnership, Talkiatry patients who need more intensive care will be able to step up to treatment with Charlie Health. Then Charlie Health patients who no longer require intensive care can step down to Talkiatry to receive ongoing psychiatric care.

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Study Highlights Need for Pharma Industry to Address Stigmatization of Acne

PharmExec

JAMA Network study evaluates current attitudes toward individuals with acne with a call for pharma companies to focus efforts on helping to overcome these stigmas.

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The Transparency in Coverage Rule Doesn’t Go Far Enough: How to Make the Mandate Meaningful

MedCity News

The mandates set the framework and data requirements for transparency but consumers need more guidance for informed decision-making and comparisons. Health plans should be acting now to turn the conversation from compliance to true member engagement.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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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3 Innovative Ways to Empower Patients with Interactive and Educational Ads

PM360

Empowering patients with comprehensive information about their health and medical conditions is a critical step towards fostering their active involvement in healthcare decisions. By equipping them with knowledge, patients can make more informed choices and collaborate effectively with healthcare providers (HCPs), ultimately enhancing the quality of care they receive.

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Why Cancer Centers of Excellence May Not Be Right for Every Patient

MedCity News

The notion that patients are always better off receiving treatment at academic centers is flawed, and when an employer offers a COE approach, it can mislead patients to choose that option when care in their local community may be more sensible.

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The many ‘myths’ of clinical trial diversity, and Genentech’s fight to disrupt them

PharmaVoice

Genentech’s chief diversity officer Quita Highsmith is on a crusade to prove that much of what the industry believes about clinical trial diversity is wrong.

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Twin Health Snags $50M to Help Employers, Health Plans Treat Metabolic Disease

MedCity News

Twin Health raked in $50 million in Series D financing. The startup seeks to help patients improve their metabolic health and reduce the need for medications through the “digital twin” technology it sells to employers and health plans.

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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.

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PharmaKure and UiTM enter research partnership for Alzheimer’s disease

PharmaTimes

The collaboration aims to develop biomarker-based diagnostics for the condition - News - PharmaTimes

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New approach for synthesis of oligonucleotide conjugates

European Pharmaceutical Review

In collaboration with Novo Nordisk, a research group from Denmark’s Aarhus University have devised a method to simplify the construction of an entire library of therapeutic oligonucleotide-peptide conjugates. Specifically, the researchers discovered a synthesis method for oligonucleotide (ON) conjugates that incorporates built-in handles and a special linker, enabling easy linkage of ONs to a peptide marker by adjusting the pH.

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Trade & Channel Strategies 2023: An Interview with Bill Trombetta, PhD, Professor Emeritus, St. Joseph's University

Pharmaceutical Commerce

Bill Trombetta, PhD, discusses successfully navigating what he calls “the coming perfect storm” in healthcare.

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Sano Genetics launches ‘Light the Way’ programme for MND

PharmaTimes

The free programme will be offered to those who are affected by the condition - News - PharmaTimes

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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.

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Trade & Channel Strategies 2023: An Interview with Douglas Bock of Archbow Consulting

Pharmaceutical Commerce

Partner for Archbow Consulting discusses the conference, the IRA, and specifics of PAP business rules

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Astellas secures EC approval for VMS treatment, fezolinetant

European Pharmaceutical Review

The European Commission has approved Astellas Pharma’s Veozatm (fezolinetant) for treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Fezolinetant is a nonhormonal neurokinin 3 (NK3) receptor antagonist. It works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to modulate neuronal activity in the hypothalamus, reducing the number and intensity of hot flashes and night sweats.

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Identifying the Most Prevalent Challenges that Impact Product Launch Success

PharmExec

In-depth study outlines the top five reasons biopharma products miss launch forecasts.

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PM360 Announces the Selections for its 12th Annual Innovations Issue

PM360

NEW YORK, NY, December, 14 2023: The life sciences industry is built on innovation. From developing ground-breaking new medicines to implementing better ways to ensure patients can access and stay on therapy to experimenting with new technology that changes how care is delivered—innovation is at the heart of everything this industry does. For 12 years, PM360 , a leading trade magazine for marketing decision makers in the pharmaceutical, biotech, medical device, and diagnostics industries, has re

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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

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White House says 48 drugs are heading for Medicare rebates

pharmaphorum

White House says 48 drugs are heading for Medicare rebates Phil.

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Get Creative, Spread the Joy: Free, Customizable Christmas Cards to Make Your Season Sparkle

Contrarian Sales Techniques

Design your dream Christmas card! Mix and match my free elements to create a greeting that's uniquely you Unleash your inner artist and design the perfect Christmas card to reflect your personality and holiday cheer! My collection of free, mix-and-match elements lets you create a one-of-a-kind greeting that's sure to warm hearts. From traditional to quirky, the possibilities are endless.

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Building Innovative Sustainability Programs: Quantify and Reduce Your Meetings’ Carbon Emissions

PM360

As we cross into the new year, we see a growing community of medical communications, pharma, and life sciences professionals focused on building innovative sustainability frameworks. The SEC’s proposed requirements on Scope 3 GHG reporting 1 are expected to evolve, adding pressure to events and meeting planners looking to host carbon intensive large-scale engagements.

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Twin Health raises $50m, and other digital health financings

pharmaphorum

Twin Health raises $50m, and other digital health financings Phil.

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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.