Mon.Nov 06, 2023

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NICE's Trikafta snub could portend another pricing standoff between Vertex and UK officials

Fierce Pharma

History may repeat for Vertex Pharmaceuticals in the U.K., where a new decision by the country’s cost-effectiveness gatekeeper threatens to spark another dispute over the cost of lifesaving cystic | Last week, the U.K.'s National Institute for Health and Care Excellence unveiled draft guidance that acknowledged the effectiveness of Vertex’s cystic fibrosis drugs Trikafta, Symkevi and Orkambi.

Medicine 257
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Why GLP-1s Alone Cannot Solve the Obesity Crisis

MedCity News

People with obesity should be offered a range of suitable treatments as well: behavioral, nutrition, exercise, medication and surgery, through a coordinated and holistic approach under one roof, with a care coordinator. Like cancer, obesity is a heterogeneous disease and recommendations and responses to all treatment modalities will be heterogeneous as well.

Medical 114
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Krystal's topical gene therapy gains steam, prompting analyst group to boost sales projection

Fierce Pharma

At the start of its first-ever conference call to present its quarterly numbers, Krystal Biotech CEO Krish Krishnan was quick to point out that the company’s positive earnings for the third quarter | Krystal Biotech's launch of Vyjuvek, the world's first topical gene therapy, has been so promising that analysts with Evercore ISI increased their 2024 sales projection to $273 million.

Sales 246
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Celldex Drug Flashes Potential to Compete With, Maybe Beat Rival Big Pharma Meds

MedCity News

Celldex drug barzolvolimab has mid-stage results in a chronic inflammatory skin disease that top those of an approved Genentech drug and two experimental Novartis therapies. The biotech is preparing to advance its drug to Phase 3 testing in 2024.

Pharma 112
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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As Vertex preps for exa-cel launch, exec touts 'very large' opportunity but tempers early expectations

Fierce Pharma

As Vertex preps for exa-cel launch, exec touts 'very large' opportunity but tempers early expectations zbecker Mon, 11/06/2023 - 20:59

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Urban Institute: 400,000 Veterans Expected to be Uninsured in 2024

MedCity News

About half (47%) of nonelderly uninsured veterans will be eligible for Medicaid or subsidies through the ACA Marketplace in 2024, according to a new report from the Urban Institute.

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More Trending

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Report: Percentage of Workers Eligible for Employment-Based Coverage Increased 5% Since 2014

MedCity News

It was expected that the Affordable Care Act would lead to many employers dropping health benefits, but that did not happen, a new report from the Employee Benefit Research Institute found.

Leads 106
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BioNTech cuts 2023 revenue guidance by 20%, but touts its financial position

Fierce Pharma

Following suit with other companies that produce COVID-19 vaccines, BioNTech has discovered demand for its Pfizer-partnered, omicron-adapted shot has not met expectations this fall and has had to a | BioNTech has slashed its estimate of 2023 revenue by 20%, now expecting it to reach 4 billion euros ($4.3 billion) versus its previous estimate of 5 billion euros ($5.4 billion).

Sales 211
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BMS Pays $100M for Next-Gen Orum Therapeutics ADC for Blood Cancers

MedCity News

Bristol Myers Squibb is expanding its scope in cancer by acquiring rights to a Phase 1-ready Orum Therapeutics program that brings a new twist to antibody drug conjugates. The deal is the latest business development move in the hot field of ADCs.

Biopharma 105
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Astellas touts 2-year results for $4.9B GA drug Izervay as it amps up Apellis rivalry

Fierce Pharma

When Astellas ponied up $4.9 billion for Iveric Bio earlier this year, the company had identified the promise of Iveric's geographic atrophy candidate, now approved as Izervay, as a future revenue | Astellas is counting on Izervay to deliver gains in a heated GA market clash against rival Apellis. Now, 2-year data show the drug's effects increase over time.

Marketing 164
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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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Increasing Solubility with Zerion Pharma at CPHI Barcelona

PharmaTech

Pharmaceutical Technology Europe® spoke with Ole Wiborg from Zerion Pharma, a Danish pharmaceutical development company, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Pharma 98
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Axsome expands sales force to support launch of fast-growing depression med Auvelity

Fierce Pharma

With revenue on the rise for its fast-working depression med Auvelity, Axsome Therapeutics is in the process of boosting its sales force with nearly 100 new hires. | The company plans to expand its Auvelity sales force from 162 to 260 reps by next quarter in an effort to reach some 18,000 new prescribers.

Sales 164
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INVEST Digital Health Pitch Perfect Spotlight: Hera Is Building a Better Way to Diagnose Endometriosis

MedCity News

Hera Biotech, a San Antonio-based startup developing a nonsurgical diagnostic test for endometriosis, won the Pitch Perfect contest at MedCity News’ INVEST Digital Health conference. The average diagnostic delay for the endometriosis is eight years, driven in large part by the fact that the only method currently used to diagnose the disease is a surgical procedure.

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MHRA authorises new treatment for rare lung cancer

European Pharmaceutical Review

A new medicine to treat adults with non-small cell lung cancer (NSCLC) with a rare mutation called KRAS G12C has been authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA). According to the MHRA, Mirati Therapeutics B.V.’s Krazati ® (adagrasib) can be used in this indication in individuals who have an advanced form of the disease, or it has spread to other parts of the body.

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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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RCM Staff Shortages Are Making It a Lot Harder for Providers to Get Paid

MedCity News

Discussions around healthcare’s workforce crisis usually center around providers’ lack of clinicians, but there’s a sweeping shortage of revenue cycle workers, too. In a new report, Experian Health surveyed 200 employees who are responsible for staffing the revenue cycle function at providers — every respondent said that staff shortages are having a significant negative impact on their organization’s ability to get paid for care and/or patient engagement.

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Global cell line development to surge in next decade

European Pharmaceutical Review

The global cell line development industry is expected to value $4,674.8 million by 2033, according to a report by Future Market Insights. Total cell line product sales are expected to reach $3,124.4 million in 2023, with a predicted compound annual growth rate (CAGR) of 4.1 percent through the next decade. Advancements in biotechnology, pharmaceutical research, and biomanufacturing processes are key factors in driving the market, the author acknowledged.

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Samay’s AI-assisted wearable technology accurately diagnoses COPD

PharmaTimes

The device successfully diagnosed COPD in patients with 90% accuracy - News - PharmaTimes

Patients 124
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Drug Diversion in Healthcare is a National Problem, but Recent Survey Shows a Promising Path Forward

PharmExec

Healthcare organizations can lower their risk of drug diversion by strengthening staffing, employee training, and technology.

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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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The thorniest questions facing pharma, according to a leading bioethicist

PharmaVoice

Bioethics guru Arthur Caplan of NYU gives his outspoken and frank opinion on the industry’s minefield of ethical challenges.

Ethics 98
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AAO 2023: intravitreal treatment shows benefit in geographic atrophy

European Pharmaceutical Review

IZERVAY ( avacincaptad pegol intravitreal solution) induced a year-over-year reductions in the rate of geographic atrophy lesion growth in patients with geographic atrophy secondary to age-related macular degeneration (AMD) in a Phase III trial, Astellas Pharma has announced. The findings presented at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting, revealed that the treatment continued to reduce the rate of geographic atrophy lesion growth for both every month and every-other-mo

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First high-resolution 3D image offers insight into heart and muscle health

PharmaTimes

The image helps researchers understand how heart muscles operate in disease - News - PharmaTimes

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A Look at Hachette v. Internet Archive

Copyright Clearance Center

The post A Look at Hachette v. Internet Archive appeared first on Copyright Clearance Center.

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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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Cell & gene therapy: the leading companies in rAAV production technology revealed

Pharmaceutical Technology

GlobalData uncovers the leading innovators in rAAV production technology for the pharmaceutical industry.

Leads 89
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UK patient data project reaches one million volunteers

pharmaphorum

UK patient data project reaches one million volunteers Phil.

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Mirati wins conditional UK approval for Krazati in NSCLC

Pharmaceutical Technology

Krazati received conditional marketing authorisation as a second-line treatment of KRAS-G12C mutated locally advanced or metastatic NSCLC.

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Drug combos from AZ, Boehringer show promise in CKD

pharmaphorum

Drug combos from AZ, Boehringer show promise in CKD Phil.

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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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Skyrocket Your Sales: Innovative Strategies to Crush Your Targets

Contrarian Sales Techniques

In the last quarter alone, businesses that revamped their sales strategies saw a staggering 34% increase in revenue, outpacing competitors who adhered to traditional methods. This statistic isn't just a number—it's a testament to the transformative power of innovative sales approaches in today's market. In an era where consumer behaviors shift as rapidly as the technologies they use, the ability to adapt sales tactics is not just advantageous—it's essential.

Sales 52
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Distinguishing E&L Testing for Combination Products (AAPS PharmSci 360)

PharmaTech

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, talks about the differences in designing E&L testing for combination products vs. conventional pharmaceuticals.

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Trinity Capital Inc. Provides $25 Million Growth Capital to Neuros Medical, Inc.

Legacy MEDSearch

Trinity Capital Inc. (NASDAQ: TRIN ) (“Trinity”), a leading provider of diversified financial solutions to growth-stage companies, today announced the commitment of $25 million in growth capital to Neuros Medical, Inc., a bioelectric technology company focused on alleviating chronic post-amputation pain and restoring quality of life. Neuros Medical’s Altius System incorporates the company’s patented platform technology, On-Demand Bioelectric Nerve Block, which patients

Medical 52
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The Future State of Oncology: The Rise of Oncology Home Care

Pharmaceutical Commerce

While there are still hurdles to overcome along the way, home healthcare could deliver better patient-centered cancer care, providing improved patient outcomes, enhanced quality of life, and reduced strain on resources.

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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.