Sat.Mar 23, 2024 - Fri.Mar 29, 2024

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Leveraging Digital Tools to Optimize Manufacturing Processes

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Barry Heavey, Life Sciences Supply Chain Lead, Accenture, discusses how companies can leverage digital tools like artificial intelligence and machine learning to optimize manufacturing processes and ensure efficient production.

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BioNTech hit with 'notice of default' from NIH in COVID-19 vaccine royalty dispute

Fierce Pharma

Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. | Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. officials are pressing the company to pay royalties linked to the commercialization of its lucrative Pfizer-partnered COVID-19 vaccine.

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Nanoscope preps filing for retinitis pigmentosa gene therapy

pharmaphorum

Nanoscope Therapeutics is on the brink of filing for FDA approval of what could be the first gene therapy for incurable eye disease retinitis pigmentosa (RP) that can be used regardless of underlying genetic mutations.

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Merck Drug for Heart and Lung Disorder Wins a First-in-Class FDA Approval

MedCity News

Merck drug Winrevair is the first in a new class of pulmonary arterial hypertension therapies that address a key signaling pathway behind the disease. The drug comes from Merck’s $11.5 billion acquisition of Acceleron Pharma.

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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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The Rising Tide of Biopharma Manufacturing Costs

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Barry Heavey, Life Sciences Supply Chain Lead, Accenture, discusses the specific factors contributing to rising manufacturing costs.

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In banner year, Lilly rewards CEO David Ricks with 24% boost in total pay to $26.6M

Fierce Pharma

In 2023, Eli Lilly CEO David Ricks received a 24% boost in pay from $21.4 million to $26.6 million. The increase coincides with the company's booming sales.

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How Can Digital Health Startups Stand Out In Today’s Landscape?

MedCity News

During a recent panel, Flare Capital Partners’ Michael Greeley and Mount Sinai’s Robbie Freeman shared some attributes that they think stand out among digital health startups that have found success in today’s environment.

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Who’s getting left behind in the weight loss bonanza?

PharmaVoice

As the new weight loss drugs take the world by storm, companies in other areas are battening the hatches for when slimmer patients need fewer medical interventions.

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Merck scores key FDA approval for pulmonary arterial hypertension drug Winrevair

Fierce Pharma

After three years, the crown jewel of Merck’s $11.5 billion acqu | After three years, the crown jewel of Merck’s $11.5 billion acquisition of Acceleron is ready to pay dividends. With the FDA’s approval of Winrevair (sotatercept) to treat pulmonary arterial hypertension (PAH), Merck is set to launch the first disease-modifying treatment for the condition.

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Are Adults With Diabetes Who Switch to High-Deductible Health Plans at Greater Risk for Complications?

Pharmaceutical Commerce

A study of patients with the long-term conditions who are required to switch to high-deductible health plans could potentially be more likely to experience diabetes complications than those who stay in standard insurance plans.

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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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AbbVie Gets Another Ulcerative Colitis Contender via $137M Landos Acquisition

MedCity News

AbbVie is acquiring Landos Biopharma, whose lead drug is a small molecule that takes a novel approach to treating ulcerative colitis. Preliminary proof-of-concept data from a Phase 2 study are expected later this year.

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Novo Nordisk agrees $1.1bn takeover of RNA biotech Cardior

pharmaphorum

Novo Nordisk has agreed to buy Cardior Pharmaceuticals for $1.1 billion, adding expertise in RNA therapeutics and a heart failure therapy in mid-stage trials.

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With Merck's key PAH approval on tap, Johnson & Johnson wins nod for combo tablet

Fierce Pharma

With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a | With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a nod from the U.S. regulator for its newest PAH treatment.

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Medical Sales Rep Recruitment: Implementing an effective selection process for better results.

MaBiCo

Medical Sales Rep Recruitment: Implementing an effective selection process for better results. For most organizations, recruiting plays a pivotal role in driving sales effectiveness, even though it remains one of the most challenging aspects to execute effectively. Several sales leaders think their companies have mastered recruitment, while others may consider it as less important compared to other SFE (sales force effectiveness) drivers.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Boundless Bio’s ‘BOLD’ IPO Reels In $100M for a New Kind of Cancer Drug

MedCity News

Cancer drug developer Boundless Bio is a pioneer in therapies that target extrachromosomal DNA. The IPO cash will support its pipeline, including a lead program on track to report preliminary data later this year.

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Brainomix AI shows its worth in AZ pulmonary fibrosis trial

pharmaphorum

Brainomix's e-Lung AI can accurately identify idiopathic pulmonary fibrosis patients most likely to progress and could inform the clinical trial design for new therapies

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Intelligence officials warned lawmakers WuXi AppTec furnished China with client's intellectual property: Reuters

Fierce Pharma

An alleged development in the national security crackdown against WuXi AppTec and a handful of other Chinese companies in the U.S. | An alleged development in the national security crackdown against WuXi AppTec and a handful of other Chinese companies in the U.S. suggests intelligence officials and lawmakers may have good reason to be concerned about the CDMO’s potential political ties to its home country.

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Nanoscope Therapeutics exhibits positive top-line Phase IIb results for MCO-010

Pharmaceutical Technology

Nanoscope Therapeutics released promising top-line results for its RESTORE trial, which is studying the gene therapy MCO-010 in patients with retinitis pigmentosa (RP).

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Novocure’s Electrical Cancer Therapy Shows It Can Treat Tumors in the Brain

MedCity News

Novocure said its “Tumor Treating Fields” met the main goal of a pivotal study enrolling non-small cell lung cancer patients with brain metastases. However, results for the electricty-based treatment fell short of statistical significance on several secondary endpoints.

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Does the Passing of a No Behavioral Health-Cost Sharing Law Have Any Bearing on Spending?

Pharmaceutical Commerce

A study investigates how a New Mexico law can impact patients’ out-of-pocket costs surrounding mental health and substance use disorder medications.

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Bristol Myers Squibb's versatile Zeposia doesn't make the grade in Crohn's disease trial

Fierce Pharma

Bristol Myers Squibb’s Zeposia (ozanimod) has attracted attention as a treatment for an unusual duo of diseases—multiple sclerosis (MS) and ulcerative colitis (UC). | Bristol Myers Squibb’s Zeposia has attracted attention as a treatment for an odd pair of unrelated diseases—multiple sclerosis (MS) and ulcerative colitis (UC). But the approval roll for the sphingosine 1-phosphate (S1P) receptor modulator may be over.

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Measles cases continue to rise in US amid lagging vaccination rates

Pharmaceutical Technology

According to the CDC, over 64 cases of measles have been documented in the US in 2024, already exceeding 2023's total of 58.

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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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Why Mass General Brigham Wants to Move 10% of Patient Care to the Home

MedCity News

At HIMSS24, Heather O’Sullivan, Mass General Brigham’s president of healthcare at home, said that the health system wants to move 10% of all its medical patients to the home. She argued that there is “no greater model of care for being patient-centric,” and highlighted the care modality’s ability to alleviate burnout for some healthcare workers.

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FDA turns down Regeneron bispecific blood cancer antibody

pharmaphorum

FDA has turned down a pair of marketing applications for Regeneron’s CD20xCD3 bispecific antibody odronextamab to treat two common forms of non-Hodgkin lymphoma

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After Amgen's stumble, BMS touts KRAS confirmatory trial win for newly bought Krazati

Fierce Pharma

Bristol Myers Squibb looks on track to overtake Amgen as the KRAS leader in lung cancer after following up its rival’s FDA setback with a positive confirmatory trial readout. | Bristol Myers Squibb looks on track to overtake Amgen as the KRAS leader in lung cancer after following up its rival’s FDA setback with a positive confirmatory trial readout.

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Positive CHMP recommendation for antibiotic combination

European Pharmaceutical Review

The Committee for Medicinal Products for Human Use (CHMP) has recommended granting of a marketing authorization for antibiotic combination Emblaveo® (aztreonam-avibactam) for treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of aerobic Gram-negative bacteria. “Gram-negative bacteria are often resistant to multiple drugs, leaving infected patients very ill and at high risk of severe complications, including mo

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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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Nearly Half of RN Vacancies in 2023 Were Agency Staffing Positions: Three Takeaways for Employers

MedCity News

It’s a complex, multifaceted problem that no magic bullet will solve — but more visibility into the data behind hiring and salaries for RNs may help. Here’s a look at how.

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Nuvation Bio nears commercial stage with AnHeart buy

pharmaphorum

Nuvation Bio speeds up its path to becoming a commercial-stage biotech with a deal to acquire AnHeart Therapeutics and its late-stage lung cancer therapy taletrectinib

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Caring Cross, Brazil's Fiocruz team up to produce cell and gene therapies at a fraction of their cost in the US

Fierce Pharma

Maryland non-profit Caring Cross has unveiled a partnership with the Brazilian government that's designed to provide access to advanced cell and gene therapies for diseases like leukemia, lymphoma | Maryland nonprofit Caring Cross has unveiled a partnership with the Brazilian government which is designed to provide access to advanced CAR-T and gene therapies for diseases like leukemia, lymphoma and HIV infection—and in the process provide a manufacturing model that demonstrates how to reduc

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Next-gen Moderna COVID-19 vaccine shows promise

European Pharmaceutical Review

Moderna’s next-generation COVID-19 vaccine mRNA-1283 demonstrated a higher immune response against SARS-CoV-2, interim results from the company’s Phase III trial show. These findings were based on data comparing the treatment to mRNA-1273.222 (Spikevax ® ), Moderna’s licensed vaccine for the condition. “We are excited to announce our fourth infectious disease vaccine programme with positive Phase III data,” stated Stéphane Bancel, Chief Executive Officer of Moderna. “mRNA

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.