Mon.Mar 04, 2024

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Pfizer stops buildout of $350M Seagen plant, leaving 120 workers' roles in question

Fierce Pharma

When Pfizer completed its $43 billion buyout of Seagen in December | Less than three months after completing its $43 billion acquisition of Seagen, Pfizer has confirmed a report that it is shutting down construction of a $350 million manufacturing facility in Everett, Washington. The decision will affect 120 employees working on the initial setup of the site, the company said.

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Cannabinoids show promise in acute migraine clinical trial

pharmaphorum

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

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Perrigo's over-the-counter birth control launch takes flight in the US

Fierce Pharma

A little more than half a year after winning a historic over-the-counter nod, Perrigo’s nonprescription birth control pill Opill is set to hit store shelves in the “coming weeks.” | A little more than half a year after winning a historic over-the-counter nod, Perrigo’s nonprescription birth control pill Opill is set to hit store shelves in the “coming weeks.

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How Food-as-Medicine Execs Are Responding to Kellogg CEO’s ‘Let Them Eat Flakes’ Remarks

MedCity News

Kellogg CEO Gary Pilnick recently encouraged families struggling to put food on the table to turn to cereal as their go-to dinner option. Food-as-medicine executives are none too thrilled about his comments — they argue that the remarks underscore the dire need to increase public education about affordable, healthy meal planning.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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RSV vaccines may raise risk of Guillain-Barré syndrome, FDA preliminary analysis finds

Fierce Pharma

After decades of research into respiratory syncytial virus (RSV), Pfizer and GSK’s groundbreaking vaccines made waves as the first immunizations against the common respiratory illness. | After a preliminary analysis found a potentially higher risk of Guillain-Barré syndrome following RSV vaccination in older adults, GSK and Pfizer said they will conduct further safety studies.

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Akero’s New MASH Drug Data: Longer Treatment Leads to More Liver Benefit

MedCity News

Akero Therapeutics’ preliminary Phase 2b data show that treatment with its MASH drug, efruxifermin, continued to distance itself from a placebo measured at nearly two years of treatment. The latest Akero data build on six-month results reported in 2022.

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Oncology emerges as dominant therapy area for CRISPR technology

Pharmaceutical Technology

In late 2023, the Medicines and Healthcare products Regulatory Agency approved Vertex’s Casgevy, which became the inaugural clustered regularly interspaced short palindromic repeats (CRISPR)-based drug for the haematological indications beta thalassemia and sickle cell disease (SCD).

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With Takeda out of the picture, J&J’s Rybrevant moves into first line in lung cancer subtype

Fierce Pharma

Johnson & Johnson continues to grow its oncology franchise with a new FDA approval that opens the lung cancer drug Rybrevant to treating certain newly diagnosed patients. | Johnson & Johnson continues to grow its oncology franchise with a new FDA approval that opens the lung cancer drug Rybrevant to treating certain newly diagnosed patients.

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Trends Shaping the Next Generation of Healthcare Workers

MedCity News

Healthcare organizations will need to proactively engage the next generation of workers in order to meet demand. They can start by factoring in these trends and creating an environment that supports a healthy work-life balance, finding opportunities to prioritize flexibility, and leaving room to staff up for new and expanding care fields.

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As Medicare price negotiations roll on, drugmakers counter HHS' initial offers

Fierce Pharma

After the U.S. | With the counteroffers, the IRA-mandated negotiations period has begun and will continue through August.

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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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Report: Few Large Employers Have Changed Abortion Coverage Following Dobbs v. Jackson

MedCity News

Only 8% of large employers have reduced or expanded their coverage for abortion after the Dobbs v. Jackson decision, a new report from KFF found.

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Architect of Indian Pharmacy Education : Prof. Mahadev Lal Schroff

Pharmatutor

Architect of Indian Pharmacy Education : Prof. Mahadev Lal Schroff admin Mon, 03/04/2024 - 16:44 ABOUT AUTHOR Dr. R. S. Thakur Former Secretary, Pharmacy Council of India. Email : drramsthakur@gmail.

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EMA awards double validation for Daiichi Sankyo and AstraZeneca’s cancer ADC

Pharmaceutical Technology

The EMA has validated the jointly developed TROP2-directed therapy for patients with breast or lung cancer following positive Phase III data.

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Delivery systems for biologics

European Pharmaceutical Review

As a cornerstone of advanced therapeutics in modern medicine, biologics command significant attention in the search for effective treatments for human diseases. These biopharmaceuticals encompass a range of products including vaccines, recombinant therapeutic proteins, tissues, cells and gene therapies – all sourced from living organisms. 1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs.

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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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EMA starts twin reviews of AZ, Daiichi’s Dato-DXd

pharmaphorum

The clock has started ticking in the EU on two marketing applications for AstraZeneca and Daiichi Sankyo’s TROP2-targeting antibody-drug conjugate datopotamab deruxtecan in breast and lung cancer. The EMA has validated the two parallel applications for the drug, also known as Dato-DXd, in adults with previously treated non-small cell lung cancer (NSCLC) and hormone receptor-positive, HER2-negative breast cancer.

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New data revealed for Novartis SMA gene therapy

European Pharmaceutical Review

According to new data in older and heavier children treated with Novartis’ spinal muscular atrophy (SMA) gene therapy, nearly all participants in the Phase IIIb trial maintained or improved motor milestones after 52 weeks. Final data from the Phase IIIb SMART study of Zolgensma ® (onasemnogene abeparvovec) highlighted its safety and efficacy in children weighing ≥ 8.5kg to ≤ 21kg, with a mean age of 4.69 years.

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The Top Strategies Healthcare Organizations Can Use to Reduce Denials

MedCity News

Here are six actionable steps healthcare organizations can take to reduce their likelihood of denials and write-offs.

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FDA doubles down on patient engagement to support rare disease research

Pharmaceutical Technology

For Rare Disease Day, several panels organised by the FDA discussed the importance overcoming accessibility barriers during drug development.

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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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Bayer pays $310m for Euro rights to ATTR therapy acoramidis

pharmaphorum

Bayer licenses European rights to BridgeBio's acoramidis, putting some big pharma muscle behind the ATTR cardiomyopathy treatment

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Poor spatial navigation could predict Alzheimer’s before symptom onset

PharmaTimes

Around 900,000 people in the UK are affected by the progressive neurodegenerative disease

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Pharma Pulse 3/4/24: Local Pharmacies on the Brink, People in MA Plans Experienced Delays in Accessing Care & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Researchers reveal two different subtypes of prostate cancer using AI

PharmaTimes

In the UK alone, the aggressive form of cancer affects around 52,000 men every year

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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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Breaking Through the Clutter in HCP Marketing

LEVO Health

Healthcare professionals (HCPs) are currently inundated with information and marketing messages. Therefore, standing out in the crowded HCP marketing space requires strategic innovation and a deep understanding of HCP needs and behaviors. Exploring effective strategies to overcome the clutter, establishing meaningful connections with each audience, and leveraging the latest trends and data-driven insights are crucial for successful HCP marketing.

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How the Pandemic Changed the Way Pharma Looks at Data Integrity in 2024

PharmExec

In this Pharmaceutical Executive video interview, Daniel Ayala, Chief Security and Trust Officer, Dotmatics, discusses data security threats from human error to AI tech and how COVID-19 impacted data integrity.

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Did the FTC get it wrong when it blocked the Sanofi-Maze deal?

PharmaVoice

In its zeal to stamp out anticompetitive practices and lower drug prices, a consultant said the FTC might have overlooked the unique considerations in rare disease drug development.

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Remote Work in Medical Sales: Navigating Challenges and Maximizing Opportunities

Rep-Lite

As remote work becomes increasingly prevalent across industries, its impact on medical sales professionals is significant. Navigating the challenges and seizing the opportunities presented by remote work in medical sales requires adaptability and strategic approaches. This comprehensive guide explores the unique dynamics of remote work in medical sales, addressing common challenges such as maintaining client relationships, overcoming communication barriers, and managing time effectively.

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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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Sandoz strengthens US biosimilar market with CIMERLI acquisition

Pharmaceutical Technology

Sandoz has concluded the acquisition of the US biosimilar CIMERLI from Coherus BioSciences, bolstering ophthalmology and biosimilar expertise.

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Amring Changes Name to Nordic Pharma, Inc. Amid Ownership Change

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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F. Hoffmann-La Roche in advanced materials: theme innovation strategy

Pharmaceutical Technology

How many patents did F. Hoffmann-La Roche submit related to advanced materials last quarter, and how many were granted? Discover the latest information here.

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Redefining Commercial with Modern Data for Today’s Complex Therapies: Q&A with Peter Stark, Executive VP and General Manager of Veeva Compass

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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.