Tue.May 10, 2022

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Pfizer to acquire Biohaven in $11.6B bet on biotech's migraine drugs

Bio Pharma Dive

The rest of Biohaven's pipeline, which includes drugs for ALS and obsessive compulsive disorder, will be spun out into a new company led by the biotech's current CEO and retaining its name.

Drugs 334
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Roche extends Kaiku digital monitoring partnership again

pharmaphorum

Roche has elevated a longstanding alliance with Finland’s Kaiku Health focusing on digital patient monitoring and management (DPMM) to the level of a strategic partnership. The two companies have been working together since 2019 on digital health interventions to provide support to people with cancer, focusing initially on tools for patients undergoing cancer immunotherapy.

Nurses 132
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Against a historic market downturn, Moma Therapeutics raises $150M for precision cancer research

Bio Pharma Dive

The biotech's Series B round, which kicked off early this year, should be able to fuel its work on "molecular machines" until at least 2024, according to CEO Asit Parikh.

Marketing 284
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Wearable tracks health by measuring skin gas emissions

pharmaphorum

Researchers in the US have developed a wearable monitor that could be used to monitor metabolic diseases through gases released from a person’s skin. It’s a spin on the use of monitors that detect chemicals in sweat using electrical signals and has the key advantage that it does not need substantial amounts of sweat to get a reading, according to the team from Ohio State University.

Engineer 130
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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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With spotlight on FDA, Congress weighs reforms to accelerated drug approvals

Bio Pharma Dive

The controversial approval of Biogen’s Aduhelm, as well as drugmaker delays in completing confirmatory trials on time, have highlighted flaws in the program, pushing lawmakers to consider changes.

Drugs 152
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Cytiva opens Swiss manufacturing facility and Center of Excellence for cell and gene therapies

BioPharma Reporter

Cytiva is opening a new 7,400m manufacturing facility in Grens, Switzerland this month: which will serve as a center of excellence for the companyâs cell and gene therapy business as well as a being a base for European customer training programs.

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Emergent Hid Evidence of Covid Vaccine Problems at Plant, Report Says

NY Times

The report sheds new light on executives’ worries about deficiencies in the company’s quality control systems at its troubled Baltimore plant; no contaminated doses were ever released to the public.

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CancerVar: A New Bioinformatics Tool Developed for Clinical Interpretation of Cancer Mutations

XTalks

CancerVar will help researchers standardize and automate clinical interpretations for 13 million somatic mutations from 1,911 cancer census genes. Approximately 75 to 80 percent of cancer cases arise from somatic variants and cancers that occur this way are also called sporadic cancers. The gene mutations that cause sporadic cancer occur only in the tumor cells and are acquired during an individual’s life, not inherited.

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Healthcare communication and how it’s changing

pharmaphorum

Engaging, strategic, customer-centric communication is important in any industry, and no industry has been unaffected by the changing world of digital communication. But healthcare communicators have an extra layer of challenges as the conveyors of serious, important information that can also have a high degree of scientific complexity. “Healthcare can be incredibly complex.

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More than starting a company: The Art and Science of Entrepreneurship

Scienmag

Entrepreneurs who are ready to start companies often lack enough knowledge and skillsets to do it correctly. How can they gain these? How can anyone, an aspiring entrepreneur, a leader, an employee, a policy maker, learn from history and from experiences of successful entrepreneurs, for key events that shaped the past economies and businesses? Credit: […].

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Pediatricians Hold the Front Lines of a Mental Health Crisis

NY Times

Around the country, the setting for adolescent mental health care looks ever more like this doctor’s office in Kentucky, the next patient arriving every 15 minutes.

Drugs 97
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Strong solar flare erupts from sun

Scienmag

The Sun emitted a strong solar flare on Tuesday, May 10, 2022, peaking at 9:55 a.m. EDT. NASA’s Solar Dynamics Observatory, which watches the Sun constantly, captured an image of the event. Credit: Credit: NASA/SDO The Sun emitted a strong solar flare on Tuesday, May 10, 2022, peaking at 9:55 a.m. EDT. NASA’s Solar Dynamics Observatory, which […].

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Gross-to-Net Bubble Update: 2021 Pricing Realities at 10 Top Drugmakers

Drug Channels

Time for Drug Channels ’ annual update on pricing at the largest pharmaceutical manufacturers. This year’s review includes 10 companies: Eli Lilly and Company, Genentech, GlaxoSmithKline, Janssen, Merck, Novartis, Novo Nordisk, Sanofi, Takeda, and UCB. You can find links to each company’s data below. When rebates and discounts were factored in, brand-name drug prices declined—or grew slowly—in 2021.

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Artificial cell membrane channels composed of DNA can be opened and locked with a key

Scienmag

Just as countries import a vast array of consumer goods across national borders, so living cells are engaged in a lively import-export business. Their ports of entry are sophisticated transport channels embedded in a cell’s protective membrane. Regulating what kinds of cargo can pass through the borderlands formed by the cell’s two-layer membrane is essential […].

DNA 92
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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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First treatment option indicated for CKD in Scotland for 20 years

Pharma Times

NICE recommendation for Forxiga could entitle 53,000 adults to the new kidney disease therapy

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Head, body, eye coordination conserved across animal kingdom, researchers find

Scienmag

UNIVERSITY PARK, Pa. — Fruit flies synchronize the movements of their heads and bodies to stabilize their vision and fly effectively, according to Penn State researchers who utilized virtual-reality flight simulators. The finding appears to hold true in primates and other animals, the researchers say, indicating that animals evolved to move their eyes and bodies […].

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University of Aberdeen study finds diabetes almost doubles risk of COVID-19 death

Pharma Times

Researchers reviewed findings from 158 global studies to determine how COVID-19 affects people living with diabetes

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Computational sleuthing confirms first 3D quantum spin liquid

Scienmag

HOUSTON – (May 10, 2022) – Computational detective work by U.S. and German physicists has confirmed cerium zirconium pyrochlore is a 3D quantum spin liquid. Credit: Jeff Fitlow/Rice University HOUSTON – (May 10, 2022) – Computational detective work by U.S. and German physicists has confirmed cerium zirconium pyrochlore is a 3D quantum spin liquid. Despite […].

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Los pediatras están al frente de la crisis de salud mental

NY Times

El panorama de la atención a la salud mental de los adolescentes en EE. UU. es cada vez más cada similar al consultorio de esta doctora en Kentucky, a donde llegan pacientes cada 15 minutos.

Drugs 54
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Climate change is pushing the pine beauty moth northward 50 years ahead of earlier predictions

Scienmag

In Finland, climate change is causing the pine pest Panolis flammea, or pine beauty moth, to shift its range northward 50 years ahead of predictions. Changes in both the distribution and size of the pine beauty moth population are linked to higher temperatures, a new study from the University of Eastern Finland shows. The findings […].

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Inventprise inaugurates manufacturing facility for pneumococcal conjugate vaccines

BioPharma Reporter

Inventprise has inaugurated its new manufacturing facility for high-capacity supply of a 25-valent Pneumococcal Conjugate Vaccine (IVT-PCV-25) for low- and middle-income countries.

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How “calming” our spinal cords could provide relief from muscle spasms

Scienmag

Poor sleep, difficulty moving and injuries from hitting something accidentally are just some of the challenges faced by suffers of often-painful involuntary muscle spasms. Credit: N/A Poor sleep, difficulty moving and injuries from hitting something accidentally are just some of the challenges faced by suffers of often-painful involuntary muscle spasms.

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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.

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New patent expiration for Optinose Us drug XHANCE

Drug Patent Watch

Annual Drug Patent Expirations for XHANCE Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. There are thirteen patents protecting this drug. XHANCE drug…. The post New patent expiration for Optinose Us drug XHANCE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Henry Ford Health first in Michigan to offer robotic high-intensity focused ultrasound for prostate cancer

Scienmag

DETROIT (May 10, 2022) – Henry Ford Health is the first in Michigan to offer Robotic High Intensity Focused Ultrasound (HIFU) for the treatment of localized prostate cancer. This non-surgical treatment option spares surrounding healthy tissue, while allowing for a quicker treatment time and recovery for the patient. Credit: Henry Ford Health DETROIT (May 10, […].

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FDA outlines benefit-risk approach to drug or biologic product quality assessment

BioPharma Reporter

The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.

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Study identifies potential target for treating childhood blood cancer

Scienmag

Scientists have pinpointed a possible new target for treating patients with the blood cancer juvenile myelomonocytic leukaemia (JMML), according to a study published today in eLife. Credit: Maja Solman (CC BY 4.0) Scientists have pinpointed a possible new target for treating patients with the blood cancer juvenile myelomonocytic leukaemia (JMML), according to a study published […].

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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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Saving lives doesn’t have to cost the Earth

pharmaphorum

Jamie Phares, managing director, The Janssen Pharmaceutical Companies of Johnson & Johnson in the Gulf Cooperation Council (GCC), talks about how the healthcare industry needs to come together to reduce its environmental impact and further protect public health. Scientists and environmentalists have long been sounding the alarm that our planet is facing a huge environmental crisis that is not under control.

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New study describes multi-agent systems for optimization and decision-making through games

Scienmag

In artificial intelligence, multi-agent systems can be thought of as a society of individuals (agents) that interact by exchanging knowledge and by negotiating with each other to achieve an individual/global goal. In real life, multi-agent systems are used in many diverse fields like resource management; information security; manufacturing planning, scheduling, and control; monitoring, diagnosis, and […].

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Pfizer upgrades Biohaven alliance to a takeover bid

pharmaphorum

Not content with a $1.2 billion licensing deal for Biohaven Pharma’s oral migraine therapy rimegepant, Pfizer has just offered to buy the company outright – for a cool $11.6 billion. Pfizer’s earlier buy-in only gave it ex-US rights to rimegepant, already approved and on sale in the US as Nurtec ODT, so taking control of the entire company will give it full ownership of the blockbuster-in-waiting, which pulled in $462 million in sales from the US market alone last year.

Sales 52
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History professor’s book examines racism in Russia

Scienmag

CHAMPAIGN, Ill. — Russia, under President Vladimir Putin’s administration, is perhaps the most dangerous country for racial violence in the world, according to University of Illinois Urbana-Champaign history professor Eugene Avrutin. Credit: Courtesy Eugene Avrutin CHAMPAIGN, Ill. — Russia, under President Vladimir Putin’s administration, is perhaps the most dangerous country for racial violence in the […].

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.