Thu.Jun 23, 2022

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Radius, maker of bone and cancer drugs, to be bought in take-private deal

Bio Pharma Dive

Two investment firms, Gurnet Point Capital and Patient Square Capital, have agreed to pay as much as $890 million for Radius, which has come under pressure amid share price declines.

Drugs 309
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EC approves Novartis’ Tabrecta for non-small cell lung cancer

Pharmaceutical Technology

The European Commission (EC) has approved Novartis’ Tabrecta (capmatinib) as a monotherapy to treat advanced non-small cell lung cancer (NSCLC) in adults. The treatment is intended for patients with NSCLC harbouring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping and for those who need systemic therapy after previous treatment with immunotherapy and/or platinum-based chemotherapy.

Medicine 263
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UniQure buoyed by early data for Huntington's gene therapy

Bio Pharma Dive

After one year, researchers detected important protein changes in patients who received a low dose of the experimental treatment. Further testing and functional data are needed to assess its potential, however.

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Non-stop investment from CMOs and US Government into continuous manufacturing

Pharmaceutical Technology

In the last year, well-known contract manufacturing organisations (CMOs) such as Agilent Technologies (Santa Clara, California) and Abzena (Cambridge, UK) have expanded their continuous manufacturing capabilities. US Congress is also making substantial investments to improve the continuous manufacturing of pharmaceuticals. As more drugs are approved with continuous manufacturing, this production method is becoming increasingly mainstream.

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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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Bristol Myers CAR-T therapy cleared by FDA for earlier lymphoma use

Bio Pharma Dive

Breyanzi is now approved in the second-line setting, matching Gilead’s Yescarta, which won a similar clearance from the FDA earlier this year.

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US FDA grants approval for Merck’s pneumococcal vaccine for children

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Merck's (MSD outside the US and Canada) pneumococcal 15-valent conjugate vaccine, Vaxneuvance, for use in children aged six weeks to 17 years. The vaccine is intended for active immunisation to prevent invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in people aged six weeks and above.

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New pricing rules lower access barriers for orphan drugs in France

Pharmaceutical Technology

As recent changes to the price setting of drugs have improved the market access risk environment in France, GlobalData looks at their impact on the pricing of orphan drugs. Changes to price negotiations positive for orphan drugs. The changes in question were introduced via the new contractual agreement signed by the French Pharmaceutical Companies Association (LEEM) and the Ministry of Health’s (MoH’s) Economic Committee for Health Products (CEPS) in March 2021.

Drugs 147
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Eisai’s brain health tool NouKNOW used in Tokyo dementia project

pharmaphorum

Eisai’s digital tool to allow self-assessment of cognitive performance – NouKNOW – will be used in a Japanese project aimed at improving the management of dementia. The smartphone app – which uses a cognition-checking algorithm developed by Australian digital health company Cogstate – will be deployed in Bunkyo City, Tokyo in a dementia monitoring programme.

Trials 135
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The Metaverse: Regulatory trends

Pharmaceutical Technology

The metaverse will make digital media experiences more immersive, inclusive, and accessible than today. However, it will raise social concerns ranging from data privacy to other forms of online harm. Listed below are the key regulatory trends impacting the metaverse theme, as identified by GlobalData. Net neutrality. Net neutrality refers to the concept that a telecom network should be a neutral gateway to the Internet rather than a gatekeeper with the power to decide what content is available o

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Ultra-thin film creates vivid 3D images with large field of view

Scienmag

WASHINGTON — Researchers have developed a new ultra-thin film that can create detailed 3D images viewable under normal illumination without any special reading devices. The images appear to float on top of the film and exhibit smooth parallax, which means they can be clearly viewed from all angles. With additional development, the new glass-free approach […].

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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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UNH team finds repurposed drug hinders enzyme activity linked to Covid-19

Pharmaceutical Technology

Researchers at the University of New Hampshire (UNH) have found that a repurposed drug, CCG-50014, could hinder the activity of a key enzyme of the SARS-CoV-2 virus, which causes Covid-19. Utilising a currently available drug compound in a new way is called drug repurposing. The main protease enzyme Mpro, a key enzyme related to Covid-19, was the key target of the team in the study.

Drugs 130
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Getting Cancer Cell Therapies to Patients: Insights from a Biopharma Industry Veteran

XTalks

Dr. Jason Bock is a biopharma industry veteran who helped build the Biologics Development team that was formerly part of the Therapeutics Discovery division at the University of Texas MD Anderson Cancer Center. Dr. Bock is currently the CEO of the Cell Therapy Manufacturing Center at the Texas Medical Center. Photo Courtesy of MD Anderson Cancer Center.

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The Metaverse: Macroeconomic trends

Pharmaceutical Technology

Gaming and social media companies are at the vanguard of metaverse development, but enterprises will lead the charge in the next three years. This shift will be driven by the future of work and digital transformation initiatives ongoing across sectors ranging from retail to healthcare and financial services. Big Tech is championing the metaverse, with Microsoft and Meta promoting it as the ideal environment to support hybrid working.

Branding 130
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Precision Bio climbs on near-$1.5bn sickle cell pact with Novartis

pharmaphorum

Novartis has shouldered its way into the in vivo gene editing category via a deal with US biotech Precision BioSciences, focused on a therapy for sickle cell disease (SCD). The Swiss pharma group is paying $75 million upfronting cash and equity to get the ball rolling on the collaboration, with another $1.4 billion in potential milestones if the project advances through development and onto the market.

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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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Unlocking the potential of direct-to-patient as decentralised trials continue to grow

Pharmaceutical Technology

The global healthcare and pharmaceutical industry is frequently faced with having to find new ways of innovating and carrying out its work in order to overcome tragic circumstances that will typically come with a huge human cost. During the peak of the Covid-19 pandemic this challenge reached new heights, as pharmaceutical firms around the world mobilised the full might of their resources to try and identify, develop, and trial a wide range of vaccines and therapeutics to alleviate the lethal th

Trials 130
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Benefits of PCD Pharma Company

Fossil Remedies

If you see the growth pattern of the Indian economy, then it has been tremendous. The country has done remarkably well and despite the setback after the pandemic, it is roaring high with full speed. All sector of the Indian economy has done good, but the pharma sector is doing exceptionally well. It is among the fastest-growing sectors in India. Since there is an opportunity to earn, every dynamic business owner wants to reap benefits from that.

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Robotics hiring levels in the pharmaceutical industry rose in May 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for robotics related positions rose in May 2022 compared with the equivalent month last year, with 20.8% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 19.7% of companies who were hiring for robotics related jobs a year ago but a decrease compared to the figure of 21.8% in April 2022.

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Spotlight on Women in Science: Giulia Guerrini

pharmaphorum

Around the world, women are making important contributions to life sciences. In this series, we chart the career progression of notable women across the industry to find out what drew them to study science and how we can encourage more women to consider a role in STEM. In this edition, Giulia Guerrini, the lead pharmacist for digital pharmacy medino, discusses her journey from classics student in Italy to start-up superintendent and why it’s important to champion women in leadership positions.

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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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Advances in lithium niobate photonics

Scienmag

Lithium niobate (LiNbO3, LN) is one of the most important artificial materials and has been widely used in the photonics area since it was firstly discovered to have a ferroelectric property in 1949. Compared with other material systems, LN has various superior characteristics, such as a wide transparency window (400 nm to 5 m), large electro-optic […].

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Sanofi-GSK COVID-19 Vaccine Candidate Effective Against Omicron

BioSpace

???????Positive news continues for COVID-19 vaccine development and distribution, with Sanofi and GSK announcing the success of their candidate against the Omicron variant.

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Self-assembled, interlocked threads: Spinning yarn with no machine needed

Scienmag

The spiral is pervasive throughout the universe – from the smallest DNA molecule to ferns and sunflowers, and from fingerprints to galaxies themselves. In science the ubiquity of this structure is associated with parsimony – that things will organize themselves in the simplest or most economical way. Credit: Raj Kumar Manna The spiral is pervasive […].

DNA 88
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Pharma poised but no recorded monkeypox deaths

Pharma Times

Global surveillance systems show that recorded cases do not include any deaths

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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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Hair-raising research: Salk scientists find surprising link between immune system, hair growth

Scienmag

LA JOLLA—(June 23, 2022) Salk scientists have uncovered an unexpected molecular target of a common treatment for alopecia, a condition in which a person’s immune system attacks their own hair follicles, causing hair loss. The findings, published in Nature Immunology on June 23, 2022, describe how immune cells called regulatory T cells interact with skin […].

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Novartis invests $250m in malaria elimination commitment

Pharma Times

The company has renewed its pledge to eliminate neglected tropical diseases and malaria over five years

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Cities of the future may be built with algae-grown limestone

Scienmag

Global cement production accounts for 7% of annual greenhouse gas emissions in large part through the burning of quarried limestone. Now, a CU Boulder-led research team has figured out a way to make cement production carbon neutral—and even carbon negative—by pulling carbon dioxide out of the air with the help of microalgae. Credit: Glenn Asakawa […].

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Merck, Seagen Talks Heat Up Under Cloud of Regulatory Scrutiny

BioSpace

Talks between Merck and Seagen are heating up as the former looks to buy the latter, according to a report published by The Wall Street Journal.

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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.

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New recommendations for prenatal care delivery

Scienmag

The American College of Obstetricians and Gynecologists partnered with the University of Michigan to convene a panel of maternity care experts to determine new prenatal care delivery recommendations. Based on emerging evidence and experience, including significant changes in prenatal care delivery during the COVID-19 pandemic, these recommendations are published in the peer-reviewed Journal of Women’s […].

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BUSM Researchers Gain Insight into Key Genetic Driver of Alzheimer’s

BioSpace

The Boston University School of Medicine has unraveled details about a known genetic component for the development of Alzheimer’s disease (AD): the APOE4 gene.

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A new light in rice flowering

Scienmag

Light affects most organisms. In plants, many behaviors and functions are determined by the length of light and dark cycles, including flowering. In the most recent publication of The Proceedings of the National Academy of Sciences (PNAS), the team of researchers that brings together the Instituto de Tecnologia QuĂ­mica e BiolĂłgica AntĂłnio Xavier da Universidade […].

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Serious Safety Signal Slows Sarepta’s MOMENTUM in DMD Trial

BioSpace

Sarepta announced that the FDA has put the Phase II trial for its SRP-5051 (vesleteplirsen) for the treatment of patients with DMD on clinical hold following a serious safety signal.

Trials 83
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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.