Thu.May 20, 2021

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Off-the-shelf CAR-T, a Tagrisso rival and the next breast cancer drugs: a look ahead at ASCO

Bio Pharma Dive

Dozens of companies have released abstracts ahead of the American Society of Clinical Oncology's meeting next month. Here are three storylines to watch.

Drugs 278
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Pharmaceutical Development and Medical Research Supply: 5 Things You Should Know

Pharma Mirror

For researchers, the challenges are endless and the journey is anything but easy and straightforward. Every year, the pharmaceutical industry of the U.K alone plays a crucial part in developing new drugs that deliver numerous health benefits. Many aim to resolve critical diseases that threaten mankind. A vast majority of these drugs are expensive and there is no doubt what financial strain they put on the ever-increasing healthcare costs of the federal government as well as the private sector.

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In the midst of a 'strategic shift,' Voyager loses CEO and R&D head

Bio Pharma Dive

The shake-ups come as the biotech prepares to invest more in its technology and also begin human testing for one of its most advanced gene therapies.

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aptaTargets’ First-in-Human Data Shows Efficacy of Aptamers in Stroke

BioSpace

Madrid-based aptaTargets S.L. announced data from its first-in-human trial using its ApTOLL aptamer to protect patients against the deleterious effects of acute ischemic stroke.

Trials 120
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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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Pfizer, BioNTech to send EU up to 1.8B coronavirus vaccine doses

Bio Pharma Dive

The deal, which the companies and the bloc have been negotiating for weeks, will significantly expand on the current contract for 600 million shots.

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Annovis Bio Shows Alzheimer’s Reversal in Humans in Phase II Study

BioSpace

Preliminary data from Annovis Bio’s Phase II study of ANVS401 shows significant cognitive improvements in Alzheimer’s patients after only one month of treatment.

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More Trending

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First-of-its-kind flower smells like dead insects to imprison ‘coffin flies’

Scienmag

First plant found to deceive pollinators by mimicking decomposing insects Credit: Credit: T. Rupp, B. Oelschlägel, K. Rabitsch et al. The plant Aristolochia microstoma uses a unique trick: its flowers emit a fetid-musty scent that seems to mimic the smell of decomposing insects. Flies from the genus Megaselia (family Phoridae) likely get attracted to this […].

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EMA, MHRA to review Vertex' Kaftrio for children with CF

Pharma Times

If approved, up to 2,000 children with CF would be eligible for treatment with the drug

Drugs 141
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Protalix to propose virtual inspection to clear barrier to FDA approval

BioPharma Reporter

Protalix BioTherapeutics is planning to propose a virtual or record review inspection to clear the barrier to approval of its Chiesi Farmaceutici-partnered Fabry disease treatment.

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Thin is now in to turn terahertz polarization

Scienmag

Rice lab’s discovery of ‘magic angle’ builds on its ultrathin, highly aligned nanotube films Credit: Kono Laboratory/Rice University HOUSTON – (May 20, 2021) – It’s always good when your hard work reflects well on you. With the discovery of the giant polarization rotation of light, that is literally so. The ultrathin, highly aligned carbon nanotube […].

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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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Thermo Fisher and University of California look to cut costs and speed up adoption of cell therapies

BioPharma Reporter

Thermo Fisher Scientific Inc and the University of California, San Francisco (UCSF) have formed a alliance to accelerate the development and manufacturing of cell-based therapies.

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NICE rejects J&J’s prostate cancer drug Erleada in initial guidance

pharmaphorum

NICE has rejected Johnson & Johnson’s oral prostate cancer drug Erleada (apalutamide) in patients with hormone-relapsed or hormone sensitive disease in first draft guidance. The cost-effectiveness body is assessing Erleada , plus androgen deprivation therapy (ADT), for prostate cancer in adults who have hormone-relapsed non-metastatic disease at high risk of metastasising and hormone-sensitive metastatic disease.

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Can Hootsuite like interface tackle data management challenges in ADC manufacturing?

BioPharma Reporter

Data management in antibody drug conjugate (ADC) manufacturing is challenging says ADC/Labs, which is trying to help scientists in the field get around such obstacles.

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Innovating power generation where ‘a river runs through it’

Scienmag

Lehigh University mechanical engineering and mechanics professor Keith Moored partners on multi-institutional hydrofoil turbine project that could help generate cleaner, more cost-effective energy for cities and rural communities alike Credit: Figure courtesy of Keith Moored/Lehigh University Hydroelectric power provides an alternative to fossil fuels, but not all generation methods are equally clean or economically viable. […].

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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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New BD plant set for Spain aims to meet growing demand for PFS

BioPharma Reporter

Becton, Dickinson and Company (BD) is to build a new plant in Zaragoza, Spain, with an investment of â165m (US$200m). The site will produce glass pre-filled syringes and plastic components.

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Motif FoodWorks’ New Technology Makes Plant-Based Cheese Stretch and Melt

XTalks

Motif FoodWorks has found a way to make plant-based cheese melt and stretch mimicking real dairy cheese. Additionally, they also improved the texture, taste and nutrient profile of plant-based meat using new technology. The company is on a mission to make plant-based food taste better and provide consumers with more nutritional value in these alternatives than what has previously been available.

Protein 98
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NICE turns down Janssen's Erleada

Pharma Times

Cost-effectiveness estimates have fallen above the threshold because of uncertain trial evidence

Trials 127
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Novel immune checkpoints have applications for cancer, autoimmune disease treatment

Scienmag

UConn researcher Laijun Lai has developed recombinant proteins and antibodies to combat autoimmune diseases and immunosuppression in cancer patients Credit: UConn Photo The immune system is a complex balancing act; if it overreacts or underreacts to foreign molecules, there can be serious health consequences. For cancer patients, tumor progression is often accompanied by immunosuppression, meaning […].

Protein 98
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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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UK booster trial will test value of third COVID jab dose

pharmaphorum

All seven COVID-19 vaccines ordered by the UK government will be tested in a new trial that will see whether they can be used as a third booster dose to protect against new variants. . The Cov-Boost trial is thought to be the first in the world to try to generate data on the value of booster doses in protecting people against COVID-19, and is being led by University Hospital Southampton NHS Foundation Trust.

Trials 97
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Biogen and Ginkgo Bioworks Partner to Redefine AAV-Based Vector Manufacturing

BioSpace

Less than two weeks after Ginkgo Bioworks announced a merger with SPAC Soaring Eagle Acquisition Corp., it announced a collaboration partnership with Biogen.

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Drug development advancements call for skilled workforce

Outsourcing Pharma

According to a leader from Saama Technologies, keeping competitive in the face of technology evolution requires staff that can keep up with the changes.

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Study Indicates Sudden Hearing Loss Not Caused by COVID-19 Vaccines

BioSpace

Researchers at John Hopkins made their preliminary conclusions that the vaccines produced by Pfizer-BioNTech and Moderna did not cause the hearing loss.

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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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Research suggests fly brains make predictions, possibly using universal design principles

Scienmag

Credit: This image was created by authors S.E. Palmer and S. Wang, with 3D fly illustrations from D.A. Drummond. Flies predict changes in their visual environment in order to execute evasive maneuvers, according to new research from the University of Chicago. This reliance on predictive information to guide behavior suggests that prediction may be a […].

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UK trial tests third doses of COVID-19 vaccines

Pharma Times

Initial results trialling seven vaccines will inform plans for Autumn booster programme

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Iovance CEO Resigns Following Regulatory Delay for Melanoma Treatment Lifileucel

BioSpace

Maria Fardis, who has been with the company since 2016, stepped down as CEO following FDA's delay on its Biologics License Application.

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Dr Reddy’s inks deal to bring ‘affordable’ CAR-T therapy to India

BioPharma Reporter

Dr Reddy's Laboratories has secured exclusive rights to Shenzhen Pregene Biopharmaâs anti-BCMA CAR-T cell therapy in India.

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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 calls for better work culture in UK research

pharmaphorum

Create a positive working culture for the UK’s researchers, or watch the country’s standing as an innovation leader crumble, says new report. From the Oxford vaccine to the RECOVERY trial, all eyes have been on the triumph of British science in recent months. But future success is at risk if we do not create a culture that inspires and supports the next generation of researchers, says a report from the Russell Group of universities.

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The when and why of foehn warming in northwestern Japan

Scienmag

First comprehensive climatological study of Japan’s south foehn on the Toyama Plain, conducted by a University of Tsukuba team, revealed that the primary mechanism was dynamic, and that dangerously hot windstorms occurred when a typhoon was present Credit: University of Tsukuba Tsukuba, Japan – Warm, dry wind events blowing down from mountain slopes, called foehns, […].

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Cancer Biotech Janux Therapeutics Files for $100 Million IPO

BioSpace

Janux plans to use the funds raised from the IPO to submit four Investigational New Drug applications to the U.S. FDA in the first half of 2022.

Drugs 84
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Engineering smarter stents

Scienmag

Pitt Engineer Youngjae Chun is part of international group that received $2M to create smarter coronary artery stents Credit: University of Pittsburgh An estimated two million people will need a coronary artery stent every year. A small mesh tube inserted into a narrow or blocked coronary artery, a stent can help ensure blood can continue […].

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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.