Mon.Jul 04, 2022

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10 clinical trials to watch in the second half of 2022

Bio Pharma Dive

The biotech industry's downturn accelerated in the first half of the year. Important study readouts for Eisai, Gilead, Merck and Seagen, among others, could determine whether the slump will endure.

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GSK acquires US-based Sierra Oncology for $1.9bn

Pharmaceutical Technology

GlaxoSmithKline (GSK) has completed the acquisition of all outstanding shares of US-based Sierra Oncology in a deal totalling $1.9bn (£1.6bn), in cash. In April this year, GSK entered an agreement for the acquisition of Sierra Oncology for $55 per share. The conclusion of the deal comes after the shareholders of Sierra Oncology approved the takeover on 29 June this year.

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Partners come on board GSK’s plan for Stevenage life science hub

pharmaphorum

GSK’s recently-unveiled plan to develop a bioscience cluster close to its main R&D site in Stevenage, UK, has moved closer to fruition, now that the first partners have joined the initiative. The asset management arm of Swiss back UBS has formed a joint venture with property developer Reef Group that will develop the 33-acre campus in Stevenage, Hertfordshire.

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Brii Bio acquires Vir’s antibody rights for Hepatitis B in Greater China

Pharmaceutical Technology

Brii Biosciences (Brii Bio) has exercised an option for the acquisition of exclusive development and marketing rights for Vir Biotechnology’s investigational antibody, VIR-3434, for Hepatitis B in Greater China, under a partnership agreement. Following the option exercise, Vir will receive the option exercise fee, regulatory and commercial milestone payments as well as tiered royalties on net product sales from Brii Bio.

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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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Medical Informatics and Rare Disease: a bridge between two worlds

pharmaphorum

Today’s rare disease landscape comprises of around 7,000 different diseases. With a broad and diverse range of symptoms and severities impacting patients around the world, connecting these individuals with the information and expertise needed to achieve the correct diagnosis can be extremely lengthy and pose a significant barrier to treatment. “As the severity, progress, and treatment potential of rare diseases varies from patient to patient, each condition is going to need to be addressed diffe

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Oxford Biomedica, AstraZeneca enter new deal for Covid-19 vaccine

Pharmaceutical Technology

Oxford Biomedica has entered a new three-year Master Services & Development Agreement to potentially manufacture AstraZeneca UK’s Covid-19 vaccines in the future. The latest deal is an extension of an original Master Supply and Development Agreement signed by the parties in September 2020. Under the initial deal, the production of Covid-19 vaccines at the Oxbox facility of Oxford Biomedica is anticipated to conclude in the last quarter of this year.

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US pharma industry IT recruitment activity drops 3.0% in June 2022

Pharmaceutical Technology

The US’s pharma industry registered a 3.0% drop in IT hiring activity in June 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The industry’s overall hiring is decreased by 5.96% in June 2022 when compared with May 2022. Out of the pharma industry’s total hiring activity, IT jobs claimed a 1.92% share in June 2022, recording an increase of 0.05% over the last three-month average share.

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FDA Clears Vertex to Continue Dosing in Diabetes Cell Therapy Trial

BioSpace

The FDA lifted its clinical hold on Vertex Pharmaceuticals' Phase I/II clinical trial of VX-880, a pancreatic islet cell replacement therapy for people with Type I Diabetes (TID).

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AstraZeneca’s IT hiring activity declines 12.3% in June 2022

Pharmaceutical Technology

UK-based company AstraZeneca’s IT hiring declined 12.3% in June 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity declined by 9.51% in June 2022 when compared with May 2022. IT jobs claimed an 8.11% share in the company’s total hiring activity in June 2022, and recorded a 0.16% growth over the last three-month average share.

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COVID-19 vaccine negotiations: EU watchdog questions Commission’s stance over text messages

BioPharma Reporter

The EU Ombudsman calls the EC's defense of its right not to keep records of text messages between its president and the Pfizer CEO linked to COVID-19 vaccine contract talks as âproblematicâ.

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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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Bayer’s IT hiring activity declines 8.0% in June 2022

Pharmaceutical Technology

Germany-based company Bayer’s IT hiring declined 8.0% in June 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity declined by 10.56% in June 2022 when compared with May 2022. IT jobs claimed a 6.24% share in the company’s total hiring activity in June 2022, and recorded a 0.43% growth over the last three-month average share.

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Fast and facile synthesis of antibacterial amino acid Schiff base copper complexes

Scienmag

Ever since their development in the late 19th century, Schiff bases have been a popular group of organic compounds, owing to their wide variety of desirable properties. The presence of both nitrogen and oxygen in their structure makes them versatile molecules with an array of applications, ranging from dyes and catalysts to environmental sensors and […].

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Johnson & Johnson’s IT hiring activity rises 57.2% in June 2022

Pharmaceutical Technology

US-based company Johnson & Johnson’s IT hiring rose 57.2% in June 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity increased by 46.7% in June 2022 when compared with May 2022. IT jobs claimed a 4.3% share in the company’s total hiring activity in June 2022, and recorded a 0.49% growth over the last three-month average share.

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Beyond Animal Testing: How AI is Increasing the Odds in Drug Development

BioSpace

Quris has developed an alternative to testing on animal models, and each one is smaller than the head of a pin. It holds the potential to increase the currently terrible odds in drug development.

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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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F. Hoffmann-La Roche’s IT hiring activity declines 16.3% in June 2022

Pharmaceutical Technology

Switzerland-based company F. Hoffmann-La Roche’s IT hiring declined 16.3% in June 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity declined by 11.52% in June 2022 when compared with May 2022. IT jobs claimed an 8.21% share in the company’s total hiring activity in June 2022, and recorded a 1.41% decline over the last three-month average share.

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Life Sciences Industry Emphasizes Growth, Purpose in Fight for Talent

BioSpace

According to a recent BioSpace report, the top three motivators for employees to look for a new job are growth opportunities, greater compensation and the desire for a new challenge.

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MerckInc’s IT hiring activity declines 1.2% in June 2022

Pharmaceutical Technology

US-based company MerckInc’s IT hiring declined 1.2% in June 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity declined by 13.1% in June 2022 when compared with May 2022. IT jobs claimed a 5.91% share in the company’s total hiring activity in June 2022, and recorded a 0.71% growth over the last three-month average share.

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After coeliac fail, 9 Meters plots phase 3 in short bowel syndrome

pharmaphorum

Two weeks after reporting disappointing results for its lead coeliac disease therapy, 9 Meters Biopharma will draw some comfort from a mid-stage trial of its candidate for short bowel syndrome (SBS), although its share price remains under pressure. Interim results of the VIBRANT study of vurolenatide have identified a suitable dosing regimen for the drug to take forward into phase 3, with preliminary evidence of efficacy and a favourable safety profile, said the North Carolina biotech. 9 Meters

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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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Cloud hiring levels in the pharmaceutical industry rose in June 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for cloud related positions rose in June 2022 compared with the equivalent month last year, with 44.8% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 40.2% of companies who were hiring for cloud related jobs a year ago but a decrease compared to the figure of 47.1% in May 2022.

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A novel therapy using unique thermogel prevents retinal scarring

Scienmag

SINGAPORE – Singapore scientists have developed a bio-functional thermogel, a type of synthetic polymer, to prevent retinal scarring caused by failed retinal detachment repair surgery. Proliferative vitreoretinopathy (PVR) occurs when the retinal scarring prevents the retina from healing and falling back into place, and accounts for more than 75 per cent of failed retinal detachment […].

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Spain’s pharma industry IT recruitment activity drops 25.5% in June 2022

Pharmaceutical Technology

Spain’s pharma industry registered a 25.5% drop in IT hiring activity in June 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The industry’s overall hiring is decreased by 7.41% in June 2022 when compared with May 2022. Out of the pharma industry’s total hiring activity, IT jobs claimed a 7.72% share in June 2022, recording a decrease of 3.34% over the last three-month average share.

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Activists Call for Over-the-Counter Access to Abortion Meds

BioSpace

Following the Supreme Court’s decision to overturn Roe v. Wade, abortion rights activists are calling for the FDA to consider making abortion medication Mifeprex an over-the-counter option for patients.

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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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UK pharma industry IT recruitment activity drops 4.9% in June 2022

Pharmaceutical Technology

The UK’s pharma industry registered a 4.9% drop in IT hiring activity in June 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The industry’s overall hiring is decreased by 3.02% in June 2022 when compared with May 2022. Out of the pharma industry’s total hiring activity, IT jobs claimed a 3.85% share in June 2022, recording a decrease of 0.22% over the last three-month average share.

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Study explores coevolution of mammals and their lice

Scienmag

CHAMPAIGN, Ill. — According to a new study, the first louse to take up residence on a mammalian host likely started out as a parasite of birds. That host-jumping event tens of millions of years ago began the long association between mammals and lice, setting the stage for their coevolution and offering more opportunities for […].

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Seagen, ANeuroTech Start July with a Clinical Bang

BioSpace

Seagen announced positive data from its Phase II trial in colorectal cancer, and the FDA provided positive feedback supporting a Phase IIIb trial for ANeuroTech’s MDD drug.

Trials 89
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Eavesdropping on whales in the high Arctic

Scienmag

Whales are huge, but they live in an even larger environment — the world’s oceans. Researchers use a range of tools to study their whereabouts, including satellite tracking, aerial surveys, sightings and deploying individual hydrophones to listen for their calls.But now, for the first time ever, researchers have succeeded in passively listening to whales — […].

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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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FDA Has Ways to Go to Keep Pace with 2020/21 Approvals

BioSpace

As the calendar pages continue to turn, the FDA has a slew of novel drugs awaiting approval, several of which are likely to become game-changers for patients and key assets for companies.

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Researchers propose a new live-attenuated influenza A vaccine approach

Scienmag

A promising strategy to reduce the impact of viral infectious diseases, such as influenza, is the use of attenuated, live viruses as vaccines. Credit: SI Longlong A promising strategy to reduce the impact of viral infectious diseases, such as influenza, is the use of attenuated, live viruses as vaccines. However, the usefulness of traditional live-attenuated […].

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Biopharma Investment in China is Thriving Amid U.S. Downturn

BioSpace

Many healthcare, pharmaceutical and biotech companies continue to place their bets on China, bringing fresh rounds of investments to and forging new partnerships with local firms.

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Probiotics don’t improve poor vaginal health

Scienmag

4 July 2022: Pregnancy chances in IVF can be affected by many factors including the type of bacteria which naturally colonise the reproductive tract. ‘Good’ bacteria in the form of probiotics are of increasing interest in treating women with an imbalance in vaginal microbiota. Now, a new study has concluded that probiotics do not improve […].

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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.