Wed.Feb 03, 2021

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Biogen laser-focused on Alzheimer's drug as rest of business falters

Bio Pharma Dive

While the biotech prepares to launch aducanumab, its latest earnings report shows significant hits to top-selling drugs, plus another pipeline failure.

Drugs 343
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The biggest threat to the pharma industry

World of DTC Marketing

SUMMARY: The biggest threat to the pharma industry isn’t the coming tsunami of healthcare changes. It’s reshaping the company to once again focus on patients instead of profits. At the end of last year, I worked with a leading cancer company on a test program that involved an email program. We started with research to uncover the needs and wants of current cancer patients (NSC lung) and caregivers.

Branding 187
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With $588M IPO, Sana leads wave of new biotechs going public

Bio Pharma Dive

Nine other drug developers are set to price initial public offerings this week, extending a record run of financing activity from last year. Sana's is one of the largest in history.

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New analysis backs safety, efficacy of AZ/Oxford COVID-19 jab

Pharma Times

The data show 100% protection against severe disease, hospitalisation and death, greater vaccine efficacy with an inter-dose interval of 12 weeks or more, and the potential for reduced asymptomatic transmission

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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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Jazz Pharma to buy GW Pharma, maker of CBD-based epilepsy drug, for $7.2B

Bio Pharma Dive

The cash-and-stock deal gives Jazz, best known for its sleep disorder drugs, access to Epidiolex, the first prescription cannabidiol medicine approved by the FDA.

Drugs 269
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McKinsey Settles for $573 Million Over Role in Opioid Crisis

NY Times

The consulting firm has reached the agreement with 47 states because of its advice to drugmakers, including Purdue Pharma, the manufacturer of OxyContin.

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UK biotech investment at record levels amid COVID-19

pharmaphorum

New figures have confirmed that the UK’s biotech sector received a massive boost from the COVID-19 pandemic last year, with investment levels soaring to £2.8 billion ($3.8 billion) from a level of £1.3 billion in 2019. That makes 2020 a new record year for the sector, exceeding the previous investment high of £2.2 billion in 2018, according to the latest BioIndustry Association (BIA) and Clarivate report, and represents a 1,000% increase on 2012.

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GSK expands CureVac vaccine partnership, changing course after setbacks

Bio Pharma Dive

The U.K. drugmaker will help CureVac make 100 million doses of its coronavirus vaccine and join in developing a multivalent shot for 2022.

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A Miracle Cure for COVID-19? We’ve Heard That One Before

BioSpace

On the other hand, when dealing with a novel coronavirus, a certain amount of speed and urgency is necessary. Professor Chris Molloy, Chief Executive Officer of the U.K,’s Medicines Discovery Catapult, told BioSpace that real-time data should be considered, with a different lens applied.

Medicine 103
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The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA

Drug Patent Watch

This article was originally published by Ioana Gherghescu and Begoña Delgado-Charro in Pharmaceutics 2021, 13(1) under a Creative Commons Attribution License. Abstract Biosimilar medicines expand the biotherapeutic market and improve…. The post The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA appeared first on DrugPatentWatch - Make Better Decisions.

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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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How the UAE’s COVID-19 Vaccination Strategy Differs from North America’s and Why It Matters

XTalks

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic. Many countries have begun to provide their citizens with the vaccine to accelerate curbing the spread of the novel coronavirus.

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UK patient group warns COVID could limit access to Novartis’ new eye drug

pharmaphorum

NICE has recommended regular NHS funding for Novartis’ long-acting eye drug Beovu (brolucizumab) in England and Wales – but a patient group warned that access could be limited until the pandemic recedes because of disruption to ophthalmology clinics. In final guidance NICE said trials have shown Novartis’ Beovu has similar efficacy in wet advanced macular degeneration (AMD) to rival Eylea (aflibercept) from Bayer/Regeneron and Novartis predecessor Lucentis (ranibizumab).

Drugs 98
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Barilla Acquires Canadian Pasta Company Catelli for $130 Million

XTalks

Italian pasta giant Barilla has finalized the acquisition of Catelli , a Montreal, Canada-based pasta firm in a deal worth around $130 million. Along with Catelli, Barilla has also acquired Lancia and Splendor pasta brands as well as a manufacturing plant in Montreal, Quebec as per the deal signed in October 2020. The acquisition closed late last week on January 29.

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Study finds childhood diet has lifelong impact

Scienmag

Effects of unhealthy food followed young mice into adulthood Credit: UCR Eating too much fat and sugar as a child can alter your microbiome for life, even if you later learn to eat healthier, a new study in mice suggests. The study by UC Riverside researchers is one of the first to show a significant […].

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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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Roche Washes Hands of Mid and Late-Stage Trial Failures

BioSpace

Roche is closing out its fourth-quarter with some house cleaning. The Swiss pharma giant announced in its earnings report that it was terminating studies of several mid- and late-stage assets, including two late-stage breast cancer programs.

Trials 98
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New Allen distinguished investigators tackle questions about metabolism & immune system

Scienmag

Awards announced by The Paul G. Allen Frontiers Group will fund research in health, disease, and technology development all centered on the emerging field of immunometabolism Credit: Katharine Ng, Tropini Lab, University of British Columbia Just like us, immune cells need fuel to do their jobs. Despite the tight links between human health — including […].

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Bryn’s Fear-Free Emergency Epinephrine Solution for Anaphylaxis

BioSpace

Anaphylaxis is a serious and potentially fatal allergy to bee venom, food, and medication, and only 50-60% of the affected population is adequately prepared for an attack. Even less are prepared in severe cases where a second dose is required.

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NICE green light for GSK's Nucala

Pharma Times

Final guidance on the drug's use to treat patients with severe eosinophilic asthma on the NHS has now been published

Drugs 120
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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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Artificial skin brings robots closer to ‘touching’ human lives

Scienmag

Researchers develop low-cost artificial robotic skin with high-performance, vision-guided sensing, opening the doors to large-scale tactile sensing technology Credit: Courtesy: Prof. Van Anh Ho from JAIST Modern-day robots are often required to interact with humans intelligently and efficiently, which can be enabled by providing them the ability to perceive touch.

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UK Plays Mix-n-Match with COVID-19 Vaccines

BioSpace

The University of Oxford in the U.K., with the National Immunisation Schedule Evaluation Consortium, is planning a trial to evaluate the use of first and second doses of different COVID-19 vaccines.

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Fungus that eats fungus could help coffee farmers

Scienmag

Credit: Beyene Zewdie Coffee rust is a parasitic fungus and a big problem for coffee growers around the world. A study in the birthplace of coffee – Ethiopia – shows that another fungus seems to have the capacity to supress the rust outbreaks in this landscape. “Coffee leaf rust is a fungal disease that is […].

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Amgen’s Sales Team Faces Layoffs, Hundreds of Jobs Cut at Headquarters

BioSpace

Amgen is in the process of eliminating hundreds of U.S. jobs, the majority of which are centered on the company’s sales team, according to a recent sales call.

Sales 101
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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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UBC study highlights the best style and fabrics for COVID-19 face masks

Scienmag

Credit: UBC In the race to stop the spread of COVID-19, a three-layer cloth mask that fits well can effectively filter COVID particles, says a group of UBC researchers. After testing several different mask styles and 41 types of fabrics, they found that a mask consisting of two layers of low-thread-count quilting cotton plus a […].

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Biotech In-Demand Job: Regional Sales Manager

BioSpace

Not every biotech job is heavily rooted in science. Some rely on additional skills, like those of communication, organization and more in order to play a crucial role in the industry.

Sales 98
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Aging-US: Screening Alzheimer’s disease by facial complexion using artificial intelligence

Scienmag

This Aging-US study showed that deep learning programs such as Xception have the ability to differentiate the faces of patients with mild dementia from that of patients without dementia. Credit: Correspondence to: Masashi Kameyama email: kame-tky@umin.ac.jp Aging-US published “Screening of Alzheimer’s disease by facial complexion using artificial intelligence” which reported that despite the increasing incidence […].

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FDA Recalls Catheter, Cardiac Devices and Meds Over Safety Issues

BioSpace

From packaging errors and contaminants to serious adverse effects, there are many reasons why products in the life sciences industry get recalled. Here’s a look at some of the latest drug and medical device recalls.

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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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Thanks to machine learning, the future of catalyst research is now!

Scienmag

New study defies conventions and proposes a technology-driven method to identify useful catalyst combinations Credit: JAIST To date, research in the field of combinatorial catalysts has relied on serendipitous discoveries of catalyst combinations. Now, scientists from Japan have streamlined a protocol that combines random sampling, high-throughput experimentation, and data science to identify synergistic combinations of […].

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Technology advancement to ease patient recruitment and engagement

Cloudbyz

Products. Enterprise IT. Project Portfolio Management (PPM). Resource Management. Agile Portfolio Management. IT Business Management (ITBM). Healthcare & Lifesciences. Clinical Trial Management (CTMS). R&D Portfolio Management. Clinical Trial Budget Management. Study Start-up. Patient Recruitment. Electronic Trial Master File (eTMF). Investigator Portal.

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RUDN University mathematicians developed new approach to 5g base stations operation

Scienmag

Credit: RUDN University Mathematicians from RUDN University suggested and tested a new method to assess the productivity of fifth-generation (5G) base stations. The new technology would help get rid of mobile access stations and even out traffic fluctuations. The results of the study were published in the IEEE Conference Publication. Stations of the new 5G […].

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Pfizer Renews Partnership for Next-Gen Approach to Autoimmune Disease

BioSpace

Pfizer struck a collaboration and licensing agreement with Belgium-based Imcyse for a rheumatoid arthritis program, which is based on that company’s Imotope technology.

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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.