Wed.Dec 15, 2021

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Adagio, after bold promises, says antibody drug won't work well against omicron

Bio Pharma Dive

Shares in the biotech, which raised nearly $500 million to develop a treatment able to neutralize a wide range of coronavirus variants, plummeted on news of the disappointing laboratory test results.

Antibody 258
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From patient engagement to patient centricity

pharmaphorum

Words matter. In the pharma industry, “patient engagement” and “patient centricity” might seem like interchangeable bits of corporate jargon. But the difference between them is not like the choice between “agreeing” and “aligning” or “getting together later” and “taking this offline.” Going from the vital activity of patient engagement to the more encompassing state of patient centricity requires big steps in the evolution of new-drug discovery, development, and delivery.

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Lilly ups revenue forecast amid windfall from COVID-19 drugs

Bio Pharma Dive

While the boost from its COVID-19 treatments might be temporary, Lilly believes next year's revenue will hold up thanks to newer products. Also on the horizon are potential approvals for key Alzheimer's and diabetes medicines.

Drugs 152
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Insilico Medicine launches trial for AI-discovered drug

Outsourcing Pharma

The artificial intelligence-driven drug discovery company has dosed its first healthy volunteer in a trial for a candidate to treat idiopathic pulmonary fibrosis.

Trials 141
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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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Sanofi, GSK say COVID vaccine works as booster, but delay key study results

Bio Pharma Dive

The companies said their shot spurred increased immune responses in people who had received one of four widely used vaccines. But they still await long-anticipated data from a large Phase 3 study.

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Now scientists can efficiently screen billions of chemical compounds to find effective new drug therapies

Scienmag

Key takeaways: Credit: USC Dornsife/Yekaterina Kadyshevskaya Key takeaways: New technology called “V-SYNTHES” uncovers more effective drug candidates in a fraction of the time other algorithms need. The method screens virtual chemical components that can be “clicked” together to build a drug. Scientists tested V-SYNTHES on the protein receptors affected by the active ingredient in marijuana, […].

Scientist 130

More Trending

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FDA sets April date for verdict on Incyte’s vitiligo drug

pharmaphorum

Incyte could be a few month away from a second FDA approval for its Opzelura cream that would make it the first medical treatment to re-pigment the skin of people with vitiligo. The FDA has kicked off a priority review of Opzelura (ruxolitinib), a JAK1/JAK2 inhibitor it approved to treat atopic dermatitis in September, and aims to decide on the vitiligo indication by 18 April next year.

Drugs 111
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International Tea Day 2021: Historical Significance and Celebrations

XTalks

Each year on December 15, International Tea Day is celebrated to pay tribute to tea-producing countries, including Bangladesh, Sri Lanka, Nepal and Vietnam, among others. Not to be confused with another International Tea Day on May 21 led by the United Nations’ Food and Agriculture Organization (FAO), this day (December 15) is meant draw attention to the impact that tea trade has on workers and growers.

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BMS’ Orencia gets FDA nod for GvHD thanks to real-world data

pharmaphorum

Bristol-Myers Squibb’s rheumatoid arthritis drug Orencia has been approved by the FDA to prevent graft versus host disease (GvHD), a serious complication of haematopoietic stem cell transplant (HSCT) used to treat leukaemias and other blood cancers. Orencia (abatacept) becomes the first drug to be approved to prevent GvHD , a condition in which donor immune cells attack tissues in the patient receiving an HSCT, commonly known as a bone marrow transplant.

Sales 105
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The heat is on: RIPE researchers show ability to future-proof crops for changing climate

Scienmag

The world is warming quickly with no indication of slowing down. This could be catastrophic for the production of food crops, particularly in already warm areas. Today, research from The University of Illinois and the US Department of Agriculture Agricultural Research Service show that bypassing a photosynthetic glitch common to crops like soybean, rice, and […].

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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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A Video History of Pharmacies and Prescription Prices: From Soda Fountains to GoodRx (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Outlook 2022. Click here to see the original post and comments from August 2021. Charlotte Morabito at CNBC has put together “Why Pharmacies Overcharge,” an entertaining and provocative video on the pharmacy industry and its generic prescription pricing.

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Johannes Gutenberg University Mainz continues coordination of DFG Priority Program in photochemistry in the second funding period

Scienmag

Generation and photochemical utilization of light are two of the most significant fundamental aspects of technological developments that will shape society, politics, science, and the economy in the future. From these can be derived energy-saving concepts in display technology, in the field of solar energy, and in the efficient, light-powered syntheses of value-added products as […].

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Needle free COVID-19 vaccine trialled in UK

Pharma Times

The DIOSvax technology produced by the University of Southampton aims to predict how the virus could mutate.

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Flawed diamonds may provide perfect interface for quantum computers

Scienmag

Flaws in diamonds — atomic defects where carbon is replaced by nitrogen or another element — may offer a close-to-perfect interface for quantum computing, a proposed communications exchange that promises to be faster and more secure than current methods. There’s one major problem, though: these flaws, known as diamond nitrogen-vacancy centers, are controlled via magnetic […].

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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Vaccines still provide ‘significant protection’ against severe COVID-19

Pharma Times

Omicron has been the latest variant to test the effectiveness of COVID-19 vaccines.

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A robotic hand with a gecko-inspired grip

Scienmag

Across a vast array of robotic hands and clamps, there is a common foe: the heirloom tomato. You may have seen a robotic gripper deftly pluck an egg or smoothly palm a basketball – but, unlike human hands, one gripper is unlikely to be able to do both and a key challenge remains hidden in […].

91
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The Definition of “Fully Vaccinated” Needs to Change

Eye on FDA

The COVID-19 pandemic is a rapidly changing landscape. We are long gone from the days of being threatened by a rampant Alpha virus to having several successive variants. It now appears that the very fast-spreading Omicron may become dominant over yesterday’s Delta variant. We now have multiple vaccines – mRNA and traditional in the U.S. and an even greater array outside the U.S.

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Stronger drought resistance of urban vegetation due to higher temperature, CO2 and reduced O3

Scienmag

Globally, plants are reaping the benefits of elevated CO2 levels in the atmosphere by increasing photosynthesis rates, a phenomenon known as the CO2 fertilization effect. However, those benefits might be offset by drier and warmer climates caused by global warming and extreme climate events. Using data collected from urban environments, researchers at Illinois have been […].

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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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Biogen puts $15m into digital health alliance with TheraPanacea

pharmaphorum

Biogen has made a $15 million investment in digital health company TheraPanacea, which will go towards a project to find digital health tools aimed at neurological diseases. There’s another $41 million in possible future payments if the partnership progresses as planned, said Biogen, which is getting exclusive rights to TheraPancea’s machine learning and artificial intelligence platforms in neuroscience.

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$30M gift to establish the Ronald Weiser Center for Prostate Cancer at Michigan Medicine

Scienmag

University of Michigan Regent Ron Weiser has committed $30 million to Michigan Medicine to establish an innovative, patient-focused program in prostate cancer. Credit: Photograph courtesy of Ron Weiser University of Michigan Regent Ron Weiser has committed $30 million to Michigan Medicine to establish an innovative, patient-focused program in prostate cancer.

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Wales is first UK country to fund GW’s Epidyolex for tuberous sclerosis

pharmaphorum

Patients in Wales with a rare disease that causes epilepsy will be the first in the UK to get access to GW Pharma’s cannabis-based medicine Epidyolex, after the drug was cleared for use by the NHS. Epidyolex (cannabidiol) can now be prescribed in Wales as a treatment for seizures associated with tuberous sclerosis complex (TSC), adding to its earlier approvals for Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two other forms of epilepsy.

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ACM recognizes 2021 Distinguished Members for pivotal educational, engineering, and scientific contributions

Scienmag

ACM, the Association for Computing Machinery, has named 63 Distinguished Members for outstanding contributions to the field. All 2021 inductees are longstanding ACM members and were selected by their peers for a range of accomplishments that advance computing as a science and a profession. “Each year we are excited to recognize a new class of […].

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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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Drug development strategy for US FDA

ProRelix Research

­­Drug development strategy for US FDA It takes a staggering 12 years on an average for a drug to travel from the laboratory bench to your bedside! This is coupled […]. The post Drug development strategy for US FDA appeared first on ProRelix Research.

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Are older people more likely to fall for Covid-19 scams than younger people?

Scienmag

Are older people more likely to fall for Covid-19 scams than younger generations? Despite a prevailing mentality that older people are less up to speed on the latest technology and 21st century scams, new research suggests that cautiousness concerning scams does not vary between age groups. In our highly interconnected age, the opportunities to try […].

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Lonza and Doer Biologics in expression system license deal

BioPharma Reporter

Lonza has signed a licensing agreement with clinical-stage biopharma, Zhejiang Doer Biologics, whereby the Hangzhou, China based biopharma company will develop multi-specific biotherapeutics using the Swiss CDMOâs XS Pichia.

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Sugar-coated COVID-19 test strip takes advantage of coronavirus’ sweet tooth

Scienmag

(CHAPEL HILL, N.C. – Dec. 15, 2021) Even those tracking each new discovery about the coronavirus and its variants may not be aware of the virus’ sugar cravings. Credit: University of California San Diego and University of North Carolina at Chapel Hill (CHAPEL HILL, N.C. – Dec. 15, 2021) Even those tracking each new discovery […].

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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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EU gives narrower label to Apellis, Sobi’s PNH drug

pharmaphorum

Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than in the US. The European Commission has cleared the complement C3 inhibitor as Aspaveli for the treatment of adults with PNH who are anaemic, but only after they have been treated for at least three months with a C5 inhibitor.

Drugs 52
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Ramesh Narayanan, MD, named deputy director of Center for Cancer Research at the University of Tennessee Health Science Center

Scienmag

Memphis, Tenn. (December 15, 2021) – Ramesh Narayanan, PhD, MBA, has been named the deputy director of the Center for Cancer Research at the University of Tennessee Health Science Center. Credit: UTHSC Memphis, Tenn. (December 15, 2021) – Ramesh Narayanan, PhD, MBA, has been named the deputy director of the Center for Cancer Research at […].

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Detect’s PCR-Quality At-Home Rapid Covid-19 Test Now Available for Purchase on Detect.com

BioTech 365

Detect’s PCR-Quality At-Home Rapid Covid-19 Test Now Available for Purchase on Detect.com Detect’s PCR-Quality At-Home Rapid Covid-19 Test Now Available for Purchase on Detect.

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Made-in-Ottawa vaccine could help in global fight against COVID-19, including new variants

Scienmag

As the COVID-19 virus continues to spread around the world, a vaccine developed and manufactured at The Ottawa Hospital could provide a unique approach to help control the pandemic. Unlike the COVID-19 vaccines currently approved by the World Health Organization, this new vaccine, dubbed TOH-Vac1, replicates inside the body’s cells. Credit: The Ottawa Hospital As […].

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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.