Tue.May 03, 2022

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Biogen CEO to step down as company pulls back from Alzheimer's drug

Bio Pharma Dive

Michel Vounatsos, Biogen's CEO since 2017, will be replaced as the company "substantially" eliminates the commercial workforce around Aduhelm, which has generated paltry sales in the face of resistance from insurers and doctors.

Doctors 333
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Biogen: It’s a cruel business world

World of DTC Marketing

Bio­gen an­nounced that CEO Michel Vounatsos is be­ing re­placed as the big biotech un­der­goes a re­struc­tur­ing of the pipeline. It’s long overdue but kind of like putting smoke detectors in a house that has burnt down. From the beginning, Aduhelm was doomed to fail. There was outrageous pricing along with data that, at best, was highly questionable.

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Pfizer cleared to restart hemophilia gene therapy trial

Bio Pharma Dive

While a voluntary pause in dosing new patients will remain in place, the FDA's decision puts the study back on track to deliver data in 2023.

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Oracle co-founder Larry Ellison leads $21.5m round for Imagene AI

pharmaphorum

Israeli cancer diagnosis startup Imagene AI has raised $21.5 million in first-round financing for its cancer diagnosis platform based digitised imaging of biopsy samples. The Series A – led by Oracle co-founder Larry Ellison and fellow investors Dr David Ahus and Zebra Medical Vision founder Eyal Gura – includes $3 million in seed funding from venture capital firm Blumberg Capital.

Genome 137
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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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How Whipnotic is Revolutionizing Whipped Cream

XTalks

Whipnotic is putting a new twist on whipped cream, using its patented technology to dispense a creamy whipped topping with flavor-infused swirls and all-natural colors. The New York-based startup delivers an entirely reimagined multi-sensory whipped cream experience, revolutionizing the relatively unchanged whipped cream market. . Whipnotic is the first swirled whipped cream that uses its patented technology to dispense an all-natural color and infused swirl with the press of the nozzle.

Branding 105
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Studying inequities throughout the pandemic

pharmaphorum

Alain Labrique, PhD, professor and associate chair of research at Johns Hopkins Bloomberg School of Public Health (JHSPH) and chair of the World Health Organization (WHO) digital health guidelines development group discusses with us the ongoing research study, National Pandemic Pulse, he and his colleagues are performing in the US. Using comprehensive, repeat surveys deployed across the US population, Labrique and fellow researchers at JHSPH are measuring disparities and inequities due to COVID

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Hidden benefit: Facemasks may reduce severity of COVID-19 and pressure on health systems, researchers find

Scienmag

HAMILTON, May 4, 2022 — McMaster University researchers who study the dynamics of infectious disease transmission have investigated the population-level consequences of a potentially significant––and unobvious––benefit of wearing masks. Credit: McMaster University, Hamilton, Ontario, Canada HAMILTON, May 4, 2022 — McMaster University researchers who study the dynamics of infectious disease transmission have investigated the population-level consequences of […].

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Idorsia is first to EU market with orexin insomnia drug

pharmaphorum

Idorsia has become the first drugmaker in the EU to claim approval for a drug for chronic insomnia in the dual orexin receptor antagonist class, ahead of rival drugs from Merck & Co and Eisai. The new drug – Quviviq (daridorexant) – has been approved by the European Commission for adults who have been suffering insomnia for at least three months and are experiencing “considerable impact” on daytime functioning, according to the Swiss pharma company.

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Physicists develop ideal testing conditions of solar cells for space applications

Scienmag

Researchers at the University of Oklahoma, with the National Renewable Energy Laboratory, the University of North Texas, the NASA Glenn Research Center and several collaborators within the space power community, have recently published a paper in the journal Joule that describes the optimal conditions for testing perovskite solar cells for space. Credit: Image provided by […].

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Byondis and Medac link up to commercialise trastuzumab duocarmazine

Pharma Times

Byondis and Medac have entered into a license and collaboration agreement for form of targeted chemotherapy

Licensing 112
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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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Experiments measure freezing point of extraterrestrial oceans to aid search for life

Scienmag

Researchers from the University of Washington and the University of California, Berkeley have conducted experiments that measured the physical limits for the existence of liquid water in icy extraterrestrial worlds. This blend of geoscience and engineering was done to aid in the search for extraterrestrial life and the upcoming robotic exploration of oceans on moons […].

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Deadly Venom From Spiders and Snakes May Also Cure What Ails You

NY Times

Efforts to tease apart the vast swarm of proteins in venom — a field called venomics — have burgeoned in recent years, leading to important drug discoveries.

Protein 90
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Study develops framework for forecasting contribution of snowpack to flood risk during winter storms

Scienmag

Reno, Nev. (May 3, 2022) – In the Sierra Nevada, midwinter “rain-on-snow” events occur when rain falls onto existing snowpack and have resulted in some of the region’s biggest and most damaging floods. Rain-on-snow events are projected to increase in size and frequency in the coming years, but little guidance exists for water resource managers […].

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Idorsia’s Quviviq approved for adults with chronic insomnia disorder

Pharma Times

The EC’s decision on the insomnia treatment was supported by phase 3 trial results

Trials 109
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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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NAU graduate student receives national science fellowship from Dept. of Energy to study future of soils

Scienmag

Northern Arizona University graduate student Victoria Monsaint-Queeney has won a fellowship from the U.S. Department of Energy (DOE) to work in one of its national labs and study the future of soil in a warmer world. Monsaint-Queeney, of the Center for Ecosystem Science and Society (Ecoss) at NAU, is one of 80 graduate students representing […].

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DCI’s Top 15 Specialty Pharmacies of 2021—And Three Factors That Will Reshape 2022

Drug Channels

In Drug Channels Institute’s list of the top 15 pharmacies of 2021 , we show that central-fill, mail pharmacies operated by large PBMs and health insurers have displaced retail chains as the largest prescription drug dispensers by revenues. To complement that broader ranking, we present below our exclusive and updated list of the top 15 pharmacies based on specialty drug dispensing revenues in 2021.

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For stroke survivors, modified cardiac rehabilitation can reduce the chances of death by 76%

Scienmag

Philadelphia, May 3, 2022 — Survivors of serious stroke can reduce their chances of dying within the year by 76% if they complete a modified cardiac rehabilitation program that includes medically supervised exercise, prescribed therapy, and physician follow-up, according to new research published in the Journal of Stroke & Cerebrovascular Diseases, published by Elsevier.

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Fifth scientist convicted in GSK trade secrets case

pharmaphorum

A scientist working in Switzerland has become the fifth person to be convicted of attempting to steal trade secrets from pharmaceutical group GlaxoSmithKline in a case that stretched back several years. Gongda Xue (52), a Chinese citizen formerly working at the Friedrich Miescher Institute for Biomedical Research in Switzerland, has been found guilty of conspiracy to steal trade secrets in relation to medicines under development at GSK between January 2010 and January 2016.

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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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Studying wealth inequality in animals can reveal clues about how their societies evolved

Scienmag

Wealth inequality is a research topic typically reserved for humans. Now, research from the Max Planck Institute of Animal Behavior and the University of Nebraska-Lincoln suggests that studying wealth inequality in animals can help shed light on social evolution. Adapting approaches from the study of wealth inequality in humans, the researchers show how wealth—in the […].

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Gilead dives deeper into NK cell therapies with Dragonfly deal

pharmaphorum

Gilead Sciences has made another foray into the natural killer (NK) cell category, paying $300 million upfront to access Dragonfly Therapeutics’ TriNKET platform to find therapies for cancer and inflammatory diseases. The deal initially focuses on preclinical-stage immunotherapy DF-7001 which targets 5T4, a protein found on cancer cells and stromal cells that is though to drive growth of various solid tumours, including non-small-cell lung cancer (NSCLC), breast cancer, pancreatic cancer a

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Seashell-inspired Sandia shield protects materials in hostile environments

Scienmag

ALBUQUERQUE, N.M. — Word of an extraordinarily inexpensive material, lightweight enough to protect satellites against debris in the cold of outer space, cohesive enough to strengthen the walls of pressurized vessels experiencing average conditions on Earth and yet heat-resistant enough at 1,500 degrees Celsius or 2,732 degrees Fahrenheit to shield instruments against flying debris, raises […].

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New patent expiration for Baxter Hlthcare drug NEXTERONE

Drug Patent Watch

Annual Drug Patent Expirations for NEXTERONE Nexterone is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from two suppliers. There are two patents…. The post New patent expiration for Baxter Hlthcare drug NEXTERONE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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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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New technology offers fighting chance against grapevine killer

Scienmag

Scientists at UC Riverside have a shot at eradicating a deadly threat to vineyards posed by the glassy-winged sharpshooter, just as its resistance to insecticide has been growing. Credit: University of California Scientists at UC Riverside have a shot at eradicating a deadly threat to vineyards posed by the glassy-winged sharpshooter, just as its resistance […].

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Is It News? Is It Promotion? OPDP’s Latest Letter Shines a Light on Native Advertising

FDA Law Blog

By Dara Katcher Levy — A few weeks back, OPDP issued its second Untitled Letter of 2022 (third letter in 2022 overall) to Bausch Healthcare alleging violative DTC and HCP promotional communications for Duobrii (halobetasol priopionate and tazarotene) lotion. Of interest (to me) is the DTC communication cited where OPDP, again, focuses on a video and alleges false or misleading representations regarding risks and efficacy.

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American Geriatrics Society opposes policies that discriminate against LGBTQ+ individuals

Scienmag

New York (May 3, 2022)?—The American Geriatrics Society (AGS) stands against discrimination, harassment, prejudice, systemic injustice, and violence targeting any individual for their identity. We have long called for healthcare policies that require equal treatment for LGBTQ+ individuals, regardless of age, and for recognition of the preferred name and gender identity of transgender individuals, regardless of legal or biological […].

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Astorg to acquire CordenPharma from ICIG

BioPharma Reporter

Astorg will acquire CDMO CordenPharma from ICIG: noting strong organic growth for the CDMO thanks to its position in fast-growing drug modalities such as mRNA vaccines, peptides and high-potency compounds notably for oncology therapeutics.

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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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Rutgers expert creates free comment moderation software for YouTube

Scienmag

As an expert in building a safer and fairer internet, Rutgers Assistant Professor Shagun Jhaver long suspected that digital content creators from minority groups suffered disproportionate online harassment. But when he heard about a 35-year-old Brazilian YouTuber who suffered a nervous breakdown and was hospitalized after a barrage of digital hate, he decided to do […].

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4th Annual Cell Engager Summit | May 24-26 | Boston, MA

pharmaphorum

With TCEs being studied in both hematological and solid tumors (39 and 34 trials respectively), there are now more than one hundred projects in the preclinical stage. Early clinical outcomes and novel TCE design modifications have fueled the development and clinical advancement of over 65 bispecific T-cell engagers (TCEs), which are presently in Phase I and Phase II investigations since the Cell Engager Series began.

Trials 52
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Green roofs are worth the cost for urban residents

Scienmag

URBANA, Ill. ­– Plant-covered roofs have become a regular sight in Portland, Oregon. The city is a leader in incorporating green infrastructure for stormwater management, including free street trees, rebates for small residential housing footprints, and green roofs. Credit: Noelwah Netusil. URBANA, Ill. ­– Plant-covered roofs have become a regular sight in Portland, Oregon.

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Is Blue Ocean Strategy The Silver Bullet For Emerging Teleradiology Players to Achieve A Breakthrough In This Highly Competitive Market?

Roots Analysis

Blue ocean strategy, a concept first introduced in 2004, by W Chan Kim, and Renee Mauborgne in their bestselling book of the same name, talks about how to achieve a breakthrough in a highly saturated market by focusing on creating a new uncontested market. Blue ocean strategy is a systematic approach that helps emerging service providers to create a new demand, rather than competing for an already existing demand.

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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.