Fri.Oct 29, 2021

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FDA clears Pfizer's coronavirus vaccine for young kids, moving US to next stage of rollout

Bio Pharma Dive

The authorization makes the shot available to nearly 28 million kids between the ages of 5 and 11, though a CDC panel next week could hold significant sway over who among them should be vaccinated.

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Petrovax Pharm is taking part in CPhI Worldwide-2021

Pharma Mirror

Petrovax Pharm, the Russian biopharmaceutical company, will participate in CPhI Worldwide-2021 – the international specialized pharmaceutical industry exhibition. This year, it will be held from 9 to 11 November in Italy (Milan) on Fiera Milano territory’s largest exhibition complex. At the exhibition stand, Petrovax Pharm will present its original pharmaceutical products, that are the flagships of the product portfolio – the immunomodulator Polyoxidonium®, the enzyme preparation Lon

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Drug price restraints dropped as Biden prioritizes other measures

Bio Pharma Dive

Despite majority control of Congress, it appears unlikely the Biden administration will be able to pass meaningful pricing reform, though a slimmed-down bill may still be in the works.

Drugs 183
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9 Ways Pharmacists Are Helping the Community

Pharma Mirror

You may not realize it, but your community pharmacist does so much more than fill the prescriptions your primary healthcare provider writes for you. In fact, pharmacists are vital to the health and wellness of the people in the areas they serve on the front line, and they play a key role when it comes to medication adherence. Pharmacists help their communities and, indeed, the medical industry as a whole by administering vaccinations, making drug recommendations, providing access to medical care

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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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Despite strong quarter, some wonder how long Gilead can rely on coronavirus drug

Bio Pharma Dive

While other drugs in Gilead’s arsenal fell short, third quarter revenue from Veklury tripled what analysts had expected, reaching nearly $2 billion.

Drugs 169
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Telstar promotes 360º solutions at CPhI Worldwide-2021

Pharma Mirror

Terrassa (Barcelona). Telstar will be actively participating at CPhI, to be held in Milan, during 9-11th November 2021, promoting its personalized GMP consultancy & engineering reply to the new trends in pharma. The company will be displaying high-tech solutions in design, engineering and construction including complete and integrated turnkey pharmaceutical process production facilities, critical installations, clean rooms, biotechnological plants, critical process facilities and R&D lab

Engineer 130

More Trending

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Patient engagement strategies: the pharmaphorum podcast

pharmaphorum

This episode of the pharmaphorum podcast is the first in an occasional series focused on patient engagement that’s being led by Mark Duman, a clinician, consultant and patient advocate. Here he takes a helicopter view of patient engagement in a discussion with MSD’s European lead for patient innovation Paul Robinson, that’s moderated by pharmaphorum’s former web editor Catherine Longworth.

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New Samsung Bio plant to be ‘partially’ operational by end of 2022

BioPharma Reporter

Construction of Samsung Biologicsâ new facility is on track, with the CDMO saying pre-sales activities are ongoing for Plant 4, as it is known, despite the challenging business environment amid the COVID-19 pandemic.

Sales 97
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Probing into life on Mars: implication from analog sites in Qaidam Basin, northwestern China

Scienmag

Astrobiology is a scientific field that studies the origin,evolution, and distribution of life and habitability in the universe. Mars is the most promising planet for the discovery of extraterrestrial life in the solar system; thus, exploration of Martian life and habitable environment have been a special focus in planetary science. Credit: ©Science China Press Astrobiology […].

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Clinical Researcher of the Year - The Americas 2021 winners announced

Pharma Times

The winners of the 2021 Clinical Researcher of the Year – The Americas have been announced, find out who emerged victorious

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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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A better way to raise chickens for low-intensity, small stakeholders

Scienmag

KNOXVILLE, Tenn. – How can rural producers in Rwanda better produce chicken for both household consumption and profit? University of Tennessee researchers are suggesting a hybrid model for the Rwandan broiler industry, among other improvements, in a new journal article. Credit: UTIA KNOXVILLE, Tenn. – How can rural producers in Rwanda better produce chicken for […].

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Novartis UK awarded Innovation Passport for investigational therapy

Pharma Times

Iptacopan is an investigational, first-in-class, orally administered factor B inhibitor for the alternative pathway of the complement system

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Is it worth trying to sway the most staunch climate deniers?

Scienmag

Thanks to algorithms that learn about social media users’ content preferences, Facebook timelines, Twitter feeds, suggested YouTube videos, and other news streams can look startlingly different from one person’s online account to the next. Media and communication experts often wrestle with how to rein in the forces that further polarize people with different views, especially […].

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Gilead and MSD collab on Trodelvy/Keytruda breast cancer trial

Pharma Times

The companies will evaluate Trodelvy plus Keytruda for the first-line treatment of certain triple-negative breast cancer patients

Trials 100
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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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Three-channel Kondo effect discovered in cubic holmium compound

Scienmag

Tokyo, Japan – A scientist from Tokyo Metropolitan University has applied numerical methods to capture the hallmarks of a quantum phenomenon known as the three-channel Kondo effect in an f-electron system for the first time. Professor Takashi Hotta showed how electrons around a holmium +3 ion interact with conduction electrons and give rise to a […].

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Takeda snaps up GammaDelta Therapeutics

Pharma Times

GammaDelta is focused on research into gamma delta T cells for potential use in immunotherapy, primarily addressing solid tumours

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Innovative chip built by UCPH physicists resolves quantum headache

Scienmag

One of the engineering headaches in the global marathon towards a large functional quantum computer is the control of many basic memory devices – qubits – simultaneously. This is because the control of one qubit is typically negatively affected by simultaneous control pulses applied to another qubit. Now, a pair of young quantum physicists at […].

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AbbVie preps filings after ABBV-951 tops oral Parkinson’s drugs in trial

pharmaphorum

AbbVie has reported that a subcutaneous infusion of Parkinson’s disease candidate ABBV-951 was more effective than standard oral therapy in a phase 3 trial, paving the way for regulatory filings. ABBV-951 is based on foslevodopa and foscarbidopa – delivered via a subcutaneous device once a day – with the aim of providing full 24-hour control of Parkinson’s symptoms that can’t be achieved easily with oral dosing of levodopa and carbidopa.

Trials 78
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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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A scientific competition assesses methods for anomalous diffusion

Scienmag

Since Albert Einstein provided a theoretical foundation for Robert Brown’s observation of the erratic or unpredictable movement of microscopic particles suspended within pollen grains, significant new findings that deviate quite a bit from the laws of Brownian motion have been uncovered in a variety of animate and inanimate systems, from biology to the stock market. […].

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¿Qué vacuna de refuerzo debo elegir?

NY Times

Las autoridades sanitarias de EE. UU. autorizaron la combinación de vacunas en la dosis de refuerzo contra la covid, pero no han indicado cuál es la mejor opción.

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Meanders help the climate

Scienmag

It takes about 8500 years for a grain of sand from the Andes to be washed across the Argentine lowlands into the Río Paraná. The 1200-kilometer journey in the river called Río Bermejo is interrupted by many stops in river floodplains, where the grain is deposited, sometimes over thousands of years, and then washed free […].

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New Intouch Short Film Envisions the End of Plaque Psoriasis

Intouch Solutions

Plaque psoriasis is a chronic autoimmune condition that affects approximately 6.7 million U.S. adults, and almost 80% of patients who have it present with mild to moderate severity. It appears on the skin as patches of thick, red, scaly skin. It’s also painful and itchy, and frankly, something that makes those who have it want to hide themselves away when flare-ups appear.

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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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Low-gravity simulator design offers new avenues for space research and mission training

Scienmag

TALLAHASSEE, Fla. — As humanity continues its exploration of the universe, the low-gravity environment of space presents unusual challenges for scientists and engineers. Credit: Courtesy of Wei Guo/FAMU-FSU College of Engineering TALLAHASSEE, Fla. — As humanity continues its exploration of the universe, the low-gravity environment of space presents unusual challenges for scientists and engineers.

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U.S. Food and Drug Administration Approves VUITY™ (pilocarpine HCI ophthalmic solution) 1.25%, the First and.

The Pharma Data

– Presbyopia, or age-related blurry near vision, is a common, progressive condition that reduces the eye’s ability to focus on near objects, affecting most adults over the age 40 – Phase 3 clinical studies demonstrated VUITY works in as early as 15 minutes and lasts for up to 6 hours, as measured on day 30, to improve near and intermediate vision without impacting distance vision – Allergan, an AbbVie company, continues legacy of eye care innovation with VUITY, a first-of

Drugs 52
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Uncovering how injury to the pancreas impacts cancer formation

Scienmag

The Idea Credit: DelGiorno, et. al. The Idea Pioneering research from scientists at the Vanderbilt University School of Medicine Basic Sciences and the Salk Institute for Biological Studies shows that acinar cells in the pancreas form new cell types to mitigate injury but are then susceptible to cancerous mutations. This research, led by Kathy DelGiorno, […].

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FDA approves Novartis Scemblix® (asciminib), with novel mechanism of action for the treatment of chronic.

The Pharma Data

Scemblix provides much-needed and long-awaited new option for patients with chronic myeloid leukemia (CML) who suffer with intolerance or inadequate response after at least two previous tyrosine kinase inhibitor (TKI) treatments 1 In the pivotal Phase III ASCEMBL trial, Scemblix demonstrated significant and clinically meaningful superiority in major molecular response (MMR) rate vs.

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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.

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Detector advance could lead to cheaper, easier medical scans

Scienmag

Researchers in the U.S. and Japan have demonstrated the first experimental cross-sectional medical image that doesn’t require tomography, a mathematical process used to reconstruct images in CT and PET scans. The work, published Oct. 14 in Nature Photonics, could lead to cheaper, easier and more accurate medical imaging. Credit: Simon Cherry, UC Davis Researchers in […].

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Merck Announces Withdrawal and Refiling under the Hart-Scott-Rodino Act and Extension of Tender Offer to.

The Pharma Data

Merck known as MSD outside the United States and Canada, moment blazoned that it has withdrawn its Premerger Announcement and Report Form under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “ HSR Act”), in connection with Merck’s pending accession of Acceleron PharmaInc. (Nasdaq XLRN). As preliminarily blazoned on October 12, 2021, Merck commenced, through a attachment, Astros Merger Sub,Inc., a cash tender offer to buy all outstanding shares of common stock of Accele

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Drug-like molecule points to novel strategies for cancer therapy

Scienmag

A decade ago, genome sequencing revealed a big surprise: about 50 percent of human cancers are linked to mutations in what are known as epigenetic regulators, which control the activity of genes. Credit: Chris Shinn A decade ago, genome sequencing revealed a big surprise: about 50 percent of human cancers are linked to mutations in […].

Genome 80
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PFIZER AND BIONTECH RECEIVE FIRST U.S. FDA EMERGENCY USE AUTHORIZATION OF A COVID-19 VACCINE IN.

The Pharma Data

PfizerInc. and BioNTech moment blazoned that theU.S. Food and Drug Administration (FDA) has authorized for exigency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 times of age ( also appertained to as 5 to< 12 times). For this age group, the vaccine is to be administered in a two- cure authority of 10-µg boluses given 21 days piecemeal.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.