Tue.Jun 08, 2021

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The FDA approved Biogen's Alzheimer's drug. The company now has years to confirm it works.

Bio Pharma Dive

Two near identical clinical trials of Aduhelm yielded conflicting results, dividing experts and even FDA staff. A third, confirmatory study is required, but Biogen has until 2029 to finish it.

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NICE recommends Tecentriq for first-line NSCLC

Pharma Times

Tecentriq is indicated for adults with metastatic NSCLC if their tumours have PD-L1 expression on at least 50% of tumour cells or 10% of tumour-infiltrating immune cells

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A first-of-its-kind Alzheimer's drug raises heavy questions around who will and won't get it

Bio Pharma Dive

Biogen priced its newly approved medicine Aduhelm at an average cost of $56,000 a year, adding affordability to other barriers patients may face.

Medicine 303
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Novartis’ $2 Million Gene Therapy Zolgensma Shows ‘Remarkable’ Results and Offers Hope for Children with SMA

XTalks

Novartis’ Zolgensma (onasemnogene abeparvovec) gene therapy has been making significant strides as of late, including dosing of the first Spinal Muscular Atrophy (SMA) patient with the treatment in the UK last week. In addition, recent data from a Phase I trial has shown ‘remarkable’ long-term results of the gene therapy in children with the disease.

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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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Country focus: China & APAC’s growing medical needs bring opportunities and challenges

pharmaphorum

Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharma companies, and gives tips for companies navigating this enormous market. Home to over 60% of the world’s population, Asia Pacific (APAC) is not a region the biopharma industry can afford to ignore. Dr Jay Mei, founder and CEO of Antengene, notes that the region has rich innovation resources but also urgent medical needs, leading to both opportunities and uncertainties for the industry.

Marketing 105
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Some People May Have a Gene Variant that Protects Against COVID-19

BioSpace

Newcastle University researchers identified a gene, HLA-DRB1*04:01, which was three times more common in asymptomatic COVID-19 patients than in people with symptomatic disease.

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More Trending

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FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

pharmaphorum

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. That was the damning conclusion of the influential Institute for Clinical and Economic Review (ICER) in the US to yesterday’s approval of Aduhelm (aducanumab), the first new treatment for Alzheimer’s since 2003, which it says has “no evidentiary basis.” Biogen meanwhile has bee

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The Rise of Audio Social Networks – Where Pharma Can Make an Impact

Pharma Marketing Network

Anyone with a smart device has been feeling the grueling effects of social isolation and screen fatigue since the start of the COVID-19 outbreak. Recently, we have witnessed a flood of new “audio-social apps” and audio features on social media platforms, aiming to finds new ways to connect, curb loneliness and cut excessive screen exposure. What are some of these audio-focused platforms and where can pharma play a role?

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NHS patient data upload delayed by two months, says UK

pharmaphorum

The UK’s decision to set back the start date of a new patient data-sharing scheme by two months has been welcomed by privacy campaigners, who have claimed it was being rushed through without sufficient public scrutiny. The centralised database of medical records from 55 million people was due to come online on 1 July, but the start date has now been pushed back to 1 September, according to Minister for Public Health, Primary Care & Prevention Jo Churchill.

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Developing the novel joint technique for copper alloy

Scienmag

This highly contributes to producing the efficient heat removal component for fusion reactor Credit: National Institute for Fusion Science The oxide dispersion strengthened copper alloy (ODS-Cu) is superior in thermal conductivity, electrical conductivity, heat resistance and friction tolerance, etc. Although the ODS-Cu can be expected to have various industrial applications, its joint with other materials […].

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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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Genentech’s Dr. Charles Fuchs: “The Era of Personalized Cancer Care is Here”

BioSpace

BioSpace caught up with Charles Fuchs, M.D., SVP, Global Head of Oncology & Hematology Product Development, Genentech during the ASCO meeting.

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How COVID-19 wreaks havoc on human lungs

Scienmag

New structure shows how virus envelope protein hijacks cell-junction protein and promotes viral spread; findings could speed the design of drugs to block severe effects of COVID-19 Credit: Brookhaven National Laboratory UPTON, NY–Scientists at the U.S. Department of Energy’s (DOE) Brookhaven National Laboratory have published the first detailed atomic-level model of the SARS-CoV-2 “envelope” protein […].

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Flagship’s Valo Health Joins SPAC Craze and Lists on Nasdaq

BioSpace

Valo Health is the latest company to go public through a merger with a special purpose acquisition company. It will merge with Khosla Ventures Acquisition Co. and begin to trade on the Nasdaq.

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Speech droplets drive transmission of SARS-CoV-2

Scienmag

Credit: Dr. Bax A new review published in the Journal of Internal Medicine indicates that unmasked speech in confined spaces poses the greatest risk of spreading SARS-CoV-2, the virus that causes COVID-19, to others. The focus of the review is on the interface between physics and medicine, and it describes how different sized respiratory droplets […].

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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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Michael J. Fox Foundation shares Parkinson’s genetic data

Outsourcing Pharma

In partnership with 23andMe, the group has released a wealth of new de-identified data from the largest-ever Parkinsonâs cohort, to aid future research.

Genetics 105
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UN: More harmful algal bloom impacts emerge amid rising seafood demand, coastal development

Scienmag

UNESCO IOC delivers 1st global assessment report after 7 years’ work by 109 experts in 35 countries, creating a baseline to detect and gauge the changing distribution, frequency, and intensity of harmful — often poisonous — algal blooms Credit: European Space Agency An unprecedented analysis of almost 10,000 Harmful Algal Bloom (HAB) events worldwide over […].

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SMC backs five new medicines for NHS use

Pharma Times

Servier's Lonsurf and AstraZeneca's Calquence are among the positive decisions

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Christopher Chesley, MD, is the 2021 ATS Fellowship in Health Equality award winner

Scienmag

Credit: ATS June 08, 2021 – Christopher Chesley, MD, of the University of Pennsylvania has been named the 2021 ATS Fellowship in Health Equality Award winner for his project “Determining disparities in care quality for patients with acute respiratory failure and sepsis: the role of hospital-wide capacity strain.” As a recipient of the Fellowship, Dr. […].

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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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Bharat Biotech Plans Phase IV Study of Covaxin While Ocugen Eyes US EUA

BioSpace

Bharat will conduct Phase IV studies to check real-world efficacy against the virus, while Ocugen says Covaxin will be a valuable tool in helping to end the COVID-19 pandemic.

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Changing the way we do science

Scienmag

The Neuro is making one of the world’s largest, highly-curated biorepositories of neurological disorders available to the global science community Credit: The Neuro Today, The Neuro (Montreal Neurological Institute-Hospital) is launching the Clinical Biospecimen Imaging and Genetic (C-BIG) Repository, one of the largest biorepositories of neurological disorders in the world, as an open access resource […].

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Let’s Get to Know Mir Imran, CEO and Chief Innovator at Rani Therapeutics

BioSpace

BioSpace recently spoke with Mir Imran, CEO and Chief Innovator at Rani Therapeutics, a company developing and testing a “robotic” pill that delivers biologics orally.

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Cholesterol metabolite induces production of cancer-promoting vesicles

Scienmag

Credit: Photo by L. Brian Stauffer CHAMPAIGN, Ill. — Scientists working to understand the cellular processes linking high cholesterol to breast cancer recurrence and metastasis report that a byproduct of cholesterol metabolism causes some cells to send out cancer-promoting signals to other cells. These signals are packaged in membrane-bound compartments called extracellular vesicles.

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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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Biogen, Eisai’s Alzheimer’s drug aducanumab makes history with US approval

Pharma Times

First new treatment approved for Alzheimer’s disease in over a decade

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Identification of RNA editing profiles and their clinical relevance in lung adenocarcinoma

Scienmag

Credit: ©Science China Press The incidence rate of lung adenocarcinoma (LUAD) is increasing gradually and the mortality is still high. Recent advances in the genomic profile of LUAD have identified a number of driver alterations in specific genes, enabling molecular classification and targeted therapy accordingly. However, only a fraction of LUAD patients with those driver […].

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Wisconsin Pharmacist Who Tampered With Vaccine Gets 3-Year Sentence

NY Times

The pharmacist, Steven R. Brandenburg, believed in conspiracy theories and thought vaccines were dangerous, the authorities said.

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Qorvo provides key enabling tech for identifying, mapping threats from near-earth objects

Scienmag

Credit: NRAO/AUI/NSF, S. Dagnello Qorvo® (Nasdaq: QRVO), a leading provider of innovative radio frequency (RF) solutions that connect the world, today announced its Spatium® solid-state power amplifier (SSPA) technology will play a key role in a new planetary radar experiment using the Green Bank Telescope in West Virginia. Planetary radar is instrumental in characterizing Near-Earth […].

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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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Alzheimer’s Drug Is Bonanza for Biogen, Most Likely at Taxpayer Expense

NY Times

Despite scant evidence that it works, the drug, Aduhelm, is predicted to generate billions of dollars in revenue, much of it from Medicare.

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The buck stops where? UNH research records longest-ever deer distance

Scienmag

Credit: Missouri Department of Conservation DURHAM, N.H.–Why did the deer cross the road? According to research from the University of New Hampshire to keep going and going and going. Researchers have discovered the longest distance ever recorded by an adult male white-tailed deer–300 kilometers, or close to 200 miles, in just over three weeks.

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A Recent Flurry Of Biotech IPOs: Lyell, Atai, Alzamend and More

BioSpace

The last few weeks have seen a flurry of filings for initial public offerings by biotech companies. Here’s a look.

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Food systems offer huge opportunities to cut emissions, study finds

Scienmag

Greenhouse gases from food production are systematically underestimated, researchers say Credit: From Tubiello et al., Environmental Research Letters 2021 A new global analysis says that greenhouse-gas emissions from food systems have long been systematically underestimated–and points to major opportunities to cut them. The authors estimate that activities connected to food production and consumption produced the […].

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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.