Sat.May 22, 2021 - Fri.May 28, 2021

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Accelerating patient care through digital transformation and decentralized clinical trials

Bio Pharma Dive

The adoption of digital health technologies (DHTs) in the industry continues to pave the way to enable decentralized clinical trials (DCTs).

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470% price increases

World of DTC Marketing

SUMMARY: Sometimes there are just no words to express my outrage. Here is the executive summary of the Government’s report on AbbVie. I’m disgusted, sad , and angry. Mostly I’m angry because this reflects badly on all the good people within our industry who are trying to do great work and help people. Here is the executive summary from the report.

Drugs 180
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Study finds Germany trails Spain and the US in digital health

pharmaphorum

Germany is lagging behind other countries in the adoption of digital health, including Spain and the US, according to a new survey carried out on behalf of drugmaker Fresenius. . The three-country poll found that Spain is way out in front, with over half of people asked responding that digital is already playing a major role in the networking of healthcare facilities, diagnosing illnesses and telemedicine.

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Less is more? New take on machine learning helps us “scale up” phase transitions

Scienmag

Features of large systems yielded from tiny simulations with super-resolution techniques Credit: Tokyo Metropolitan University Tokyo, Japan – Researchers from Tokyo Metropolitan University have enhanced “super-resolution” machine learning techniques to study phase transitions. They identified key features of how large arrays of interacting “particles” behave at different temperatures by simulating tiny arrays before using a […].

Research 141
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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In first, FDA approves KRAS-blocking cancer drug from Amgen

Bio Pharma Dive

For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective.

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CVS Health broadens commitment to improving clinical trial infrastructure

Outsourcing Pharma

The owner of the pharmacy giant has announced plans to partner with various stakeholders in an effort to effect improvements across the trial ecosystem.

More Trending

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Tips for Budgeting Your Own Laboratory Effectively

Pharma Mirror

If you are trying to set up your own laboratory, then you should prepare for a myriad of expenses. Budgeting is a process that is required throughout the running of your lab. It keeps everything in order and ensures the continued efficiency of whatever operation or experiment you are overseeing. Without the proper financial backing, things may quickly fall apart soon after.

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'A hugely consequential decision:' How Biogen's Alzheimer's drug came to face the FDA

Bio Pharma Dive

By June 7, the FDA will decide on whether to approve aducanumab, a decision that could have far-reaching consequences for patients, Biogen and Alzheimer's research.

Drugs 344
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Legend Biotech’s CEO Ying Huang on Cilta-cel’s High PFS in Myeloma Patients

BioSpace

Legend Biotech and its partner Janssen are presenting six abstracts at the ASCO meeting in June detailing ciltacabtagene autoleucel (cilta-cel) CAR-T studies in multiple myeloma.

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BMS’ Opdivo/Yervoy improves long-term survival for melanoma patients

Pharma Times

At six and a half years 49% of patients treated with combination therapy remained alive

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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CPhI Worldwide and Pharmapack Europe given the all-clear by host country governments

Pharma Mirror

The second week of CPhI Discover is open amid news that both the Italian and French governments have confirmed they will allow trade shows to resume – providing formal confirmation for both CPhI Worldwide and Pharmapack Europe. The last year has seen pharma evolve its approach to meeting new partners and existing customers, with wider pools of suppliers now needed, and remote and virtual networking being used to begin conversations much earlier than in the past.

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Moderna, with new results, set to seek vaccine clearance for young teens

Bio Pharma Dive

The biotech's shot was strongly protective against COVID-19 in a study of 12- to 17-year-olds, a finding that could soon make it the second vaccine available for adolescents in the U.S.

Vaccine 331
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UK says Pfizer, AZ COVID-19 vaccines work against Indian variant

pharmaphorum

People who have received two doses of the AstraZeneca or Pfizer/BioNTech COVID-19 vaccines have good protection against the Indian variant of SARS-CoV-2 , according to new UK data. The Pfizer/BioNTech shot provided 88% protection against the B.1.617.2 variant first identified in India and currently gaining ground across the UK and other countries around the world, according to the Public Health England (PHE) study.

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NICE green lights Tremfya to treat active psoriatic arthritis

Pharma Times

Tremfya has already been recommended for NHS use to treat eligible patient with moderate-to-severe plaque psoriasis

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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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Kintor’s Proxalutamide is Bolsonaro’s Newest Answer to Brazil’s COVID-19 Crisis

BioSpace

Proxalutamide, a selective high-affinity silent antagonist of the androgen receptor, is being developed by Chinese biotech, Kintor Pharmaceutical Limited (9939.HK).

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Lyell aims to follow Juno, Sana as Wall Street cools to biotech IPOs

Bio Pharma Dive

The ambitious cell therapy developer, which has already raised nearly $1 billion from investors, will test the IPO market just as the pace and performance of recent biotech offerings have slowed considerably.

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Now what? The future of clinical trials after the pandemic

pharmaphorum

Sheila Rocchio highlights four key areas life sciences must improve on as an industry to drive real change in how clinical trials are conducted. This is definitely a time for the life sciences industry to be proud of our accomplishments. The way in which the industry came together to support the development of the COVID-19 vaccines has shown that it is equally important to determine how to apply the lessons of the last year to the future.

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Biogen partners with Ginkgo Bioworks on gene therapy manufacturing platform

Pharma Times

Collaboration will aim to address challenge of timely and costly AAV-based vector manufacturing

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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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Will COVID-19 Vaccines Need a Booster? CDC Will Meet to Decide

BioSpace

Drug companies have been suggesting that booster shots will be needed. However, it is up to the CDC's recommendation if booster shots are necessary.

Vaccine 120
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J&J's new cancer drug leads a growing pipeline of dual-targeting antibodies

Bio Pharma Dive

Pharma and biotech companies alike see potential in using bispecific antibodies for hard-to-treat cancers like leukemia, myeloma and solid tumors.

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Campaigners challenge NHS England’s latest plan to share patient data

pharmaphorum

Remember the Care.data debacle? Now, a new move by NHS England to move the records of 55 million patients into a database that will be accessible by third-party companies is under fire by privacy campaigners, who claim it could be unlawful. . The new General Practice Data for Planning and Research (GPDPR) service was unveiled earlier this month by NHS Digital, which described it as a way to “improve” the collection of patient information that would allow better planning of healthcare

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Abivax’s ABX464 shows ‘impressive’ efficacy in severe ulcerative colitis patients

Pharma Times

Once-daily oral treatment was well-tolerated and demonstrated a good safety profile in Phase IIb study

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Ocugen Closes in on Seeking EUA for India-Developed COVID-19 Vaccine

BioSpace

Ocugen submitted a “Master File” to the U.S. FDA for COVAXIN, the vaccine that has already received authorization in India for people ages 12 and above.

Vaccine 112
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UniQure moves Huntington's gene therapy to next phase of key trial

Bio Pharma Dive

Safety monitors cleared the company to test a higher dose after reviewing data from 10 patients, providing some hopeful news after recent setbacks for experimental drugs targeting the genetic disease.

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Assessment of SARS-CoV-2 Reinfection 1 Year After Primary Infection in a Population in Lombardy, Italy

JAMA Internal Medicine

This cohort study examines the rate of SARS-CoV-2 reinfection among people in Lombardy, Italy, who previously recovered from COVID-19.

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Opdivo plus Yervoy moves closer to EU approval for dMMR/MSI-H colorectal cancer

Pharma Times

CHMP recommended EU approval for combination treatment in its May decisions

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pfizer explores co-administration of pneumococcal vaccine with COVID-19 booster shot

BioPharma Reporter

Pfizer has enrolled the first subjects in a study exploring the co-administration of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 vaccine.

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Centessa raises $330M in third largest biotech IPO this year

Bio Pharma Dive

The public offering follows just three months after Centessa, created from the merger of 10 Medicxi-backed drug startups, launched with $250 million in venture funding.

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Closing the feedback loop to drive patient experience improvements

pharmaphorum

Is collecting near real time data the key to unlocking improvements in patient experience and national benchmarking? Small things can go a long way in terms of improving patient experience, but healthcare facilities cannot fix what they don’t know is broken. In the first of our series of articles from the Patient Experience: Empathy and Innovation Digital Summit, we look at how uncovering actionable data through simple feedback surveys can boost organisations’ standing on the national stage.

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FDA approves Pfizer, Myovant’s uterine fibroids drug Myfembree

Pharma Times

Once-daily treatment has been approved for the management of heavy menstrual bleeding

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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.