Sat.Mar 27, 2021 - Fri.Apr 02, 2021

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FDA approves first CAR-T cell therapy for multiple myeloma

Bio Pharma Dive

Approval of Bristol Myers Squibb and Bluebird bio's Abecma expands use of CAR-T treatment beyond leukemia and lymphoma.

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Should doctors refuse to treat obese patients?

World of DTC Marketing

IN BRIEF: Doctors are not required to treat obese patients who won’t do anything to lose weight but the problem is more than reminding patients they need to get exercise and drop pounds. One study found that only 50 percent of patients follow the instructions associated with taking their medication, and even fewer implement necessary lifestyle changes suggested by their doctor.

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Pfizer and BioNTech ramp up COVID-19 vaccine production to 2.5 billion doses

BioPharma Reporter

Pfizer and BioNTech expect to expand COVID-19 vaccine manufacturing capacity to up to 2.5 billion doses by the end of 2021, thanks to the optimization of production processes and the recent initiation of production in Marburg, Germany.

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Novartis UK signs digital partnership with Cievert for chronic disease management

Pharma Times

Initiative is aiming to support NHS patient care in rheumatology and dermatology

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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5 FDA approval decisions to watch in the second quarter

Bio Pharma Dive

A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June.

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What’s the call to action on DTC?

World of DTC Marketing

TEASER: What DTC marketers and consumers do as the result of seeing a relevant DTC ad differs by a wide margin. DTC marketers would like to think that patients ask for the advertised drug when visiting their doctor, but that’s largely untrue. Online searches for health information remain brisk, according to Google. Many people are going online for health information as the Internet has become cluttered with misinformation.

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Caribou Biosciences is Armoring Cells to Fight Disease Through CRISPR

BioSpace

The company’s overarching aim is to edit and equip cells with molecular tools, through CRISPR, to eliminate certain cancers.

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A year with COVID-19: The impact of data on pharma marketing

Bio Pharma Dive

Learn how three pharma brands used data to validate and adjust their promotional spend in 2020.

Branding 338
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Personal responsibility in our healthcare

World of DTC Marketing

IN BRIEF: At some point, we need to realize that good health is our personal responsibility. All prescription drugs don’t make us healthy; they just mask a potentially unhealthy lifestyle that eventually will cost patients and our healthcare system a lot of money, time, and pain. Responsibility for health should be a collaborative effort among individuals and the societies in which they live.

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CPhI Discover: connecting global pharma & pre-qualifying partners ahead of in person events

Pharma Mirror

Informa Markets is launching an annual dedicated online platform for pharma in May (17-28th), CPhI Discover – designed to encourage suppliers and customers to source, meet and discover – providing the industry with a new synergistic offering to sit alongside CPhI’s portfolio of in person events. In the last year, the pharma industry has adapted its approach to meeting new partners and existing customers, with wider pools of suppliers now needed, putting greater pressure on resources to find and

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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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Country focus: Hungary carves out a niche in digital pharma

pharmaphorum

AI simulated cell company Turbine is just one of many digital drug discovery firms on the rise in Hungary. We speak to the company’s CEO and co-founder, Szabolcs Nagy, to find out why moving beyond traditional biotech drug development is a good fit for the country’s ecosystem. Hungarian company, Turbine, is taking an alternative approach to the standard biotech drug development model with its AI-based simulated cell technology, which helps the bulk of preclinical drug discovery take place digita

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FDA advisers reassert case against approval of Biogen's Alzheimer's drug

Bio Pharma Dive

In a new editorial, three of the agency's advisers reiterated that they see "no persuasive evidence to support approval of aducanumab at this time.

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Allocating DTC budgets

World of DTC Marketing

I N BRIEF : DTC managers usually have a tough time allocating DTC budgets, but once you layout your brand objectives and better understand your audience, the choices become clearer. Learn everything you can about your audience, such as “where are they online and what are they really looking for in treatment options?” The budgeting process is over, and as a DTC manager, you need to decide how much of your budget goes in each bucket.

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NHS extends ‘COVID-friendly’ at-home cancer care

Pharma Times

Funding for effective, 'less risky' treatments extended until summer 2021

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

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Lilly and GSK/Vir antibody pairing offers resistant COVID-19 hope

pharmaphorum

Two antibodies targeting different parts of the COVID-19 virus spike protein, from Eli Lilly and GlaxoSmithKline/Vir Biotech, can cut viral load dramatically within a week. . The BLAZE-4 trial found that co-administration of Lilly’s bamlanivimab – already granted emergency approval as a COVID-19 treatment – and GSK/Vir’s experimental antibody VIR-7831 reduced virus levels by 70% after seven days compared to placebo in people with mild or moderate COVID-19 symptoms.

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Pfizer vaccine data show durable protection, hint at efficacy against virus variant

Bio Pharma Dive

Updated Phase 3 study results could position Pfizer to file for full approval of its vaccine and might have implications for its plans to develop a booster shot.

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AI algorithm automates analysis of cystic fibrosis scans

Outsourcing Pharma

Artificial intelligence software company Thirona has released PRAGMA-AI, technology that automates and accelerates CT scans in cystic fibrosis analysis.

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GSK agrees to support manufacture of Novavax' COVID-19 vaccine

Pharma Times

British drugmaker will help to produce up to 60 million doses for use in the UK

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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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Germany and Canada restrict AZ vaccine again over blood clot fears

pharmaphorum

Germany and Canada have both slapped restrictions on the AstraZeneca vaccine, recommending its use only in older patients, because of concerns over a link with blood clots. The moves come after the country’s medicines regulator found 31 cases of a rare type of blood clot known as cerebral venous sinus thrombosis (CVST) in people who had received the vaccine produced by AZ.

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A biotech shelves its Huntington's drugs after trial failures

Bio Pharma Dive

Two drugs developed by Wave Life Sciences didn't appear to have an effect on disease-causing proteins, another setback for Huntington's research after disappointing results last week from Roche and Ionis.

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After About 50 Years, the mRNA Revolution is Here

BioSpace

Between the Moderna and Pfizer-BioNTech COVID-19 vaccines, there are two mRNA therapeutics on the market … the only two.

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New research project aims to improve understanding of differing decisions on medicine use

Pharma Times

Review will collate global information to help identify differences between regions

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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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Cytiva diagnostics design lab goes live in China

BioPharma Reporter

Cytiva has opened a new diagnostics design lab in Tonglu, its manufacturing site close to Shanghai in East China, where it has been making filtration products for many years.

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Manufacturing mix-up could blunt supply boost from J&J vaccine

Bio Pharma Dive

One vaccine batch being manufactured for J&J by Emergent Biosolutions failed quality checks, reportedly ruining material sufficient for up to 15 million doses.

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Global Vaccine Passports Edge Closer, Speeding Arrival of the Next “Normal”

BioSpace

Vaccine passports are an interim step that can speed the return of some semblance of normality by allowing the rapidly growing numbers of vaccinated people to travel more easily and to attend typically crowded sporting events, concerts and religious services.

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Positive results for Pfizer/BioNTech’s COVID-19 vaccine in 12-15 year olds

Pharma Times

The vaccine demonstrated 100% efficacy in a Phase III trial in adolescents aged 12 to 15 years old

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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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Akili’s gaming therapy improves attention in ADHD kids

pharmaphorum

Akili has published data backing the efficacy of its childhood attention-deficit hyperactivity disorder (ADHD) video game therapy EndeavorRx in the peer-review journal Nature Digital Medicine. . The results come from the STARS-Adjunct trial, an open-label study of EndeavorRx (AKL-T01) that supported approval of the app and video game combination in the US and Europe last year.

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UniQure says hemophilia gene therapy likely not cause of study volunteer's cancer

Bio Pharma Dive

The determination, made by UniQure and an independent lab, could ease safety concerns spurred by the patient's diagnosis in December.

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Is Electrolyte Beer the Next Big Beverage Trend?

XTalks

There is no shortage of post-workout drinks on the market, including innovative new additions to the category, like high-protein chocolate milk to sports drinks made with upcycled dairy byproducts. But could an electrolyte beer be just the thing to quench consumers’ thirst after a session at the gym? A few breweries in the US are trying to make that a reality with low alcohol by volume (ABV) beers infused with electrolytes and other nutrients.

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How Long Will COVID-19 Vaccines Be Effective? Six Months and Counting

BioSpace

A current Phase III trial of the Pfizer-BioNTech COVID-19 vaccine has confirmed the protection remains high for at least six months after the second dose. In a statement, Pfizer and BioNTech reported the vaccine was 91.3% effective against the disease.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time