Sat.Jun 05, 2021 - Fri.Jun 11, 2021

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In historic move, FDA approves a closely watched and controversial Alzheimer's drug

Bio Pharma Dive

With the decision, the agency cleared the way for what many predict will become a lucrative and highly sought-after option — though fierce debate continues over whether the medicine, Biogen's aducanumab, actually benefits patients' daily lives.

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Novo’s obesity drug has serious warnings and barriers to overcome

World of DTC Marketing

SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings. Can diabetes patients really stay adherent to a drug for 63 weeks in which 85% of patients report GI side effects and will insurance cover the cost? The headlines read “FDA approves obesity drug that helped people cut weight 15%” But buyer beware.

Drugs 318
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Niche Nonclinical Studies: Uncommon Routes of Administration and Animal Models

Camargo

Camargo Research Group , Camargo’s managed nonclinical solution, has worked on more than 200 nonclinical programs since its inception in 2005, many of which include rare routes of administrations (ROAs) and use of uncommon animal species. We have collaborated with sponsors on many niche programs that have shone a light on both the creativity and the broad range of specialized capabilities needed for such complex development programs.

Reagent 178
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South African HIV Patient Was a Natural Laboratory for SARS-CoV-2 Mutations

BioSpace

An immunocompromised patient in South Africa became a veritable COVID-19 variant laboratory as the virus mutated more than 30 times in 216 days of her infection, according to recent, not-yet-peer-reviewed research paper published in medRxiv.

Research 145
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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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'The lights are no longer green': Antitrust regulators reassess pharma deals

Bio Pharma Dive

The FTC and its counterparts abroad are rethinking their approach to drugmaker acquisitions. Past scrutiny offers clues where they may look next.

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A sad day for us all as the FDA continues to lose credibility

World of DTC Marketing

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. In the meantime, caregivers are going to put their hope in a drug that doesn’t work and in garbage science with cherry-picked data.

Drugs 207

More Trending

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“Ethno-pharma” Opportunities in India

Pharma Mirror

In the new normal scenario of Healthcare, where the approaches are patient-centric and no longer product-centric, traditional and integrative medicinal practices are rooting to the greater extent so does the ‘Ethno-pharmacy’ At the intersection of social and natural sciences, Ethno-pharmacy is a field that focuses on the traditional medicines (and pharmaceuticals) and the cultural determinants to investigate the possible use/perception of traditional medicines (and also pharmaceutica

Pharmacy 130
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Biogen Alzheimer's approval could open the door for other similar drugs

Bio Pharma Dive

Approval of Aduhelm sets a precedent that could enable some drugs, like Eli Lilly's drug donanemab, to advance quickly and cause other previously sidelined ones to get a second look.

Drugs 336
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Obesity represents a catastrophic failure of government policy, public health, and medicine

World of DTC Marketing

SUMMARY: Obesity has many causes, and while we would like to think the answer is as easy as people exercising more and eating less, it isn’t that simple. There is disagreement whether obesity is really considered a disease or a behavioral risk factor, similar to smoking, alcohol, and substance abuse that may lead to disease. Obesity is a multifactorial disease in which environmental conditions and several genes play an important role in developing this disease.

Medicine 193
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Ensuring accessibility: Crossing the digital divide in healthcare

pharmaphorum

“Rarely does the answer come from the boardroom” – what can user experience teach us about building accessible digital health? No one should be left behind as the world embraces digital healthcare say leading user experience voices. The experts discussed the benefits and merits of co-creation during a session on bridging the digital divide, held during the recent Patient Experience Digital Summit.

Engineer 134
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Telstar addresses the latest trends in aseptic process solutions at Achema Pulse 2021

Pharma Mirror

Terrassa (Barcelona): Telstar will be exhibiting the latest developments in aseptic technology for pharmaceutical production and integrated turnkey engineering & construction services for process facilities at Achema Pulse 2021. The company will be present at the digital flagship event of the global process industries during the whole of June and will be live during 15-16th June.

Engineer 130
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Blood disease treatment from CRISPR, Vertex shows promise in more patients

Bio Pharma Dive

The latest results from the companies' trials give support to hopes that CRISPR gene editing could functionally cure sickle cell disease and beta thalassemia.

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Your HCP marketing just became harder, a lot harder

World of DTC Marketing

Key Points: Trust in the CDC and FDA has decreased dramatically during the COVID-19 pandemic among health care professionals, according to a new WebMD/Medscape poll. Out of nearly 450 U.S. doctors surveyed in the same time period, 77% said their trust in the CDC has decreased and 48% said their trust in the FDA has decreased. Health care professionals have been critical of these agencies’ decisions during the pandemic, with some concerned that their work has been politicized and now wit

Marketing 187
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Trial finds Orion digital therapeutic helps chronic pain sufferers

pharmaphorum

A digital therapeutic aimed at people with chronic lower back pain based on virtual reality (VR) has shown encouraging results in a clinical trial, helping patients manage the fear of movement that can reduce their activity and impede recovery. The therapy uses a VR headset to guide people with chronic pain through a series of cognitive behavioural therapy (CBT) exercises that are designed to help them overcome the fear of movement – also known as kinesiophobia.

Trials 129
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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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5 Ways the Right EPCR Software Can Benefit EMS Organizations

Pharma Mirror

Emergency medical response requires a coordinated effort. It’s a field that burdens people with the task of providing an organized and immediate medical response in an often chaotic and high-pressure environment. To be able to do this in a consistent and timely manner, many emergency medical services (EMS) providers rely on electronic patient care reports (ePCR) solutions. ePCR is critical to the operation of EMS organizations because it allows staff members and response coordinators to stay on

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Vertex stops work on second rare disease drug after study results disappoint

Bio Pharma Dive

The biotech said its drug for alpha-1 antitrypsin deficiency wasn't potent enough to advance into further testing, but plans to move others into clinical trials next year.

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Using the Internet to reach doctors, numbers don’t matter. What you have to say and how you say are more important.

World of DTC Marketing

SUMMARY: Several online providers promise that they can reach physicians with your message, but I would argue that numbers are only important if they can be measured against key brand objectives. Ask your target audience what THEY use and how they use it to understand each platform’s relevance. According to research from HealthLink Dimensions, more than a third of physicians reported using social networks to communicate with their professional peers, and 59% said they see the value in s

Doctor 143
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Amicus' Pompe disease therapy joins early access scheme

Pharma Times

The MHRA has issued an EAMS scientific opinion opening the door to use of cipaglucosidase alfa with miglustat in eligible patients with Pompe disease

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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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Pacira BioSciences, Inc. partners with Ashfield Engage to deliver European commercial infrastructure

Pharma Mirror

Ashfield Engage, part of UDG Healthcare plc, today announced that it has been selected by US-based Pacira BioSciences, Inc. to provide strategic commercialization services for its non-opioid pain management products in select European countries. Pacira has partnered with Ashfield Engage to develop a commercial strategy and deliver outsourced operations in numerous European countries, including the UK, Germany, Sweden, Austria, Netherlands and Finland.

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US bets $1.2B on Merck's last hope for a COVID-19 drug

Bio Pharma Dive

Though most of Merck's COVID-19 efforts have come up short, its antiviral pill could still have a role, as signaled by the U.S. government's sizable financial commitment.

Drugs 312
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Aducanumab Saga Continues as FDA Committee Members Resign Over Approval

BioSpace

David S. Knopman and Joel S. Perlmutter both resigned from the committee after the approval of the drug aducanumab.

Drugs 122
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MHRA approves Venclyxto for newly diagnosed AML

Pharma Times

The approval is based on results from the Phase III VIALE-A study as well as the Phase Ib M14-358 clinical trial

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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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Phesi COVID-19 study indicates obesity a major complicating factor

BioPharma Reporter

The virtual clinical development firmâs analysis of patient profiles reflects obesity is the most significant indicator for severity in those under 40.

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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 310
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Will the H10N3 Avian Flu Strain, Now in Humans, Become the Next Pandemic?

BioSpace

The first human case of a new strain of avian flu was diagnosed in China in late May. Chinese health authorities say there is a low risk of contagion. After China notoriously underreported COVID-19 mortality, can this new assurance be trusted?

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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

Medicine 123
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Keeping clinical trial data safe – handling cybersecurity in a risky world

pharmaphorum

The development of vaccines for COVID-19 has been a masterclass in effective collaboration and applied digitisation in healthcare. However the increased complexity and involvement of different parties, exposes manufacturers to heightened threat levels. Abel Archundia discusses how COVID-19 has highlighted the importance of securing clinical trials against cyber threats.

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Novo keeps price in line with FDA approval of second obesity shot

Bio Pharma Dive

Wegovy, a weekly drug, joins daily Saxenda in the pharma's portfolio, which could soon be under pressure from an experimental Lilly medicine.

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Aduhelm Approval Draws Mixed Reaction, Sparks New Controversy Over Pricing

BioSpace

Not everyone is so confident that Aduhelm will transform the Alzheimer’s drug development landscape.

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New research identifies single biomarker that can indicate underlying neurodegeneration

Pharma Times

Blood test can be used to identify the presence of a protein that can reveal underlying neurodegeneration

Protein 123
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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.