October, 2021

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Why natural language processing (NLP) is a critical part of your real world data strategy

Bio Pharma Dive

The barrier to knowledge can be eliminated when pharmaceutical companies use natural language processing to analyze unstructured content.

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Open Source “Wikipedia” for Drug Discovery

Pharma Mirror

By Kambiz Shekdar, Ph.D. Open source drug discovery was proposed in the past in connection with third-world diseases like tuberculosis and malaria, but it is in the context of first-world indications where it is needed most. Despite untold investment by numerous pharmaceutical companies, FDA-approved drugs that target critical brain functions and conditions like anxiety, depression, and sedation continue to present severe and unpredictable side effects, including suicidal ideation.

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The future of healthcare?

World of DTC Marketing

SUMMARY: One definitive trend to emerge from the pandemic is that more people are becoming healthcare consumers. They want healthcare to be easier to access and don’t want to wait for necessary medical tests. This could lead to an evolution in urgent care centers, but it will require disruptive thinking. Urgent care centers aren’t new, but they are evolving to become “total care” in some areas.

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Regulatory Strategy for Combination Devices: Working with the FDA for Program Success

Camargo

As pharmaceutical science and innovation advance, breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents. Combination products can be either two or more active pharmaceutical molecules, combined to address different aspects of a health condition, or the combination of a medical device and a small or large molecule product.

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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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UK COVID-19 patients able to take GP prescribed medicine at home

Pharma Times

The drug acts by inhibiting SARS-CoV-2 from replicating in the human system

Medicine 159
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Pfizer says new data show booster shots of its vaccine are highly protective against Covid.

NY Times

The company said that in a study, boosters cut down the number of breakthrough infections among fully vaccinated people by more than 95 percent.

Vaccine 145

More Trending

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CPhI Worldwide: 9-11 November 2021 in Milan, Italy

Pharma Mirror

“In a year when literally hundreds of our exhibitors have contributed to overcoming COVID, the greatest healthcare challenge of recent times, we are delighted to be welcoming back the pharma community. CPhI Worldwide is an essential conduit in helping pharma supply chains work, partners meet, empowering the industry with learning. But this year, more than ever, the event will also be a celebration of everything pharma has achieved.

Branding 246
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Pharma is “big business” that uses excuses to keep prices high

World of DTC Marketing

SUMMARY: Americans spend twice as much per capita on drugs as residents of other wealthy nations, because ours is the only country that lets drugmakers set any price they want for their products. Seventy-nine percent of Americans think the price of prescription drugs is “unreasonable,” according to a 2019 Kaiser Family Foundation poll , and about 9 in 10 say they support the idea of the government negotiating prices.

Sales 241
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In the News: September 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Discusses Focus Areas for PDUFA VII During Public Meeting. Following the August publication of the proposed PDUFA VII commitment letter negotiated with industry, the FDA held its corresponding required public meeting on September 28.

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Priority review for Novartis CAR-T cell therapy Kymriah

Pharma Times

Novartis is eyeing approval for Kymriah to treat adult patients with relapsed or refractory follicular lymphoma

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

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F.D.A. to Allow ‘Mix and Match’ Approach for Covid Booster Shots

NY Times

The agency may act this week, when it is expected to authorize booster shots for recipients of the Moderna and Johnson & Johnson vaccines.

Vaccine 145
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A three-decade monopoly: How Amgen built a patent thicket around its top-selling drug

Bio Pharma Dive

Through high-stakes litigation, aggressive patenting practices and a bit of luck, Amgen will likely stretch Enbrel's monopoly until 2029, more than 30 years after it was approved.

Drugs 354
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Pharmapack Europe 2021 Award Winners Announced

Pharma Mirror

Paris, Pharmapack Europe (#PharmapackEU) announce the winners of the 2021 Pharmapack Awards and, due to the exceptional quality of this year’s entries, seven winners have been chosen across both the ‘Exhibitor Innovation’ and ‘Health Product’ awards. The Exhibitor Innovation awards recognise four winners plus one highly commended product. EVEON was given the ‘routes of administration’ innovation award for their Intuity® Spray.

Packaging 246
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New FDA head needs to examine the accelerated approval program

World of DTC Marketing

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. More than $170 million of this spending was for products voluntarily withdrawn by their manufacturers after clinical trials showed that they did not improve overall survival in people with various types of cancer.

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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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Generic Portfolio Management, Partnering with Brands, and Staying Competitive

Drug Patent Watch

This is my talk from the 14th Annual Portfolio Planning and Partnership for Generic Conference. I discuss: Identifying generic entry opportunities at the earliest stages Discovering opportunities that avoid litigation…. The post Generic Portfolio Management, Partnering with Brands, and Staying Competitive appeared first on DrugPatentWatch - Make Better Decisions.

Branding 144
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New asthma drug approved on NHS branded a ‘wonder drug’

Pharma Times

Dupilumab (also known as Dupixent) will be available to patients through injections

Branding 147
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Moderna, Racing for Profits, Keeps Covid Vaccine Out of Reach of Poor

NY Times

Some poorer countries are paying more and waiting longer for the company’s vaccine than the wealthy — if they have access at all.

Vaccine 145
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CRISPR touts new results as fresh questions surround 'off-the-shelf' CAR-T

Bio Pharma Dive

The gene editing company aims to expand its trial and add a second dose to improve effectiveness. However, safety worries have emerged since the FDA ordered CRISPR's rival Allogene to suspend clinical work.

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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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COVID-19 has propelled the regulatory industry years ahead

pharmaphorum

Janssen’s Saskia De Haes, VP EMEA Regulatory Affairs, looks at how the pandemic response has shaped tomorrow’s regulatory landscape. In my 26 years of industry experience, I’ve often found the regulatory process to have plenty of opportunities to become more efficient and faster. When the COVID-19 pandemic hit, it lit a fire under the regulatory system.

Vaccine 143
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The social media problem for healthcare

World of DTC Marketing

SUMMARY: The Facebook whistleblower lawsuit can be summed up in one sentence: Facebook prioritizes engagement above all else because it leads to more profits even if that engagement containing inflammatory information. Earlier this year, I was asked by a client to write a position paper on using Facebook for the DTC marketing of an oncology product.

Branding 224
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Samsung Biologics to help Enzolytics advance clinical development of mAbs

BioPharma Reporter

Samsung Biologics and Enzolytics have entered into a strategic CDMO partnership agreement targeting monoclonal antibody production.

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Double vaccinated can still spread COVID-19 at home, says UK study

Pharma Times

Experts say that it is vital to ensure that every member who is eligible for a vaccine has received one

Vaccine 142
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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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Merck Says Its Antiviral Pill Is Effective Against Covid

NY Times

The drug maker will seek authorization for molnupiravir, the first drug of its kind for Covid. Experts said such pills could be a powerful tool against the virus.

Drugs 144
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How a busy year for biotech IPOs measures up at the three-quarter mark

Bio Pharma Dive

Drugmaker initial public offerings could break records set just a year ago. But valuations and stock performance have slipped from historic highs.

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Twin Health raises $140m for “digital twin” diabetes reversal app

pharmaphorum

The developer of a toolkit that promises to create a “digital twin” of individuals with chronic metabolic diseases like diabetes to help model the impact of lifestyle changes has secured $140 million in funding to develop the technology. US and India-based Twin Health says the Whole Body Digital Twin platform uses Internet of Things (IoT) sensors and self-reported data within an artificial intelligence-driven software platform to generate a virtual copy of a person’s unique met

Insulin 143
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DTC is evolving: 10 things you must do

World of DTC Marketing

SUMMARY : DTC marketing is evolving as patients become more thoughtful about choosing treatment options. The model of “heavy TV followed by a website designed to sell people isn’t going to work anymore. I hear more and more from top pharma clients that “our DTC ROI is not where we want it to be.” In a detailed analysis across different health conditions, I’m finding two common causes.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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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

Vaccine 130
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Fungus-derived cancer killing drug by Oxford University shows promise

Pharma Times

A chemotherapy drug, NUC-7738, which is derived from a Himalayan fungus has been found to have 40 times greater potency in killing cancer cells than its original parent compound.

Drugs 141
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Trial For World’s First Potential Breast Cancer Vaccine Begins

BioSpace

The decision to move forward with the trial comes on the heels of the FDA's approval of its IND application, allowing Cleveland Clinic and Anixa Biosciences to proceed.

Trials 129
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Vertex aligns with another CRISPR gene editing startup

Bio Pharma Dive

A new alliance with Mammoth Biosciences marks the latest evidence of Vertex's interest in gene editing, which has already been the focus of multiple deals with emerging biotechs.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g