Sat.Jul 17, 2021 - Fri.Jul 23, 2021

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Gene therapy for Fabry: early stages, promising results

Bio Pharma Dive

Three companies are testing their gene therapies in early clinical trials, with initial results due later this year. Others are in preclinical stages and aim to follow soon.

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Is pharma hiring the right people?

World of DTC Marketing

SUMMARY: Older, more experienced employees are being shoved aside in favor of more inexperienced ones. The culture within pharma is driving people away, including new hires. More and more meetings are based on ROI, not the voice of the patient. Don’t hire people who want big salaries; hire people who want to be part of an industry that helps patients.

Marketing 309
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Virtual reality therapy: The future of chronic pain management?

pharmaphorum

Could virtual reality tools be effective in helping patients ‘unlearn’ their chronic pain? p harmaphorum speaks to Professor Christopher Eccleston from the University of Bath’s Centre of Pain Research to find out how digital therapeutics are shaping the future of pain management. A digital software developed by Finnish drugmaker Orion is aiming to address chronic pain conditions using virtual reality (VR) devices that provide an immersive gamified therapeutic treatment program.

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Preclinical Data on New Pancreatic Cancer Drug Shines with over 90% Efficacy

BioSpace

Preclinical data for its drug candidate, LP-184, reportedly showed over 90 percent efficacy in shrinking pancreatic cancer tumors in mouse models in vitro, in-vivo, and ex-vivo.

In-Vivo 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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Caribou raises $304M in one of gene editing's most lucrative IPOs

Bio Pharma Dive

The IPO is several times larger than what CRISPR Therapeutics, Intellia and Editas raised several years ago, and ranks well ahead of a more recent offering from gene editing startup Beam.

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The debate on DTC marketing is going to heat up again

World of DTC Marketing

SUMMARY: DTC marketing is not the reason why prescription drugs cost so much. DTC ads raise awareness around health conditions. DTC ads do NOT lead to unnecessary Rxs. The FDA needs to study what people do when they see a DTC ad. The voices in Washington DC are once again calling for a moratorium on DTC marketing but lawmakers need to understand what DTC marketing actually does as upped to what people believe it does.

Marketing 285

More Trending

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Koselugo: The First Non-Surgical Alternative for Rare Plexiform Neurofibroma

BioSpace

Notably, Koselugo was studied in pediatric populations first, a reversal of the typical development path taken by the majority of drugs.

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A biotech's eye gene therapy faces longer odds as serious side effects pile up

Bio Pharma Dive

Five trial participants with diabetic macular edema who received Adverum Biotechnologies' treatment experienced side effects never before reported for an eye gene therapy.

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Catalent Plans Multi-Phase, $100 Million Expansion of Italian Facility to Increase Biologics Manufacturing Capabilities in Europe

Pharma Mirror

SOMERSET, N.J. — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it will commence the first phase of a planned $100 million expansion program at its facility in Anagni, Italy, to add biologics drug substance manufacturing capabilities, supporting the growing European market demand for biologics manufacture and supply.

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New plans to improve patient access to mental health services unveiled in England

Pharma Times

NHS England has set out new plans to introduce five new waiting time guarantees for mental health services

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

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Ten tips on pharma time management

pharmaphorum

Oliver Stohlmann’s new Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. In this first instalment he tackles managing time. A month into exiting my career of over two decades in global life-science multinationals, I’m alive – still, but waiting for withdrawal symptoms to kick in.

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Bluebird, with little fanfare, is first to bring a second gene therapy to market

Bio Pharma Dive

The approval of Skysona for a genetic brain disease is a milestone for one of gene therapy's pioneering companies, but isn't expected to turn Bluebird's financial fortunes around.

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CPhI Awards 2021 Open for Entries in Incredible Year for Pharma Innovation

Pharma Mirror

On 9 November 2021, the 18th Annual CPhI Pharma Awards will take place in Milan, Italy at the Stella Polare Convention Centre. The CPhI Pharma Awards celebrate innovators and thought leaders breaking new ground in the pharma and biopharma industries, and their commitment to advancing new approaches, processes and technologies. Held as part of CPhI Worldwide (9-11 November 2021), the world’s largest pharma exhibition, these prestigious awards recognise the individuals, teams and companies who tur

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NHS England unveils new Innovative Medicine Fund

Pharma Times

The new fund will build upon the Cancer Drugs Fund to fast-track access to promising new treatments

Medicine 135
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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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Pfizer puts up $1bn to buy into Arvinas breast cancer programme

pharmaphorum

Pfizer has pledged a whopping $1 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ natural protein-denaturing machinery to remove rogue proteins associated with disease. The deal focuses on ARV-471, currently in phase 2 testing for advanced breast cancer patients whose tumours expresses oestrogen receptors – so are hormone sensitive – but test negative for HER2 receptors that would make them candidates for treatment w

Protein 116
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BioNTech returns to cancer roots with deal for Gilead cell therapy factory

Bio Pharma Dive

The German biotech purchased Kite Pharma's Gaithersburg, Maryland-based site, along with related research on T cell receptor-based cancer treatments.

Research 317
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NuVasive Resumes Shipping of Spinal Implant, Continues to Address FDA Safety Warnings

XTalks

NuVasive , a medical device company focused on developing devices and procedures for minimally invasive spine surgery, has recommenced shipping of the newest version of its MAGEC line of spinal curve-correcting magnetic rod systems. The previous version of the MAGEC spinal implant was flagged by the US Food and Drug Administration (FDA) for potential mechanical risks.

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AZ says its COVID-19 vaccine protects against severe disease caused by variants

Pharma Times

Real-world data shows jab is effective after one dose against hospitalisation/death caused by Beta and Delta variants

Vaccine 130
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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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GSK names McNamara as CEO of consumer health spinout

pharmaphorum

GlaxoSmithKline has said that Brian McNamara – currently head of its three-year-old consumer health joint venture with Pfizer – will retain the top job at the business after it is hived off into a separate company next year. The appointment, which had been expected, was confirmed in a statement by GSK’s board today. McNamara has been with GSK since 2015, when he joined the company as head of consumer health for Europe and the Americas, and previously worked for 10 years at Novartis, ultima

Sales 111
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J&J predicts faster coronavirus vaccine sales amid debate over boosters

Bio Pharma Dive

The pharmaceutical company expects $2.5 billion in sales from its shot this year, despite concerns over protection against variants and significant manufacturing setbacks.

Sales 306
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Statins may reduce risk of COVID-19 death: researchers

Outsourcing Pharma

A recent study indicates patients taking the cholesterol-lowering drugs prior to COVID hospitalization are far less likely to die as a result of the virus.

Research 111
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Celltrion says its COVID-19 antibody shows ‘strong neutralising activity’ against Delta variant

Pharma Times

A therapeutic dose of regdanvimab also reduced the viral load of the SARS-CoV-2 virus and inflammation in the lungs

Antibody 130
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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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Celltrion: COVID-19 antibody treatment effective against Delta variant

BioPharma Reporter

Celltrion Group has reported that data from an in vivo efficacy study shows that its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59), has a strong neutralizing effect against the rapidly spreading Delta variant.

Antibody 111
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Ardelyx latest biotech surprised by unexpected FDA criticism of drug application

Bio Pharma Dive

The FDA cited problems with Ardelyx's case for its kidney disease drug just weeks before an approval deadline — feedback one analyst described as "troubling" evidence of FDA inconsistency.

Drugs 299
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One Dose of J.&J. Vaccine Is Ineffective Against Delta, Study Suggests

NY Times

Many who received the shot may need to consider boosters, the authors said. But federal health officials do not recommend second doses.

Vaccine 110
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Orbit Discovery raises $7.6m to boost peptide drug discovery services

Pharma Times

The latest funding round was led by Oxford Sciences Innovation

Drugs 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Weight Loss-Focused Gelesis Heads to NYSE via SPAC Deal, Other IPOs Filed

BioSpace

The Boston-based company merged with Capstar Special Purpose Acquisition Corp. and will begin trading on the New York Stock Exchange under the ticker symbol “GLS.

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Seres, after earlier success, fails a key test for microbiome drugs

Bio Pharma Dive

A pill made of gut bacteria wasn't effective at treating ulcerative colitis in a closely watched study that was viewed as a proof point for the emerging field.

Bacteria 290
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Is Macadamia Nut Oil the New Olive Oil for Cooking?

XTalks

For years, consumers have been using olive oil on food and in cooking. Still, Strength Genesis believes it is time for a change and a move towards a more versatile cooking oil option — macadamia oil, otherwise known as “liquid gold” to some. Olive oil is known for its healthy omega-3 fats and is used to aid in body repair and improve health in general.

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Roche reveals new safety data for haemophilia treatment Hemlibra

Pharma Times

No new safety signals identified with longer-term Hemlibra treatment in adult and adolescent patients

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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.