Sat.Jun 03, 2023 - Fri.Jun 09, 2023

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ASCO 2023: Keytruda becomes a new option in perioperative NSCLC  

Pharmaceutical Technology

Early-stage non-small cell lung cancer (NSCLC) is typically treated with surgery followed by adjuvant therapy (chemo ± radiation) in patients deemed to be at higher risk. The use of a pre-surgical course of drug treatment (neoadjuvant), is not well established thus far and can differ substantially between countries and even hospitals within the same country.

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Unlocking the impact of medical affairs: overcoming challenges in defining and measuring success

Bio Pharma Dive

Discover how medical affairs teams can overcome challenges to define and measure their impact, with a focus on KOL engagement, using a scientific journey approach and a comprehensive strategy.

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ASCO: Seagen's top-selling drug under threat as Bristol Myers' Opdivo beats Adcetris in lymphoma

Fierce Pharma

The rising antibody-drug conjugate class has hit a setback as Seagen’s Adcetris, one of the earliest and fast-growing members of the group, was defeated by immune checkpoint inhibitor. | The rising antibody-drug conjugate class has hit a setback as Seagen’s Adcetris, one of the earliest and fast-growing members of the group, was defeated by immune checkpoint inhibitor in classical Hodgkin lymphoma.

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ASCO: Novartis touts Kisqali adjuvant breast cancer data

pharmaphorum

ASCO: Novartis touts Kisqali adjuvant breast cancer data Phil.

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Running Decentralized Trials at Scale: Planning for Success

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

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China’s NMPA accepts Akeso’s NDA for ebronucimab

Pharmaceutical Technology

China’s National Medical Products Administration (NMPA) has accepted Akeso’s new drug application (NDA) for ebronucimab (AK102) for two indications. Ebronucimab is intended to treat heterozygous familial hypercholesterolemia (HeFH), primary hypercholesterolemia and mixed hyperlipidemia. It is a fully human anti-PCSK9 monoclonal antibody co-developed by the company and AD Pharmaceuticals.

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More trust for pharma in the UK than the US

Drug Discovery World

Six out of 10 people in the UK trust pharma businesses to do what is right: up 1% on last year. The UK places more trust in pharma than European neighbours France (52%), Germany (55%), or the industry’s largest global market, the US (54%). People living in the world’s second largest and fastest-growing pharma market, China report the highest level of trust in the industry (89%), closely followed by India (86%).

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World Food Safety Day 2023: “Food Standards Save Lives”

XTalks

World Food Safety Day 2023 is an occasion to commemorate progress and advocate for continued improvement in the safety of our food supply. This year’s theme , “Food standards save lives,” acknowledges the vital role of food standards in protecting consumers and fostering fair food trade globally​​. The origins of World Food Safety Day, which takes place each year on June 7, trace back to the United Nations’ (UN) Food and Agriculture Organization (FAO), which has been pivo

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Cybersecurity in pharma: Securing the future

Pharmaceutical Technology

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. A ransomware group later claimed responsibility for the incident, which was one of several high-profile cybersecurity breaches in India over the past three years. Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health.

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Comment: LSX World Congress 2023 

Drug Discovery World

The LSX World Congress 2023 took place at the Business Design Centre in London, UK in May 2023. DDW’s Megan Thomas comments on the event. New approaches to partnering In this event in the Biotech track, Clive Cookson, Science Editor at the Financial Times, interviewed John McDonald, Corporate Vice President, Global R&D Business Development, Novo Nordisk.

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ASCO: Can Imfinzi bring immunotherapy to ovarian cancer?

pharmaphorum

ASCO: Can Imfinzi bring immunotherapy to ovarian cancer? Phil.

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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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Pharmaceutical Portfolio Planning in Today’s Drug Development Climate

XTalks

Pharmaceutical portfolio planning involves crucial decision-making about which drug development projects to pursue and how to allocate resources effectively. It is an essential aspect of pharmaceutical strategy and involves a complex balance of scientific potential, market opportunity, risk and financial considerations. The major steps often involved in strategic pharmaceutical portfolio planning include: Portfolio Analysis: This involves evaluating the current portfolio of drugs, which may incl

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Open Philanthropy awards $1.7m to Evotec for henipavirus therapy discovery

Pharmaceutical Technology

German biotechnology company Evotec has secured a $1.7m grant from a philanthropic funder, Open Philanthropy, to research RNA-targeting henipavirus therapeutics. The company will use the funding for the discovery and development of small molecule antivirals that target viral RNA in henipaviruses, a genus of zoonotic viruses that can cause fatal encephalitis in humans.

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Successful Phase I results for cardioprotective drug 

Drug Discovery World

Serca Pharmaceuticals, a cardioprotection company that is developing 13-M, a novel first in class treatment for minimising tissue damage that occurs with blood reperfusion post myocardial infarction (MI) and stenting, has presented data on a novel approach to modulate the beta-adrenergic receptor-cAMP protein kinase A (PKA) signalling pathway that modulates the contractility.

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AMCP Format for Formulary Submissions Revision – Comment Period Now Open!

FDA Law Blog

By Dara Katcher Levy — The Academy of Managed Care Pharmacy (AMCP)’s Format Executive Committee is excited to let you know that after two years of work, version 5.0 of the Format for Formulary Submissions (also known as dossiers) is on the horizon. And we need your feedback! We’ve included revisions to the Format in key areas related to digital therapeutics, health disparities, streamlining dossiers, as well as AMCP guidance on Pre-Approval Information Exchange (PIE) decks.

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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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FDA Warns About Compounded Versions of Ozempic and Wegovy

XTalks

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Ozempic was approved for the management of type 2 diabetes mellitus in adults in addition to a reduced-calorie diet and exercise. Wegovy, in conjunction with diet and exercise, is authorized to assist adults and children aged 12 years and older struggling with obesity, or some adults grappling with excess weight alongside weight-related medical conditions, in their eff

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NICE recommends Bristol-Myers Squibb’s mavacamten

Pharmaceutical Technology

The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of Bristol-Myers Squibb’s mavacamten (Camzyos) as an add-on to standard care to control symptoms of obstructive hypertrophic cardiomyopathy (HCM). The symptoms of obstructive HCM include fatigue, palpitations and shortness of breath.

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Novel glycan-coated nanoparticle enters trials for geographic atrophy

Drug Discovery World

Aviceda Therapeutics has dosed the first patient in its Phase II SIGLEC trial investigating AVD-104 as a treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). AVD-104 is a novel glycan-coated nanoparticle, supported by a strong pre-clinical in vivo efficacy and safety profile. “I am honoured to be the first to dose a new agent that we hope will usher in a generation of safe treatments for GA with better outcomes than were ever possible before,” said Ashkan Ab

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BenevolentAI progresses BEN-34712 for the potential treatment of ALS into IND-enabling studies

Drug Discovery Today

London, UK, 5 June 2023, BenevolentAI (Euronext Amsterdam: BAI), a leader in the development of cutting-edge AI that accelerates biopharma discovery, announces the successful delivery of its pre-clinical candidate for the potential treatment of amyotrophic lateral sclerosis (ALS), BEN-34712.

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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

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thINc’s Specialty Networks and Patient Support Services Summit

Drug Channels

thINc’s Specialty Networks and Patient Support Services Summit In-Person Event | August 29-30, 2023 Lowes Philadelphia, Philadelphia, PA www.thinc360.com/specialty Early rates are in effect. Use promo code DC5123 to save an additional $100 off the early rates. Register Today! View the Agenda Snapshot Enhance Patient Service, Network Design, and Channel Strategies to Improve Patient Access and Support In its 8th year, the Specialty Network and Patient Support Services Summit is an important event

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PharmaEssentia picks Pint-Pharma to market BESREMi in Latin America

Pharmaceutical Technology

PharmaEssentia has chosen Pint-Pharma as commercial partner for BESREMi (ropeginterferon alfa-2b-NJFT) in Latin America. The companies have entered into an exclusive licence agreement to register and promote BESREMi to treat polycythemia vera (PV), a rare type of blood cancer, in Ecuador, Chile, Mexico, Argentina, Brazil, Colombia and Peru. PharmaEssentia may be entitled to receive certain milestone payments along with royalties based on sales of the product.

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DDW Highlights: 5 June 2023

Drug Discovery World

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. With National Cancer Research Month coming to an end in May and the American Society of Clinical Oncology Annual Meeting currently taking place in Chicago from 2-6 June, it’s been another busy week for cancer drug development news.

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ASCO: Vorasidenib shows its glioma potential in INDIGO

pharmaphorum

ASCO: Vorasidenib shows its glioma potential in INDIGO Phil.

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Mandatory COVID Vaccination Policy Template

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!

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Celebrating pharmaceutical innovation & sustainability at Lab Innovations 2023

Drug Discovery Today

The home of the UK’s lab industry expands floor plan to accommodate increased interest in this year’s show

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Innovation in immuno-oncology: Leading companies in T-cell culturing

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: T-cell culturing.

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New podcast episode: DDW Highlights, 5 June 2023

Drug Discovery World

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. With National Cancer Research Month coming to an end in May and the American Society of Clinical Oncology Annual Meeting currently taking place in Chicago from 2-6 June, it’s been another busy week for cancer drug development news.

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ASCO: AZ gets a practice-changing win in lung cancer

pharmaphorum

ASCO: AZ gets a practice-changing win in lung cancer Phil.

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Which drugs have supplementary protection certificates in the most countries?

Drug Patent Watch

This chart shows the drugs with the most supplementary protection certificates (SPCs). SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating for the long… The post Which drugs have supplementary protection certificates in the most countries? appeared first on DrugPatentWatch - Make Better Decisions.

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Leading innovators in transcription factors for AAV for the pharmaceutical industry

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on on Innovation in Pharmaceuticals: Transcription facto

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Ariceum Therapeutics expands pipeline with acquisition 

Drug Discovery World

Ariceum Therapeutics, a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, has acquired Theragnostics, a UK-based private biopharmaceutical company engaged in the development of radio-labelled PARP inhibitors for the diagnosis and treatment of tumours. The acquisition provides Ariceum with an expanded portfolio of therapeutic and diagnostic assets in late preclinical and early clinical development.

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Novo Nordisk in talks to buy device maker Biocorp

pharmaphorum

Novo Nordisk in talks to buy device maker Biocorp Phil.

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Which pharmaceutical companies have the most SPCs in Italy?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Italy. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating… The post Which pharmaceutical companies have the most SPCs in Italy? appeared first on DrugPatentWatch - Make Better Decisions.

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Leading innovators in transcription factors for genetically modified cells for the pharmaceutical industry

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Transcription factors

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