Sat.Jan 07, 2023 - Fri.Jan 13, 2023

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JPM23, Day 1: BMS touts new launches as patent cliff looms; Regeneron's Eylea sales disappoint

Fierce Pharma

JPM23, Day 1: BMS touts new launches as patent cliff looms; Regeneron's Eylea sales disappoint. esagonowsky. Mon, 01/09/2023 - 09:55.

Sales 345
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Meet the First Startup to Come Out of UC Davis Health’s Innovation Incubator

MedCity News

UC Davis Health announced the first startup to come out of its health tech innovation incubator. The company, named WellCent, is a platform that allows patients and caregivers to onboard medical devices into their home and access digital health resources.

Medical 142
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Health Canada gives approval to Enhertu for breast cancer treatment

Pharmaceutical Technology

Health Canada has granted approval to Enhertu (trastuzumab deruxtecan) to treat unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Enhertu has been approved to treat HER2-low breast cancer adult patients who have previously received at least one line of chemotherapy in the metastatic setting or who have seen disease recurrence during or within six months after the adjuvant chemotherapy.

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Is machine learning the answer for long-acting injectable drugs?

European Pharmaceutical Review

Machine learning models used to guide the design of long-acting injectable drug formulations have been successfully tested by scientists at the University of Toronto. The research results signal the potential for machine to reduce reliance on trial-and-error testing, which slows the development of long-acting injectables (LAIs). The study was published Nature Communications and is one of the first to apply machine learning techniques to the design of polymeric long-acting injectable drug formula

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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JPM23: Moderna reaped $18.4B in COVID vaccine sales last year, projects at least $5B in 2023

Fierce Pharma

JPM23: Moderna reaped $18.4B in COVID vaccine sales last year, projects at least $5B in 2023. kdunleavy. Mon, 01/09/2023 - 10:34.

Sales 325
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Claiming Insulin Price Conspiracy, CA Sues Lilly, Novo Nordisk, Sanofi & PBMs

MedCity News

California’s Office of the Attorney General contends that drugmakers and pharmacy benefit managers work together to “aggressively raise the list price of insulin in lockstep with each other to artificial levels.” Insulin manufacturers deny the allegations, pointing to availability of lower-cost versions of their products.

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Are we entering the era of biologics for COPD?

Pharmaceutical Technology

In 2023, the pharmaceutical industry will mark 20 years since Xolair, an anti-IgE antibody, became the first biologic approved to treat asthma. Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma. Approaches like bronchodilator inhalers focus on treating both asthma and chronic obstructive pulmonary disease (COPD).

Patients 119
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JPM23: Pfizer entering the 'most important' 18-month stretch in company history, CEO says

Fierce Pharma

JPM23: Pfizer entering the 'most important' 18-month stretch in company history, CEO says. esagonowsky. Tue, 01/10/2023 - 08:51.

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Nest Genomics Raises $8.5M to Increase Access to Patients’ Genetic Information

MedCity News

Nest Genomics just closed a $8.5 million seed financing round. The company provides the software infrastructure needed for health systems, clinics, drugmakers and payers to launch and scale genomic programs. It also provides tools for patients to easily access their genetic information.

Patients 125
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AI and the Big Data paradigm – big ambitions in novel drug discovery

pharmaphorum

Over the past few decades, data generation has veritably exploded. However, the ‘Big Data paradigm’ is not so much concerned with the volume of that data, but how businesses and, indeed, industries can derive meaningful insights from what has become a glut of information. With the currently popular approach to artificial intelligence (AI) focussing on the Big Data paradigm, also, pharmaphorum spoke with Adityo Prakash, CEO of Verseon, about the whys and wherefores, delving deeper into the proces

Training 119
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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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Stars Aligned for Pricing Model? Value-Based Contracts May be Poised for Takeoff

PharmExec

As new forms of cell and gene therapies continue to be developed, life sciences companies and payers need to find alternative ways to pay for these expensive treatments. Value-based contracts, though slow to gain traction so far, may provide the solution these groups are looking for.

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JPM23: Novavax hopes end of COVID emergency—and open vaccine market—will help it grow market share

Fierce Pharma

JPM23: Novavax hopes end of COVID emergency—and open vaccine market—will help it grow market share. aarmstrong. Tue, 01/10/2023 - 10:24.

Marketing 293
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4 Trends to Watch in 2023, According to a Digital Substance Use Disorder Company

MedCity News

There are several trends to watch out for in the substance use disorder space in 2023, according to CHESS Health’s CEO Hans Morefield. These trends include rising addiction rates and increased comfort in virtual health.

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Free access to Zolgensma curbed, says Novartis

pharmaphorum

Novartis’ programme providing free access to its spinal muscular atrophy (SMA) gene therapy Zolgensma is being scaled back to a dozen countries worldwide, according to the company. First introduced in 2020, the global Managed Access Programme (gMAP) has provided Zolgensma (onasemnogene abeparvovec) free of charge to nearly 300 children with the genetic disorder across 36 countries where the therapy has not yet received approval or in which no formal access pathway exists.

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

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Ph. Eur. adopts revised general monographs after adding paragraph on N-nitrosamines

European Pharmaceutical Review

The European Pharmacopoeia (Ph. Eur.) Commission (EPC) adopted the revised general monographs 2034 and 2619 , at its 174th session in November 2022 , which now includes a paragraph explaining the Ph. Eur. approach to the control of N -nitrosamine impurities. A paragraph on N -nitrosamines has been added to Substances for pharmaceutical use (2034) under ‘Production’: “ N -Nitrosamines.

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JPM23, Day 2: Takeda readies for dengue vaccine launch; Merck touts recent deals

Fierce Pharma

JPM23, Day 2: Takeda readies for dengue vaccine launch; Merck touts recent deals. kdunleavy. Tue, 01/10/2023 - 06:24.

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Sanofi CEO: We Don’t Have a Leaky Bathtub

MedCity News

In a media briefing during the J.P. Morgan Healthcare Conference in San Francisco, Paul Hudson said unlike Sanofi, large pharma companies with top-selling drugs have a portfolio akin to a leaky bathtub because in a few years, they will have to replace much of that revenue as drug patents expire.

Media 123
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BioNTech buys UK-based AI startup InstaDeep in £562m deal

pharmaphorum

mRNA specialist BioNTech has driven its partnership with UK artificial intelligence InstaDeep into top gear, agreeing to buy the company outright in a cash and equity deal that values it at up to £562 million ($683 million). The deal , billed as BioNTech’s largest to date and unveiled at the JP Morgan healthcare conference today, includes $362 million upfront with another £200 million on offer if performance targets are met.

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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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Gut microbiome key in Parkinson’s, suggests study

European Pharmaceutical Review

The largest microbiome study conducted at the highest resolution concluded the gut microbiome is involved in multiple pathways in the pathogenesis of Parkinson’s disease (PD). The findings, published in Nature Communications , show a wide imbalance in microbiome composition in people with Parkinson’s. Investigators at the University of Alabama at Birmingham, US employed metagenomics, the study of genetic material recovered directly from the stool microbiome of individuals with PD and neurologica

Medicine 105
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JPM23: Is GSK’s 15-day accelerated approval withdrawal the new normal? Hear FDA commissioner Califf’s response

Fierce Pharma

JPM23: Is GSK’s 15-day accelerated approval withdrawal the new normal? Hear FDA commissioner Califf’s response. esagonowsky. Wed, 01/11/2023 - 10:34.

FDA 252
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Novo Nordisk’s Diabetes Pill Rybelsus Gets FDA O.K. as First-Line Therapy

MedCity News

The FDA approved a change in Rybelsus’s label, allowing the drug to be used as an initial therapy for type 2 diabetes patients. The once-daily pill has already become a blockbuster product for Novo Nordisk.

FDA 122
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Astellas licenses companion drug for Pompe gene therapy

pharmaphorum

Astellas has licensed rights to a drug developed by Selecta Biosciences that could make more patients eligible for treatment with its gene therapy for inherited neuromuscular disorder Pompe disease. The exclusive deal – which includes an upfront payment of $10 million and up to $340 million in milestone payments at the back end – covers the use of Selecta’s immunoglobulin G (IgG) protease drug IdeXork (Xork) alongside Astellas’ AT845, currently in the phase 1/2 FORTIS study in late-o

Patients 117
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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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EC approves influenza antiviral for children over one years old

European Pharmaceutical Review

The European Commission (EC) has approved Xofluza ® (baloxavir marboxil) in children aged one year and above for uncomplicated influenza and post-exposure prophylaxis of influenza. . The European Commission’s approval. The agency’s regulatory approval, based on the results of two Phase III studies, marks the first single-dose, oral influenza medicine approved in Europe for children.

Safety 105
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AstraZeneca's first-in-class rescue inhaler Airsupra wins FDA nod—but only for adult use

Fierce Pharma

AstraZeneca's first-in-class rescue inhaler Airsupra wins FDA nod—but only for adult use. esagonowsky. Wed, 01/11/2023 - 09:03.

FDA 276
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Oula Rakes in $19.1M for Hybrid Maternity Clinic

MedCity News

The funding round was led by 8VC and included participation from Chelsea Clinton’s fund, Metrodora; the Female Founders Fund; Collaborative Fund; and Alumni Ventures. In total, Oula has raised $22.3 million. The company plans to use the funds to grow in its New York market and add more services.

Marketing 122
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JP Morgan 2023 – Day 1

pharmaphorum

We’re preparing to start JP Morgan week with a busy day Monday, with day 1 of the Informa Biotech Showcase, including a dedicated mini-event on Cell and Gene Therapy in the morning. Then in the evening, we’ll be at STAT@JPM for presentations by event sponsor GSK as well as the guest of honour: FDA Commissioner Robert Califf. Check below for updates throughout the day.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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2022 Terra Carta Seal: three pharma companies awarded

European Pharmaceutical Review

The Sustainable Market Initiative’s (SMI) 2022 Terra Carta Seal , which recognises global companies who are driving innovation and leadership within their industry, has been awarded to pharmaceutical companies GlaxoSmithKline PLC, Sanofi, and Samsung Biologics. Launched in January 2021, Terra Carta is a sustainability recovery plan for Nature, People and Planet.

Pharma 105
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JPM23: GSK's Luke Miels on RSV and mRNA vaccines, Blenrep and Zejula withdrawals, plus more

Fierce Pharma

JPM23: GSK's Luke Miels on RSV and mRNA vaccines, Blenrep and Zejula withdrawals, plus more. qanderson. Wed, 01/11/2023 - 17:28.

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What Excites and Concerns VillageMD’s CEO About the Future of Healthcare

MedCity News

Tim Barry, CEO of VillageMD, is encouraged by the shift he’s seeing to value-based care, but is worried that new technologies could create a fragmented system. He made these comments after the value-based company announced Thursday that it completed its $8.9 billion acquisition of Summit Health-City MD.

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JP Morgan 2023 – Pre event

pharmaphorum

Before the main event at JP Morgan 2023 even kicks off, we’re checking out the Sachs Associates Neuroscience Innovation Forum on Sunday. Speakers from Lilly, Boehringer Ingelheim, Takeda, and many more pharma firms big and small will present on key trends and developments in one of the most exciting areas of pharmaceutical and digital innovation. We’ll also wander over to the UC Davis Health Future & Health CEO Summit a little later this afternoon.

Pharma 116
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time