Sat.Jan 28, 2023 - Fri.Feb 03, 2023

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Navigating One’s Bio-Pharma Career through 2023’s Turbulent Job Markets

Pharmaceutical Commerce

Jasmin Patel of a-Connect provides insight on how to navigate the ebbs and flows of employment.

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J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries

Fierce Pharma

J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries mbayer Fri, 02/03/2023 - 09:29

Pharma 363
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Trending Sources

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GoodRx Illegally Sold Users’ Data to Google & Facebook, FTC Says

MedCity News

GoodRx failed to notify users that it sold their personal health information to Google, Facebook and other tech companies, the FTC claimed. The agency filed an order that prohibits GoodRx from sharing its users’ data with third parties for advertising purposes and requires the company to pay a $1.5 million penalty. GoodRx agreed to pay the settlement but did not admit to wrongdoing.

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HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

Medicine 117
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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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Halting Europe’s essential medicines manufacturing exodus

European Pharmaceutical Review

While maintaining a healthy manufacturing industry for production of ‘high tech’ pharmaceuticals, Europe has stepped away from manufacturing essential medicines and active pharmaceutical ingredients (APIs) due to unrelenting price pressures and is now heavily reliant on the import of these critical ingredients. There is now a large regional concentration in the production of generic APIs in Asia with 66 percent of the world’s API production by volume manufactured in India and China. 1 Europe is

Medicine 111
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Pfizer warns Comirnaty sales will plummet by nearly two-thirds in 2023. And Paxlovid won't fare much better

Fierce Pharma

Pfizer warns Comirnaty sales will plummet by nearly two-thirds in 2023.

Sales 338

More Trending

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uniQure signs license deal for Apic Bio’s gene therapy for SOD1-ALS

Pharmaceutical Technology

Gene therapy company uniQure has entered into a global licensing agreement with Apic Bio for APB-102 to treat patients with amyotrophic lateral sclerosis (ALS) caused by mutations in superoxide dismutase 1 (SOD1). Under the terms of the deal, uniQure will obtain the worldwide rights to develop and market the clinical stage gene therapy, APB-102. uniQure stated that the license of APB-102 further strengthens its gene therapies pipeline developed for the treatment of neurological disorders as well

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Three-year patent strategy for greater medicine access announced

European Pharmaceutical Review

A new strategy for 2023-2025 by the Medicines Patent Pool (MPP) aims to reduce access inequities, by improving the availability and affordability of health products in low- and middle-income countries (LMICs). The MPP is a United Nations-backed public health organisation working to increase medicine access and facilitate the development of life-saving medicines for LMICs.

Medicine 105
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Amid mainstream hype, Eli Lilly takes a hard line marketing its buzzy diabetes med Mounjaro

Fierce Pharma

Amid mainstream hype, Eli Lilly takes a hard line marketing its buzzy diabetes med Mounjaro fkansteiner Thu, 02/02/2023 - 11:20

Marketing 246
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Why Telehealth Implementation Is Not Just a Project for IT

MedCity News

Telehealth implementation should be a joint responsibility of IT, administration, and providers. Otherwise, a lack of teamwork between departments leads to siloing and lots of passing the telemedicine “hot potato” among those who don’t have all the information.

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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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US FDA approves GSK’s Jesduvroq to treat anaemia of CKD

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). It is claimed to be the only HIF-PHI approved in the country that offers a new oral treatment option for adult patients on dialysis with anaemia of CKD.

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Smart Walking Stick for Visually Impaired People

Medgadget

Researchers at the University of Colorado at Boulder have developed a smart walking stick that can assist blind or visually impaired people to navigate their environment, from grocery shopping to finding a seat in a busy café. The system employs cameras to visualize the environment and items within it, such as products in a supermarket, and uses AI to identify objects and provide guidance for the user.

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Amgen's Humira biosimilar Amjevita hits the market with two different list prices

Fierce Pharma

Amgen's Humira biosimilar Amjevita hits the market with two different list prices zbecker Tue, 01/31/2023 - 10:58

Marketing 271
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I’m a GI Doctor. A Colon Cancer Screening Could Save Your Life.

MedCity News

A recent NEJM publication concluded that although colonoscopy is widely used as a dependable screening test to detect colorectal cancer, its overall effect on the risks of colorectal cancer death is potentially less clear than previously reported. The doubt sprouting from this study is misplaced, dangerous and will potentially lead to more deaths from this disease.

Doctors 124
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Clinical Trials Information System mandatory in EU

European Pharmaceutical Review

From 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). According to the European Medicines Agency (EMA), CTIS is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data. This follows a one-year transition, during which sponsors could choose whether to apply for a new clinical trial in the EU/EEA in line with the Clinical

Ethics 104
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Pfizer reports 30% operational growth in full-year 2022 revenues

Pharmaceutical Technology

Pfizer has reported a 30% operational growth in revenues to $100.3bn in full-year 2022 compared with $81.2bn reported last year. The revenues grew 2% operationally excluding Paxlovid and Comirnaty’s contributions. In the fourth quarter (Q4) of 2022, they increased 13% operationally to $24.3bn compared to $23.8bn in the same quarter last year. On an operational basis, the revenues rose by 5%, omitting contributions from Paxlovid and Comirnaty.

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Menarini shows Big Pharma how it's done with first approval for oral SERD drug in breast cancer

Fierce Pharma

Menarini shows Big Pharma how it's done with first approval for oral SERD drug in breast cancer kdunleavy Mon, 01/30/2023 - 10:22

Pharma 246
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Healthcare Spent $18B More on Administrative Tasks in 2022 Than Year Prior

MedCity News

The U.S. healthcare system spent $60 billion on administrative tasks last year, which is about $18 billion more than it spent in 2021, according to a new report. There are a couple reasons for this — the workforce shortage and Americans’ increased utilization of healthcare services.

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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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France gets new sterile liquid drug manufacturing facility

European Pharmaceutical Review

Switzerland-based contract development and manufacturing organisation (CDMO) CARBOGEN AMCIS has opened a new facility in France, dedicated to the custom development and production of sterile injectable drug products. The facility forms two new fully-automated production lines for liquid and freeze-dried drugs, including highly potent compounds and advanced therapies such as antibody drug conjugates (ADCs).

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Magazine: CRISPR gene therapies cut through in 2023

Pharmaceutical Technology

If things go as per plan, in a few months, the US Food and Drug Administration (FDA) will deliberate on the first-of-its-kind CRISPR-based gene therapy for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. Having made significant advances in a relatively short period of time, CRISPR research is now edging closer to reaching the clinic , and this month’s cover story takes a look at the major players in this field and the big events that could break through this year.

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In mysterious FDA approval, Pfizer quietly wins Ibrance breast cancer expansion

Fierce Pharma

In mysterious FDA approval, Pfizer quietly wins Ibrance breast cancer expansion aliu Tue, 01/31/2023 - 10:37

FDA 260
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With Livongo, did Zane Burke sell a lemon to Teladoc’s Jason Gorevic?

MedCity News

Was Livongo a good business? As Burke, now CEO of Quantum Health, touts its strength to investors ahead of a potential IPO, should the Livongo-Teladoc history give them pause?

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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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GitHub is Sued, and We May Learn Something About Creative Commons Licensing

Copyright Clearance Center

This article was originally published in The Scholarly Kitchen. I have had people tell me with doctrinal certainty that Creative Commons licenses allow text and data mining, and insofar as license terms are observed, I agree. The making of copies to perform text and data mining, machine learning, and AI training (collectively “TDM”) without additional licensing is authorized for commercial and non-commercial purposes under CC BY , and for non-commercial purposes under CC BY-NC.

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First medicine approved in EU for eosinophilic esophagitis

European Pharmaceutical Review

The European Commission (EC) has expanded the marketing authorisation for Dupixent® (dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE). It is the “… first and only targeted treatment option clinically proven to reduce both oesophageal inflammation and damage,” explained Dr Naimish Patel, Head of Global Development, Immunology and Inflammation at Sanofi.

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Court rejects Johnson & Johnson's Texas two-step bankruptcy ploy for talc claims

Fierce Pharma

Court rejects Johnson & Johnson's Texas two-step bankruptcy ploy for talc claims kdunleavy Mon, 01/30/2023 - 16:24

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FDA Asks Gene Therapy Biotech to Run Clinical Trial That Might Be Impossible

MedCity News

Taysha Gene Therapies has encouraging data from an open-label, Phase 1/2 study in the rare disease giant axonal neuropathy. It might not be enough. The FDA recommended the biotech conduct a randomized and placebo-controlled study—a challenge in any ultra-rare disease.

FDA 121
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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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Merck reports 2% increase in worldwide sales in Q4 2022

Pharmaceutical Technology

Merck (MSD outside North America) has reported a 2% increase in worldwide sales to $13.83bn in the fourth quarter (Q4) of 2022 from $13.52bn in the previous year’s quarter. The company’s pharmaceutical sales recorded a 1% rise to $12.18bn compared to $12.03bn in the prior-year quarter. For the quarter, GAAP earnings per share (EPS) from continuing operations was $1.18, indicating a 22% decline from $1.5 in the same quarter last year.

Sales 98
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First biosimilar to HUMIRA® available in US

European Pharmaceutical Review

AMJEVITA (adalimumab-atto), a biosimilar to Humira ® (adalimumab), is now available in the US. Amgen’s AMJEVITA was the first biosimilar to Humira approved by the US Food and Drug Administration (FDA), in 2016. The active ingredient in the anti-TNF-α monoclonal antibody has the same amino acid sequence as Humira. The Humira biosimilar will be available in prefilled syringe and autoinjector presentations to support dosing in each of the approved indications.

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Following in Lilly's footsteps, Teva takes 2nd long-acting schizophrenia drug into phase 3

Fierce Pharma

Following in Lilly's footsteps, Teva takes 2nd long-acting schizophrenia drug into phase 3 ntaylor Tue, 01/31/2023 - 06:26

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What Health Plans Need To Know About QHPs Now That the ACA Is Here To Stay

MedCity News

Now that numerous calls for repeal and legal challenges brought against the ACA over the years have failed, health plans can finally invest confidently in this line of business.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time