Tue.Jan 31, 2023

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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 337
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Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System

Legacy MEDSearch

Axonics, Inc., a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, announced that the U.S. Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The newly approved Axonics R20 neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to just on

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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 264
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What Role Does Healthcare SEO Play in a 2023 Marketing Strategy?

LEVO Health

As the healthcare industry continues to evolve, digital marketing strategies, such as search engine optimization (SEO), have become increasingly crucial for healthcare organizations. Search engine optimization sits at the heart of any successful healthcare marketing strategy. Therefore, it is essential to become familiar with the role SEO strategy plays in healthcare marketing and healthcare SEO best practices that should be employed in 2023 to create a successful digital marketing plan.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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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 258
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Where Big Pharmas Faltered, Stemline Succeeds and Lands FDA Nod in Breast Cancer

MedCity News

Orserdu, a drug from Menarini Group subsidiary Stemline Therapeutics, is now approved for treating breast cancers that carry the ESR1 mutation. The drug is the first approved oral therapy from a class of therapies called selective estrogen receptor degraders (SERDS).

Pharma 96

More Trending

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How Employers’ Investment in Health Benefits Has Transformed Over Time

MedCity News

Point solutions for areas like behavioral health, family planning and more have risen in popularity in recent years, experts said. But as employers deal with point solution fatigue, healthcare navigation companies are proving beneficial.

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FDA extends review of argenx's subcutaneous efgartigimod, pushing decision date back into June

Fierce Pharma

FDA extends review of argenx's subcutaneous efgartigimod, pushing decision date back into June ntaylor Tue, 01/31/2023 - 06:29

FDA 226
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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.

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Waste not, want not: Aptar creates metal-free nasal spray pump to boost recyclability

Fierce Pharma

Waste not, want not: Aptar creates metal-free nasal spray pump to boost recyclability ntaylor Tue, 01/31/2023 - 10:56

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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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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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The pharmacy channel is playing a critical role in marketing

Fierce Pharma

The pharmacy channel is playing a critical role in marketing mteefey Tue, 01/31/2023 - 18:29

Marketing 241
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Insurers Slam CMS for Medicare Advantage RADV Final Rule

MedCity News

The final rule calls for stricter audits on Medicare Advantage plans. AHIP president and CEO Matt Eyles referred to the rule as “unlawful and fatally flawed.

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Seeking improved efficacy, Sensorion taps Eveon to deliver gene therapy to inner ear

Fierce Pharma

Seeking improved efficacy, Sensorion taps Eveon to deliver gene therapy to inner ear ntaylor Tue, 01/31/2023 - 10:23

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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How Students and New Grads Can Break into Medical Sales

MedReps

If getting into medical sales is your goal, then there’s a number of things you can do in order to make that dream come true, even if you’re still in college or have just graduated. How Students and New Grads Can Break into Medical Sales Continue reading to find out what college students and those who have recently earned their degree can do to successfully break into the medical sales field.

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More modalities, more problems? Not necessarily, says SmartLabs

Fierce Pharma

More modalities, more problems?

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SunGlow Lifescience Pvt. Ltd-Walk-In Interviews for Production/ QC/ RA/ QMS/ ARD/ FRD/ Boiler Operator/ Maintenance/ Engineering/ Warehouse/ Regulatory Affairs/ QA On 5th Feb’ 2023

Pharma Pathway

SunGlow Lifescience Pvt. Ltd-Walk-In Interviews for Production/ QC/ RA/ QMS/ ARD/ FRD/ Boiler Operator/ Maintenance/ Engineering/ Warehouse/ Regulatory Affairs/ QA On 5th Feb’ 2023 Job Description SunGlow Lifescience Pvt. Ltd was incorporated in January 2010 and was founded by a group of experienced industry professionals. Our Corporate office is located in Chennai, Indian.

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Inside One Startup’s Effort to Make Mental Healthcare Progress Seem Less Subjective

MedCity News

Less than 20% of behavioral healthcare providers collect data on how patients are progressing with their treatment. To buck this trend, Two Chairs is rolling out “mental health snapshots,” which are consistent summaries of patients’ well-being designed to offer real-time insight to both clinicians and clients.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Vaxxinity eyes global COVID-19 vaccine market with ‘next-gen’ booster

PharmaVoice

The biotech aims to complete rolling submissions with regulators in the U.K. and Australia in the first half of 2023.

Marketing 105
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MedCity Pivot Podcast Season 1 Launches With Focus on Chronic Disease Management

MedCity News

Season one focusing on chronic disease management kicks off with a conversation with Stephanie Tilenius, CEO of VIda Health that aims to treat both the mind and the body.

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This biotech CEO secured two billion-dollar Big Pharma deals during the pandemic

PharmaVoice

With the industry focused on cancer and COVID-19, Marc de Garidel made deals centered on cardio.

Pharma 116
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Paradigm Launches with $203M to Transform Clinical Trial Recruitment

MedCity News

Paradigm, a new startup co-incubated by ARCH Venture Partners and General Catalyst, recently launched with $203 million in Series A funding. The company is focused on improving equitable access to trials by creating a less fragmented and more efficient clinical research ecosystem.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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BDR Pharmaceuticals- Openings for Production/ QA/ QC/ CVC/ Packing/ Engineering- Apply Now

Pharma Pathway

BDR Pharmaceuticals- Openings for Production/ QA/ QC/ CVC/ Packing/ Engineering- Apply Now Job Description BDR Pharmaceuticals was Established in 2002 into API manufacturing, We have a consolidated position in the domestic and global market for the API Business. In today’s dynamic global pharmaceutical market, we at BDR Pharmaceuticals have carved a niche for ourselves, with our formulations portfolio for specialty medication.

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CDMO Startup Vector BioMed Launches to Fill Lentiviral Gap for Cell & Gene Therapies

MedCity News

Vector BioMed has developed a technology platform for designing and manufacturing the lentiviruses used to deliver cell and gene therapies. The startup is launching as the field continues to experience shortages of these viral vectors.

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Bliss GVS Pharma- Walk-Ins for Formulation Development On 4th Feb’ 2023

Pharma Pathway

Bliss GVS Pharma- Walk-Ins for Formulation Development On 4th Feb’ 2023 Job Description Walk-Ins for Research Associate/ Senior Research Associate/ Research Executive in Formulation Development @ Bliss GVS Pharma Departments: Formulation Development Designation: Research Associate/ Senior Research Associate/ Research Executive Experience: 01 to 08 years Job Location: Andheri, Mumbai Date : 4th Feb’ 2023 Time: 10:00 AM to 04:00 PM Venue: Bliss GVS Pharma Ltd. 302, Hyde Park, Saki Vih

Pharma 81
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Be The Match BioTherapies Launches CRO Services for Cell and Gene Therapy

PharmaTech

Be the Match BioTherapies’ and CIBMTR’s expanded service offering is intended to aid in the design, implementation, and oversight of cellular therapy clinical trials.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Rakshit Drugs Pvt. Ltd-Walk-In Interviews for QC/ Engineering/ R&D On 4th Feb’ 2023

Pharma Pathway

Rakshit Drugs Pvt. Ltd-Walk-In Interviews for QC/ Engineering/ R&D On 4th Feb’ 2023 Job Description Dear all Greetings from Rakshit drugs….! We are looking for below positions: Department: QC/ Engineering/ R&D Experience: 02 to 07 years Qualification: B.Sc/ M.Sc/ Diploma/ B.Tech (Mech.) No of Vacancies: 18 Walk-In Date: 4th Feb’ 2023 Time: 9:30 AM onwards Venue: Rakshit Drugs Pvt.

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Sanofi’s efanesoctocog alfa may be game-changer for haemophilia A patients

PharmaTimes

Phase 3 study demonstrated that efanesoctocog alfa met both primary and secondary endpoints

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Aurobindo Pharma-Walk-In Interviews for Quality Control On 3rd Feb’ 2023

Pharma Pathway

Aurobindo Pharma-Walk-In Interviews for Quality Control On 3rd Feb’ 2023 Job Description Company Profile: Aurobindo Pharma Ltd’ (APL). APL is a growing India multinational pharmaceutical manufacturing firm with turnover of over US$2.8 Billion revenues for 2018-19, with presence in more than 34 countries fronted presence with products exported to 155 nations.

Pharma 77
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AlzeCure’s neuropathic pain candidate study reaches crucial phase

PharmaTimes

Research concerns ACD440 – a non-opioid drug which treats peripheral neuropathic pain

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.