Tue.Dec 06, 2022

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Emergent snags speedy FDA review, potentially teeing up over-the-counter Narcan by next spring

Fierce Pharma

Emergent snags speedy FDA review, potentially teeing up over-the-counter Narcan by next spring. fkansteiner. Tue, 12/06/2022 - 10:58.

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Entact Bio Emerges With $81M to Play Matchmaker to Protein-Enhancing Drugs

MedCity News

Taking the opposite approach of targeted protein degradation, biotech company Entact Bio is developing medicines that stabilize proteins and even enhances their function. This approach that could apply to cancer and certain rare diseases and Entact’s $81 million in Series A financing enables it to work on multiple programs in parallel.

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Leo Pharma scores with its JAK inhibitor cream in chronic hand eczema trial

Fierce Pharma

Leo Pharma scores with its JAK inhibitor cream in chronic hand eczema trial. kdunleavy. Tue, 12/06/2022 - 10:04.

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9 Healthcare Marketing Trends to Embrace in 2023

Healthcare Success

Healthcare consumers continue to move swiftly down the paths of least resistance toward quality care. This spells trouble for healthcare organizations that cannot change with the times. It’s time to pay attention to what competitors offer and find ways to remove unnecessary obstacles to care. In this blog, I share nine healthcare marketing trends you need to embrace in 2023 to remain competitive in today’s ever-changing healthcare marketplace. 9 Healthcare Marketing Trends 2023. 1.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Vaxxas raises $23M to fund needle-free COVID-19 vaccine trial

Fierce Pharma

Vaxxas raises $23M to fund needle-free COVID-19 vaccine trial. ntaylor. Tue, 12/06/2022 - 10:15.

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There Is a Shortage of Public Health Workers. How Can That Be Fixed?

MedCity News

Every public health system is unique, and the reasons for shortages vary. To respond, leaders can analyze their particular needs and then take action to develop and re-stock the talent pool. Here are four actions that can help.

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Medicare Needs to Pay for Some of Hospitals’ Discharge Delays, AHA Says

MedCity News

Hospitals are struggling to discharge patients in a timely manner, according to the American Hospital Association. This is often because there are no available spots for patients being transferred to outpatient facilities. To remedy the increased costs hospitals face as a result of this issue, an AHA exec said Medicare should establish a temporary per diem payment for cases in which a patient is ready for discharge but is unable to be discharged appropriately.

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Re-Vana reels in $12M to develop sustained-release eye implants

Fierce Pharma

Re-Vana reels in $12M to develop sustained-release eye implants. ntaylor. Tue, 12/06/2022 - 10:12.

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Report: Employed Individuals Experience Worse Anxiety, Depression Than National Average

MedCity News

The report was commissioned by Wysa, a company that created an AI chatbot for mental health support. It found that 40% of working adults suffer from moderate to severe anxiety and/or depression. Many of these employees would prefer talking to an app about their struggles than someone in their workplace.

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SABCS: After Enhertu's modest showing in neoadjuvant breast cancer, Daiichi Sankyo's clinical oncology chief wants to see more

Fierce Pharma

SABCS: After Enhertu's modest showing in neoadjuvant breast cancer, Daiichi Sankyo's clinical oncology chief wants to see more. fkansteiner. Tue, 12/06/2022 - 17:08.

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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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Centene Invests $7.9M in New Community Center in Uvalde, Texas

MedCity News

The center is in partnership with Community Health Development, Inc. (CHDI), a federally qualified health center. The community center will provide medical care, behavioral health care, youth development resources, college and job preparation services for students and retail space for local businesses. It will also have a tranquility garden honoring the 21 victims of the May 24 shooting at Robb Elementary School.

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EpiPen litigation comes back to haunt Teva a decade after initial settlements

Fierce Pharma

EpiPen litigation comes back to haunt Teva a decade after initial settlements. fkansteiner. Tue, 12/06/2022 - 09:13.

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Activ Surgical Secures CE Mark Approval for ActivSight™ Intelligent Light

Legacy MEDSearch

Activ Surgical, a digital surgery pioneer, announced that it is has received CE Mark approval for its ActivSight Intelligent Light (“ActivSight”). The CE Mark validates that ActivSight meets the requirements of the European Medical Devices Regulation, allowing Activ Surgical to commercialize the enhanced imaging system across the European Union and other CE Mark required regions.

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Virtual Steering Committee & Peer Influence Program: A Customer Story

Impetus Digital

In this customer story, we describe the methodology and results of our client’s ongoing Virtual Steering Committee & Peer Influence program. . As part of this program, the client first engaged 16 physicians and nurses from across the APAC region, virtually. By alternating between asynchronous (over-time, anytime) and synchronous (real-time) virtual meetings –all available on the same, comprehensive online collaboration platform–the client was able to effectively gather insights, co-create an

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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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Why Baptist Health Joined Nuance’s Precision Imaging Network

MedCity News

Nuance recently added Baptist Health and Einstein Healthcare to its precision imaging network, a platform that allows healthcare providers to adopt AI-powered diagnostic imaging tools at the point of care. Joining the network means physicians will have an easier time quickly figuring out which tools make the biggest impact on patient care, Baptist’s chief medical information officer said.

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16 Tips to Help Sales Reps Manage Time, Stay Organized & Boost Efficiency

Spotio

Since the dawn of time, getting sales reps to better organize and manage their days has been plaguing teams from reaching optimum efficiency. Salespeople have been spending more of their time on administrative tasks than they have actually selling. In addition to what you should be doing, sales time management often comes down to what you shouldn’t be doing.

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EMA accepts marketing application for ALS treatment

European Pharmaceutical Review

The European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for tofersen, to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). If approved tofersen, an antisense medicine, could be the first drug to target the rare genetic cause of ALS, which affects less than 1,000 people in Europe and makes up around two percent of ALS cases.

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Ind-Swift Laboratories Ltd-Walk-In Interviews for Packing / Production On 9th Dec’ 2022

Pharma Pathway

Ind-Swift Laboratories Ltd-Walk-In Interviews for Packing / Production On 9th Dec’ 2022. Job Description. Ind-Swift Laboratories Ltd. today is a global manufacture of APIs With regulated 6+ manufacturing sites in Punjab and Jammu we cater to the API need of regulated markets including USFDA, EDQM, PMDA, ANVISA, EU-GMP, KFDA, NMO, ANSM, Cofepris, TGA, WHO, ROW.

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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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France’s ATU reform: early access remains possible, but not all diseases are equal

European Pharmaceutical Review

In July 2021, the French temporary authorisation for use (Autorisation Temporaire d’Utilisation, ATU) programme was the subject of a major reform, initially published within the 2021 healthcare plan on the 14th December 2020 (Article 78 – La Loi de financement de la sécurité sociale , FSSL). Among key changes, the reform introduced the need to meet three criteria: a presumption of innovation compared with the most clinically relevant comparator, an appropriate development plan, and an abse

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Sai Life Sciences Limited- Walk-In Interview for Quality Assurance On 10th Dec’ 2022

Pharma Pathway

Sai Life Sciences Limited- Walk-In Interview for Quality Assurance On 10th Dec’ 2022. Job Description. Sai Life Sciences delivers advanced Discovery, Contract Development and Manufacturing Solutions, through a broad suite of expert capabilities across the molecular lifecycle. Interested and eligible candidates can attend interview on scheduled Time & Venue.

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A historic approval could transform CSL from being ‘the biggest company no one has ever heard of’

PharmaVoice

The company’s head of R&D on its profile-raising FDA approval of a gene therapy that’s now the world’s most expensive drug.

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4 Strategies for Strengthening the Payer-provider Relationship

MedCity News

Given that providers are under increased pressure from CMS to take on some form of downside risk by 2025, they and health plans can utilize these four strategies to make the transition smoother.

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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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Medopharm Pvt. Ltd-Walk-In Interview for Quality Control/ Quality Assurance On 10th Dec’ 2022

Pharma Pathway

Medopharm Pvt. Ltd-Walk-In Interview for Quality Control/ Quality Assurance On 10th Dec’ 2022. Job Description. Walk-In Interview for Quality Control/ Quality Assurance On 10th Dec’ 2022 @ Medopharm Pvt. Ltd. Departments: Quality Control/ Quality Assurance. Qualification: M.Pharm/ B.Pharm/ M.Sc / B.Sc. Experience : Freshers for QC Or 2 to 4 years for QA.

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Pfizer/BioNTech strike back in Moderna COVID vaccine lawsuit

pharmaphorum

Pfizer and partner BioNTech have launched a countersuit against Moderna in a patent despite centring on their mRNA-based vaccines for COVID-19. Moderna fired the first volley back in August, claiming in a Boston court that Pfizer and BioNTech’s Comirnaty vaccine infringes three patents covering its own Spikevax shot, after initially promising it would not enforce its mRNA intellectual property amid the public health emergency.

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The Keys to Success as a Medical Sales Rep

MedReps

What does “success” mean for a medical sales representative? Does it consist of meeting those sales goals every quarter? Developing good customer relationships? Having plenty of industry knowledge and being able to discuss the particulars of your company’s products with just about everyone? Perhaps the keys to success as a medical sales rep consist of a combination of all of these things and more.

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Evidence standard drawn up for digital therapeutics

pharmaphorum

A model framework for generating the evidence to demonstrate the efficacy of digital therapeutics so they can secure regulatory approval and reimbursement has been published by a trade organisation representing digital health companies. The non-profit Digital Therapeutics Alliance (DTA) – working with clinical trials specialist Curebase – has drawn up the document to help encourage the development of DTx products and get them accepted in clinical practice.

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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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Top biopharma firms report Q3 market capitalisation decline

European Pharmaceutical Review

According to a market report by GlobalData, expanding generic drug competition and a drop in demand for COVID-19 vaccines and therapies have lowered the aggregate market capitalisation of the global top 20 biopharmaceutical companies by 9.1 percent from $3.45 trillion in Q2 2022 to $3.14 trillion in Q3 2022. GlobalData’s Pharmaceutical Intelligence Center Companies Database found that 16 of the 20 top biopharmaceutical companies indicated a decline in quarter-on-quarter (QoQ) market capitalisati

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Lupin Limited- Walk-In Interview for B.Sc/ M.Sc/ B.Pharm/ M.Pharm in Quality Control On 10th Dec’ 2022

Pharma Pathway

Lupin Limited- Walk-In Interview for B.Sc/ M.Sc/ B.Pharm/ M.Pharm in Quality Control On 10th Dec’ 2022. Job Description. Walk-In Interview for B.Sc/ M.Sc/ B.Pharm/ M.Pharm in Quality Control @ Vadodara, Gujarat. Lupin Limited is an Indian Multinational pharmaceutical Company based in Mumbai, Maharashtra, India. It is one of the largest generic pharmaceutical Companies by revenue globally.

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Could new 3D material advance drug delivery?

European Pharmaceutical Review

Japanese researchers have created TUS-84, a new three dimensional (3D) covalent organic framework (COF) with scu-c topology for the first time, a material which could facilitate efficient, extended-release drug delivery. The study was published in ACS Applied Materials & Interfaces. The new generation of porous solids are porous organic materials produced from linking molecular building blocks with strong covalent bonds into crystalline, extended, net-like reticular 3D structures.

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Chasing a ‘holy grail’ cancer gene

PharmaVoice

Omega Therapeutics’ president and CEO Mahesh Karande on its attempts to drug the elusive c-Myc gene.

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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.