Fierce Pharma

JUNE 7, 2023

On Wednesday, that vision came into better focus as the FDA released a document showing how the agency views the drug. . | As Alzheimer's partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval.

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FDA 322

MedCity News

FEBRUARY 6, 2024

The San Francisco-based company offers tools to alleviate clinicians’ burnout by helping them with documentation, coding, referrals and after-visit summaries. SaaS startup Ambience Healthcare raised $70 million from investors including OpenAI, Andreessen Horowitz, Optum Ventures and Kleiner Perkins.

Healthcare 305

Healthcare Healthcare 305

MedCity News

SEPTEMBER 17, 2023

A recent academic study of the leading LLM AI models’ ability to read and interpret clinical information demonstrates the incredible power of these tools to support healthcare, but concludes that LLMs should be used as “a supplement to existing workflows rather than as a replacement for human expertise.”

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Leads Healthcare Healthcare 321

MedCity News

JANUARY 24, 2025

The program has been going on for a little more than a year and Amy Rosa, the health systems chief nursing informatics officer, says the initiative is already resulting in increased efficiency, documentation accuracy and patient safety. The post Why Sentara Health Invested $11M Into iPhones for Nurses appeared first on MedCity News.

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Safety Patients Healthcare Healthcare 289

MedCity News

JULY 6, 2025

From mobile documentation to emergency handoffs, EMS providers handle sensitive patient information in fast-moving environments. Understanding how HIPAA applies — and how to comply — can improve care, reduce risk, and build systemwide trust.

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Patients 274

MedCity News

MARCH 2, 2023

Abridge announced the largest deployment of its technology to date — the University of Kansas Health System will adopt the software for more than 1,500 of its physicians across 140 locations. The startup’s technology listens to visits and creates a near-instant summary that adheres to physicians’ prototypical note structure.

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Physicians Medical 264

Infuse Medical

APRIL 8, 2024

Software documentation plays a pivotal role in the success of any software product. However, traditional documentation often needs to engage users effectively. It is where the integration of immersive visuals comes into play, revolutionizing the way software documentation is presented and consumed.

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Engineering Media Marketing Distribution 130

MedCity News

JUNE 9, 2025

[Sponsored] A new independent study from Phyx Primary Care’s Innovation Lab points to measurable improvements in physician burnout, documentation efficiency, and key VBC metrics among primary care practices. The post Navina’s AI Copilot Eases the Value-Based Burden, Study Shows appeared first on MedCity News.

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Physicians Healthcare Healthcare 256

MedCity News

JUNE 11, 2025

[Sponsored] AI can free up 20% of nurses’ time by reducing documentation, which takes up to 60% of their shifts, helping combat burnout and improve patient care. The post 7 Ways AI Is Helping Nurses and Transforming Healthcare appeared first on MedCity News.

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Healthcare Healthcare Patients Medical 243

MedCity News

NOVEMBER 28, 2023

Developed as part of the due diligence process for the disclosure of confidential documents, VDRs provide a secure repository for all types of confidential materials including merger and acquisition (M&A) documents, financial statements, contracts, intellectual property details, and legal agreements.

Medical 300

Medical 300

MedCity News

SEPTEMBER 18, 2023

The most developed project under this initiative is a pilot that began in February in which HCA’s emergency department physicians are testing a voice-enabled medical dictation tool to save them time on clinical documentation.

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Physicians Healthcare Healthcare Medical 312

Fierce Pharma

NOVEMBER 22, 2023

Novartis has withdrawn its request to access Takeda’s documents as part of an investigation over potential trade secrets theft. Novartis has withdrawn its request to access Takeda’s documents as part of an investigation over potential trade-secrets theft.

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MedCity News

NOVEMBER 30, 2023

By revisiting practice workflows to implement more strategic habits of communication and documentation, clinicians can promote positive outcomes and mitigate practice liability risks at a time when patients maybe accessing care from myriad sources, some online.

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Patients Medical 334

MedCity News

JUNE 21, 2023

I interview Punit Singh Soni, CEO of Suki and Niall O’Connor, CTO, Cohere Health to evaluate two areas where AI can have an outsize impact: clinical documentation and prior authorization.

Electronics 258

Electronics Physicians 258

MedCity News

JUNE 24, 2025

To do that, providers must actively engage, document their impact, and advocate for their inclusion in evolving models of care. The CMS vision is ambitious, but so is the potential for rehab therapy to shape its execution. The post What the New CMS Strategy Signals for Rehab Professionals appeared first on MedCity News.

Healthcare 191

Healthcare Healthcare 191

MedCity News

MARCH 11, 2024

The solution is a portable tablet device designed to provide clinicians with point-of-care support — it flags care and coding gaps, assists with clinical documentation and advises clinicians on possible diagnosis pathways.

Marketing 264

Marketing Healthcare Healthcare 264

MedCity News

MAY 8, 2023

Hire and lean on your quality expert to formalize documents to meet requirements, find gaps in best practices, and utilize internal audits to verify standards are being followed. Ensuring Quality is the best first step any company, especially startups, can take steps toward preparing for future changes to LDT regulations.

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MedCity News

DECEMBER 11, 2023

The future of clinical research is a connected user experience with automated workflows, streamlined document exchange and transparency to accelerate studies without compromising compliance.

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Management Biopharma 289

MedCity News

AUGUST 16, 2023

Epic announced that it will integrate Abridge’s clinical documentation tool into its EHR workflow. The startup’s generative AI tool listens to visits and creates a near-instant summary that adheres to physicians’ prototypical note structure.

Physicians 246

Physicians 246

MedCity News

OCTOBER 14, 2022

By making documentation and images easily transferrable immediately after the imaging is performed, clinician workflow can be simplified. With modern point-of-care ultrasound workflows, healthcare providers can easily share patient information and provide optimal care.

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Physicians Healthcare Provider Healthcare Healthcare 290

MedCity News

NOVEMBER 2, 2022

Voice-enabled technology powered by AI reduces documentation time by several hours per week, but physicians won’t adopt a solution unless it’s affordable and intuitive.

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Physicians 279

Fierce Pharma

FEBRUARY 27, 2024

BioMarin has provided documents to the U.S. BioMarin has provided documents to the U.S. Department of Justice in response to a subpoena which requested information on the company’s government-sponsored testing programs for enzyme replacement therapies Vimizim and Naglazyme.

Government 244

Government 244

Fierce Pharma

JUNE 6, 2024

. | In an eight-observation Form 483, the FDA chided Hengrui for a laundry list of manufacturing missteps, including poor contamination controls, subpar cleaning protocols, failure to promptly hand over documentation to inspectors and quality control shortfalls.

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Manufacturing FDA 295

MedCity News

AUGUST 22, 2023

It comprises four different solutions — one for answering healthcare executives’ questions about their business metrics, one for automating care planning and documentation, one for generating clinical visit summaries, and one for streamlining workflows at contact centers. Innovaccer announced a new suite of healthcare products.

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Doctors Management Healthcare Healthcare 246

MedCity News

MARCH 17, 2023

CMS should honor its commitment to Medicare beneficiaries, especially those who began home respiratory therapy under the PHE, without requiring them to “restart” the documentation process. Requiring requalification would also be a nightmare for physicians who are already overwhelmed with patient demands.

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Physicians Patients 290

MedCity News

MARCH 17, 2023

Without a new set of tools that clinicians can access at the point of care, the availability of information from QHINs will increase provider burdens because they will struggle to find the information needed to evaluate a patient, take action, complete documentation, and move to the next patient.

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Patients Healthcare Healthcare 290

MedCity News

JULY 31, 2023

With this approach, Amazon is seeking to collaborate with companies that are building clinical documentation AI apps rather than compete with them. Amazon recently unveiled HealthScribe, an API that software companies can use to create clinical note generation apps that providers can later adopt.

Competition 246

Competition Physicians 246

Fierce Pharma

SEPTEMBER 11, 2024

Ahead of an advisory committee meeting slated for Friday, the FDA unleashed damning briefing documents calling into question the effectiveness and safety of Intercept’s rare liver disease drug Ocaliva. For Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming.

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FDA Safety Pharmaceutical Marketing 276

MedCity News

MARCH 3, 2023

James Comer (R-Ky), House Committee on Oversight and Accountability chairman, sent letters to the Office of Personnel Management, Centers for Medicare and Medicaid Services and the Defense Health Agency asking for documents that show how PBMs’ practices are affecting federal government healthcare programs.

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Government Management Healthcare Healthcare 299

MedCity News

AUGUST 30, 2022

In the near future, healthcare organizations will likely need to document how they collect health equity data, screen patients for social determinants of health, and address disparities in care.

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Healthcare Healthcare Patients 264

Fierce Pharma

OCTOBER 3, 2023

As an FDA advisory committee gears up to discuss the data supporting Amgen’s Lumakras, a pre-meeting briefing document from the agency suggests the KRAS inhibitor might have a tough road ahead. |

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FDA 274

Fierce Pharma

JULY 2, 2024

. | The FTC has launched an investigation into Teva over the Israeli-American drug giant's refusal to remove roughly two dozen patents for its asthma and chronic obstructive pulmonary disease inhalers, The Washington Post first reported, citing confidential agency documents.

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MedCity News

NOVEMBER 8, 2022

Following an investigation, the AG claimed Express Scripts, “billed and obtained payment for prescription drugs from payers of workers’ compensation claims in excess of amounts permitted by Massachusetts laws and regulations,” according to court documents. .

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Prescription Management 246

Fierce Pharma

MAY 22, 2024

Department of Justice on Wednesday announced that Florida residents Pen Yu, 51, and Gregory Muñoz, 45, each pleaded guilty to one count of wire fraud conspiracy for their roles in a scheme to “fraudulently procure deeply discounted products” from Merck KGaA's MilliporeSigma and export them to China using faked export documents.

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Fierce Pharma

DECEMBER 1, 2023

Less than two weeks after documents were unsealed showing that Texas has accused Pfizer and manufacturer Tris Pharma of providing a compromised ADHD medicine to the state, Paxton has sued Pfizer for “unlawfully misrepresenting the effectiveness” of the company’s COVID-19 vaccine. Texas attorney general Ken Paxton is going after Pfizer—again.

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Manufacturing Medicine Pharma 246

Integrity Solutions

FEBRUARY 12, 2021

Sure, they know the obvious rules—don’t falsify documents, don’t surf inappropriate websites, don’t share trade secrets. This document can address any and all aspects of behavior at work, from interaction with clients and colleagues to email etiquette to “good manners” (e.g., Have everyone, from CEO to receptionist, sign it.

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Training Distribution Education Sales 234

Fierce Pharma

JULY 27, 2023

Catalent’s Brussels factory, responsible for filling the self-injection pens for Novo Nordisk’s obesity blockbuster Wegovy, suffered a number of lapses in recent years and had to shut down twice, a | Catalent’s Brussels factory, responsible for filling the self-injection pens for Novo Nordisk’s obesity blockbuster Wegovy, suffered a number of lapses (..)

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FDA 246