MedCity News

JULY 14, 2022

Ambient scribing solutions are technical marvels, but in the end, don’t address the root problem of physician documentation. The fundamental goal is to provide an easier way for physicians to take the mental model in their head and put it into the patient’s digital file.

Physicians 119

Physicians 119

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Novartis has withdrawn its request to access Takeda’s documents as part of an investigation over potential trade secrets theft. Novartis has withdrawn its request to access Takeda’s documents as part of an investigation over potential trade-secrets theft.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

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.

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Healthcare Healthcare 122

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.

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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 298

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 278

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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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

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 277

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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Healthcare Healthcare Leads 128

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.

Manufacturing 246

Manufacturing Medicine Pharma 246

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

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 105

Fierce Pharma

AUGUST 28, 2023

It’s been well documented how Novo Nordisk has had difficulty in meeting the soaring demand for its GLP-1 weight loss treatments.

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Medicine 246

World of DTC Marketing

JULY 6, 2022

The McKinsey records include more than 15 years of emails, slide presentations, spreadsheets, proposals and other documents. She added that the newly released documents “expose McKinsey’s role in the opioid crisis and will inform policymakers’ efforts to prevent this from happening again.”.

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Pharma Distribution Prescription Doctors 238

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.

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Medical 120

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 124

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 133

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.

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Marketing Healthcare Healthcare 105

World of DTC Marketing

OCTOBER 21, 2021

billion, with more than half of that devoted to products that did not provide a “documented overall survival benefit” in clinical trials. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 This is another example of just how screwed up our healthcare system really is.

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FDA Insurance Prescription Medicine 234

Pharmaceutical Technology

MARCH 28, 2024

According to the CDC, over 64 cases of measles have been documented in the US in 2024, already exceeding 2023's total of 58.

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PharmaTech

OCTOBER 23, 2024

This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs.

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FDA 111

pharmaphorum

MAY 1, 2024

The MHRA's regulatory sandbox for artificial intelligence as medical device technologies, AI-Airlock, will go live this spring, according to a new strategy document

Medical 111

Medical 111

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.

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Electronics Physicians 103

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 115

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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pharmaphorum

MAY 24, 2024

AffyImmune Therapeutics has recorded what it says is the first documented complete response in a patient with a solid tumour treated with CAR-T therapy.

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Patients 118

European Pharmaceutical Review

JANUARY 25, 2024

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

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Food and Drug Administration FDA Safety Manufacturing 98

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.

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Physicians 98

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 116

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 111

World of DTC Marketing

OCTOBER 25, 2021

While most patients do believe in the efficacy of prescription drugs, JAMA recently reported, “results suggest that the estimated use of new cancer drugs without documented clinical benefit has substantially increased over the past decade, with major cost implications.”

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Healthcare Healthcare Prescription Physicians 257

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 98

PharmaTech

MARCH 7, 2024

FDA has published final guidance documents regarding validation and development of analytical procedures.

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FDA 96

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.

Physicians 116

Physicians Patients 116

World of DTC Marketing

FEBRUARY 7, 2022

The FTC, an antitrust regulator, has requested documents related to a civil investigative demand, similar to a subpoena, on the marketing and approval of the Alzheimer’s drug.” ” To me, an enormous warning flag went up when the VP of Market Access was on a call with the commercial organization (sales).

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Marketing Sales Pharma Management 253

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.

Patients 116

Patients Healthcare Healthcare 116