Sat.Apr 13, 2024 - Fri.Apr 19, 2024

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What Does the FTC’s $7M Fine Against Cerebral Mean for the Industry?

MedCity News

This week, the FTC ordered Cerebral to pay a $7 million fine, accusing the company of mishandling users’ sensitive health data and misleading consumers about cancellation policies. Experts agree that other virtual healthcare providers need to work on their legal and compliance strategies in order to avoid a similar fate. The post What Does the FTC’s $7M Fine Against Cerebral Mean for the Industry?

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Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir

Fierce Pharma

Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year.

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Traditional gene therapies are uber-niche. Ocugen hopes to change that.

PharmaVoice

The biotech is developing a ‘gene-agnostic’ approach to expand the patient pool for gene therapies.

Patients 145
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Smart sensor cleared for use with AZ asthma, COPD inhalers

pharmaphorum

A smart sensor developed by Adherium has been cleared by the FDA for use with AstraZeneca's asthma inhaler Airsupra and Breztri for COPD.

FDA 131
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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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Two CVS Locations Make Moves To Join National Pharmacy Union Movement

MedCity News

Two CVS stores in Rhode Island have filed petitions to join the Pharmacy Guild, which is building a national pharmacy union. The locations are close to CVS Health’s headquarters in Woonsocket, Rhode Island. The post Two CVS Locations Make Moves To Join National Pharmacy Union Movement appeared first on MedCity News.

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Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus

Fierce Pharma

One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.

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‘Stiffness’ of cells could give early warning of cancer

pharmaphorum

Researchers from the UK have developed an endoscopic device that uses 3D imaging to look at the stiffness of cells and could diagnose cancer earlier.

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A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health

MedCity News

Pharmaceutical companies use Feel Therapeutics’ technology to monitor the mental state of participants in clinical trials of behavioral medications. But the startup envisions its technology eventually also finding a place as a part of clinical care. The post A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health appeared first on MedCity News.

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Pfizer, BioNTech win pause in patent infringement case from rival Moderna

Fierce Pharma

After nearly two years of legal back and forth, Pfizer and its German partner BioNTech have won a brief reprieve in their patent fight against mRNA rival Moderna. | In a docket entry dated Friday, Massachusetts federal judge Richard G. Stearns granted a stay on Moderna's COVID-19 vaccine patent infringement lawsuit against Pfizer and BioNTech. The move will give the Patent Trial and Appeal Board more time to review challenges against two of the three relevant patents in the litigation.

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Behind the ‘encouraging’ new results for Amylyx’s beleaguered drug

PharmaVoice

Where Amylyx ultimately failed in ALS, it could prevail in a rare disease. The doctor leading this research explains why.

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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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Regeneron launches $500m venture capital arm

pharmaphorum

Regeneron has formed a corporate venture capital unit with $100 million a year to invest over the next five years in “biopharmaceutical, healthcare, and health technology” start-ups.

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In the World of Interoperability, How to Meaningfully Strengthen Cybersecurity

MedCity News

Achieving strong cybersecurity is a vast, interconnected web that must incorporate the correct software, procedures, and workflows and take into account the human element across an entire organization. The post In the World of Interoperability, How to Meaningfully Strengthen Cybersecurity appeared first on MedCity News.

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Another Caplyta trial win moves Intra-Cellular closer to FDA filing in major depressive disorder

Fierce Pharma

Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug. | Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug.

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Francis Crick researchers reveal pathways linking intestinal inflammation and colitis

PharmaTimes

Affecting over 500,000 people in the UK, IBD comprises Crohn’s disease and ulcerative colitis

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

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Telehealth firm Cerebral faces $7m FTC fine over privacy

pharmaphorum

The FTC is seeking a $7 million fine on telehealth company Cerebral for violating patients' data privacy and making cancellation difficult.

Patients 119
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NationsBenefits, Instacart Team Up To Provide Online Grocery Services

MedCity News

Through a new partnership, health plans that use NationsBenefits can offer Instacart’s grocery delivery services as a supplemental benefit. The post NationsBenefits, Instacart Team Up To Provide Online Grocery Services appeared first on MedCity News.

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Roche snags postsurgery FDA nod for Alecensa, eyes even broader lung cancer use

Fierce Pharma

Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. | Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. The Swiss pharma has now secured an FDA approval in the post-surgical setting as it continues to test the drug in additional patient populations.

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Norgine seeks approval for high-risk neuroblastoma treatment

Pharmaceutical Technology

Norgine has sought approval for eflornithine (DFMO) for the treatment of patients with high-risk neuroblastoma (HRNB).

Patients 111
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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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FDA fast-tracks AskBio’s heart failure gene therapy

pharmaphorum

A gene therapy for heart failure being developed by Bayer’s AskBio unit has been granted fast-track status by the FDA.

FDA 115
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Eli Lilly Shows Obesity Drug Zepbound Can Treat Sleep Apnea Too

MedCity News

Eli Lilly drug tirzepatide, marketed as Zepbound for weight management, has results from two Phase 3 studies showing reductions in the breathing problems caused by obstructive sleep apnea. Lilly is now preparing regulatory submissions to add this indication to the drug’s label. The post Eli Lilly Shows Obesity Drug Zepbound Can Treat Sleep Apnea Too appeared first on MedCity News.

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Sanofi, busy with cost-savings campaign, restructures US commercial vaccine group

Fierce Pharma

During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. | During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. A spokesperson said the company would offer affected employees a chance to apply for new roles, plus "outplacement services.

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India sees insignificant revision to price ceiling in 2024

Pharmaceutical Technology

The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.

Pharma 111
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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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Boehringer says R&D pipeline is the best in its long history

pharmaphorum

Boehringer Ingelheim says the strongest R&D pipeline in its history is set to deliver 25 new product launches between now and 2030

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Included Health Announces New Specialty Care Offering

MedCity News

Included Health’s new specialty care clinic, which will become available in 2025, is starting by offering three centers: the Cancer Center, the Center for Women’s Health and the Center for Metabolic Health. The post Included Health Announces New Specialty Care Offering appeared first on MedCity News.

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Novartis touts surrogate endpoint win, nabs priority review for Fabhalta in IgAN

Fierce Pharma

A Novartis drug with "pipeline in a pill" potential, according to one analyst group, has delivered on that promise once again. | In a phase 3 trial, treatment with Fabhalta led to a statistically significant 38.3% reduction of proteinuria (protein in the urine) in patients with IgA nephropathy, Novartis said on Monday.

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Bio-Rad and Oncocyte partner to develop and commercialise transplant monitoring products

PharmaTimes

Solid organ transplantation is used to treat end-stage organ failure, including the kidneys

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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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FDA clears Roche’s Alecensa for adjuvant use in NSCLC

pharmaphorum

Roche's Alecenesa has become the first ALK inhibitor to be approved by the FDA for adjuvant use in early-stage, ALK+ NSCLC

FDA 115
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Depression Trial Win Moves Intra-Cellular Drug Closer to Label Expansion & Blockbuster Status

MedCity News

Intra-Cellular Therapies reported its drug Caplyta met the main and secondary goals in the first of three pivotal studies in major depressive disorder. Success in two of them could support expanding the label of the drug, which is currently approved in schizophrenia and bipolar depression. The post Depression Trial Win Moves Intra-Cellular Drug Closer to Label Expansion & Blockbuster Status appeared first on MedCity News.

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Shinobi strikes deal with electronics powerhouse Panasonic to create new cell therapy manufacturing platform

Fierce Pharma

History is coming full circle as induced pluripotent stem (iPS) cell-derived cell therapy maker Shinobi Therapeutics links up with Panasonic and Japan’s Kyoto University, where the first mouse iPS | Shinobi Therapeutics has entered an accord with electronics powerhouse Panasonic and Kyoto University in a bid to develop a new closed-system manufacturing device for cheaper and more efficient production of cell therapies.

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Researchers introduce new AI tool to help clinicians capture uncertainty in medical images

PharmaTimes

The Tyche model could help clinicians and researchers capture crucial information in images

Medical 106
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time