Tue.Dec 17, 2024

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FDA rejects J&J's subcutaneous Rybrevant filing and AZ's full approval bid for Andexxa

Fierce Pharma

Johnson & Johnson has received coal in its stocking from the FDA as manufacturing issues have tripped up the companys attempt to gain approval of its subcutaneous version of lung cancer drug R | The FDA has sent complete response letters to Johnson & Johnson and AstraZeneca, rejecting J&J's application for subcutaneous Rybrevant and AZ's bid for a full approval of Andexxa.

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WellTheory Announces Women’s Health Program to Address Hormonal Conditions

MedCity News

WellTheory has launched a new program that will address the link between autoimmune disease and hormone imbalances. The post WellTheory Announces Womens Health Program to Address Hormonal Conditions appeared first on MedCity News.

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After studies flag possible link between Novo's Ozempic and rare eye disorder, Danish agency calls for probe

Fierce Pharma

Its not a new question, but it is one that is gaining increased traction: Is there a link between Novo Nordisks diabetes superstar Ozempic and blindness? | After the recent release of two independent studies from the University of Southern Denmark suggested the use of Ozempic increases patients' chances of developing a rare eye disorder, the Danish Medicines Agency has asked European officials to investigate.

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FDA Clears Withings’ New Blood Pressure Monitor That Allows Providers to Communicate Directly with Patients

MedCity News

This week, the FDA granted clearance to Withings BPM Pro 2 cellular blood pressure monitor. The device seeks to help providers scale remote patient monitoring for heart failure patients. The post FDA Clears Withings New Blood Pressure Monitor That Allows Providers to Communicate Directly with Patients appeared first on MedCity News.

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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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Cozadd's coda: Jazz unveils succession plan as longtime CEO and co-founder plots retirement

Fierce Pharma

Its the end of an era at Jazz Pharmaceuticals as the drugmakers co-founder and CEO, Bruce Cozadd, eyes his exit after nearly 22 years with the companysome 15 of which were spent at the helm. | Current helmsman Bruce Cozadd plans to retire from his role at Jazz Pharmaceuticals in the next 12 months, the company said Monday. Jazz aims to complete its search for a CEO successor by the end of 2025, after which Cozadd will stay on board as the drugmaker's board chair.

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The Future of Men’s Healthcare: A Path to Improved Access, Outcomes, and Cost Savings

MedCity News

Telehealth empowers men to take control of their health in a way that is easy, confidential, and fits into their busy lifestyles. The post The Future of Mens Healthcare: A Path to Improved Access, Outcomes, and Cost Savings appeared first on MedCity News.

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Novo Nordisk invests $1.2bn in new Denmark facility

Pharmaceutical Technology

Construction has already begun on the Ozempic-producers new Denmark production facility and 40,000m2 warehouse.

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Sandoz shells out $275M in latest effort to move past 'legacy' price-fixing litigation

Fierce Pharma

Sandoz has agreed to pay another group of plaintiffs in the long-running price-fixing litigation it inherited from former parent company Novartis, marking a further step by the company to leave the | Sandoz has agreed to pay another group of plaintiffs in the long-running price-fixing litigation it inherited from former parent company Novartis, marking a further step by the company to leave the "legacy" allegations behind.

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Teva and Sanofi Mid-Stage Data Reveal Shows Best-in-Class Potential for IBD Drug

MedCity News

The Teva Pharmaceuticals and Sanofi drug, duvakitug, showed statistically significant and clinically meaningful results in a Phase 2b study in ulcerative colitis and Crohns disease. The drug is part of an emerging class of therapies that target TL1A, a protein involved in signaling that drives inflammation. The post Teva and Sanofi Mid-Stage Data Reveal Shows Best-in-Class Potential for IBD Drug appeared first on MedCity News.

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Regeneron's Eylea HD passes key test in retinal vein occlusion, teeing up 2025 FDA filing as Eylea threats mount

Fierce Pharma

With Eylea biosimilar competition creeping in and Roches Vabsymo jockeying for market share in key indications, Regeneron is racing to carve out a new market for the high-dose version of its block | High-dose Eylea demonstrated non-inferiority to the original version of the drug in patients with macular edema following retinal vein occlusion, an indication Eylea has held for a decade.

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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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CTO Europe 2024: keep the burden of trials away from patients, say experts

Pharmaceutical Technology

The two-day event included talks on subjects ranging from how to best utilise AI to how to build a stable CRO.

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Let’s Rethink AI — Patient Intake Is the Perfect Place to Start

MedCity News

Solutions like AI-powered patient intake offer a tangible ROI by streamlining administrative tasks, reducing errors, and improving care quality. The post Lets Rethink AI Patient Intake Is the Perfect Place to Start appeared first on MedCity News.

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China NMPA approves MSD’s KEYTRUDA for stages of NSCLC

Pharmaceutical Technology

China National Medical Products Administration (NMPA) has approved MSDs KEYTRUDA for treating certain non-small cell lung cancer (NSCLC).

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Teva, Sanofi score well with anti-TL1A drug in IBD test

pharmaphorum

Phase 2b results with Sanofi and Teva's duvakitug are exciting and warrant a swift move to phase 3 in inflammatory bowel disease, say the companies.

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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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Biotech bounces back as venture funding grows $3.8m from 2023 to 2024YTD

Pharmaceutical Technology

However, caution persists:166 of 785 US venture-backed companies with an innovator drug in development have not raised capital since 2021.

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German cancer centre treats first patient with Elekta Evo

PharmaTimes

New CT-guided radiotherapy system offers personalised cancer treatment

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GSK’s lung cancer therapy gains EMA PRIME designation

Pharmaceutical Technology

GSKs GSK227 has gained Priority Medicines (PRIME) designation from the EMA for the treatment of relapsed ES-SCLC.

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MindMed begins phase 3 study of MM120 for anxiety disorder

PharmaTimes

First patient dosed in landmark trial for GAD treatment

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

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Bavarian Nordic signs mpox vax deal with Serum Institute of India

Pharmaceutical Technology

Bavarian Nordic has signed a licence and manufacturing agreement with the Serum Institute of India (SII) for its mpox vaccine, MVA-BN.

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Study backs Closed Loop's drug+digital blood pressure plan

pharmaphorum

Closed Loop Medicine's smartphone app for blood pressure monitoring has shown proof-of-concept in the Cure-19 study.

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Pharma’s ‘Best-Kept Secret’

PharmExec

Margaret Keegan, the new CEO of Precision Medicine Group, is eager to elevate the profile of the expert-rich service provider and build it into an industry leader in next-gen drug development and commercialization support.

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Trade & Channel Strategies 2024: Boosting Patient Support & Engagement Across Care Settings

Pharmaceutical Commerce

Cheryl Allen, BS Pharm, MBA, founding partner, Curatio Scientia Advisors, discusses "Enhancing Patient Access and Support Through Technology: A Comprehensive Assessment," and upcoming industry challenges.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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FDA Approves Organon’s Vtama Cream, 1% for Atopic Dermatitis

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Maternal mortality trends remain dire — and researchers face an uphill battle to solve them

PharmaVoice

Rising maternal mortality, particularly among vulnerable populations, stems in part from a lack of research in pregnant women.

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Seeking More Value, Less Cost

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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A biotech’s race to tackle the most severe hepatitis

PharmaVoice

Bluejay Therapeutics is one of just a handful of companies developing treatments for hepatitis D.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Dealmaking Dormant No More

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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CHMP recommends novel long-acting HIV treatment

European Pharmaceutical Review

The Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for a marketing authorisation to approve the first complete long-acting regimen to treat HIV. The regimen comprises of Vocabria (cabotegravir long-acting injections) in combination with Johnson & Johnson Innovative Medicines Rekambys (rilpivirine long-acting injections), as a treatment of HIV-1 infection in virologically suppressed adolescents aged 12 years and over who weigh at least 35 kg.

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Beyond Translation: The Art of Cross-Cultural Communication in Pharma

PharmExec

In this part of her Pharmaceutical Executive video interview, Angela Tenuta, President, Full Service Agencies, at EVERSANA INTOUCH, shares some best practices for pharma companies to ensure their messaging resonates across different cultures and healthcare systems.

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Novo Nordisk to Establish New Production Facility for Rare Disease Therapies in Denmark with DKK 8.5 Billion Investment

PharmaTech

Novo Nordisk will use the DKK 8.5 billion (US$1.2 billion) to build a new modular and flexible production facility in Odense, Denmark, that will produce multiple products for rare diseases.

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A