Sat.Nov 16, 2024 - Fri.Nov 22, 2024

article thumbnail

AstraZeneca to go on defense for Andexxa as FDA questions bleeding reversal agent's safety ahead of adcomm

Fierce Pharma

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

Safety 288
article thumbnail

Market Trends to Watch for Health Systems and Their Specialty Pharmacies

MedCity News

The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. The post Market Trends to Watch for Health Systems and Their Specialty Pharmacies appeared first on MedCity News.

Marketing 124
article thumbnail

Keytruda represents almost half of Merck’s sales, and a new formulation could fend off rivals

PharmaVoice

A subcutaneous version of Merck’s Keytruda was as effective as the infused version in a late-stage study, but the company won’t be the first to market.

Sales 116
article thumbnail

AbbVie’s Elahere wins European approval for certain ovarian cancers

Pharmaceutical Technology

The decision in Europe follows an approval granted by the US Food and Drug Administration (FDA) in March this year.

article thumbnail

5 Ways You Can Win Faster with Gen AI in Sales

Incorporating generative AI (gen AI) into your sales process can speed up your wins through improved efficiency, personalized customer interactions, and better informed decision- making. Gen AI is a game changer for busy salespeople and can reduce time-consuming tasks, such as customer research, note-taking, and writing emails, and provide insightful data analysis and recommendations.

article thumbnail

Roche files patent suit to fend off potential Evrysdi generics from Zydus, Natco

Fierce Pharma

Roche's spinal muscular atrophy (SMA) medicine Evrysdi only gained its FDA approval in 2020, but generics companies are already eying the blockbuster as a potential target. | The spinal muscular atrophy drug is a growth driver for the Swiss pharma giant, prompting the company to prioritize its defense against potential generics.

Medicine 309
article thumbnail

Value-Based Care Is a Four Layer Cake — Why Do We Only Focus on The Icing?

MedCity News

During a recent panel discussion, three healthcare experts discussed reasons why value-based care is struggling to reach scale. The post Value-Based Care Is a Four Layer Cake — Why Do We Only Focus on The Icing? appeared first on MedCity News.

More Trending

article thumbnail

Daiichi Sankyo and AstraZeneca’s Enhertu snubbed by UK’s NICE for third time 

Pharmaceutical Technology

The UK’s NICE has rejected a deal for the reimbursement of Daiichi Sankyo and AstraZeneca's breast cancer drug Enhertu for the third time.

102
102
article thumbnail

Johnson & Johnson, Merck lay off workers in China as local headwinds take a toll

Fierce Pharma

Johnson & Johnson and Merck are laying off workers in Chi | Johnson & Johnson and Merck are laying off workers in China, according to a story from Bloomberg which cites reports from Chinese news outlets.

286
286
article thumbnail

GSK Wagers $80M on a Tech Platform and Parkinson’s Drug from Flagship-Founded Vesalius

MedCity News

Vesalius Therapeutics’ AI-based technology finds novel targets and intervention points for subgroups of patients within a common disease. A small molecule that Vesalius has been developing for a novel Parkinson’s disease target is now headed to GSK, which has licensed global rights. The post GSK Wagers $80M on a Tech Platform and Parkinson’s Drug from Flagship-Founded Vesalius appeared first on MedCity News.

Patients 114
article thumbnail

AI could 'cut ECG result wait times and speed up treatment'

pharmaphorum

Using AI-powered PanEcho software for screening ECGs could deliver results more quickly and allow treatment to be started earlier.

102
102
article thumbnail

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.

article thumbnail

Easing the mental health burden with psychedelic therapies – what’s next for the regulatory and clinical landscape?

European Pharmaceutical Review

In June, the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) rejected 1 Lykos Therapeutics’ psychedelic new drug application (NDA) for midomafetamine (MDMA) capsules used alongside MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) in adults. With the recent failure of Lykos’ trial, how do you see the future of psychedelic therapies in research, especially in treating disorders like depression, PTSD, and substance use diso

article thumbnail

Jazz's HER2 bispecific snags FDA nod, teeing up showdown with AZ and Daiichi's Enhertu

Fierce Pharma

A bispecific antibody has entered the HER2 fray with a differentiated profile from traditional agents and a chance to challenge AstraZeneca and Daiichi Sankyo’s star antibody-drug conjugate Enhertu | A bispecific antibody has entered the HER2 fray with a differentiated profile from traditional agents and a chance to challenge AstraZeneca and Daiichi Sankyo’s star ADC Enhertu.

FDA 284
article thumbnail

Patient Dies in Gene Therapy Trial, But FDA Permits Neurogene to Proceed With Low Dose

MedCity News

A patient death in a clinical trial usually prompts the FDA to impose a clinical hold. But Neurogene is able to avoid a lengthy clinical trial pause largely because of its participation in an FDA pilot program intended to speed up the development of therapies for rare diseases. The post Patient Dies in Gene Therapy Trial, But FDA Permits Neurogene to Proceed With Low Dose appeared first on MedCity News.

FDA 103
article thumbnail

Sage wilts as Huntington's prospect flunks trial

pharmaphorum

Sage Therapeutics' run of bad news has continued with a failed phase 2 trial of dalzanemdor as a treatment for Huntington's disease

article thumbnail

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

article thumbnail

Health Canada issues NOC to J&J’s CARVYKTI for multiple myeloma

Pharmaceutical Technology

Health Canada has issued a Notice of Compliance (NOC) for Johnson & Johnson’s (J&J) CARVYKTI for multiple myeloma treatment.

98
article thumbnail

Despite fears over RFK Jr. pick, industry should focus more on FDA job: analyst

Fierce Pharma

Robert F. | In a contrarian take offered by BMO Capital Markets' Evan Seigerman, the analyst said Robert F. Kennedy Jr. may not rock the boat as much as feared for the biopharma industry.

Biopharma 271
article thumbnail

Twin Brothers Launch Seen Health with $22M to Provide Culturally-Focused Care for Seniors

MedCity News

Seen Health emerged from stealth on Monday. The company builds on the Program of All-Inclusive Care for the Elderly model and focuses on Asian and Pacific Islander communities. The post Twin Brothers Launch Seen Health with $22M to Provide Culturally-Focused Care for Seniors appeared first on MedCity News.

109
109
article thumbnail

Modernising drug delivery through gel-based technology

European Pharmaceutical Review

Accessibility, as well as optimised nutrient and medicine release, are the driving forces behind modernising drug delivery. With millions around the world struggling with dysphagia and other conditions that affect their ability to take pills and other medications, innovative delivery methods with gel-based platforms are necessary to promote greater accessibility and medication adherence.

article thumbnail

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

article thumbnail

“No magic wand” for Novo Nordisk, as CagriSema pen supply rumours swirl

Pharmaceutical Technology

Novo Nordisk and Ypsomed’s 2023 deal is rumoured to include an autoinjector supply for potential Wegovy successor CagriSema.

98
article thumbnail

Sanofi lays out €40M to beef up transplant, diabetes drug production in France

Fierce Pharma

With several high-profile manufacturing outlays already in the books in Europe this year, Sanofi is returning to the bloc in a bid to boost production for a long-approved transplant treatment and a | Sanofi has unveiled a 40 million euro investment at its Lyon Gerland biomanufacturing site in France. The cash infusion will help bolster local production of the company’s polyclonal antibody Thymoglubulin for kidney transplant rejection, as well as expected future capacity needs for the type 1 diab

article thumbnail

World Class Health Snags $8M To Expand Global Centers of Excellence Network

MedCity News

World Class Health’s $8 million in seed funding was led by AlleyCorp. The company serves self-funded employers and offers access to a global centers of excellence network. The post World Class Health Snags $8M To Expand Global Centers of Excellence Network appeared first on MedCity News.

article thumbnail

The Dodgers’ World Series run brought attention to a rare disease. Annexon is stepping up to the plate.

PharmaVoice

The company is looking to score an FDA nod for its investigational therapy that targets a molecule linked to Guillain-Barré syndrome and other autoimmune diseases.

FDA 98
article thumbnail

10 Ways to Leverage Buyer Signals and Drive Revenue

In today’s ultra-competitive markets, it’s no longer enough to wait for buyers to show obvious signs of interest. Instead, sales teams must be proactive, identifying and acting on nuanced buyer behaviors — often before prospects are fully ready to make a purchase. In this eBook from ZoomInfo & Sell Better, learn 10 actionable ways to use these buyer signals to transform your sales strategy and close deals faster.

article thumbnail

Kura Oncology partners Kyowa Kirin to advance AML treatment

Pharmaceutical Technology

Kura has partnered Kyowa Kirin in a strategic global collaboration for developing and commercialising oral ziftomenib to treat AML

98
article thumbnail

Taking its best shot at Roche, Merck scores in phase 3 trial of subcutaneous Keytruda

Fierce Pharma

Two months after Roche scored FDA approval for its subcutaneous ve | Two months after Roche scored FDA approval for its subcutaneous version of PD-LI inhibitor Tecentriq, Merck has achieved a key milestone in lining up its checkpoint inhibitor Keytruda to follow suit. On Tuesday, the company revealed that its subcutaneous formulation of Keytruda has aced a phase 3 trial, demonstrating non-inferiority to the immunotherapy’s intravenous version.

FDA 276
article thumbnail

Telehealth Advocates Praise DEA’s 3rd Extension of Telemedicine Flexibilities, but Call for Further Action

MedCity News

The DEA recently announced the third extension of Covid-19 flexibilities for the virtual prescribing of controlled substances. Telehealth advocates applaud this move but remain hopeful for a more permanent solution in the future. The post Telehealth Advocates Praise DEA’s 3rd Extension of Telemedicine Flexibilities, but Call for Further Action appeared first on MedCity News.

116
116
article thumbnail

How Copyright Clearance Center’s Michael Healy Advocates for ‘Responsible AI‘

Copyright Clearance Center

In a rapidly evolving publishing landscape, the executive director of the CCC is taking the lead on addressing one of the industry’s most pressing concerns: the use of copyrighted material in artificial intelligence systems.

Leads 98
article thumbnail

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

article thumbnail

Wes Streeting says patients should view data sharing ‘the same as taxes’

Pharmaceutical Technology

UK Health Secretary Wes Streeting outlaid the key shifts needed to fix a “fragmented” NHS at the Jefferies London Healthcare Conference.

article thumbnail

Roche's Vabysmo shows potential to treat eye disorder common in Asia

Fierce Pharma

Few pharmaceutical products have taken the market by storm like Roche’s Vabysmo. | Interim results from a late-stage trial of Roche's Vabysmo on Asian patients with polypoidal choroidal vasculopathy suggest that the injected treatment is effective. After 16 weeks, patients showed vision improvement which was equivalent to reading roughly one and a half more lines on an eye chart.

article thumbnail

Startup Valora Unveils a Sweet Way to Stop Cancer and Autoimmune Disease, Plus $30M for R&D

MedCity News

Valora Therapeutics’ antibody lectin chimeras, or AbLecs, target glyco-immune checkpoints, pathways that modulate cellular communication with the immune system. The startup’s science is based on research from Carolyn Bertozzi, a Stanford professor who was awarded the 2022 Nobel Prize in Chemistry. The post Startup Valora Unveils a Sweet Way to Stop Cancer and Autoimmune Disease, Plus $30M for R&D appeared first on MedCity News.

Biopharma 107
article thumbnail

GSK drug raises hopes for patients with PBC itch

pharmaphorum

GSK has reported promising phase 3 results with linerixibat in treating severe itching that plagues patients with primary biliary cholangitis

article thumbnail

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.