Fierce Pharma
NOVEMBER 20, 2024
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.
MedCity News
NOVEMBER 22, 2024
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.
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PharmaVoice
NOVEMBER 21, 2024
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.
pharmaphorum
NOVEMBER 22, 2024
The patient affected by a serious adverse event in Neurogene's clinical trial of Rett syndrome gene therapy has now died
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Fierce Pharma
NOVEMBER 20, 2024
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.
MedCity News
NOVEMBER 18, 2024
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.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
pharmaphorum
NOVEMBER 18, 2024
Eli Lilly's tirzepatide has been shown to significantly cut cardiovascular risks in patients with obesity and a form of heart failure with few treatment options, in another big win for the GLP-1 receptor agonist class.The results from the SUMMIT trial of tirzepatide in obese patients with heart failure with preserved ejection fraction (HFpEF) showed that Lilly's drug cut the risk of cardiovascular mortality and worsening heart failure events by 38% over a median follow-up of roughly two years.
Fierce Pharma
NOVEMBER 20, 2024
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.
MedCity News
NOVEMBER 22, 2024
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.
PharmaVoice
NOVEMBER 19, 2024
AbbVie’s head of R&D cures has lofty ambitions to end diseases like HIV through a community of researchers that work as one.
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
pharmaphorum
NOVEMBER 22, 2024
AstraZeneca is facing some pushback as it tries to upgrade anticoagulant antidote drug Andexaa to full approval in the US.
Fierce Pharma
NOVEMBER 20, 2024
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.
MedCity News
NOVEMBER 22, 2024
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.
Pharmaceutical Technology
NOVEMBER 20, 2024
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.
pharmaphorum
NOVEMBER 20, 2024
Sage Therapeutics' run of bad news has continued with a failed phase 2 trial of dalzanemdor as a treatment for Huntington's disease
Fierce Pharma
NOVEMBER 18, 2024
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
MedCity News
NOVEMBER 17, 2024
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.
European Pharmaceutical Review
NOVEMBER 21, 2024
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
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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.
pharmaphorum
NOVEMBER 20, 2024
MSD's subcutaneous formulation of top-selling cancer drug Keytruda was non-inferior to the current intravenous version in a head-to-head trial
Fierce Pharma
NOVEMBER 22, 2024
After six straight quarters in which Eli Lilly or Novo Nordisk achieved the highest year-over-year revenue growth among the top companies in the biopharma industry, there was a new champion in the | After six straight quarters in which Eli Lilly or Novo Nordisk achieved the highest year-over-year revenue increases among the top companies in the biopharma industry, there was a new growth champion in the third quarter.
MedCity News
NOVEMBER 19, 2024
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.
Pharmaceutical Technology
NOVEMBER 22, 2024
Health Canada has issued a Notice of Compliance (NOC) for Johnson & Johnson’s (J&J) CARVYKTI for multiple myeloma treatment.
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pharmaphorum
NOVEMBER 21, 2024
Novartis buys gene therapy specialist Kate Therapeutics for $1.
Fierce Pharma
NOVEMBER 21, 2024
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.
MedCity News
NOVEMBER 20, 2024
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.
Pharmaceutical Technology
NOVEMBER 22, 2024
Novo Nordisk and Ypsomed’s 2023 deal is rumoured to include an autoinjector supply for potential Wegovy successor CagriSema.
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pharmaphorum
NOVEMBER 18, 2024
Using AI-powered PanEcho software for screening ECGs could deliver results more quickly and allow treatment to be started earlier.
Fierce Pharma
NOVEMBER 18, 2024
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.
MedCity News
NOVEMBER 20, 2024
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.
Pharmaceutical Technology
NOVEMBER 21, 2024
Kura has partnered Kyowa Kirin in a strategic global collaboration for developing and commercialising oral ziftomenib to treat AML
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