Fri.Aug 30, 2024

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Are PBMs to blame for high drug prices in the US?

Pharmaceutical Technology

US Congress labelled pharmacy benefit managers (PBMs) as ‘anticompetitive’; PBMs blame manufacturers for increasing pharmaceutical prices.

Pharmacy 233
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Full study data back Alnylam heart drug’s benefit, but leave doctors with tough choices

Bio Pharma Dive

Detailed results from the Helios-B study support summary findings disclosed in June. But they may not make vutrisiran the standard of care as easily as Alnylam hopes.

Doctor 214
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J&J targets generalised myasthenia gravis landscape with nipocalimab

Pharmaceutical Technology

J&J’s BLA was supported by data from the Phase III VIVACITY study, demonstrating the safety and efficacy of biweekly nipocalimab.

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Novo builds heart failure case for semaglutide; Ventyx CFO departs

Bio Pharma Dive

A new analysis showed semaglutide reduced the risk of worsening heart failure. Elsewhere, the FDA approved a vaccine for mpox and a biotech planned layoffs.

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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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ESC 2024: Latest FLOW trial analysis highlights how Ozempic can benefit CKD patients

Pharmaceutical Technology

If approved, Novo Nordisk's Ozempic will become the first GLP-1 therapy option for patients with type 2 diabetes and chronic kidney disease.

Trials 130
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Emergent's smallpox vaccine picks up FDA nod for mpox as Africa outbreak spreads

Fierce Pharma

As a new deadly strain of mpox continues its global spread, Emergent BioSoultion's smallpox vaccine ACAM2000 has officially joined the ranks of FDA-approved defense measures against the virus. | With the nod, Emergent's vaccine joins Bavarian Nordic's Jynneos as approved protection options to address the continued outbreak in Africa, which was recently deemed a public health emergency.

Vaccine 122

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Eli Lilly partner Hutchmed scraps China stomach cancer filing as approval seems unlikely

Fierce Pharma

Hutchmed, the original developer of Takeda’s Fruzaqla, has decided not to pursue an approval for the VEGFR inhibitor in stomach cancer for now in its home country. | Hutchmed, the original developer of Takeda’s Fruzaqla, has decided not to pursue an approval for the VEGFR inhibitor in stomach cancer in its home country for now thanks to doubts around patients’ overall survival.

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ESC Congress: Amvuttra data signals positive prospects in cardiomyopathy for Alnylam

Pharmaceutical Technology

Alnylam announced positive final results from the Helios-B trial for patients with ATTR amyloidosis with cardiomyopathy at the ESC Congress.

Trials 130
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Novo rekindles heart failure hopes for semaglutide with new pooled analysis

Fierce Pharma

After a regulatory hiccup earlier this month, Novo Nordisk’s heart failure ambitions for its obesity star Wegovy (semaglutide) are starting to get back on track. | Novo’s semaglutide cut the risk of combined cardiovascular death or worsening heart failure events by 31%, based on an incident rate of 5.4% in semaglutide patients versus 7.5% in those on placebo, the company said Friday.

Trials 111
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Nuvectis’ NXP800 gains FDA ODD for cancer treatment

Pharmaceutical Technology

The FDA has granted ODD status to Nuvectis Pharma’s NXP800 for ARID1a-deficient ovarian, fallopian tube and primary peritoneal cancers.

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

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Emergent Bio gets FDA green light for mpox vaccine

pharmaphorum

Emergent BioSolutions has been given FDA approval to extend the indications for its smallpox vaccine ACAM2000 to include the prevention of mpox, currently deemed a public health emergency by the WHO.

Vaccine 108
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EC approves GSK’s RSV vaccine for adults aged 50-59 years

Pharmaceutical Technology

The European Commission (EC) has authorised GSK’s Arexvy for active immunisation against LRTD caused by RSV in adults aged 50 to 59 years.

Vaccine 130
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UK biotech ReNeuron quits AIM as financing push fails

pharmaphorum

Troubled UK biotech ReNeuron will cancel its AIM listing, saying it has been unable to raise the funds it needs to bring it out of administration

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Emergent gains FDA approval for ACAM2000 vaccine for Mpox

Pharmaceutical Technology

Emergent BioSolutions has received FDA approval for ACAM2000 to expand its use for the prevention of Mpox.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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ESC 2024: UK's George Medicines posts positive results for triple-combo blood pressure drug on heels of FDA submission

Fierce Pharma

ESC 2024: UK's George Medicines posts positive results for triple-combo blood pressure drug on heels of FDA submission fkansteiner Fri, 08/30/2024 - 15:54

Medicine 105
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RevolKa secures funds for drug discovery programmes

Pharmaceutical Technology

RevolKa has closed a Series A extension funding round, securing Y250m ($1.7m) to expedite drug discovery programmes.

Drugs 130
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Pharma Pulse 8/30/24: Medication Mistakes Pharmacists Want You to Stop Making, Express Scripts to Remove Humira & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Cholecystokinin Receptor Type A drugs in development, 2024

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the Cholecystokinin Receptor Type A pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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BioMarin's change in direction claims more jobs

pharmaphorum

BioMarin wields axe again, slashing 225 positions from its global workforce as it continues a major restructuring drive

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Procollagen Proline Dioxygenase drugs in development, 2024

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the Procollagen Proline Dioxygenase pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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Top 10 Largest Publicly Traded Pharma and Biotech Companies in 2024 by Market Cap

XTalks

The pharma and biotech sectors have been leaders of innovation and economic growth in 2024. As this industry navigates evolving healthcare demands, it demonstrates remarkable resilience. This trend aligns with the broader surge in biotech stocks , which have outperformed many other sectors this year, fueled by a series of high-impact drug approvals, mergers and a promising pipeline of next-generation therapies.

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P Selectin Glycoprotein Ligand 1 drugs in development, 2024

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the P Selectin Glycoprotein Ligand 1 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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How CTMS Enhances Clinical Trial Efficiency and Compliance

Cloudbyz

Clinical trials are the backbone of medical advancements, but their complexity and the regulatory environment pose significant challenges to researchers, sponsors, and clinical trial managers. The introduction of Clinical Trial Management Systems (CTMS) has revolutionized how trials are conducted by streamlining operations, enhancing regulatory compliance, and reducing the risk of errors.

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Platelet Glycoprotein 4 drugs in development, 2024

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the Platelet Glycoprotein 4 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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How the Life Sciences Innovative Manufacturing Fund can boost funding for pharma

pharmaphorum

Discover how the Life Sciences Innovative Manufacturing Fund can help boost funding for pharmaceutical companies. Learn how this fund can support innovation and growth in the life sciences sector.

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CD44 Antigen drugs in development, 2024

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the CD44 Antigen pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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J&J launches gMG market bid with nipocalimab filing

pharmaphorum

J&J files FcRn blocker nipocalimab for generalised myasthenia gravis (gMG) in US, setting up a challenge to rival drugs from Argenx and UCB

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Acute On Chronic Liver Failure (ACLF) drugs in development, 2024

Pharmaceutical Technology

GlobalData tracks 15 drugs in development for Acute On Chronic Liver Failure (ACLF) by 11 companies/universities/institutes. The top development phase for Acute On Chronic Liver Failure (ACLF) is preclinical, with seven drugs in that stage.

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Alnylam's Amvuttra turns in 'grand slam' showing in ATTR-CM, but leaves a window open for rivals

Fierce Pharma

Alnylam is circling the bases after walloping—in the words of chief medical officer Pushkal Garg M.D.—a “grand slam” with data that position its RNA silencer Amvuttra (vutrisiran) to potentially be | At the European Society of Cardiology conference in London, Alnylam presented positive data from the phase 3 HELIOS-B trial which assessed RNA silencer Amvuttra (vutrisiran) as a treatment for transthyretin amyloid cardiomyopathy (ATTR-CM).

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Corneal Dystrophy drugs in development, 2024

Pharmaceutical Technology

GlobalData tracks 25 drugs in development for Corneal Dystrophy by 24 companies/universities/institutes. The top development phase for Corneal Dystrophy is preclinical, with nine drugs in that stage.

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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.