Thu.Aug 29, 2024

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Merck’s Keytruda flunks pivotal studies in early-stage lung and skin cancers

Fierce Pharma

A Merck & Co. effort to move its PD-1 behemoth Keytruda into early treatment of lung cancer has reached a dead end, along with another bid to expand into a type of early-stage skin cancer. | A Merck & Co. effort to move its PD-1 behemoth Keytruda into early treatment of lung cancer has reached a dead end, along with another bid to expand into a type of early-stage skin cancer.

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The Promise of Value-Based Care and MedTech Innovation

MedCity News

Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. The post The Promise of Value-Based Care and MedTech Innovation appeared first on MedCity News.

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AbbVie's Ubrelvy wards off migraines when used in reaction to early warning signs: study

Fierce Pharma

Despite competing against several drugs that have been approved to fend off migraine headaches, AbbVie’s Ubrelvy (ubrogepant) —which is approved only to treat them—has carved out a significant nich | Recent trial results indicate that AbbVie's migraine treatment Ubrelvy works as a preventative. In a study published this week in the journal Neurology, Ubrelvy was 73% more effective in preventing a migraine attack than placebo.

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Aetna Expands Access To Fertility Services, Covers IUI

MedCity News

Aetna will begin covering intrauterine insemination. It is the first major insurer to update this coverage policy nationwide, the payer claimed. The post Aetna Expands Access To Fertility Services, Covers IUI appeared first on MedCity News.

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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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IRA biosimilar measure intended to boost uptake so far has 'limited' impact: report

Fierce Pharma

It’s been two years since the Inflation Reduction Act was passed, and while the law's Medicare-negotiated price cuts haven’t yet gone into effect, a change surrounding biosimilar reimbursement rate | The Inflation Reduction Act features a five-year boost in Medicare Part B reimbursement rates for biosimilars. The measure was intended to boost uptake, but has it worked so far?

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Elation Health Launches Its Own Clinical Documentation Tool

MedCity News

Primary care EHR company Elation Health recently launched an AI-powered ambient note generation tool called Note Assist. The tool is now competing with those made by Microsoft, Abridge, DeepScribe and Suki. The post Elation Health Launches Its Own Clinical Documentation Tool appeared first on MedCity News.

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In the Pharmaceutical Industry, Ethics are Still More Valuable Than AI

MedCity News

This responsibility goes beyond mere box-ticking; it requires a deep, introspective examination of our own biases and blind spots and a genuine commitment to putting the well-being of the communities we serve first. The post In the Pharmaceutical Industry, Ethics are Still More Valuable Than AI appeared first on MedCity News.

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Fierce Pharma Asia—Sanofi's flu shot setback; DualityBio's IPO plan; UCB's China asset sale

Fierce Pharma

Sanofi has suspended distribution of its two flu vaccines in China out of concern of waning potency. BioNTech's antibody-drug conjugate partner, DualityBio, has filed for a Hong Kong IPO. | Sanofi has suspended distribution of its two flu vaccines in China. BioNTech's ADC partner, DualityBio, has filed for a Hong Kong IPO. UCB will offload some Chinese assets for $680 million.

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Neurocrine slides as schizophrenia data disappoints

pharmaphorum

Shares in Neurocrine Biosciences took a tumble after it reported mid-stage data for a key pipeline drug for schizophrenia that failed to impress investors

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Cancer Biotech Repare Therapeutics Restructures to Focus on Clinical-Stage Pipeline

MedCity News

Repare Therapeutics is cutting discovery and preclinical work to focus on its clinical-stage cancer drugs. The most advanced program is camonsertib, whose rights Repare recently regained from Roche after the pharma giant terminated an alliance started in 2022. The post Cancer Biotech Repare Therapeutics Restructures to Focus on Clinical-Stage Pipeline appeared first on MedCity News.

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

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Women's health DTx developer Curio raises funds for PPD app

pharmaphorum

Digital health firm Curio raises $10m+ in first-round financing that will be used to fund the rollout of its MamaLift Plus app for postpartum depression

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HDA 2024 Traceability Seminar: A Legal Perspective Regarding DSCSA

Pharmaceutical Commerce

Panel offers suggestions on how compliance teams should be considering handling SOPs, stabilization, and much more.

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GSK gets EU okay for RSV shot in younger age group

pharmaphorum

GSK gets EU approval for its RSV vaccine Arexvy in a younger age group, a potential leg-up in a market tussle with Pfizer and Moderna

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Their Alzheimer’s treatment worked — but shares fell anyway

PharmaVoice

Cognition Therapeutics touted what the C-suite saw as a promising mid-stage study in Alzheimer’s, but investors read a different story.

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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

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Push for self-injected drugs prompts Novartis/Lindy alliance

pharmaphorum

Novartis partners with startup Lindy in a near-$1bn deal to develop subcutaneous formulations of biologic drugs

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Patients Everywhere Deserve Safer Care – Here’s How We Get There

MedCity News

Healthcare organizations tend to view issues in pockets – how they are impacting their specific organization and region – but patient safety is a collective mission. No matter what hospital or health system they are in, or which care model they belong to, patients everywhere deserve safer care. The post Patients Everywhere Deserve Safer Care – Here’s How We Get There appeared first on MedCity News.

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Innovative pharma-government partnership to enhance UK clinical trials

European Pharmaceutical Review

A major new £400 million public-private collaboration has launched in the UK, aimed at enhancing the life sciences sector’s economic growth and the competitiveness over the next five years. The Voluntary Scheme for Branded Medicine Pricing, Access and Growth (VPAG) Investment Programme is a joint initiative between the Department of Health and Social Care (DHSC), NHS England and the Association of the British Pharmaceutical Industry (ABPI).

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Bayer takes lung cancer therapy hope into phase 3

pharmaphorum

Bayer takes oral anti-HER2 drug into phase 3 for HER2-altered lung cancer, a key pillar of its drive to become a major player in oncology

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pharma Pulse 8/29/24: Talkspace and PTPA Join Forces, Digital Medicines Information & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Claudin 18 drugs in development, 2024

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the Claudin 18 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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Roflumilast Cream Demonstrates Efficacy, Safety Treating Mild to Moderate Atopic Dermatitis in Children

PharmExec

Results of the INTEGUMENT-OLE study found that the roflumilast cream not only maintained but improved its efficacy over time treating children from two to five years of age with mild to moderate atopic dermatitis.

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Steroid 17 Alpha Hydroxylase/17,20 Lyase drugs in development, 2024

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the Steroid 17 Alpha Hydroxylase/17,20 Lyase pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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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 Grants Priority Review to Mirdametinib for Neurofibromatosis Type 1-Associated Plexiform Neurofibromas

PharmExec

Submission of a New Drug Application for mirdametinib included data from the Phase IIb ReNeu trial, which evaluated patients with NF1-associated plexiform neurofibromas causing significant morbidity.

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T Lymphocyte Activation Antigen CD80 drugs in development, 2024

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the T Lymphocyte Activation Antigen CD80 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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AstraZeneca’s Imfinzi Gets Expanded Indication in Lung Cancer on FDA Approval

PharmaTech

Phase III trial results showed that Imfinzi (durvalumab in combination with chemotherapy reduced the risk of recurrence, progression, or death by 32% in patients with resectable non-small cell lung cancer before and after surgery.

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E3 Ubiquitin Protein Ligase CBL B drugs in development, 2024

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the E3 Ubiquitin Protein Ligase CBL B 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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Efgartigimod Alfa Provides Much-Needed Treatment Options for Patients With Generalized Myasthenia Gravis

Pharmacy Times

Pharmacists can provide extra resources for patients, including explanations of the therapy options for the patients, the course of therapy, and what patients can expect.

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Myotonin Protein Kinase drugs in development, 2024

Pharmaceutical Technology

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

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Using AI to drive successful clinical development planning

PharmExec

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

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Growth/Differentiation Factor 15 drugs in development, 2024

Pharmaceutical Technology

GlobalData’s report assesses the drugs in the Growth/Differentiation Factor 15 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.