Mon.Sep 09, 2024

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Emerging microbiome market – unlocking new frontiers

Pharmaceutical Technology

The microbiome, which consists of a vast array of microorganisms inhabiting the human body, has gained considerable attention for its role in health and disease.

Marketing 130
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HPV Linked to Disturbing Changes in Human Sperm, Scientists Find

AuroBlog - Aurous Healthcare Clinical Trials blog

(Derek Berwin/Getty Images) TThe human papillomavirus (HPV) is responsible for the vast majority of cervical cancer cases, but this isn’t a sexually transmitted infection that just one half of the population needs to worry about.

Scientist 193
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PRV-3279 by Sanofi for Systemic Lupus Erythematosus: Likelihood of Approval

Pharmaceutical Technology

PRV-3279 is under clinical development by Sanofi and currently in Phase II for Systemic Lupus Erythematosus.

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Ophthalmologists eye gene therapies for vision-threatening conditions as NGS facilitates precision diagnosis

AuroBlog - Aurous Healthcare Clinical Trials blog

The convergence of gene therapies and clinical research is pushing the boundaries of what’s possible in ophthalmic care, offering hope for more effective treatments and potential cures for a range of vision-threatening conditions.

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

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KOS-1803 by Bristol-Myers Squibb for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

KOS-1803 is under clinical development by Bristol-Myers Squibb and currently in Phase I for Solid Tumor.

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Early study data puts Terns among obesity drug contenders

Bio Pharma Dive

A once-daily pill the biotech is developing helped some people with obesity lose more than 5% of their weight in a month, spurring a stock bump and plans to bring the drug into further testing.

Drugs 176

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Candid, with $370M, sets out to prove bispecifics’ worth in autoimmune disease

Bio Pharma Dive

The startup believes T cell engagers, rather than cell therapies, will prove the “right horse to bet on” in the race to develop new inflammatory disease treatments, its CEO said.

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Envafolimab by Alphamab Oncology for Merkel Cell Carcinoma: Likelihood of Approval

Pharmaceutical Technology

Envafolimab is under clinical development by Alphamab Oncology and currently in Phase II for Merkel Cell Carcinoma.

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Relay breast cancer drug shows potential in early trial

Bio Pharma Dive

Results from a small study suggest Relay's drug could avoid some of the toxicity associated with existing PI3Ka inhibitors like Novartis' Piqray.

Drugs 176
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Ifetroban by Cumberland Pharmaceuticals for Asthma: Likelihood of Approval

Pharmaceutical Technology

Ifetroban is under clinical development by Cumberland Pharmaceuticals and currently in Phase II for Asthma.

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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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Accelerating Alzheimer’s therapy innovation: A new horizon in blood-based biomarkers

Bio Pharma Dive

The escalating global challenge of Alzheimer's Disease (AD) demands new approaches to detection, diagnosis and treatment.

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Venetoclax by AbbVie for Mantle Cell Lymphoma: Likelihood of Approval

Pharmaceutical Technology

Venetoclax is under clinical development by AbbVie and currently in Phase III for Mantle Cell Lymphoma.

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Digital Solution Implementation

Pharmaceutical Commerce

In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Meghan Mullooly, Archbow Consulting’s Vice President, offers advice to pharma manufacturers for successfully applying digital solutions to their patient support programs.

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CC-115 by Bristol-Myers Squibb for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

CC-115 is under clinical development by Bristol-Myers Squibb and currently in Phase I for Solid Tumor.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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How Chiesi is walking the walk on pharma sustainability

pharmaphorum

Discover how Chiesi is leading the way in pharmaceutical sustainability by partnering with EcoVadis and implementing innovative practices. Learn how they are making a positive impact on the environment and society.

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Alpha-1 proteinase inhibitor (human) second generation by Kamada Pharmaceuticals for Alpha-1 Antitrypsin Deficiency (A1AD): Likelihood of Approval

Pharmaceutical Technology

Alpha-1 proteinase inhibitor (human) second generation is under clinical development by Kamada Pharmaceuticals and currently in Phase II for Alpha-1…

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Top 10 Largest Publicly Traded Medical Device Companies by Market Cap in 2024

XTalks

The medical device industry continues to thrive in 2024, with advancements in technology shaping the future of healthcare. From cutting-edge surgical robotics to innovative diagnostic tools, the top publicly traded medical device companies are delivering solutions that improve patient care and expand the capabilities of healthcare professionals. Abbott, for instance, leads the industry with breakthroughs in diabetes care and diagnostics, while Stryker’s innovations in orthopedic devices and robo

Marketing 105
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Avadomide hydrochloride by Bristol-Myers Squibb for Glioblastoma Multiforme (GBM): Likelihood of Approval

Pharmaceutical Technology

Avadomide hydrochloride is under clinical development by Bristol-Myers Squibb and currently in Phase I for Glioblastoma Multiforme (GBM).

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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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Building Inclusive Science: The Vital Role of Diversity, Equity and Inclusion in Clinical Research

XTalks

Diversity, equity and inclusion (DEI) have become important elements in the landscape of clinical research. It is important for the principles of DEI to be understood for their goals, intended outcomes and applications; otherwise, they may be regarded as mere buzzwords or just another box to tick on organizational mandates. DEI are critical components of building a thriving, fair, all-encompassing, respectful and innovative society.

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Alectinib by F. Hoffmann-La Roche for Inflammatory Myofibroblastic Tumor (IMT): Likelihood of Approval

Pharmaceutical Technology

Alectinib is under clinical development by F. Hoffmann-La Roche and currently in Phase II for Inflammatory Myofibroblastic Tumor (IMT).

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WCLC: Summit trumpets data with Keytruda challenger

pharmaphorum

Summit Therapeutics and Akeso's ivonescimab tops Merck's Keytruda in head-to-head phase 3 trial in first-line NSCLC, reported at WCLC.

Trials 113
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EASD24: PolTREG’s T-cell therapy shows long-term remission in type 1 diabetes

Pharmaceutical Technology

PolTREG plans to start a pivotal Phase II/III trial for its Treg cell therapy after it induced clinical remission in type 1 diabetics.

Trials 130
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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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WCLC: Biomarker could guide Dato-DXd use in lung cancer

pharmaphorum

AI biomarker could help identify lung cancer patients most likely to benefit from AstraZeneca and Daiichi Sankyo's TROP2 drug Dato-DXd.

Drugs 104
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Formosa Pharma ships APP13007 ophthalmic drug to US

Pharmaceutical Technology

Formosa Pharmaceuticals has announced the first shipment of clobetasol propionate ophthalmic suspension 0.05% (APP13007) to the US.

Drugs 130
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ChatGPT outperforms trainee doctors in assessing respiratory illness in children

Pharma Times

Research suggests that LLMs could be used to support trainee doctors, nurses and GPs

Doctor 117
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Alectinib by F. Hoffmann-La Roche for Central Nervous System (CNS) Tumor: Likelihood of Approval

Pharmaceutical Technology

Alectinib is under clinical development by F. Hoffmann-La Roche and currently in Phase II for Central Nervous System (CNS) Tumor.

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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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Teva resolves Baltimore's opioid litigation with $80M settlement

Fierce Pharma

After opting out of Teva’s $4.25 billion national opioid settlement last year, the city of Baltimore has secured its own payout through a settlement deal worth $80 million. | The city scored its own deal after opting not to join in on Teva's $4.25 billion national opioid settlement.

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OrsoBio gains funds to develop obesity portfolio

Pharmaceutical Technology

OrsoBio has secured $67m in a Series B financing round to expedite the development of its mitochondrial protonophore portfolio.

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AstraZeneca's Alexion loses $130M to Syntimmune shareholders in post-merger payment suit

Fierce Pharma

When AstraZeneca’s Alexion picked up rare disease specialist Syntimmune in 2018 for $ | A Delaware judge agreed that AstraZeneca's Alexion breached its contract and failed to pay a milestone payment of $130 million tied to the development of a now scrapped autoimmune candidate originally developed by Syntimmune.

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Epsilogen secures additional funds in Series B for cancer treatment

Pharmaceutical Technology

Epsilogen has raised £12.5m in a Series B expansion financing round to progress the development of IgE antibodies for cancer.

Antibody 130
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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.