pharmaphorum

SEPTEMBER 17, 2024

Apple has the FDA authorisation it needs to bring its software for detecting sleep apnoea to the Apple Watch, coinciding with the launch of its new operating system for the wearable.The Breathing Disturbances function is part of watchOS 11, which makes its debut today alongside the release of the latest Apple Watch Series 10 which was revealed at the company's new product reveal earlier this month and is due to become available on 20th September.

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Production 105

Bio Pharma Dive

SEPTEMBER 17, 2024

Summary study results show Ascendis’ drug for achondroplasia could be competitive to BioMarin's Voxzogo, which is the foundation of the latter company's growth plans.

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Trials Drugs 279

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 17, 2024

(Andrew Brookes/Connect Images/Getty Images) The more we know about how depression takes hold in the brain, the better we can prevent and treat it, and new research has identified a brain network that seems to be twice its typical size in most people with depression.

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Scientist Research Clinical Trials Clinical Trials 186

Bio Pharma Dive

SEPTEMBER 17, 2024

The FDA previously rejected patritumab deruxtecan over manufacturing issues. Tuesday's study data should boost the companies' case, however.

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Development Manufacturing Trials 307

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Clinical Supply

Pharmaceutical Technology

SEPTEMBER 17, 2024

Poseida Therapeutics has received RMAT designation from the US FDA for its CAR-T cell therapy, P-BCMA-ALLO1.

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Bio Pharma Dive

SEPTEMBER 17, 2024

The funding will support mid-stage testing of a drug the company believes to have the potential to treat a range of neurodegenerative conditions.

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Drugs 301

Bio Pharma Dive

SEPTEMBER 17, 2024

Backed by Bristol Myers Squibb, Ratio Therapeutics has a front row seat to the pharmaceutical industry’s pivot into the field of targeted radiation drugs.

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Drugs 144

Pharmaceutical Technology

SEPTEMBER 17, 2024

The clinical hold was placed on three studies investigating azenosertib in June after two patients died due to presumed sepsis.

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Bio Pharma Dive

SEPTEMBER 17, 2024

The pharmacy benefit manager said its lawsuit is necessary to protect against misinformation about the industry, while the FTC promised to defend its research.

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Pharmacy Research 130

Pharmaceutical Technology

SEPTEMBER 17, 2024

MaxCyte has entered into a license agreement with Kamau Therapeutics, a clinical-stage company focused on stem cell therapy gene correction.

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Licensing Licensing Gene 130

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

Clinical Trials

Fierce Pharma

SEPTEMBER 17, 2024

An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis and Eli Lilly in early breast cancer. | An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis' Kisqali and Eli Lilly's Verzenio in early breast cancer.

FDA Approval 108

FDA Approval Marketing 108

Pharmaceutical Technology

SEPTEMBER 17, 2024

The partnership will see AI-enabled screening used to address bioavailability issues with Equillium’s cytokine-targeting peptide.

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Bioavailability 130

Fierce Pharma

SEPTEMBER 17, 2024

With a hefty investment led by Bain Capital and a new commercial facility on the horizon, growing CDMO Serán Bioscience is looking to bridge the gap between clinic and market for its cust | With a hefty investment led by Bain Capital and a new commercial facility on the horizon, growing CDMO Serán Bioscience is looking to bridge the gap between clinic and market for its customers.

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Marketing 92

Pharmaceutical Technology

SEPTEMBER 17, 2024

The SBTi has validated and approved India's Piramal Pharma’s near-term greenhouse gas (GHG) emission reduction targets.

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Clinical Supply

Outsourcing Pharma

SEPTEMBER 17, 2024

One year after a rejection by the US Food and Drug Administration (FDA), the UK firm F2G has raised $100 million to push its candidate olorofim to the market for the treatment of rare fungal infections in 2026.

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Marketing Drugs 111

Pharmaceutical Technology

SEPTEMBER 17, 2024

Sanofi has commenced the shipping of BEYFORTUS to the US for healthcare providers and the Vaccines for Children programme.

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Vaccination Vaccine 130

Fierce Pharma

SEPTEMBER 17, 2024

Three months after a jury awarded $260 million to an Oregon woman who claimed | Three months after a jury awarded $260 million to an Oregon woman who claimed that her use of Johnson’s Baby Powder caused her to develop mesothelioma, a state judge has overturned the verdict and granted the company a new trial.

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Trials Development 91

Pharmaceutical Technology

SEPTEMBER 17, 2024

The company claims that the FTC’s July 2024 report is riddled with “false and misleading claims” about the PBM industry.

Drugs 130

Drugs 130

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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.

Clinical Trials

BioPharma Reporter

SEPTEMBER 17, 2024

The FDA has granted Orphan Drug and Rare Pediatric Disease Designations to Somiteâs cell replacement therapy for the treatment of Duchenne muscular dystrophy.

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Drugs Development 116

Pharmaceutical Technology

SEPTEMBER 17, 2024

Drones are starting to play a vital role in the clinical supply chain across sub-Saharan Africa to reach more patients.

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Clinical Supply Chain Clinical Supply 130

Outsourcing Pharma

SEPTEMBER 17, 2024

uMotif, a fast-growing company in the clinical research technology sector, has taken a significant step in expanding its platform with the acquisition of ClinOne, a provider of site platform solutions.

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Clinical Research Research 97

Pharmaceutical Technology

SEPTEMBER 17, 2024

Bicara was one of three biotechs that went public last week in one of the busiest biotech IPO windows this year.

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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

Clinical Research

BioPharma Reporter

SEPTEMBER 17, 2024

The original concerns of the US regulatory agency over the manufacturing of Eli Lillyâs Ebglyss seem to have been resolved, as the FDA greenlit the antibody drug on Friday.

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FDA Approval Drugs Antibody Manufacturing 98

Pharmaceutical Technology

SEPTEMBER 17, 2024

BMS paid $150m upfront to enter a collaborative development deal for bispecific IMA401 with Immatics in 2021.

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Development 130

pharmaphorum

SEPTEMBER 17, 2024

Boehringer will file its idiopathic pulmonary fibrosis drug nerandolimast next year, a successor to its blockbuster Ofev, after a phase 3 win

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Drugs Trials 109

Drug Discovery World

SEPTEMBER 17, 2024

DDW’s Megan Thomas looks at a day in the life of Liam Tremble, Principal Scientist at Poolbeg Pharma. 1. Where do you work, and can you tell us what you’re working on at the moment?  I work at Poolbeg Pharma, where we are developing novel treatments for diseases with unmet medical needs and large addressable markets, with programmes in oncology, infectious diseases and endocrinology.

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Research Scientist Clinical Trials Clinical Trials 88

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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.

Clinical Trials

pharmaphorum

SEPTEMBER 17, 2024

MSD and Daiichi Sankyo's patritumab deruxtecan hit its main objective in a phase 3 lung cancer study that reinforces its potential as a new treatment option for patients after first-line treatment with EGFR inhibitors.The HERTHENA-Lung02 study in EGFR-mutated non-small cell lung cancer (NSCLC), involving patients with locally advanced or metastatic disease previously treated with EGFR drugs, revealed a significant improvement in progression-free survival (PFS) compared to a chemotherapy regimen.

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Drugs 96

Pharma Times

SEPTEMBER 17, 2024

The centre aims to discover new drug targets for diseases such as Parkinson’s and hypertension

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Research Drugs 113

pharmaphorum

SEPTEMBER 17, 2024

Mitigating diagnostic errors in clinical trial participants: The role of drug safety/pharmacovigilance Mike.

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Clinical Trials Clinical Trials Trials Drugs 108

Fierce Pharma

SEPTEMBER 17, 2024

Nearly a year after Coherus BioSciences’ on-body injector for Udenyca was rejected over external production issues, a third-party manufacturer has caused another spot of bother for the Ca | Thanks to “over-commitments and capacity constraints” facing the U.S.-based contractor in charge of final packaging for Coherus' Udenyca, the copycat cancer med will suffer a “temporary” supply interruption, the company said last week.

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Contract Manufacturing Manufacturing Packaging Packaging 61

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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.

Clinical Supply