Tue.Sep 17, 2024

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FDA clears sleep apnoea feature for new Apple Watch

pharmaphorum

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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ADC developed by Daiichi, Merck outperforms chemo in lung cancer trial

Bio Pharma Dive

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

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Podcast: How drones are transforming the clinical supply chain in Africa

Pharmaceutical Technology

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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Nura Bio gets another $68M, new CEO to advance ‘neuroprotective’ brain drugs

Bio Pharma Dive

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

Drugs 306
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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FDA grants RMAT to Poseida’s CAR-T cell therapy P-BCMA-ALLO1

Pharmaceutical Technology

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

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Ascendis trial data piles pressure on BioMarin

Bio Pharma Dive

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.

Trials 284

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‘Really exciting times’: One biotech’s view of radiopharma’s boom

Bio Pharma Dive

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.

Drugs 147
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Biology opens up new frontiers in medicine to cure genetic diseases: Kiran Mazumdar Shaw

AuroBlog - Aurous Healthcare Clinical Trials blog

Biology is opening up new frontiers in medicine. We are witnessing a revolution in healthcare, driven by advances in genetics, Omics, RNA and CRISPR gene-editing technology, to deliver precision and personalised medicine, said Kiran Mazumdar-Shaw, executive chairperson, Biocon and Biocon Biologics. This holds the potential to cure genetic diseases that have plagued families for generations.

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FDA lifts partial clinical hold on Zentalis Pharma’s cancer WEE1 inhibitor  

Pharmaceutical Technology

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

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UKRI’s MRC awards £27.4m to University of Dundee research unit

Pharma Times

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

Research 137
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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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Express Scripts sues FTC over report critical of PBM business practices

Bio Pharma Dive

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

Pharmacy 130
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ESMO 2024: BMS cuts ties as Immatics regains full rights to bispecific

Pharmaceutical Technology

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

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FDA designations boost AI-Driven cell therapy approach for Duchenne muscular dystrophy

BioPharma Reporter

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

Drugs 116
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Equillium collaborates with Vivtex for oral formulation of autoimmune therapy

Pharmaceutical Technology

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

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

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Tobacco firm PMI divests Vectura at a loss after backlash

pharmaphorum

Tobacco giant PMI is selling pharma unit Vectura for a fraction of the £1.

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Express Scripts sues FTC and demands drug pricing report retraction

Pharmaceutical Technology

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

Drugs 130
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F2G raises $100 million to combat innovation 'paucity in antifungals

Outsourcing Pharma

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.

Marketing 110
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Bicara Therapeutics closes $362m IPO in flurry of biotech listing activity

Pharmaceutical Technology

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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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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Trial sets up filings for Boehringer IPF drug nerandolimast

pharmaphorum

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

Drugs 110
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SBTi approves Piramal Pharma’s GHG reduction targets

Pharmaceutical Technology

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

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

pharmaphorum

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

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Sanofi begins shipping BEYFORTUS to US for RSV prevention in infants

Pharmaceutical Technology

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

Vaccine 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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The critical importance of payer-provider collaboration goes beyond prior authorisation

pharmaphorum

This article discusses the critical importance of payer-provider collaboration in the Medicare system, highlighting its impact beyond prior authorisation processes. Learn more about how collaboration between payers and providers can improve patient outcomes and streamline healthcare delivery.

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MaxCyte and Kamau Therapeutics sign platform license agreement

Pharmaceutical Technology

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

Licensing 130
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After FDA no, MSD/Daiichi post new data with lung cancer ADC

pharmaphorum

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.

Drugs 103
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Novartis heaps pressure on Lilly with broad FDA approval for Kisqali in early breast cancer

Fierce Pharma

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.

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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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Boehringer Ingelheim score with phase 3 idiopathic pulmonary fibrosis win

Outsourcing Pharma

The German big pharma will submit a new drug application to the US FDA after success at phase 3 for nerandomilast.

Drugs 98
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Eli Lilly's eczema drug receives FDA approval one year after its initial rejection

BioPharma Reporter

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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CDMO Serán snags $200M Bain-led investment to build its first commercial facility

Fierce Pharma

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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uMotif expands site and patient platform with ClinOne acquisition

Outsourcing Pharma

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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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