Tue.Oct 01, 2024

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5 FDA decisions to watch in the fourth quarter

Bio Pharma Dive

Over the next three months, the agency could approve a rival to a fast-selling Pfizer heart drug, a much-debated lung cancer medicine and an addition to Vertex's dominant cystic fibrosis business.

Medicine 195
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Fresenius Kabi wins FDA approval for Stelara biosimilar Otulfi

Pharmaceutical Technology

Otulfi is the fourth Stelara biosimilar approved in the US but will not launch until early 2025.

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Kailera Therapeutics emerges from stealth with $400M for obesity drugs

Bio Pharma Dive

The company’s official launch comes five months after major investors such as Atlas Venture and Bain Capital filed a Shanghai stock exchange filing for a biotech named “Hercules CM NewCo.

Drugs 317
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Will Water Save You From a Hangover? Science Says Probably Not.

AuroBlog - Aurous Healthcare Clinical Trials blog

(Bambu Productions/DigitalVision/Getty Images) Of all the advice on preventing hangovers, drinking water to prevent dehydration seems like the most sensible. A new study has found no evidence to support claims that drinking a generous amount of water after a night of boozing alleviates the pain the next day.

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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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The top biopharma conferences in 2025

Bio Pharma Dive

Medical meetings often feature important clinical trial results, making them barometers of biotech and pharma companies' research progress. Here’s a list of conferences to watch in 2025.

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Pain management making a paradigm shift towards drug free regimes: Dr Apoorva Shrivastava

AuroBlog - Aurous Healthcare Clinical Trials blog

Pain management is making a paradigm shift towards drug free regimes with active physiotherapy. This not only reduces reliance on medications but also promotes long-term wellness and resilience. Such a holistic approach addresses the root causes of pain and manage the conditions effectively, said Dr.

Drugs 179

More Trending

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Genentech buys Regor’s CDK inhibitors in $850m deal 

Pharmaceutical Technology

Genentech’s parent company Roche said the $850m deal lines up with its plan to focus on three therapeutic areas including oncology.

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October 1, 2024: NIH CARE for Health Issues Awards to Inaugural Research Network Hubs

Rethinking Clinical Trials

The NIH Communities Advancing Research Equity for Health , or CARE for Health , program announced 3 inaugural hubs for its primary care–focused clinical research network. These awards are part of a pilot project to test the feasibility of a research network that expands research opportunities to primary care settings. NIH envisions this approach will accelerate research advances for adoption into everyday healthcare to improve health outcomes and health equity for everyone.

Research 147
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Ascendis Pharma submits sBLA for growth hormone deficiency therapy

Pharmaceutical Technology

Ascendis Pharma has submitted a supplemental biologics licence application (sBLA) to the US Food and Drug Administration (FDA) for TransCon hGH to treat adults with growth hormone deficiency (GHD).

Hormones 147
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Big Pharma's layoff wave in New Jersey rolls on with hundreds of J&J cuts, 57 at Bayer

Fierce Pharma

Johnson & Johnson is laying off 231 employees in New Jersey and Bayer is cutting 57 positions in the state, according to separate Worker Adjustment and Retraining Notification (WARN)

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

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BioCryst secures $69m contract from US to supply RAPIVAB for influenza

Pharmaceutical Technology

BioCryst Pharmaceuticals has received a contract valued at up to $69m from the US Department of Health and Human Services (HHS) for the procurement of RAPIVAB to treat influenza.

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CVS to lay off 2,900 employees amid reports of strategic review

Bio Pharma Dive

As CVS pursues a massive cost-cutting plan — and reportedly considers a potential breakup of its businesses — the healthcare behemoth has decided to cut 1% of its workforce.

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The course to forging long-term manufacturing partnerships for gene therapies

Pharmaceutical Technology

The 12th Annual Outsourcing in Clinical Trials & Clinical Trial Supply Nordics conference provided a venue to discuss the ideal criteria for CDMO partnerships.

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European Commission approves yuvanci for pulmonary arterial hypertension treatment

Pharma Times

Janssen-Cilag therapy becomes the first single tablet combination therapy for PAH in europe

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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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Specialty Pharmacies for the Pharmaceutical Industry

Pharmaceutical Technology

Discover the leading Specialty Pharmacies for the Pharmaceutical Industry. Download the free Buyer's Guide today for full contact details.

Pharmacy 130
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Amid large cost-cutting drive, Pfizer plans manufacturing layoffs in Ireland

Fierce Pharma

No large pharma company has traversed this decade's ups and downs quite like Pfizer. | No large pharma company has traversed this decade's ups and downs quite like Pfizer. As the company rolls ahead with a large restructuring campaign, some staffers in Ireland will soon feel the effects.

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Medication Adherence Solutions for the Pharmaceutical Industry

Pharmaceutical Technology

Discover the leading medication adherence solutions and companies. Download the free Buyer's Guide today for full contact details.

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BMS skates again on $6.4B Celgene shareholder lawsuit but is still not free from another filing

Fierce Pharma

For the second time in 19 months, a federal judge in New York has dismissed a lawsuit claiming that Bristol Myers Squibb slow-walked its request for FDA approval of blood cancer drug Breyanzi to av | For the second time in 19 months, a federal judge in New York has dismissed a lawsuit claiming that Bristol Myers Squibb slow-walked its request for FDA approval of blood cancer drug Breyanzi to avoid paying $6.4 billion to Celgene shareholders in contingent value rights.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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BMS and Prime ink potential $3.5bn deal to develop T cell therapies

Pharmaceutical Technology

As part of the deal, which could be worth $3.5bn, BMS will gain developmental support and therapeutic reagents from Prime Medicine.

Reagent 130
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Calculating the Regulatory Review Period for Patent Term Extension: A Comprehensive Guide

Drug Patent Watch

In the complex world of intellectual property and pharmaceutical development, understanding the intricacies of patent term extension (PTE) is crucial for innovators and businesses alike. One of the most critical aspects of PTE is calculating the regulatory review period, which can significantly impact the lifespan and profitability of a patented product.

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Speciality Chemicals for the Pharmaceutical Industry

Pharmaceutical Technology

Discover the leading speciality chemicals companies in the pharmaceutical industry. Download the free Buyer's Guide for full contact details.

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When Do Drug Patents Expire: Understanding the Lifecycle of Pharmaceutical Innovations

Drug Patent Watch

Have you ever wondered why some medications seem to cost an arm and a leg, while others are surprisingly affordable? The answer often lies in the complex world of drug patents. Let’s dive into the fascinating realm of pharmaceutical intellectual property and explore when drug patents expire. Drug patents are a crucial aspect of the pharmaceutical industry.

Drugs 111
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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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Aktis Oncology raises $175m to advance radiopharmaceutical pipeline

Pharmaceutical Technology

Aktis Oncology, a clinical-stage biotechnology company, has announced the successful closure of a $175m Series B financing round for advancing its radiopharmaceutical pipeline.

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Changing Faces – Pharma and biotech September 2024

pharmaphorum

Stay up to date with the latest developments in the pharma and biotech industry with a focus on companies like Eli Lilly, UCB, Chiesi, Orbital Therapeutics and more. Get insights and updates on Changing Faces in September 2024.

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BPGbio’s mitochondrial disorder drug gets paediatric disease status

Pharmaceutical Technology

BPGbio has received a Rare Pediatric Disease Designation from the US Food and Drug Administration (FDA) for BPM31510IV to treat primary coenzyme Q10 deficiency, an ultra-rare mitochondrial disorder.

Drugs 130
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How are prescription drug prices determined?

Drug Patent Watch

In the world of healthcare, few topics spark as much debate and confusion as prescription drug pricing. Have you ever wondered why that little pill in your medicine cabinet costs so much? Let’s dive into the intricate world of pharmaceutical economics and uncover the factors that determine the price tags on our prescriptions.

Drugs 105
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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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Piramal Pharma to expand Lexington sterile injectables facility in US

Pharmaceutical Technology

Piramal Pharma Solutions, a contract development and manufacturing organisation, has announced an $80m investment to expand its sterile injectables facility in Lexington, Kentucky, in the US.

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New Diagnostic Drug Flyrcado Enhances Coronary Artery Disease Diagnosis

XTalks

GE HealthCare’s newly US Food and Drug Administration (FDA)- approved flurpiridaz F 18 positron emission tomography (PET) radiotracer, Flyrcado, could offer a new approach to diagnosing coronary artery disease (CAD). As the first of its kind, Flyrcado could provide higher diagnostic efficacy compared to the commonly used single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) procedure.

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Ensuring compliance - The Functional Point of Contact (FPOC) story

pharmaphorum

Learn how Advanced Clinical ensures compliance through the Functional Point of Contact (FPOC) story. Explore their innovative approach to maintaining regulatory standards.

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Pfizer gins up £2.4B after unloading hundreds of millions of Haleon shares

Fierce Pharma

Following a similar move in March, Pfizer is offloading another tranche of Haleon shares. | Pfizer has sold 640 million shares in Haleon for 380 pence (roughly $5.09) apiece. The sale amounts to a total value of 2.43 billion pounds sterling (about $3.26 billion) and follows a similar move in March.

Sales 105
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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.