NVIDIA doubles down on AI in healthcare with drug discovery deals
Pharmaceutical Technology
MARCH 19, 2024
In addition to drug discovery deals, NVIDIA also announced partnerships with J&J MedTech and GE Healthcare for genAI in MedTech.
Tue.Mar 19, 2024
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Expert Reveals What Intermittent Fasting Could Be Doing to Your Brain
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 19, 2024
Intermittent fasting has become a popular dietary approach to help people lose or manage their weight. It has also been promoted as a way to reset metabolism, control chronic disease, slow ageing and improve overall health.
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Biden’s administration initiative aims to advance women’s health conditions
Pharmaceutical Technology
MARCH 19, 2024
The new initiative aims to spur innovation and mobilisation of sectors to drive women’s health research.
AstraZeneca buys into radiopharmaceuticals with $2.4B deal for Fusion Pharma
Bio Pharma Dive
MARCH 19, 2024
The deal hands AstraZeneca a prostate cancer drug that’s designed differently than Novartis’ fast-selling Pluvicto and currently in mid-stage testing.
FDA approves Orchard’s Lenmeldy gene therapy for MLD
Pharmaceutical Technology
MARCH 19, 2024
The US FDA has granted approval to Orchard Therapeutics' Lenmeldy for specific forms of metachromatic leukodystrophy (MLD).
Orchard follows buyout with FDA approval of rare disease gene therapy
Bio Pharma Dive
MARCH 19, 2024
The U.S. clearance of Lenmeldy, for a rare and inherited metabolic disease, triggers an additional payout related to Kyowa Kirin’s recent deal to acquire the once high-flying gene therapy developer.
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Engrail’s precision psychiatry drugs get more buy in from venture investors
Bio Pharma Dive
MARCH 19, 2024
The San Diego-based startup added $157 million in new funding to back a drug for generalized anxiety order that’s now in human testing.
DoP revises SCOD and bank guarantee clauses of PLI schemes for bulk drugs and medical devices
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 19, 2024
The Department of Pharmaceuticals (DoP) has revised the guidelines of the production linked incentive (PLI) schemes for promotion of bulk drugs and medical devices, revising the provisions related to Scheduled Commercial Operation Date (SCOD) and invocation of bank guarantee.
With new data, Bayer readies rival to Astellas menopause drug
Bio Pharma Dive
MARCH 19, 2024
Following a third successful Phase 3 trial, the company is planning approval filings for the medicine, which it acquired in a $425 million deal four years ago.
Asieris showcases Phase III win in treating precancerous cervical lesions
Pharmaceutical Technology
MARCH 19, 2024
Asieris presented positive Phase III results at the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting in San Diego, US.
The New Age of Decentralized Clinical Trials
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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
Elevance to buy Kroger’s specialty pharmacy
Bio Pharma Dive
MARCH 19, 2024
Major pharmacy benefit managers continue to double down on specialty as a reliable source of business amid a growing crop of pharmacy upstarts.
Prevention over cure? Understanding the evolved care continuum and centralised data
Pharmaceutical Technology
MARCH 19, 2024
Preventative care is a shift away from a reactive approach that primarily focuses on treating diseases and managing symptoms after they have manifested.
Riding GLP-1 wave, Novo Nordisk lays out $560M to boost drug production in China
Fierce Pharma
MARCH 19, 2024
This year marks Novo Nordisk’s 30th anniversary in China, and it could also be the year the company's red-hot weight loss injection Wegovy (semaglutide) wins approval in the populous East Asian nat | 2024 marks Novo Nordisk’s 30th anniversary in China, and it could also be the year the Danish drugmaker’s red-hot weight loss injection Wegovy (semaglutide) wins approval in the populous East Asian nation.
AstraZeneca to acquire radioconjugate biotech Fusion in $2.4bn deal
Pharmaceutical Technology
MARCH 19, 2024
As AstraZeneca looks to move past chemotherapy and radiotherapy, it will enter a market firmly controlled by Novartis.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Does Biopharma Drug Discovery Need to Evolve to Include Objective, Longitudinal, Broad-Spectrum Real-World Data?
XTalks
MARCH 19, 2024
It is well established that drugs for psychiatric conditions suffer some of the lowest approval rates when compared to other major therapeutic areas. There are many underlying factors, including complex and poorly understood etiology which are heterogeneous in presentation and presumably underlying pathophysiology. Additionally, traditional clinical studies fail to objectively assess cognitive function as part of patient eligibility criteria or stratify patients according to the presence or degr
Microsoft and NVIDIA expand collaboration in healthcare innovation
Pharmaceutical Technology
MARCH 19, 2024
Microsoft has announced plans to broaden its partnership with NVIDIA to leverage gen AI to enhance healthcare and life sciences innovation.
Orchard Sets $4.25M US Price for Gene Therapy Lenmeldy on Heels of Approval
BioSpace
MARCH 19, 2024
Two days after winning FDA approval, Orchard Therapeutics on Wednesday provided its U.S. launch plans for metachromatic leukodystrophy gene therapy Lenmeldy, which has a wholesale acquisition cost of $4.25 million for the one-time treatment.
Eli Lilly’s partnership with Amazon to boost presence in diabetes and obesity markets
Pharmaceutical Technology
MARCH 19, 2024
Eli Lilly's LillyDirect allows for online consultations and prescriptions, and Amazon delivers medicines to the patient’s home.
The New Age of Decentralized Clinical Trials
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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.
Edible Food Packaging: A Sustainable Solution to Plastic Waste
XTalks
MARCH 19, 2024
In recent years, the food industry has faced growing scrutiny over its environmental impact, particularly concerning the use of plastic packaging. This scrutiny has sparked significant interest and investment in alternative packaging solutions, with edible food packaging emerging as a particularly innovative and sustainable option. Let’s explore the rise of edible food packaging and delve into the technologies and types of edible packaging available.
China NMPA approves KeChow’s tunlametinib for melanoma
Pharmaceutical Technology
MARCH 19, 2024
The China NMPA has granted approval to KeChow Pharma's tunlametinib for treating patients with NRAS-mutated advanced melanoma.
Improving patient engagement and drug development through AI and enhanced medical affairs roles
pharmaphorum
MARCH 19, 2024
Learn how AI and enhanced medical affairs roles are transforming the landscape of drug development and patient engagement in the health industry. Explore the benefits and advancements in this exciting field.
Bristol Myers Squibb acquires Karuna Therapeutics for $14bn
Pharmaceutical Technology
MARCH 19, 2024
Bristol Myers Squibb (BMS) has concluded the acquisition of Karuna Therapeutics for an equity value totalling $14bn.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Takeda Reaps Rewards of $5.2B Ariad Bet as FDA Expands Iclusig’s Label
BioSpace
MARCH 19, 2024
Takeda on Tuesday secured another label expansion for the kinase inhibitor, this time in the first-line setting for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia.
PAP 2024: John Hoffman Discusses the Health Equity Spotlight Panel
Pharmaceutical Commerce
MARCH 19, 2024
In an interview with Pharma Commerce Associate Editor Don Tracy, John Hoffman, Principal, Advocate for Success, LLC talks about his 'Health Equity Spotlight' panel and advocacy accomplishments.
Clasp Emerges with $150M Series A Financing to Advance T Cell Engagers
BioSpace
MARCH 19, 2024
Clasp Therapeutics announced Wednesday that the Series A funding, which was led in part by Novo Holdings, will support development of its T cell engagers for highly specific tumor targeting.
The unmentionables: Challenging inequalities in women’s health
pharmaphorum
MARCH 19, 2024
As Women’s History Month continues, pharmaphorum web editor Nicole Raleigh welcomed a group of expert individuals onto the podcast to discuss not just the inequalities in women’s health, but female leaders within life sciences, too.
How Machine Learning Drives Clinical Trial Efficiency
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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.
FDA unveils comprehensive strategy for regulating AI in medical products
BioPharma Reporter
MARCH 19, 2024
With the pharma and healthcare landscape increasingly being shaped by artificial intelligence (AI), the US Food and Drug Administration (FDA) has taken proactive steps to outline a comprehensive strategy for regulating AI in medical products.
Lonza to Buy Roche Biologics Manufacturing Site in California for $1.2B
BioSpace
MARCH 19, 2024
The contract manufacturer plans to expand its U.S. footprint with a former Roche facility in Vacaville, California, which Lonza contends is one of the largest biologics manufacturing facilities in the world by volume.
Bristol Myers Squibb completes $14 billion acquisition of Karuna Therapeutics from PureTech
Outsourcing Pharma
MARCH 19, 2024
Yesterday (March 18) PureTech Health plc announced the completion of the acquisition of its founded entity, Karuna Therapeutics, Inc., by Bristol Myers Squibb for a staggering $14 billion.
EU Parliament Endorses New Pharma Legislation, Provides More Market Protection for Companies
BioSpace
MARCH 19, 2024
Under the European Union’s proposed regulations, companies will have data protection for at least seven-and-a-half years preventing competitors from accessing their product data.
Accelerating Clinical Supply Through Integrated Drug Development
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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