Fierce Pharma
JULY 25, 2024
Three months after bagging FDA approval, Pfizer’s hemophilia B gene therapy has been cleared to expand its reach across the pond. | The company's first gene therapy will debut in Europe as Durveqtix. In the U.S., the drug is approved under the brand name Beqvez.
Pharma IQ
JULY 26, 2024
Discover how AI is transforming drug discovery and the future of AI in pharmaceutical research.
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MedCity News
JULY 23, 2024
The National Community Pharmacists Association and providers argued that Change Healthcare didn’t take the needed precautions against the cyberattack that happened earlier this year. The post NCPA, Providers File Lawsuit Against UHG Over Change Healthcare Cyberattack appeared first on MedCity News.
pharmaphorum
JULY 25, 2024
Ipsen has signed yet another portfolio-expanding deal – its fifth of the year so far – claiming rights outside the US to a drug for common brain cancer glioma from Day One Biopharmaceuticals.
Copyright Clearance Center
JULY 25, 2024
As AI continues to revolutionize corporate operations, a new collective licensing solution from CCC ensures that both content creators and users can thrive.
Fierce Pharma
JULY 22, 2024
As lawmakers and industry groups seek to get a handle on U.S. | As lawmakers and industry groups seek to get a handle on U.S. drug shortages, a new white paper from German market analytics firm QYOBO supports the thesis that disproportionately low prices for generic medicines can make it difficult for drugmakers to keep supplies afloat.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
JULY 25, 2024
Autobahn Therapeutics’ platform technology enables small molecules to selectively hit targets in the brain. In addition to a lead program ready for Phase 2 testing in two types of depression, the startup has a preclinical molecule with potential applications in neuroinflammatory disorders such as multiple sclerosis. The post Fueled With $100M, Autobahn Therapeutics Gears Up for Depression Drug Clinical Trials appeared first on MedCity News.
pharmaphorum
JULY 23, 2024
Agilent has boosted its contract development and manufacturing organisation (CDMO) capacity with a $925 million deal to buy Biovectra, a Canadian provider of fill-and-finish services and active pharmaceutical ingredients (APIs).It's a statement of intent from Agilent, whose primary business is lab instrumentation and equipment, suggesting that it intends to grow the outsourcing side of its business, which is currently focused on the production of oligonucleotide and peptide medicines.
PharmaTimes
JULY 24, 2024
The neurodegenerative disease is currently the most common cause of dementia
Fierce Pharma
JULY 24, 2024
From flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from the FDA reads like a textbook example of what not to do when the U.S. | From flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from the FDA reads like a textbook example of what not to do when the U.S. regulator comes knocking at your facility.
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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.
Integrity Solutions
JULY 24, 2024
In an increasingly complex and competitive business world, small businesses often face unique challenges that can hinder their growth and success. One of the most critical areas where small businesses can gain a competitive edge is by investing in their teams’ development, particularly through sales training. Small business sales training is not just about learning how to sell more products or services; it’s about transforming the mindset of your sales team, enhancing the value they
MedCity News
JULY 21, 2024
The dynamics of care delivery have already begun to shift, whether healthcare likes it or not. And it’s an opportunity to collaborate alongside healthcare consumers to shape what will be. The post Healthcare’s Failure of AI Imagination appeared first on MedCity News.
pharmaphorum
JULY 24, 2024
The top three pharmacy benefit managers in the US felt the heat at a hearing of the House Oversight Committee, as lawmakers grilled executives over their business practices and accused them of monopolising the supply chain.
Pharmaceutical Technology
JULY 25, 2024
JNJ-2056 is being investigated in the Phase IIb ReTain study which enrols participants who are yet to show Alzheimer’s symptoms.
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Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr
Fierce Pharma
JULY 25, 2024
While manufacturing and supply hitches have troubled the rollout of Sanofi’s key respiratory syncytial virus (RSV) drug, the near-term expected approval of a pair of new filling lines is giving the | While manufacturing and supply hitches have troubled the rollout of Sanofi’s key respiratory syncytial virus drug, the near-term expected approval of a pair of new filling lines is giving the French pharma assurance that its AstraZeneca-partnered antibody Beyfortus can breach the billion-dollar thre
PharmaVoice
JULY 26, 2024
Citius Pharmaceuticals CEO Leonard Mazur has personally invested $22.5 million into the company, which is fast approaching a potential turning point.
MedCity News
JULY 23, 2024
By prioritizing user-centric design, responsible data practices, and evidence-based solutions neurotech companies can not only drive user adoption but also foster long-term brand loyalty. The post Earning Trust in Neurotech appeared first on MedCity News.
pharmaphorum
JULY 25, 2024
There has been a gene therapy on the market for people with the bleeding disorder haemophilia A since 2022, but take-up has been very slow. Pfizer and Sangamo are hoping for a faster trajectory with their experimental treatment.The partners' one-shot giroctocogene fitelparvovec therapy has cleared a phase 3 trial, showing it was better than regular prophylaxis injections with Factor VIII (FVIII) replacement therapies at reducing bleeding episodes, and could now be heading for regulatory review.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Pharmaceutical Technology
JULY 23, 2024
Johnson & Johnson is seeking approval for SPRAVATO for treatment-resistant depression with the submission of an sNDA to the US FDA.
Fierce Pharma
JULY 25, 2024
Among AstraZeneca’s growth drivers with $5 billion or more in peak sales potential, the company is counting on Daiichi Sankyo-partnered Enhertu to chart new territory. | Among AstraZeneca's growth drivers with $5 billion or more in peak sales potential, the company is counting on Daiichi Sankyo-partnered Enhertu to chart new territory. And stalling sales underscore the challenges facing the HER2 drug.
Quantified
JULY 24, 2024
Executive Summary Mastering sales training strategies is crucial for overcoming challenges and driving success. Traditional sales kickoffs often fail to engage and prepare teams effectively. Modernizing events with interactive elements like AI role-playing scenarios, live product demos, and gamified training boosts engagement and retention.AI-driven personalized coaching addresses seller blind spots through targeted training and real-time feedback, leading to continuous improvement and higher su
MedCity News
JULY 22, 2024
Ionis Pharmaceuticals is looking ahead to a Phase 3 study for an antisense medicine it is developing to treat Angelman syndrome, a rare neurodevelopmental disorder with no FDA-approved therapies. Its main competition is an Ultragenyx Pharmaceutical drug set to begin pivotal testing later this year. The post Neuro Drug Passed Up by Biogen Posts Positive Data for Ionis, Setting Stage for Phase 3 Test appeared first on MedCity News.
pharmaphorum
JULY 25, 2024
NICE clears NHS use of Boehringer's clot-busting drug Metalyse for acute ischaemic stroke, saying it could 'save millions'
PharmaTech
JULY 24, 2024
In the second episode of the Ask the Expert video series, Susan J. Schneipp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice-president, Technical, at Parexel, discuss the quality requirements needed when incorporating AI in bio/pharmaceutical development and manufacturing.
Fierce Pharma
JULY 25, 2024
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously called for a revamp of perioperative clinical trial designs in resectable non-small cell lung cancer (NSCLC) to include assessmen | In a discussion prompted by AstraZeneca's application for Imfinzi, the FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously called for a revamp of perioperative clinical trial designs in resectable non-small cell lung cancer.
Healthcare Success
JULY 23, 2024
Entrepreneurial Insights from a Market Disruptor Market disrupters are drastically changing the healthcare industry, creating more accessible solutions and lucrative business models by addressing unmet needs with innovative solutions and scalable business models. Psych360 was one of the early disruptors to transform access to mental health care in long-term care facilities.
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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
MedCity News
JULY 24, 2024
Cigna announced the launch of the Cigna Group Health Equity Impact Fund and committed $9 million on Monday. It will focus on health disparities in Houston, Texas, and Hartford, Connecticut. The post Cigna Addresses Health Disparities Through $9M Commitment appeared first on MedCity News.
pharmaphorum
JULY 25, 2024
Digital dementia detection specialist Linus Health has expanded its patient care focus with the acquisition of Together Senior Health.
PharmaTimes
JULY 25, 2024
The research will help to better understand how this pathway is coordinated in the cell
Fierce Pharma
JULY 22, 2024
After changing hands several times throughout the 2010s, Canadian specialty contract development and manufacturing organization (CDMO) Biovectra has agreed to fly the Agilent flag. | Agilent has revealed that it’s signed a definitive agreement to acquire Biovectra for $925 million through a mix of cash and debt financing. The deal is expected to close this year.
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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.
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