Fierce Pharma
APRIL 29, 2024
The price tag includes both the approved cancer drug Qinlock and another Deciphera candidate heading to the FDA’s desk in the coming months.
Pharma IQ
APRIL 29, 2024
Discover how artificial intelligence is revolutionizing the field of precision medicine. In this insightful article, Tim O’Connor, Chief Data Scientist at Phenomix Sciences, discusses the pivotal role.
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Fierce Pharma
APRIL 29, 2024
AstraZeneca and Daiichi Sankyo’s trailblazing Enhertu appears to have outdone itself. | AstraZeneca and Daiichi Sankyo’s trailblazing Enhertu appears to have outdone itself. After spearheading the new HER2-low category in breast cancer treatment, Enhertu has shown it could be useful against tumors with even lower expression of the HER2 protein.
MedCity News
APRIL 29, 2024
Ono Pharmaceutical’s acquisition of Deciphera Pharmaceuticals adds to a cancer drug pipeline that already spans multiple modalities. Deciphera develops drugs that target the on-off switch of enzymes that drive cancer cell growth. The post Ono Pharma’s Plan to Become a Global Player Picks Up a New Piece With $2.4B Deciphera Acquisition appeared first on MedCity News.
Fierce Pharma
APRIL 29, 2024
For Novo Nordisk to gain approval in the United States for its groundbreaking Awiqli (insulin icodec), it will have to first pass muster with a panel of experts next month,
pharmaphorum
APRIL 29, 2024
A partnership between Huma Therapeutics and Merck KGaA to develop digital support tools for cancer patients has borne fruit with the launch of a bladder cancer app in the UK
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Pharmaceutical Commerce
APRIL 29, 2024
A one-on-one with Thermo Fisher’s Wilfredo Marin, who dives into the value of ultra-low temperature storage, the need for flexibility in the cold chain logistics space, and more.
Fierce Pharma
APRIL 29, 2024
After losing majority shareholder support for his directorship at Blueprint Medicines last year, serial biotech entrepreneur Alexis Borisy has cut two outside titles to retain his seat at the compa | After losing majority shareholder support for his directorship at Blueprint Medicines last year, serial biotech entrepreneur Alexis Borisy has cut two outside titles to retain his seat at the company, which is further tightening its board policy.
pharmaphorum
APRIL 29, 2024
Patients in the US with the ultra-rare disease WHIM syndrome now have their first approved treatment, after X4 Pharma’s Xolremdi was given a green light by the FDA. Oral CXCR4 antagonist Xolremdi (mavorixafor) can be used in patients aged 12 and over with WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome, a congenital immunodeficiency characterised by low neutrophil counts that affects fewer than 1,000 people in the US.
Fierce Pharma
APRIL 29, 2024
With the approval of X4 Pharmaceuticals’ first product mavorixafor, there’s a new commercial rare disease player in town. | Following a 10-year development journey, the FDA on Monday approved X4 Pharmaceuticals’ Xolremdi. The nod marks X4’s commercial debut and provides WHIM patients with the first therapy to tackle the underlying cause of their disease.
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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.
MedCity News
APRIL 29, 2024
Season 2 of the MedCity Pivot Podcast has launched with a special focus on the evolution of pharmacy and pharmacy benefit management. The first guest this season is A.J. Loiacono, who leads Capital Rx. The post Pivot Podcast: A Conversation with Capital Rx CEO A.J. Loiacono appeared first on MedCity News.
pharmaphorum
APRIL 29, 2024
Japan’s Ono Pharma has bolstered its cancer pipeline with a $2.4 billion agreement to buy Deciphera Pharma of the US and its fast-growing gastrointestinal stromal tumour (GIST) therapy Qinlock. Ono is offering $26.50 per share in cash for the Waltham, Massachusetts-based company, saying the deal will enable it to “build a robust presence in oncology,” one of the group’s key priority areas.
MedCity News
APRIL 29, 2024
The FDA approved X4 Pharmaceuticals drug Xolremdi for treating WHIM syndrome. The molecule, which addresses the underlying cause of this rare immunodeficiency, was licensed from Sanofi’s Genzyme subsidiary. The post Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency appeared first on MedCity News.
pharmaphorum
APRIL 29, 2024
CHMP backs EU approval of J&J's Rybrevant as a first-line therapy for NSCLC with EGFR exon 30 insertion mutations, filling a void left after Takeda's Exkivity was pulled from sale
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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
APRIL 29, 2024
What EHR/EMR vendors need to know to comply with ONC’s HTI-1 final rule The post Navigating Healthcare’s New Era of Algorithmic Transparency appeared first on MedCity News.
pharmaphorum
APRIL 29, 2024
George Medicines has appointed former Ironwood CEO Mark Mallon to lead the company as it tries to get its triple therapy for hypertension over the finish line.
MedCity News
APRIL 29, 2024
Abbott earned FDA approval for its dissolving stent designed to unclog arteries below the knee. This marks the first time the FDA has approved a stent or drug-coated balloon to help arteries stay open below the knee. The post Abbott Earns FDA Approval For Dissolving Stent That Unclogs Arteries Below The Knee appeared first on MedCity News.
European Pharmaceutical Review
APRIL 29, 2024
Articles included in Issue 2 of European Pharmaceutical Review – our cell and gene therapy focus – include: CELL & GENE THERAPY Proper planning prevents CMC disasters for cell and gene therapies Drew Hope, Ryan Guest and Clare Blue eXmoor Pharma SUPPLY CHAIN Fresh or frozen? Navigating the cryopreservation dilemma for CGT Priya Baraniak OrganaBio GUIDE TO TESTING LoD requirements of qualitative microbiological methods for short shelf-life products Edwin van den Heuvel Eindhoven U
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
Pharmaceutical Technology
APRIL 29, 2024
Pfizer has received approval from the US Food and Drug Administration (FDA) for its one-time gene therapy BEQVEZ for haemophilia B.
PharmaTimes
APRIL 29, 2024
The new process makes generating active pharmaceutical ingredients quicker and easier
Pharmaceutical Technology
APRIL 29, 2024
Experts hold scalability challenges and high costs accountable for market failures within the cell and gene therapy landscape.
European Pharmaceutical Review
APRIL 29, 2024
The Cell and Gene Therapy Catapult (CGT Catapult) has appointed three new Non-Executive Directors to its board. This supports the organisation ’s mission to advance the industry in the UK and facilitate wider adoption of advanced therapies. Dr Jim Faulkner is an “experienced, innovative biopharmaceutical development leader with specialist skills in cell and gene therapy”, according to CGT Catapult.
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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.
PharmaVoice
APRIL 29, 2024
The company's schizophrenia drug picked up in its $14 billion acquisition of Karuna Therapeutics recently generated positive long-term data from its phase 3 program.
European Pharmaceutical Review
APRIL 29, 2024
The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. The treatment is indicated for adults with moderate to severe haemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening haemorrhage, Pfizer stated.
PharmaTimes
APRIL 29, 2024
The method has the potential to be used to deliver RNA to the bloodstream for a range of diseases
European Pharmaceutical Review
APRIL 29, 2024
Researchers have reported a novel universal fungal identification method called Analysis of whole GEnome (AGE) for “the first-time demonstration of the identification potential of sequences from unannotated genomic regions”. Developing new approaches for microbiological identification across the entire fungal kingdom remains “a major challenge”, Qi et al. explained.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
MedCity News
APRIL 29, 2024
Interoperability is moving ahead, but major health systems and hospitals in large population centers must ensure they don’t leave their smaller and more rural counterparts behind. The post Inequity in Interoperability: The Haves and Have-Nots & How QHINs Can Help appeared first on MedCity News.
Pharmaceutical Technology
APRIL 29, 2024
AstraZeneca has recently announced that Fasenra has been approved for severe asthma, specifically for the eosinophilic phenotype, in children aged 6-11 years in more than 80 countries, including the US, EU, and Japan.
MedCity News
APRIL 29, 2024
With the right solutions, providers can spend more time with the patient, building the relationship, earning their trust, and focusing on the forward-looking health journey. The post Provider Feedback Loop: The Missing Link in AI Development, Use and Adoption appeared first on MedCity News.
European Pharmaceutical Review
APRIL 29, 2024
Unlocking the potential of biologics production: a comprehensive exploration Different types of biologics require different sized bioreactors and different manufacturing approaches, as Sridevi Khambhampaty, Vice President at Syngene International Limited, elucidates. Bioconjugation of antibody-drug conjugates: the past, present and future Development of antibody-drug conjugates (ADCs) has experienced significant growth over the past two decades.
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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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