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.
MedCity News
APRIL 30, 2024
Enlaza Therapeutics’ drugs form covalent bonds that lock the therapy onto its target. With cancer as its initial focus, the startup contends its approach could offer safety and efficacy advantages compared to currently available targeted therapies. The post J.P. Morgan Leads $100M Financing for Startup’s R&D of Covalent Biologic Drugs for Cancer appeared first on MedCity News.
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Pharmaceutical Technology
APRIL 24, 2024
Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.
pharmaphorum
APRIL 30, 2024
For the last few years, Walmart has been promising to disrupt the US healthcare sector with a national network of clinics providing low-cost care and telehealth services. Now, it is reining back on those plans.
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
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,
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Pharmaceutical Technology
APRIL 28, 2024
Artificial intelligence tools can be used for infection control through facial recognition systems designed to identify proper face mask use within hospitals.
pharmaphorum
APRIL 30, 2024
California will start selling its own generic of overdose reversal agent naloxone in another example of the use of government-level purchasing power to reduce drug prices
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 26, 2024
After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. | After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on the antibody-drug conjugate Trodelvy. With a busy year ahead across therapeutic areas, CEO Dan O'Day emphasized a "time of focused execution.
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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 25, 2024
Regeneron Pharmaceuticals is collaborating with CRISPR technologies startup Mammoth Biosciences to develop in vivo gene-editing therapies. The deal marks the third pharmaceutical industry partnership for Mammoth, which initially focused on developing CRISPR-based diagnostics. The post Regeneron Bets $100M That Mammoth’s CRISPR Tech Can Deliver on Next Wave of Genetic Medicines appeared first on MedCity News.
Pharmaceutical Technology
APRIL 30, 2024
Dengue fever is now found in over 120 countries compared to nine that experienced severe epidemics in the 1970s given the spread of infectious diseases due to climate change.
pharmaphorum
APRIL 24, 2024
A new FDA initiative is seeing how augmented reality and virtual reality (AR/VR) can make patients’ own homes an integral part of the healthcare system
European Pharmaceutical Review
APRIL 30, 2024
The Committee for Human Medicinal Products (CHMP) has recommended the approval of new eight medicines. A positive opinion of a marketing authorisation was granted for Altuvoct (efanesoctocog alfa), as a treatment and prophylaxis of bleeding in patients with the rare blood disorder haemophilia A. Last week, the US FDA approved a new gene therapy for eligible adults with haemophilia B.
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Fierce Pharma
APRIL 30, 2024
While an ongoing production expansion push for Eli Lilly's popular tirezeptide-based medicines Mounjaro and Zepbound should help out with perpetual supply strains later this year, the expected | While Eli Lilly's supply for Mounjaro and Zepbound is scheduled to increase during the second half of the year, demand is still expected to outpace supply through 2024 and possibly into 2025, executives said.
MedCity News
APRIL 25, 2024
Walgreens announced that it is expanding its specialty pharmacy offerings. Experts think that this move could yield several strategic benefits, given the higher profit margins associated with specialty medications compared to traditional drugs. They also think Walgreens’ move could lead to greater competition, consolidation and innovation within the broader pharmacy industry.
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.
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.
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.
European Pharmaceutical Review
APRIL 30, 2024
Researchers in Germany have developed an technique to increase the speed of spectroscopic analysis , which typically takes from minutes to hours to acquire measurement. [the technique] can greatly accelerate data acquisition in ultrafast spectroscopy, particularly in higher-dimensional analyses” According to the paper published in the Journal of Ultrafast Science , the innovative technique “can greatly accelerate data acquisition in ultrafast spectroscopy, particularly in higher-dimensiona
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 24, 2024
More than 33,000 Providence employees filed a class-action complaint against the health system in 2021, alleging that it had been withholding their wages by denying them breaks and rounding down their working hours. Last week, Providence was ordered to pay more than $200 million in damages — a decision that “sends a message to healthcare corporations,” according to an attorney representing the workers.
Pharmaceutical Technology
APRIL 29, 2024
Experts hold scalability challenges and high costs accountable for market failures within the cell and gene therapy landscape.
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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
pharmaphorum
APRIL 26, 2024
Owlstone Medical has secured a $5 million equity investment and initial $1.5 million grant funding, committed by the Bill and Melinda Gates Foundation, for development of breath-based diagnostic solutions to improve outcomes in the developing world.
European Pharmaceutical Review
APRIL 26, 2024
A paper has reported the first time that 3D printing has facilitated two active pharmaceutical ingredients (APIs) to be combined in the same formulation. This method enables the number of administrations of the drug evaluated to be minimised, the researchers found. The authors aimed to evaluate and compare the efficacy and acceptability of chewable 3D printed medicines containing citrulline, isoleucine, and valine alone or in combination.
Fierce Pharma
APRIL 30, 2024
Besides the diabetes and obesity duo of Mounjaro and Zepbound, the SGLT2 inhibitor Jardiance and the CDK4/6 cancer drug Verzenio were cited as the main growth drivers for Eli Lilly’s first quarter. | Besides the diabetes and obesity duo of Mounjaro and Zepbound, the SGLT2 inhibitor Jardiance and the CDK4/6 cancer drug Verzenio were cited as the main growth drivers for Eli Lilly’s first quarter.
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.
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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.
PharmaTimes
APRIL 30, 2024
GPT-4 is trained on datasets to offer eye-related advice, diagnosis and management suggestions
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.
Pharmaceutical Technology
APRIL 30, 2024
The FDA granted accelerated approval for the drug back in September 2021 following positive Phase II trial data.
Fierce Pharma
APRIL 30, 2024
With WuXi AppTec’s very existence under threat from proposed biosecurity legislation in the U.S., the Chinese CDMO giant is standing its ground on its quest to preserve its business and “do the rig | With WuXi AppTec’s very existence under threat from proposed biosecurity legislation in the U.S., the Chinese CDMO giant is standing its ground on its quest to preserve its business and “do the right thing,” the company’s CEO, Ge Li, said in the company’s first-quarter earnings report.
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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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