FDA approves Takeda’s Adzynma for rare blood clotting disorder
Pharmaceutical Technology
NOVEMBER 10, 2023
The US FDA has granted approval for Takeda’s Adzynma for congenital thrombotic thrombocytopenic purpura, a rare blood clotting disorder.
Fri.Nov 10, 2023
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CAR-T biotech Cargo Therapeutics prices $281M IPO
Bio Pharma Dive
NOVEMBER 10, 2023
Cargo Therapeutics is the seventh oncology biotech to successfully price an IPO this year.
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AstraZeneca posts 16% drop in Q3 2023 profit after tax
Pharmaceutical Technology
NOVEMBER 10, 2023
AstraZeneca has posted a profit after tax of $1.37bn for Q3 2023 versus $1.64bn in the same quarter of the previous year, a decline of 16%.
3 Considerations of the Patient Perspective from the 2023 Pain Therapeutics Summit
Worldwide Clinical Trials
NOVEMBER 10, 2023
Pain for chronic patients is not merely a condition they must manage but a social dynamic with various feelings and opinions. Its psychological impact is often understated, though it carries the same weight as pain’s physical effects. At this year’s annual Pain Therapeutics Summit , which took place in San Diego, CA, October 19 to 20th, I heard brilliant presentations on novel pain medication development, targeted discoveries, pain classifications, the NIH HEAL Initiative , trial designs, biomar
Novo takes aim at obesity drug shortages with $6B manufacturing plan
Bio Pharma Dive
NOVEMBER 10, 2023
The maker of Wegovy and Ozempic plans to expand production in its home country of Denmark to help meet surging demand for the GLP-1 drugs.
My Military Experience Was a Springboard to Career Success
Worldwide Clinical Trials
NOVEMBER 10, 2023
As someone who joined the military right after high school, I can say that it was one of the best decisions I ever made. My nearly perfect score on the Armed Services Vocational Aptitude Battery Test (ASVAB) qualified me for three positions, and I ended up taking the one that required a top-secret/SCI security clearance – as a Record Telecommunications Center Operator.
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Valneva wins FDA approval for the first chikungunya vaccine
Pharmaceutical Technology
NOVEMBER 10, 2023
Following the three-month FDA review delay, Valneva’s live-attenuated chikungunya vaccine, Ixchiq received accelerated approval.
100th patient joins ChariotMS trial for multiple sclerosis
Pharma Times
NOVEMBER 10, 2023
The trial is testing whether Mavenclad could benefit upper limb movement in MS patients - News - PharmaTimes
Novartis’ urticaria drug meets all endpoints in Phase III trials
Pharmaceutical Technology
NOVEMBER 10, 2023
Novartis expects final Phase III REMIX trial readouts and regulatory submissions for remibrutinib in 2024.
uMotif and Cogstate collaboration will include work on psychedelic trial
Outsourcing Pharma
NOVEMBER 10, 2023
A partnership between clinical research technology company uMotif and cognitive science company, Cogstate Limited, will see the companies continue existing work that includes a major phase 2 clinical trial of a psychedelic therapeutic.
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
EC approves Daiichi Sankyo’s Vanflyta for acute myeloid leukaemia
Pharmaceutical Technology
NOVEMBER 10, 2023
The EC has granted approval for Daiichi Sankyo’s Vanflyta to treat FLT3-ITD positive acute myeloid leukaemia (AML) in adults.
SynaptixBio says NHS diagnostic service for rare diseases could be expanded
Pharma Times
NOVEMBER 10, 2023
A rare disease is defined as a condition that affects fewer than one in 2,000 people - News - PharmaTimes
Bayer and Recursion expand oncology research partnership
Pharmaceutical Technology
NOVEMBER 10, 2023
Bayer has expanded a drug discovery research partnership with Recursion Pharmaceuticals in the precision oncology sector.
Phesi 'cracks the code' on validating sites' enrollment potential with patient access store
Outsourcing Pharma
NOVEMBER 10, 2023
Excessive costs cost and time to market in clinical trials could soon be eliminated thanks to the addition of a patient access store (PAS) to Phesi's trial accelerator platform.
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
Bristol Myers Squibb’s CAR-T Breyanzi wins FDA priority review
Pharmaceutical Technology
NOVEMBER 10, 2023
If approved, Breyanzi would become the first and only CAR T cell therapy available for this specific patient population.
Sosei Heptares and Kallyope collaboration milestone with first GPCR target
Outsourcing Pharma
NOVEMBER 10, 2023
The first scientific milestone stemming from a collaboration between Sosei Heptares and Kallyope that was announced last year (2022) has been reached.
BIO-Europe 2023: Barriers remain in the AI pharma revolution
Pharmaceutical Technology
NOVEMBER 10, 2023
At the BIO-Europe conference, experts discussed remaining challenges in AI healthcare interventions.
Valneva wins race, gaining FDA approval for chikungunya vaccine Ixchiq
Fierce Pharma
NOVEMBER 10, 2023
Valneva has won the race in the U.S. | The FDA has approved the world’s first chikungunya vaccine, giving a thumbs-up to Valneva’s Ixchiq. The French company receives a priority review voucher from the FDA, which it said it will sell. It is an accelerated approval and subject to a confirmatory, real-world study.
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.
Eli Lilly reiterates POINT acquisition plans with tender offer extension
Pharmaceutical Technology
NOVEMBER 10, 2023
Amidst POINT’s shareholder turbulence, Lilly is keen to move forward with the $1.4bn acquisition.
New tentative approval for Rising drug acetylcysteine
Drug Patent Watch
NOVEMBER 10, 2023
Acetylcysteine is the generic ingredient in seven branded drugs marketed by Cumberland Pharms, Aspen, Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Indoco, Rising, Sagent Pharms Inc, Steriscience, Zydus Pharms, Alvogen,… The post New tentative approval for Rising drug acetylcysteine appeared first on DrugPatentWatch - Make Better Decisions.
Innovations Powering the Future of mRNA: What Biomanufacturers Need to Know
Pharmaceutical Technology
NOVEMBER 10, 2023
The advent of messenger RNA (mRNA) therapeutics has revolutionized modern medicines.
Four Trends That Are Shaping the Future of Market Access
Drug Channels
NOVEMBER 10, 2023
Today’s guest post comes from James Pisano, Partner, Market Access at The Dedham Group and Dinesh Kabaleeswaran, SVP of Insights & Advisory Teams at MMIT. James and Dinesh offer four trends that they predict will shape medication access in the coming years. Click here to learn about consulting services from MMIT and its sister company The Dedham Group.
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.
Bayer pledges up to $1.5bn for Recursion oncology alliance
pharmaphorum
NOVEMBER 10, 2023
Bayer pledges up to $1.5bn for Recursion oncology alliance Phil.
Adzynma Wins FDA Approval as First Treatment for Ultra-Rare Blood Clotting Disorder cTTP
XTalks
NOVEMBER 10, 2023
The US Food and Drug Administration (FDA) has approved Takeda Pharmaceuticals’ Adzynma, the first recombinant protein product for prophylactic (preventive) or on‑demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare blood clotting disorder. Adzynma is administered intravenously once every other week for prophylactic ERT and once daily for on-demand ERT. cTTP is a very rare, inherited and life-threatening
Novo Nordisk sets aside $6bn to boost production capacity
pharmaphorum
NOVEMBER 10, 2023
Novo Nordisk sets aside $6bn to boost production capacity Phil.
EU regulator changes its mind on Mirati's KRAS inhibitor Krazati with a thumbs-up following initial snub
Fierce Pharma
NOVEMBER 10, 2023
Mirati Therapeutics’ KRAS inhibitor Krazati’s EU prospects weren’t looking good after an initial rejection from Europe's drugs regulator. | European Medicines Agency’s (EMA's) Committee for Medicinal Products for Human Use (CHMP) snubbed the KRAS inhibitor in July, but changed its tune after a formal re-examination initiated by Mirati.
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.
Takeda gets okay in US for rare blood disorder drug
pharmaphorum
NOVEMBER 10, 2023
Takeda gets okay in US for rare blood disorder drug Phil.
TraceLink Introduces Digital Recalls Solution
Pharmaceutical Commerce
NOVEMBER 10, 2023
New E2E workflow orchestration service is expected to simplify the processes of health systems and retail pharmacies while also reducing the risk of recalled items reaching patients.
Molecular photoswitch improves visual acuity in retinitis pigmentosa
Drug Discovery World
NOVEMBER 10, 2023
Topline results from a Phase I/II clinical trial have shown that Kiora’s light-restoring small molecule KIO-301 has the potential to meaningfully improve vision in patients with retinitis pigmentosa (RP). The results of the ABACUS study for Kiora’s intravitreal (IVT) molecular photoswitch were presented at the American Academy of Ophthalmology annual conference by Russell Van Gelder, Professor and Chair, Department of Ophthalmology, University of Washington, School of Medicine.
Creating patient-centric outreach materials for clinical trial patient recruitment [Antidote 2023 survey data]
Antidote
NOVEMBER 10, 2023
In 2018, we partnered with SCORR Marketing to conduct a survey aimed at gaining knowledge about the patient perception of clinical trial participation. We collected nearly 4,000 responses from individuals regarding what matters most to when considering a clinical trial.
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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