After Shkreli's run in with the law, Pharma Bro's former company Vyera files for bankruptcy
Fierce Pharma
MAY 11, 2023
After Shkreli's run in with the law, Pharma Bro's former company Vyera files for bankruptcy fkansteiner Thu, 05/11/2023 - 11:06
Thu.May 11, 2023
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BioNTech’s RNA vaccine sparks potential in pancreatic cancer
Pharmaceutical Technology
MAY 11, 2023
Results published in Nature for a personalised pancreatic cancer vaccine that uses neoantigens from patients’ tumours have lent further support to early positive signals. The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later. In the study, 16 patients were treated with a vaccine called autogene cevumeran that contained a maximum of 20 neoantigens, alongside Roche’s anti-PD-L1 immunotherapy Tecentriq (atez
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Sanofi, AstraZeneca strengthen case for RSV antibody with data from real-world trial
Fierce Pharma
MAY 11, 2023
Sanofi, AstraZeneca strengthen case for RSV antibody with data from real-world trial kdunleavy Thu, 05/11/2023 - 15:23
FDA Approves First Drug for Treating Agitation in Alzheimer’s Patients
MedCity News
MAY 11, 2023
Rexulti, a drug for schizophrenia and depression, now has an additional approval for treating agitation in Alzheimer’s disease patients. The FDA decision makes the Otsuka Pharmaceutical and Lundbeck product the first drug approved for this indication.
Despite rough quarter, Bayer's duo of Nubeqa and Kerendia continue to excel
Fierce Pharma
MAY 11, 2023
Despite rough quarter, Bayer's duo of Nubeqa and Kerendia continue to excel kdunleavy Thu, 05/11/2023 - 10:52
FDA’s Landmark Guidance on Decentralized Clinical Trials (DCTs) Signals a New Era of Patient-Centered Research
MedCity News
MAY 11, 2023
With the FDA’s acceptance and encouragement of decentralized trials, we can expect to see a continued shift towards remote trial conduct, virtual sites, and the use of innovative digital technologies.
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What 4 Employers Want From Health Vendors
MedCity News
MAY 11, 2023
Employers are looking for more honesty from their potential health vendor partners. This was the topic of conversation during a Wednesday panel among benefit leaders at the Midwest Business Group on Health conference in Chicago.
GSK to raise $1B by selling partial stake in former consumer health unit Haleon
Fierce Pharma
MAY 11, 2023
GSK to raise $1B by selling partial stake in former consumer health unit Haleon zbecker Thu, 05/11/2023 - 16:22
Sobi Emerges as Savior for CTI Biopharma Cash Crunch With $1.7B M&A Deal
MedCity News
MAY 11, 2023
Swedish Orphan Biovitrum is acquiring CTI Biopharma in a $1.7 billion deal centered on the biotech’s commercialized drug for the blood cancer myelofibrosis. Sobi says the drug, Vonjo, complements one of its own assets approved for a different blood disorder.
'The Top Line': The final installment of a series on Narcan, plus this week's headlines
Fierce Pharma
MAY 11, 2023
'The Top Line': The final installment of a series on Narcan, plus this week's headlines tcarey Thu, 05/11/2023 - 22:02
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.
Without Change, Lifesaving HCT and Cell Therapies Will Be Out of Reach for Many
MedCity News
MAY 11, 2023
Ending access and outcomes disparities in HCT and cell therapy will require a collaborative effort, from clinicians, associations and non-profit organizations in the hematology/oncology, HCT and cell therapy communities to policy makers and payers
Mirati's KRAS drug beats estimates in Q1, but Keytruda combo plan remains unclear
Fierce Pharma
MAY 11, 2023
Mirati's KRAS drug beats estimates in Q1, but Keytruda combo plan remains unclear aliu Thu, 05/11/2023 - 10:36
FDA publishes paper on AI/ML in drug development
European Pharmaceutical Review
MAY 11, 2023
The US Food and Drug Administration (FDA) has released a discussion paper to complement and inform future guidance on artificial intelligence (AI) and machine learning (ML) in drug development. The paper is intended to initiate communication with stakeholders, including industry and academia, to foster mutual learning and discussion. The questions in Section B aim to initiate a discussion with stakeholders and solicit feedback on three key areas in the context of AI/ML in drug development.
Fierce Pharma Asia—Roche, Eisai's HER2 deals; Takeda's layoffs in the US
Fierce Pharma
MAY 11, 2023
Fierce Pharma Asia—Roche, Eisai's HER2 deals; Takeda's layoffs in the US aliu Thu, 05/11/2023 - 15:14
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
People Say Healthcare Check-in Should Be Like Airline Check-in. We Can Do So Much Better.
MedCity News
MAY 11, 2023
Although the flight check-in process is quick and easy, it lacks the intelligence and personalization that would make it truly exceptional.
How pharma’s rocky real estate market has changed — for better and worse
PharmaVoice
MAY 11, 2023
Whether you’re looking to build a new site or expand lab space, here are the biggest trends impacting life sciences real estate.
High-Throughput Testing of Hundreds of Anti-Cancer Drug Combinations
Medgadget
MAY 11, 2023
Researchers at ETH Zurich in Switzerland have developed a high-throughput screening method for anti-cancer drugs that they have called “pharmascopy” To date, the researchers have tested the system with multiple myeloma samples, a cancer that has a poor prognosis and is difficult to treat because of drug resistance. In such cancers, finding the right drug or drug combination for a given patent is critical.
Launching Revvity: a scientific solutions company powering innovation from discovery to cure
European Pharmaceutical Review
MAY 11, 2023
Born from two words, ‘revolutionise’ (rev) and ‘vita’ (vit) meaning “life” in Latin, Revvity, Inc. officially launches as a science-based solutions company that leverages innovation across life sciences. Delivering end-to-end expertise and solutions from research discovery to development, and diagnosis to cure, Revvity provides reagents, consumables, assays, instruments and software to customers in markets ranging from pharma and biotech , diagnostic labs, academia and go
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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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.
Trends from the Spring 2023 Meetings and Conferences
Copyright Clearance Center
MAY 11, 2023
The post Trends from the Spring 2023 Meetings and Conferences appeared first on Copyright Clearance Center.
European Commission green lights Servier’s Tibsovo
PharmaTimes
MAY 11, 2023
Treatment concerns patients with IDH1-mutated acute myeloid leukaemia and IDH1-mutated cholangiocarcinoma
From Science to Strategy
PharmExec
MAY 11, 2023
How the pivot to corporate development became a natural fit for once-destined scientist.
Bayer and Bicycle Therapeutics to develop radioconjugates for oncology targets
Pharmaceutical Technology
MAY 11, 2023
Bayer has entered a strategic collaboration agreement with biotechnology company Bicycle Therapeutics to discover, develop, manufacture and commercialise Bicycle’s radioconjugates for a number of oncology targets. The collaboration will see Bicycle use its phage platform to discover and develop bicyclic peptides while Bayer will fully fund and manage further preclinical and clinical development, manufacturing and commercialisation aspects.
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.
Ariceum and UCB link up to take on immune-related diseases
PharmaTimes
MAY 11, 2023
The companies will use proprietary technology to enable the discovery of peptide-radioisotope conjugates
Drug Approvals And Launches From A Legal Perspective
PharmExec
MAY 11, 2023
Torrey Cope, partner, food, drug, and medical device practice, Sidley Austin LLP, reveals current regulatory challenges in the U.S. for drug approvals, how a one-sized-fits-all approach to marketing and global launches no longer works, and when a global launch may be advantageous.
Otsuka and Lundbeck’s sNDA for Rexulti gains US FDA approval
Pharmaceutical Technology
MAY 11, 2023
Otsuka Pharmaceutical and H Lundbeck have received approval for the supplemental new drug application (sNDA) from the US Food and Drug Administration for Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzheimer’s disease. Rexulti has become the first and only pharmacological treatment to receive approval for this indication in the US.
Pharma’s Breakthrough with Alzheimer’s Disease and What the Future Looks Like
Pharma Marketing Network
MAY 11, 2023
Pharmaceutical companies have made major strides in developing new treatments for Alzheimer’s disease, offering hope for the millions of people affected by this debilitating condition. Alzheimer’s is a progressive brain disorder that destroys memory and cognitive abilities, and currently there is no cure. However, recent advancements in research have resulted in new drugs that show promising results in slowing the progression of the disease.
Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics
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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
Mainland China’s regulatory evolution brings greater access to novel drugs
Clarivate
MAY 11, 2023
Mainland China has streamlined regulatory protocols for testing and approving prescription drugs in recent years, making dozens of urgently needed treatments, from domestic and international manufacturers alike, available to patients in the process. Over the past five years, healthcare leaders in Mainland China have made significant strides in their efforts to reduce lag time in availability of novel drugs versus western markets.
The Change in Pharmaceutical Conferences Post Covid-19
Pharma Marketing Network
MAY 11, 2023
Healthcare conferences have undergone significant changes since 2020 due to the COVID-19 pandemic. Prior to the pandemic, healthcare conferences were typically large in-person events, attracting thousands of attendees from around the world. However, with the outbreak of the virus and the need for social distancing, traditional in-person events have been disrupted, forcing the healthcare industry to find new ways to connect, share information, and collaborate.
Internet of Things related social media posts decreased by 9% in the pharma industry in Q1 2023
Pharmaceutical Technology
MAY 11, 2023
The global pharma industry experienced a 9% drop in social media posts on internet of things in Q1 2023 compared with the previous quarter, with the highest share accounted for U.S. Centers for Disease Control and Prevention, according to GlobalData’s analysis of social media posts. The growing application of internet of things will prove to have a transformative impact on the pharmaceutical sector.
Pre-ASCO Excitement Report
InCrowd
MAY 11, 2023
Instant Insights It’s just 3 weeks until ASCO (American Society of Clinical Oncology’s annual meeting), and oncologists have shared with us the agenda topics that most interest them. Immunotherapies topped the list, with CAR-T the most popular among them. Take a look at our latest Instant Insights report to get physicians’ thoughts on the upcoming conference.
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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