Bio Pharma Dive
AUGUST 31, 2023
Houman Ashrafian, currently a scientific advisor at SV Health Investors, will fill the role left by John Reed, who oversaw the transformation of research and development during his five years at Sanofi.
Pharmaceutical Technology
AUGUST 29, 2023
The clinical trials industry is facing a number of hurdles, but AI and digitalisation are being heralded as key to overcoming them, particularly when it comes to preparing for inspections and audits
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Worldwide Clinical Trials
AUGUST 10, 2023
As one of the more recent fields to emerge in the clinical space, psychedelics have gained significant traction as a potential treatment for various neuropsychiatric diseases. With so many exciting developments in the last few years, it’s critical for the psychedelic community to come together to reflect on our progress, share the latest discoveries, and discuss the future of psychedelic research.
Rethinking Clinical Trials
AUGUST 22, 2023
In an article published this month in Clinical Trials , researchers from the NIH Pragmatic Trials Collaboratory’s Distributed Research Network share opportunities for conducting pragmatic trials embedded in health insurance plans. “There are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensing
Fierce Pharma
AUGUST 30, 2023
After 16 years on the market, Takeda's blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. | After 16 years on the market, Takeda's blockbuster ADHD med Vyvanse has finally reached its patent cliff. And the FDA's approval of several generics comes amid a U.S. shortage of the drug.
Antidote
AUGUST 30, 2023
At the outset, many people may experience apprehension when considering joining a clinical trial. Opting to participate in a research study is a personal one — but it can also be quite gratifying. Various types of clinical studies play a pivotal role in ensuring the approval of life-saving medications and treatments. For this to happen, we need volunteers to take part.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 25, 2023
The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.
Worldwide Clinical Trials
AUGUST 15, 2023
Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. At Worldwide, we understand the significance of this collaboration and are dedicated to becoming an extension of your team, providing personalized clinical development solutions that align with your corporate objectives and milestones.
Pharma Times
AUGUST 31, 2023
The candidate is a peripherally restricted small-molecule PDE10 inhibitor to treat ulcerative colitis - News - PharmaTimes
Fierce Pharma
AUGUST 30, 2023
Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. | Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. Outlook Therapeutics has been trying to get an official approval for a reformulated version, but instead got a rejection letter.
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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
Outsourcing Pharma
AUGUST 31, 2023
More people are talking about mental illness than ever before. However, despite increased awareness, it remains one of the most neglected areas of public health globally, with research and quality of care lagging behind physical health conditions.
Bio Pharma Dive
AUGUST 31, 2023
Two founding executives are leaving Sage alongside a major restructuring announced weeks after the FDA approved the medicine, Zurzuvae, for much narrower use than the company had hoped.
Pharmaceutical Technology
AUGUST 9, 2023
The global pharmaceutical industry experienced a 52% decline in the number of artificial intelligence related patent applications in Q2 2023 compared with the previous quarter, according to GlobalData's Patent Analytics.
XTalks
AUGUST 31, 2023
Food giant Nestlé has once again claimed the top spot on the list of the world’s most valuable food brands in Brand Finance’s “Food & Drink 2023” report. The report, which delves into brand strength, revenue and royalty rates to gauge brand worth, has consistently placed the Vevey, Switzerland-based brand as the most valuable food brand ever since its inception in 2015.
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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.
Pharma Times
AUGUST 31, 2023
The therapy is used to treat patients with psoriatic arthritis and axial spondyloarthritis - News - PharmaTimes
Fierce Pharma
AUGUST 31, 2023
Seven weeks after saying it would allow generic competition for drug-resistant tuberculosis (TB) treatment Sirturo (bedaquiline) in low- and middle-income countries (LMICs), Johnson & Johnson h | Seven weeks after saying it would allow generic competition for drug-resistant tuberculosis (TB) treatment Sirturo (bedaquiline) in low- and middle-income countries (LMICs), Johnson & Johnson has slashed its own drug's price by 55% to $130 for a six-month course.
BioPharma Reporter
AUGUST 8, 2023
A new report from Angelini Pharma has highlighted an ongoing treatment gap for epilepsy care in Europe, including significant differences in access to treatment between countries.
Bio Pharma Dive
AUGUST 29, 2023
The list includes the top-selling blood thinners Eliquis and Xarelto, as well as the arthritis drug Enbrel and heart failure medicine Entresto.
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
AUGUST 24, 2023
The newly-launched business, called Corvardis, is already targeting the Humira biosimilar landscape with Hyrimoz via a planned Sandoz-partnered launch in Q1 2024.
Drug Discovery World
AUGUST 29, 2023
The pharmaceutical industry continues to maintain strong levels of public trust and favourability in the UK, according to data from the Association of the British Pharmaceutical Industry (ABPI). Opinions showed consistent recognition of the sector’s support for the NHS, with 67% of respondents saying the industry is committed to developing new medicines to meet patient needs.
FDA Law Blog
AUGUST 24, 2023
Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B. Mullen (FDA Law), and Anne K. Walsh (FDA Law), as well as McKenzie E.
Fierce Pharma
AUGUST 30, 2023
Last month, during a quarterly conference call—as Johnson & Johnson considered its future beyond the separation of its consumer health unit—Chief Financial Officer Joe Wolk described the compan | Last month, during a quarterly conference call—as Johnson & Johnson considered its future beyond separation of its consumer health unit—Chief Financial Officer Joe Wolk described the company’s appetite for M&A as “voracious.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
BioPharma Reporter
AUGUST 24, 2023
Cell and Gene Therapy Catapult, Rentschler Biopharma, and Refeyn have announced a new partnership to develop and apply âinnovativeâ process analytical technologies (PAT) to improve the process and efficiency of AAV manufacture.
Bio Pharma Dive
AUGUST 23, 2023
The company doesn’t know if the needles have caused retinal vasculitis in some people receiving its geographic atrophy drug Syfovre, but is no longer recommending their use.
Pharmaceutical Technology
AUGUST 4, 2023
Amid one of the worst dengue fever outbreaks in decades, Bangladesh has recorded the highest number of hospitalised cases of the disease in a day.
Drug Discovery World
AUGUST 25, 2023
DDW’s Megan Thomas looks at a day in the life of Giusy Di Conza , Head of Research at iOnctura. MT: Where do you work, and can you tell us what you’re working on at the moment? GDC : I’m Head of Research for a young, dynamic biotech called iOnctura. We are pioneering research into new biological mechanisms for established drug targets. Whereas traditionally biotechs have studied the effect of a drug on a singular pathway, we are focused on targets that are involved in multiple independent tumour
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
XTalks
AUGUST 25, 2023
In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). The FDA established the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which requires that food labels clearly identify the food source names of any ingredients that contain any protein derived from the nine most common food allergens.
CTTI (Clinical Trials Transformation Initiative)
AUGUST 23, 2023
The U.S. Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a virtual public workshop to solicit input on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups.
ACRP blog
AUGUST 23, 2023
The latest regulatory guidance addressing elements of decentralized clinical trials (DCTs) is the draft ICH E6(R3) Good Clinical Practice (GCP) guideline from the International Council for Harmonization (ICH). Much like recent guidances proposed by the U.S. Food and Drug Administration (FDA) and regulatory authorities in other nations, the ICH document outlines regulators’ expectations on how DCTs should be conducted, and with its addition to the list, stakeholders in digital, hybrid, and fully
Bio Pharma Dive
AUGUST 10, 2023
The deal will help fund a cell-based treatment that completed Phase 1 testing last year and is designed to provide a “functional cure” for patients with HIV infections.
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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
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