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.
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.
BioSpace
AUGUST 30, 2023
Following the FDA’s recent rejection of zuranolone in major depressive disorder, Sage Therapeutics has launched a strategic reorganization initiative including a 40% reduction in headcount.
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.
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.
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.
BioSpace
AUGUST 30, 2023
Amid a supply shortage of the attention-deficit/hyperactivity disorder and binge-eating disorder medication, the regulator has cleared a slew of generic drugs of Takeda’s Vyvanse pill.
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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
Pharma Times
AUGUST 31, 2023
The candidate is a peripherally restricted small-molecule PDE10 inhibitor to treat ulcerative colitis - News - PharmaTimes
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 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.
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.
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.
BioSpace
AUGUST 29, 2023
Warning signs that preceded the current economic squeeze in the biopharma sector were not heeded by investors seeking rapid profits. Now, biotechs interested in making the leap to the public markets must get creative.
Pharma Times
AUGUST 31, 2023
The therapy is used to treat patients with psoriatic arthritis and axial spondyloarthritis - News - PharmaTimes
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 21, 2023
The EC approved Janssen's Type II variation application for reduced dosing frequency of bispecific antibody TECVAYLI for multiple myeloma.
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.
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.
BioSpace
AUGUST 30, 2023
The current workforce lacks the skills to move these biological treatments through the regulatory and production pipeline, a new report finds.
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.
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.
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 28, 2023
Specialised Therapeutics has entered into a licensing agreement with Treeway for TW001, designed for treating amyotrophic lateral sclerosis.
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
Fierce Pharma
AUGUST 31, 2023
For six years, Sanofi's specialty care chief Bill Sibold has helped the company make the most of its Regeneron-partnered immunology superstar Dupixent. | Bill Sibold, who took over the company's specialty care unit in 2017 just after Dupixent's first approval, is leaving Sanofi effective immediately. The company further shook up its leadership by appointing a new R&D head, a chief digital officer and adding an entirely new position.
BioSpace
AUGUST 29, 2023
This is the Danish company’s second obesity-focused acquisition in three weeks. Under the deal, Novo Nordisk receives the full rights to develop and commercialize Embark’s lead metabolic platform.
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 22, 2023
Billing itself as both a scientific and investment partner, Foundery aims to provide research grants and drug development support to researchers developing new immunotherapies.
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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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