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.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 31, 2023
It’s often claimed that if you’re trying to lose weight, one of the things you should do each day is drink plenty of water – with some internet advice even suggesting this should be as much as a gallon (about 4.5 liters).
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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 31, 2023
Novo Nordisk has acquired Embark Biotech and its lead asset targeting obesity and other cardiometabolic diseases.
Rethinking Clinical Trials
AUGUST 31, 2023
In an article published this month in the American Journal of Bioethics , FDA Commissioner Robert Califf and coauthors suggest that—despite the potential of embedded pragmatic research to generate information to improve clinical practice and public health policy—it is still relatively uncommon in US healthcare. “Simply stated, what we are currently doing does not work, and in the face of declining health status we lack answers to critical questions about what we should be doing in health care an
Bio Pharma Dive
AUGUST 31, 2023
Yoo, who leads health tech investment at venture capital firm Andreessen Horowitz, outlined her fintech investment thesis and why the healthcare industry is at an inflection point.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 31, 2023
Daiichi Sankyo and AstraZeneca’s blockbuster anti-cancer drug Enhertu could become a pan-tumour drug, with projected sales of $9.9bn by 2029.
Pharma Times
AUGUST 31, 2023
The candidate is a peripherally restricted small-molecule PDE10 inhibitor to treat ulcerative colitis - News - PharmaTimes
Pharmaceutical Technology
AUGUST 31, 2023
The $15m acquisition would give Zerva rights to Acer’s FDA-approved rare Urea cycle disorders drug Olpruva.
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.
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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
Pharmaceutical Technology
AUGUST 31, 2023
Pfizer and BioNTech have received a marketing authorisation recommendation from the EMA Committee for COMIRNATY Omicron XBB.1.5.
Pharma Times
AUGUST 31, 2023
The therapy is used to treat patients with psoriatic arthritis and axial spondyloarthritis - News - PharmaTimes
Pharmaceutical Technology
AUGUST 31, 2023
The NMPA's Center for Drug Evaluation (CDE) has granted breakthrough therapy designation to Zai Lab’s repotrectinib.
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.
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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
Pharmaceutical Technology
AUGUST 31, 2023
Alkermes settled the lawsuit with Teva, allowing the latter to market the generic version of Vivitrol from January 2027.
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.
Pharmaceutical Technology
AUGUST 31, 2023
Apellis aims to attain long-term success and focus on star candidate Syfovre by trimming staff and cutting costs.
XTalks
AUGUST 31, 2023
As Takeda’s blockbuster attention-deficit/hyperactivity (ADHD) drug Vyvanse (lisdexamfetamine dimesylate) reached its patent cliff this month after enjoying 16 years on the market, the US Food and Drug Administration (FDA) gave approval to a slew of generics to coincide with the end of its patent protections. These are the first approved generics of the ADHD medication, which is also used for treating moderate to severe binge-eating disorder (BED) in adults.
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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.
Pharmaceutical Technology
AUGUST 31, 2023
The FDA has released final draft recommendations for using real-world data and evidence in drug development.
Fierce Pharma
AUGUST 31, 2023
For the JAK inhibitor momelotinib, which GSK obtained in its $1.9 billion acquisition of Sierra Oncology, a three-month delay at the FDA was worth the wait. | For the JAK inhibitor momelotinib, which GSK obtained in its $1.9 billion acquisition of Sierra Oncology, the three-month extension of the FDA's review turned out to be worth the wait.
Pharmaceutical Technology
AUGUST 31, 2023
Serina Therapeutics has entered into an agreement to merge with AgeX Therapeutics’ wholly-owned subsidiary.
Outsourcing Pharma
AUGUST 31, 2023
Eight new companies have joined The BioInnovation Instituteâs (BIIâs) Venture Lab acceleration program for early-stage companies, it was announced today (August 31).
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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.
BioPharma Reporter
AUGUST 31, 2023
GEDiCube is joining NVIDIA Inception, a program which guides start-ups by providing access to cutting-edge technology, technical resources, and venture capitalists.
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.
BioPharma Reporter
AUGUST 31, 2023
Lonza and Vertex Pharmaceuticals have revealed plans to open a dedicated manufacturing facility in Portsmouth, New Hampshire.
Fierce Pharma
AUGUST 31, 2023
Zevra Therapeutics has jumped the queue to become a commercial rare disease company, thanks to a fresh acquisition and the addition of a new marketed product. | Zevra is laying out $91 million to get its hands on rare disease compatriot Acer Therapeutics, the companies announced Thursday. Under the deal, which is expected to close in the fourth quarter, Acer is also in line to receive up to $76 million in potential cash payments tied to Contingent Value Rights (CVRs) around commercial and regula
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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.
BioPharma Reporter
AUGUST 31, 2023
The moment that major pharma companies have been dreading, since the approval of Biden's Inflation Reduction Act, has arrived.
Fierce Pharma
AUGUST 31, 2023
Generics to Takeda's blockbuster ADHD drug Vyvanse are now approved in the U.S. Merck and Eisai's Keytruda-Lenvima combo failed in another pivotal trial. | Generics to Takeda's blockbuster ADHD drug Vyvanse are now approved in the U.S. Merck and Eisai's Keytruda-Lenvima combo failed in another pivotal trial. ADC Therapeutics walked away from an antibody-drug conjugate partnership with Adagene.
Drug Discovery World
AUGUST 31, 2023
Arvinas and Pfizer UK have been awarded a UK Innovation Passport for vepdegestrant (ARV-471), an investigational PROTAC ER (estrogen receptor) degrader. It is intended for the treatment of patients with oestrogen receptor (ER)+/ human epidermal growth factor receptor (HER)2- locally-advanced breast cancer or metastatic breast cancer. The Innovation Passport is the entry point for the Innovative Licensing and Access Pathway (ILAP).
pharmaphorum
AUGUST 31, 2023
How the UK can compete with the US in biotech: Focus on the tech Nicole.
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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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