UK Agency targets blood thinners in personalised medicine pursuit
Pharmaceutical Technology
FEBRUARY 13, 2024
The MHRA kicks off phase two of the Yellow Card biobank to explore the genetic link to side effects of direct oral anticoagulants.
Tue.Feb 13, 2024
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Two GV partners on biotech’s reset and building their next drug startups
Bio Pharma Dive
FEBRUARY 13, 2024
Newly named partner Anthony Philippakis and managing partner Krishna Yeshwant spoke with BioPharma Dive about biotech’s newfound optimism and their investing “North Star.
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CRISPR gene therapy Casgevy secures approval in Europe
Pharmaceutical Technology
FEBRUARY 13, 2024
The regulatory greenlight makes it the only gene therapy available in Europe for sickle cell disease and TDT.
BioAge raises $170M to back Phase 2-ready obesity drug
Bio Pharma Dive
FEBRUARY 13, 2024
BioAge’s Series D will fund a study combining its medicine with Eli Lilly’s Zepbound, a strategy the company hopes could help people lose weight while maintaining muscle mass.
When You Got Your Period May Impact Dementia Risk, Study Finds
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 13, 2024
The ages at which a person starts and stops menstruating could impact their risk of developing dementia later in life, according to the largest study of its kind.
Kalvista pill succeeds in late-stage study for rare swelling disorder
Bio Pharma Dive
FEBRUARY 13, 2024
The biotech's drug quickly alleviated symptoms of the swelling attacks associated with hereditary angioedema, supporting the idea it could be an oral alternative to existing medicines.
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ADC startup ProfoundBio, led by Seagen veterans, raises $112M
Bio Pharma Dive
FEBRUARY 13, 2024
The Series B round will fund development of antibody-drug conjugates now in clinical testing, among them a rival to AbbVie’s ovarian cancer drug Elahere.
Employee Spotlight: Rubén Berdejo, Associate Director, Clinical Operations Site Management in León, Spain
Worldwide Clinical Trials
FEBRUARY 13, 2024
Get to know Rubén through this Q&A What attracted you to Worldwide, and what keeps you here? Before I joined Worldwide in June 2016, I worked at a large Contract Research Organization (CRO). In fact, my entire career as a Clinical Research Associate (CRA) was developed at large CROs, where the roles are very limited in their responsibilities, making it hard to learn anything different.
February 13, 2024: New Chapter of Living Textbook Highlights Value of Patient Engagement and Provides Practical Strategies
Rethinking Clinical Trials
FEBRUARY 13, 2024
Dr. Steven George The NIH Pragmatic Trials Collaboratory published a new chapter in its Living Textbook of Pragmatic Clinical Trials. The chapter, Patient Engagement , describes principles and strategies for effectively engaging patient partners. Because patients can provide valuable insights and perspectives about clinical care for specific conditions, they are key partners for pragmatic clinical trials.
Why patient centricity is the answer to the clinical trial enrolment gap
Pharmaceutical Technology
FEBRUARY 13, 2024
Research indicates that designing clinical trials with the patient in mind reduces recruitment times and enhances trial performance.
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
Biogen has a fuzzy line of sight on prized Alzheimer’s drug
Bio Pharma Dive
FEBRUARY 13, 2024
CEO Chris Viehbacher said there are about 3,800 U.S. patients on a registry for Leqembi. But Biogen doesn’t have all the details, as development partner Eisai is leading commercial efforts.
BioVaxys snatches up ‘bankrupt’ IMV’s preclinical and clinical assets
Pharmaceutical Technology
FEBRUARY 13, 2024
BioVaxys will pay $750,000 in upfront payment along with milestone-based payments and royalties on licencing revenue and product sales.
Precision medicine in mental health - one size really doesn’t fit all
pharmaphorum
FEBRUARY 13, 2024
In this episode of the pharmaphorum podcast, web editor Nicole Raleigh welcomed Dr Hans Eriksson, chief medical officer at HMNC Brain Health, a precision psychiatry biopharma company, to discuss his work exploring current studies into the use of ketamine in mental health, HMNC Brain Health having last year announced topline results from a Phase 2 study looking at a take-at-home, oral ketamine option for Treatment Resistant Depression (or TRD).
Takeda’s EOHILIA receives FDA approval for EoE treatment
Pharmaceutical Technology
FEBRUARY 13, 2024
Takeda has received the US FDA approval for EOHILIA (budesonide oral suspension), an oral treatment for eosinophilic esophagitis (EoE).
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
European Commission grants approval for first therapy to treat Friedreich’s ataxia
Outsourcing Pharma
FEBRUARY 13, 2024
Biogen Inc. has taken a step closer to bringing its âgroundbreaking treatmentâ to patients with a rare, genetic, life-shortening, debilitating, and neurodegenerative disorder.
Gilead aims to cash in on liver disease wave with $4.6bn CymaBay deal
Pharmaceutical Technology
FEBRUARY 13, 2024
Gilead announced its $4.6bn acquisition of CymaBay, gaining an advanced PBC candidate, as it aims to follow the success of Ocaliva.
New data from Japan shows early resolution of common Covid-19 symptoms
BioPharma Reporter
FEBRUARY 13, 2024
Japanese pharmaceutical company Shionogi has announced the first peer-reviewed publication of its phase 3 study investigating ensitrelvir to treat patients with mild to moderate COVID-19 in Japan, South Korea and Vietnam.
FDA grants fast track status to GSK’s bepirovirsen for hepatitis B
Pharmaceutical Technology
FEBRUARY 13, 2024
The US FDA has granted fast track designation to GSK’s bepirovirsen, an investigational treatment for chronic hepatitis B (CHB).
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.
Biogen’s Skyclarys is first EU drug for Friedreich’s ataxia
pharmaphorum
FEBRUARY 13, 2024
Biogen’s Skyclarys is the first approved medicine for the inherited neurological disease Friedreich’s ataxia (FA) in the EU, after getting a green light from the European Commission.
AbbVie concludes acquisition of ImmunoGen for $10.1bn
Pharmaceutical Technology
FEBRUARY 13, 2024
AbbVie has completed the acquisition of ImmunoGen for $10.1bn, a move that significantly bolsters its oncology pipeline.
Biogen CEO plots long-term turnaround after analysts brand company's recent results as 'weak'
Fierce Pharma
FEBRUARY 13, 2024
While Biogen’s financials are in rough shape now, the company’s CEO, Chris Viebacher, sees reason to be optimistic about the future. | With four new drug launches rolling and the majority of the company’s losses of exclusivity in the rearview, Biogen figures it could chart continued revenue growth over the next 10 years, CEO Chris Viehbacher said Tuesday.
Pfizer and Saama expand deal to expedite clinical research
Pharmaceutical Technology
FEBRUARY 13, 2024
Pfizer has expanded its multi-year agreement with Saama, intensifying efforts to expedite clinical research.
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.
The innovative future of CRISPR tech
pharmaphorum
FEBRUARY 13, 2024
CRISPR technology is revolutionising gene editing and paving the way for innovative advancements in various fields. Explore the exciting potential and future possibilities of this cutting-edge technology.
SCOPE: FDA facilitates AI and ML use for clinical trials and drug development
Pharmaceutical Technology
FEBRUARY 13, 2024
Two FDA representatives FDA spoke at the ongoing 2024 SCOPE Summit about how the agency is focusing on AI.
With FDA nod for Onivyde combo, Ipsen ends 10-year drought in newly diagnosed pancreatic cancer
Fierce Pharma
FEBRUARY 13, 2024
It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017. | It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017. The FDA has approved Onivyde as part of a combination dubbed Nalirifox to treat patients with newly diagnosed metastatic pancreatic cancer.
First biologic treatment for chronic skin disease available in Scotland on NHS
BioPharma Reporter
FEBRUARY 13, 2024
Following positive advice from the Scottish Medicines Consortium (SMC), the first biologic treatment for inflammatory skin disease, hidradenitis suppurativa (HS), is now available in Scotland on the NHS.
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.
Lawmakers urge White House officials to enforce sanctions on China's WuXi AppTec, WuXi Biologics: Reuters
Fierce Pharma
FEBRUARY 13, 2024
After introducing legislation targeting certain Chinese biopharma companies, a group of bipartisan lawmakers are taking their concerns to the White House—and upping the stakes. | After proposing a bill to revoke funding from certain Chinese biopharmas, a group of bipartisan legislators penned a letter to certain White House officials pressing for sanctions on the two companies based on alleged links to China's Communist Party and its military.
Biomarkers ‘may predict dementia 15 years before diagnosis’
pharmaphorum
FEBRUARY 13, 2024
Researchers have used proteomics data from the UK Biobank to identify protein biomarkers in blood that could give warning of dementia years before diagnosis
Incyte crosses $1B in quarterly revenue for the 1st time, even as Jakafi faces off against GSK rival
Fierce Pharma
FEBRUARY 13, 2024
Buoyed by JAK inhibitor market-leader Jakafi and its cream counterpart Opzelura, Incyte crossed the $1 billion threshold in quarterly revenues for the first time. | Buoyed by JAK inhibitor market-leader Jakafi and its cream counterpart Opzelura, Incyte crossed the $1 billion threshold in quarterly revenues for the first time. But only one of the drugs met Wall Street’s expectations.
White House wins in first Medicare negotiation legal ruling
pharmaphorum
FEBRUARY 13, 2024
Texas judge has thrown out the first lawsuit brought by PhRMA claiming Medicare negotiation of drug pricing is unconstitutional
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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