Fierce Pharma
JUNE 27, 2023
AbbVie recently filed a patent infring | AbbVie recently filed a patent infringement lawsuit against BeiGene over their blockbuster BTK franchises. Although the litigation was launched right after a patent’s issuance, AbbVie may actually have a case here, according to one expert.
European Pharmaceutical Review
JUNE 27, 2023
Riding on the momentum of the first faecal microbiota product approved for C. difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Recent developments in microbiome therapeutics In May this year, first-in-human study interim results revealed that a CRISPR-based microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”.
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Fierce Pharma
JUNE 27, 2023
This has been a second straight year of regulatory struggles in the United States for UCB with one of the those issues revolving around the FDA needing additional time to
MedCity News
JUNE 27, 2023
The National Alliance of Healthcare Purchaser Coalitions released a playbook on Monday that outlines the key concerns employers have about pharmacy benefit management, and provides several recommendations for employers.
Fierce Pharma
JUNE 27, 2023
Despite Regeneron’s impressive high-dose Eylea data, its high-stakes launch is delayed thanks to an unexpected FDA rejection. | In a surprise decision, the FDA issued powerhouse Eylea's high-dose version a complete response letter. But the company said it has nothing to do with the drug's efficacy or safety.
MedCity News
JUNE 27, 2023
Eli Lilly’s retatrutide led to an average weight reduction of 24.2%, or 58 pounds, after 48 weeks of treatment in Phase 2 testing. Based on these results, Lilly now plans a comprehensive Phase 3 program that will evaluate the once-weekly injectable drug in weight reduction as well as various complications of obesity.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
JUNE 27, 2023
A Kaiser Permanente Southern California study published in JAMA Health Forum found that Medicare Advantage members who received meals after being discharged from the hospital had lower odds of rehospitalization and death.
Fierce Pharma
JUNE 27, 2023
Swiss skincare company Galderma is keeping its eyes on a highly anticipated initial public offering (IPO) after scooping up around $1 billion in private placement funding for newly issued shares.
Pharmaceutical Commerce
JUNE 27, 2023
In an interview at the DIA Global Annual Meeting with Pharma Commerce Editor, Nicholas Saraceno, Cal Collins, CEO of OpenClinica discusses impacting the broader supply chain.
Fierce Pharma
JUNE 27, 2023
Diabetes patients in the United Kingdom may have to wait a bit longer to get their hands on Eli Lilly’s Mounjaro after the country’s drug value watchdog kiboshed its coverage recommendation. | England’s National Institute for Health and Care Excellence (NICE) on Tuesday said more evidence is needed on the clinical efficacy and cost-effectiveness of Mounjaro, also known as tirzepatide, before the health technology assessor can recommend Lilly's dual GIP/GLP-1 drug for use by the country’s Na
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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.
MedCity News
JUNE 27, 2023
BeeKeeperAI — which offers a platform to facilitate the development and deployment of healthcare AI models — raked in $12.1 million in Series A funding led by Santé Ventures. The startup was spun out of UCSF last year.
European Pharmaceutical Review
JUNE 27, 2023
Lonza and Vertex Pharmaceuticals Incorporated have agreed to collaborate to support the manufacture of Vertex’s Type 1 diabetes cell therapy portfolio. The companies will partner in the process development and manufacturing scale-up at a new, large-scale facility in Portsmouth, New Hampshire, US. Operated by Lonza, the 130,000 square foot facility is anticipated to create up to 300 new jobs at peak capacity.
MedCity News
JUNE 27, 2023
To deliver real value in today’s highly fragmented market, healthtech startups stand to significantly benefit by working with incumbents. Rather than focusing solely on disruption, these startups working with established partners concentrate on proving demonstrable ROI, clinical value, dollars saved, better outcomes and improved healthcare economics.
European Pharmaceutical Review
JUNE 27, 2023
AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. This follows FDA clearance of the Investigational New Drug (IND) application, enabling expansion to the US of the ongoing Phase Ib/II ABATE study of ACI-24.060 in Alzheimer’s patients and individuals with Down’s syndrome.
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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
MedCity News
JUNE 27, 2023
Putting in the due diligence prior to implementing an EHR software establishes a clear game plan for everyone involved. It will empower your team to work towards a common goal and ultimately serves to improve the lives of physicians and patients.
European Pharmaceutical Review
JUNE 27, 2023
Included in this issue of European Pharmaceutical Review : FOREWORD Nitrosamines: the beginning of the end? David Elder, David P Elder Consultancy MANUFACTURING Meeting rising demands of a new radiotheranostic era Leila Jaafar-Thiel, Nuclidium AG Developing point‑of-care CAR T manufacturing Arnon Nagler, Sheba Medical Center and Tel Aviv University IN-DEPTH FOCUS: FORMULATION Titanium dioxide (E171) and its role in formulation Mike Tobyn, Bristol Myers Squibb, Jonathan Kaye, GSK David Harris
MedCity News
JUNE 27, 2023
The traditional transactional approach to the coding of diagnoses to support billing in a fee-for-service environment is not adequate to meet the care requirements of VBC programs.
Pharmaceutical Technology
JUNE 27, 2023
Vertex and Lonza have entered a partnership to establish a facility in Portsmouth, US, to manufacture cell therapies for type 1 diabetes.
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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.
European Pharmaceutical Review
JUNE 27, 2023
Janssen’s investigational monoclonal antibody (mAb) therapy nipocalimab enabled 54 percent of participants in the proof-of-concept Phase II UNITY study to achieve a live birth at or after gestational age of 32 weeks without intrauterine transfusions (IUTs). These participants were at high risk of early-onset severe (EOS) haemolytic disease of the foetus and newborn (HDFN).
MedCity News
JUNE 27, 2023
The series, part of a content partnership between HLTH and MedCity News, will share insights from executives from both public and private payer organizations based on developments and trends they’ve seen in the healthcare industry and what keeps them up at night.
Pharmaceutical Technology
JUNE 27, 2023
The FDA has accepted a biologics license application (BLA) for Pfizer's fidanacogene elaparvovec to treat adults with haemophilia B.
MedCity News
JUNE 27, 2023
The FDA approved UCB’s Rystiggo for treating generalized myasthenia gravis. Drugs are already available for the rare neuromuscular disorder, but Rystiggo’s approval includes treatment of a subset of patients not addressed by other products.
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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.
Pharmaceutical Technology
JUNE 27, 2023
UCB's Rystiggo has been granted FDA approval to treat myasthenia gravis in anti-AchR or anti-MuSK antibody-positive adults.
PharmaTech
JUNE 27, 2023
The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.
Pharmaceutical Technology
JUNE 27, 2023
The Japanese MHLW has granted approval for a renewed indication of GSK's shingles (herpes zoster) vaccine, Shingrix.
MedCity News
JUNE 27, 2023
In this month’s episode, we dive into some of the recent executive appointments occurring in the healthcare sector, as well as layoffs affecting the industry. We also hear from Danny Sanchez, who recently became the new CEO of EmpiRx Health, a value-based pharmacy benefit manager.
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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
MedReps
JUNE 27, 2023
Companies with a high amount of turnover have to look internally to see what the issue is. Do employees not like the company’s culture? Is the stressful workplace to blame? Are there employee cliques determined to take others down? Or is the issue with your hiring process? More often than not, it all comes down to the way you determine which candidates are the best and how you choose who to hire.
PharmaTimes
JUNE 27, 2023
Update on radiosensitising impact of SFX-01 when treating common soft tissue sarcoma condition - News - PharmaTimes
MedCity News
JUNE 27, 2023
Here is a selection of recent executive hires, exits, promotions and layoffs occurring across the healthcare industry.
PharmaTimes
JUNE 27, 2023
The company is seeking to address the worldwide impact of group B streptococcus in older adults - News - PharmaTimes
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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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