Fierce Pharma
JUNE 22, 2023
Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. | Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. Intercept is now swinging into restructuring mode, and the NASH baton passes on to Madrigal Pharma.
MedCity News
JUNE 22, 2023
Sarepta Therapeutics’ Elevidys is now the first FDA-approved gene therapy for Duchenne muscular dystrophy. Elevidys is an engineered version of a gene intended to restore function lost to the mutation at the root of the inherited muscle disease.
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Fierce Pharma
JUNE 22, 2023
The EMA is scrutinizing GLP-1s, raising a safety signal about the risk that drugs from Novo Nordisk, Eli Lilly and other companies could cause cancer.
MedCity News
JUNE 22, 2023
In the 12 months leading up to May 15, health services deal volumes decreased just 4% from the year prior, a new report from PwC found. There was a 15% decrease in deal values.
Fierce Pharma
JUNE 22, 2023
The Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) has recommended that adults 60 and older—in consultation with their doctors—receive vacc | The CDC's Advisory Committee on Immunization Practices has recommended that adults 60 and older—in consultation with their doctors—receive vaccines to prevent lower respiratory tract disease caused by respiratory syncytial virus.
PharmaVoice
JUNE 22, 2023
These six Big Pharma companies have ranked among the best places to work for LGTBQ+ equality by the Human Rights Campaign Foundation for over 10 years. Here’s why.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
JUNE 22, 2023
Amazon has launched and shuttered several healthcare solutions over the years, including Amazon Halo, Amazon Care and Haven. But there have been several lessons learned from these previous solutions, Amazon execs told MedCity News last week at the AHIP 2023 conference in Portland.
Fierce Pharma
JUNE 22, 2023
After several delays and a narrow advisory committee vote, Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy has finally won an accelerated approval. | After the FDA said it needed "modest additional time" to review the therapy, the agency has ultimately approved the Duchenne muscular dystrophy gene therapy under the accelerated approval pathway.
MedCity News
JUNE 22, 2023
We need more research and consideration of other approaches to cancer treatment and development of new therapies that better account for the quality of life of cancer patients.
Fierce Pharma
JUNE 22, 2023
AstraZeneca has reportedly drafted a contingency plan to spin out its China business amid increasing geopolitical risks. | AstraZeneca has reportedly worked out a contingency plan to spin out its China business amid increasing geopolitical risks. The British pharma is still forming collaborations in the country, the latest being an R&D pact focused on hypercholesterolemia.
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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 22, 2023
Providence spinout DexCare recently closed a $75 million Series C funding round, bringing its total funding to date to $146 million. The startup gives health systems a platform that helps them coordinate and manage digital care services so they can better address the modern healthcare consumer’s demands for convenience and immediacy.
Fierce Pharma
JUNE 22, 2023
It's safe to say that a lack of clinical trials in a drug application raises red flags for the FDA. | Aldeyra's bid for an approval in primary vitreoretinal lymphoma wasn't supported by clinical trial data as the company doesn't think a study in the rare and fatal disease is feasible, CEO Todd Brady, M.D., Ph.D., said in a statement.
European Pharmaceutical Review
JUNE 22, 2023
A study published in Pharmaceutics has illustrated the superior sensitivity of mechanistic compartmental analysis for nanomedicines. The paper described how both techniques were applied to two small molecule, nanomaterial-based formulations for intravenous injection: albumin-stabilised rifabutin nanoparticles and rifabutin-loaded PLGA nanoparticles.
Fierce Pharma
JUNE 22, 2023
More than a year ago, eight pharma giants partnered to | A partnership among pharma giants to provide cancer medicines to some poorer nations just took a major step toward fruition. The United Nations-backed Medicines Patent Pool signed up four generic drugmakers to produce copycats of Novartis’ myeloid leukemia blockbuster Tasigna.
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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 Pharmaceutical Review
JUNE 22, 2023
On 6 June 2023, the British Standards Institute (BSI) launched its Minimized Risk of Antimicrobial Resistance (AMR) certification for antibiotic manufacturing. According to the information sharing platform AMR Insights , AMR is considered one of the biggest global threats to health and food safety. Combatting AMR calls for international cooperation based on the One Health Approach. 1 Adopting both the Antibiotic Manufacturing Standard and certification will help to “mitigate the risk of the deve
Pharmaceutical Technology
JUNE 22, 2023
Eli Lilly and Boehringer Ingelheim have received approval from the US FDA for Jardiance to treat type 2 diabetes in children
PharmaTimes
JUNE 22, 2023
ATLX-1088 is regarded as a possible first-in-class human antibody targeting CD33 – a cell surface protein - News - PharmaTimes
Pharmaceutical Technology
JUNE 22, 2023
The SFDA of the KSA has granted approval to Amarin’s VASCEPA (icosapent ethyl) capsules for reducing cardiovascular risk.
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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.
MedCity News
JUNE 22, 2023
Organizations across most industries, especially the technology sector, have adopted Multi-Factor Authentication (MFA) to fortify their security measures.
Pharmaceutical Technology
JUNE 22, 2023
The recommendation comes after GSK published data showing its vaccine’s protection lasts over two RSV seasons.
PharmaTimes
JUNE 22, 2023
Poolbeg’s platform will possess the capability to generate vaccines for a wide range of diseases - News - PharmaTimes
Pharma Marketing Network
JUNE 22, 2023
This content is password protected. To view it please enter your password below: Password: The post Protected: Horizon Therapeutics’ Experiences with Executing Multiple Highly Innovative Campaigns Simultaneously to Challenge Disease State Misperceptions, Create Urgency and Change Treatment Behaviors appeared first on Pharma Marketing Network.
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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.
eMediWrite
JUNE 22, 2023
The process of giving a pharmaceutical product a unique identity on the market is called pharmaceutical product positioning. It entails recognising the special qualities and advantages of your product and conveying them to the intended market in a way that sets it apart from rival goods. Your pharmaceutical firm can gain a competitive edge, boost sales, and develop brand loyalty by using effective product positioning.
Pharmaceutical Commerce
JUNE 22, 2023
In this latest Harvard Business School Healthcare Alumni Association Q&A, Ayelet Israeli, PhD, explains the potential—as well as limitations—of these offerings and pragmatic guardrails for deployment in organizations.
Clarify Health
JUNE 22, 2023
San Francisco, Calif.,–(Business Wire)— Berkshire Hathaway Homestate Companies (BHHC), Workers Compensation, a leader in workers’ compensation insurance, and Clarify Health , a leading healthcare analytics, and value-based payments platform company, are pleased to announce a new partnership to improve quality of care and outcomes for injured workers.
PharmExec
JUNE 22, 2023
HBA mentor of the year and director of U.S. public affairs for AbbVie, Jag Dosanjh, divulges in this Pharm Exec Podcast his approach to leadership and how: “If you listen well, you can learn well.
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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
MedTechVets
JUNE 22, 2023
JUNE 21st – On May 23rd, MedTechVets held its Spring Networking Conference to mark the end of a successful Spring MTV Academy. This conference, we were honored to be joined by our two Keynote Speakers, Derek Herrera and Ann Holder. We also had 36 attendees from our Veteran Graduates, Mentors, Alumni, and representatives from 9 different companies.
Clarivate
JUNE 22, 2023
In the parable of the blind men and the elephant, each man describes what the elephant must look like based on their limited experience of touching different parts of the animal. This ancient tale of the Indian subcontinent, which dates to at least 500 BCE, illustrates the limitations of individual experience and suggests that by combining different perspectives and understanding the limitations of our own perceptions, we gain a more comprehensive understanding of the world around us.
Pharmaceutical Technology
JUNE 22, 2023
Calliditas Therapeutics has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for complete approval of TARPEYO (budesonide). The TARPEYO delayed-release capsule is a corticosteroid indicated for reducing proteinuria to treat primary immunoglobulin A nephropathy (IgAN) in adult patients at risk of quick disease progression, generally having a urine protein-to-creatinine ratio greater than or equal to 1.5g/g.
PharmaTech
JUNE 22, 2023
The new headquarters located in Columbus, Ohio, more than triples Andelyn Biosciences’ footprint to meet growing demand for CGT services.
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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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