Bio Pharma Dive
JULY 29, 2021
The startup manufacturing specialist National Resilience, which raised $800 million when it launched last year, will pay Bluebird $110 million for the North Carolina facility, bringing its North American network up to 10.
BioSpace
JULY 29, 2021
?Pfizer has reported several highlights regarding its mRNA COVID-19 vaccine. As the world deal with rising Delta variant cases, Pfizer-BioNTech is still arguing that a third booster shot will be likely.
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Bio Pharma Dive
JULY 29, 2021
An injectable insulin from Viatris has become the first-ever biosimilar product that can be directly substituted for a marketed biologic, a long-awaited decision that could put pricing pressure on other diabetes drugs.
pharmaphorum
JULY 29, 2021
The use of specialty drugs in the U.S. has skyrocketed in recent years driven primarily by an increase in chronic condition diagnosis and the number of new medications on the market. Krishnanjan Alaparthi explores how tech-driven hub services can help manage the complexities of specialty pharma. It’s estimated specialty medications account for 75% of the approximately 7,000 prescription drugs currently in development, and by 2022, more than 60% of the 600 drugs expected to gain FDA approval will
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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
Bio Pharma Dive
JULY 29, 2021
The company now expects to file for full approval by year’s end and has a variant-specific shot in advanced testing. But the long-term prospects for AstraZeneca's new vaccine business are unclear.
BioSpace
JULY 29, 2021
The FDA Watch List considers drug-resistant Candida auris (C. auris) an urgent threat, drug-resistant Candida species a serious threat, and azole-resistant Aspergillus Fumigatus worth watching – especially since person-to-person transmission of drug-resistant fungi has been recently documented.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JULY 29, 2021
Two artificial intelligence (AI) algorithms designed to diagnose people with heart rhythm abnormalities have been approved by the FDA for use with Medtronic’s LINQ II cardiac monitor. The AccuRhythm algorithms can be used to improve the accuracy of detecting atrial fibrillation (AF) – an irregular or rapid rhythm in the upper chambers of the heart – and asystole, a long pause between heartbeats.
Eye on FDA
JULY 29, 2021
In the face of a crisis situation, it is a given that the clarity and thoroughness of the communications response is key to resolving the issue and mitigating any reputational damage. Perhaps no other decision by the Food and Drug Administration has garnered as much controversy, as the recent one to authorize the accelerated approval a new treatment for Alzheimer’s.
BioSpace
JULY 29, 2021
The United States and other wealthy nations now stand at an important place in their COVID-19 vaccine campaigns. The question largely turns to vaccinating the remainder of the population – namely, those under 12 years.
XTalks
JULY 29, 2021
It has become increasingly apparent that COVID-19 can have significant long-term health impacts, with the potential of symptoms lingering for weeks and months after infection in a condition dubbed “long COVID.”. In addition to respiratory and gastrointestinal symptoms, long COVID-related impairments can include short- or long-term neurological symptoms such as loss of smell and taste, and cognitive and attention deficits known as “brain fog.
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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
pharmaphorum
JULY 29, 2021
The FDA has started a priority review of Roche’s bispecific antibody faricimab for two major causes of blindness, preparing for a market showdown with Bayer and Regeneron’s market-leading Eylea. The US regulator will review the drug for both neovascular or ‘wet’ age-related macular degeneration (AMD) and diabetic macular oedema (DME), as well as diabetic retinopathy under a standard review.
XTalks
JULY 29, 2021
Just as clinical researchers in other therapeutic areas have renewed their commitment to improving participant diversity in clinical trials, so too have those working in Alzheimer’s research. African Americans are twice as likely to be diagnosed with dementia compared to Caucasians, but make up just five percent of all clinical trial participants. Similarly, older Latino and Hispanic individuals are 1.5 times more likely than white Americans to suffer from dementia, less than one percent have pa
pharmaphorum
JULY 29, 2021
The UK has levied another big fine for anticompetitive activity in the pharma market in a fortnight, with Advanz Pharma and former owners on the hook for more than £100 million ($140 million) after increasing the price of a thyroid disease drug by 1,110% over an eight-year period. The Competition and Markets Authority (CMA) said the fine “sends a clear message” to the pharmaceutical industry that breaking the law will not be tolerated.
Delveinsight
JULY 29, 2021
Teneobio and its next-gen cancer work acquired by Amgen . Amgen has penned a major new buyout deal to boost its oncology pipeline further. The biopharma is putting USD 900 million down upfront, with USD 1.6 billion in biobucks on the table to buy Teneobio and its suite of bispecific and multispecific antibody technologies focused on cancer and other disease targets.
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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.
pharmaphorum
JULY 29, 2021
Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – namely Sanofi’s once-daily insulin Lantus. Mylan’s Semglee has been approved for over a year as a regular biosimilar to Lantus (insulin glargine), meaning that it could be used in place of Sanofi’s drug, but only if specifically prescribed for a patient.
BioSpace
JULY 29, 2021
Eli Lilly and Company presented data analysis from the Phase II TRAILBLAZER-ALZ study at the Alzheimer’s Association International Conference (AAIC) that supports the argument that decreases in beta-amyloid in Alzheimer’s disease slows cognitive decline.
pharmaphorum
JULY 29, 2021
AstraZeneca said this morning that it has made $1.2 billion in sales from its COVID-19 vaccine Vaxzevria in the first half of this year, but making it available at no profit had weighed on its profit margins. R&D expenses leaped 28% in the period, an increase that AZ said was “primarily” a result of its continued investment in the COVID-19 vaccine and other potential medicines to prevent and treat the coronavirus.
BioSpace
JULY 29, 2021
As Gilead gets ready to open its doors to its new operations site in North Carolina, the company reported its product sales for the second quarter increased 21% year-over-year primarily driven by Veklury.
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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.
Pharma Times
JULY 29, 2021
CSU is the fifth disease for which Dupixent has positive Phase III data, according to Sanofi and Regeneron
BioSpace
JULY 29, 2021
The U.S. Centers for Disease Control and Prevention issued a warning that the Delta variant is as infectious as chickenpox and can cause a much more severe COVID-19 infection.
Pharma Times
JULY 29, 2021
The company was co-founded in 2019 by Jeffrey Pollard and Luca Cassetta of the University of Edinburgh
BioSpace
JULY 29, 2021
Collaborating with Frazier Healthcare Partners, the team spun out a new company dubbed HilleVax to take Takeda’s norovirus vaccine into Phase 3 trials.
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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.
Pharma Times
JULY 29, 2021
Findings come from a year-long study into the perceptions of the pharma sector in the UK
BioSpace
JULY 29, 2021
Shares of Ardelyx, Inc. have fallen nearly 13% in premarket trading after the U.S. FDA rejected the company's chronic kidney disease drug, tenapanor.
Pharma Times
JULY 29, 2021
BKX-001 is designed to target the apoptosis, or programmed cell death, pathway
BioSpace
JULY 29, 2021
The U.S. Securities and Exchange Commission has halted registrations of U.S. initial public offerings (IPOs) by Chinese companies.
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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
JULY 29, 2021
Yesterday saw the US Food and Drug Administration (FDA) approve the first interchangeable biosimilar drug.
BioSpace
JULY 29, 2021
?Kaiser Permanente has reportedly filed a lawsuit against drug maker Merck for allegedly allowing a "pay-for-delay" scheme that cost the former millions of dollars.
Pharma in Brief
JULY 29, 2021
CADTH has convened a pan-Canadian Advisory Panel on a Framework for a Prescription Drug List (the Panel ). The Panel will provide recommendations on developing a potential pan-Canadian prescription drug list (or formulary). Stakeholder consultations are scheduled to take place in the fall and winter of 2021, leading to a final public report setting out the Panel’s non-binding recommendations in April 2022.
BioSpace
JULY 29, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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