Bio Pharma Dive
JULY 14, 2022
The deferral puts the drug in regulatory limbo, setting back the Swiss pharma's efforts to catch up to top immunotherapy developers Merck, Bristol Myers Squibb and Roche.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 14, 2022
The COVID-19 pandemic has seen multiple lockdowns in multiple countries as governments have tried to limit transmission – and a new study uses those lockdowns to look at how we experience isolation and feelings of loneliness. What’s clear is that we all experience being on our own differently. For some people, it can be damaging […].
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Bio Pharma Dive
JULY 14, 2022
The prolific biopharma dealmaker is paying Theravance $1.1 billion and Innoviva $282 million to acquire rights to royalties on GSK’s asthma and COPD drug Trelegy Ellipta.
Pharmaceutical Technology
JULY 14, 2022
Novavax has obtained the US Food and Drug Administration (FDA) emergency use authorization (EUA) for its Covid-19 vaccine. The EUA for the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has been granted for providing a two-dose primary series for active immunisation aimed at preventing the disease in individuals aged 18 years and above. Novavax president and CEO Stanley Erck said: “Today's FDA emergency use authorization of our Covid-19 vaccine provides the US with access to the first protei
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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 14, 2022
A shaky biotech market has forced another drugmaker to adjust, with CytomX revealing plans to reduce its workforce by 40%.
Pharmaceutical Technology
JULY 14, 2022
It is estimated that there are currently more than 7,000 orphan diseases, many of which are considered life-threatening and most of which have a genetic basis. Despite this high number, orphan diseases are rare by definition, affecting around one in 2,000 people as defined by the European Union. Historically, the pharmaceutical industry has failed to meet the needs of this patient population.
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Pharmaceutical Technology
JULY 14, 2022
Innoviva has signed an agreement for the sale of its 15% economic stake in Theravance Respiratory Company (TRC) to Royalty Pharma for nearly $282m in upfront cash payments and a potential contingent sales-based milestone payment of $50m. TRC receives royalties generating from sales of TRELEGY ELLIPTA (the combination FF/UMEC/VI). According to the agreement, TRC also transferred all of its ownership stakes and investments in InCarda Therapeutics, ImaginAb, Gate Neurosciences, and Nanolive to Inno
Rethinking Clinical Trials
JULY 14, 2022
During the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, Dr. Keith Marsolo, Co-chair of the Electronic Health Records Core , moderated a panel on “Barriers and Challenges: Data Collection and Merging Datasets.” Four panelists shared their experiences collecting and aggregating data from diverse data sets and how they solved unexpected challenges.
Pharmaceutical Technology
JULY 14, 2022
Processing powder blends can present a number of challenges: component powders may be poorly flowing in the process, the blends may be susceptible to segregation, or the formation of agglomerates may affect homogeneity. Granulation is used in a range of industries and applications to combine multiple components of a blend into a more free-flowing, homogeneous intermediate product for downstream processing.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 14, 2022
The Drug Controller General (India) has issued a notice classifying around 70 medical devices pertaining to rehabilitation under the provisions of Medical Devices Rules, 2017. The decision comes as the latest in the drug regulator’s efforts to classify the medical devices sold in the country based on the perceived risk of the product type and […].
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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
JULY 14, 2022
Avrobio has received orphan drug designation for its gene therapy, AVR-RD-05, from the US Food and Drug Administration (FDA) to treat mucopolysaccharidosis type II (MPSII) or Hunter syndrome. The rare and seriously debilitating lysosomal disorder, Hunter syndrome primarily affects young boys and is caused by a deficiency in the lysosomal enzyme iduronate-2-sulfatase (IDS).
NPR Health - Shots
JULY 14, 2022
A federal judge ordered thousands of dogs to be rehomed from a Virginia research facility after several inspections revealed poor conditions. Animal rescue groups are working to do just that.
Pharmaceutical Technology
JULY 14, 2022
Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. In this ongoing series , we put a spotlight on contracts between pharma companies and contract manufacturing organizations (CMOs).
NPR Health - Shots
JULY 14, 2022
With COVID safety protocols rescinding around the country, many are returning to a sense of pre-pandemic normalcy. But disabled and immunocompromised people can't do so, and are being left behind.
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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.
Rethinking Clinical Trials
JULY 14, 2022
This podcast continues the discussion with Dr. John Concato as he discusses the FDA draft guidance on real-word evidence. Click on the recording below to listen to the podcast. NIH Pragmatic Trials Collaboratory · Podcast 42: FDA Draft Guidance on Real-World Evidence. Want to hear more? View the full Grand Rounds presentation. For alerts about new episodes, subscribe free on Apple Podcasts or SoundCloud.
NPR Health - Shots
JULY 14, 2022
Birth control pills are available in the U.S. only with a prescription. Now a drugmaker is asking the FDA to approve a progestin-only contraceptive that would be available without one at pharmacies.
BioSpace
JULY 14, 2022
Recent advances in precision medicine and genomics have launched an explosion in immunotherapies that are resulting in real cures and earlier diagnoses - and more healthy years for individuals.
STAT News
JULY 14, 2022
Turning students into competent physicians in just four years is a tall order. They have so much to learn: anatomy and physiology and genetics, disease processes, how to diagnose disease and communicate with patients, and more. It’s made even harder by the fact that medical knowledge continues to evolve at an accelerating pace, necessitating ongoing learning throughout a physician’s career.
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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.
NPR Health - Shots
JULY 14, 2022
The BA.5 strain represented 65% of cases from July 3 to 9, according to data from the Centers of Disease Control and Prevention.
XTalks
JULY 14, 2022
Rare and rheumatic disease-focused biotech Horizon Therapeutics has received expanded approval from the US Food and Drug Administration (FDA) for its gout injection Krystexxa (pegloticase) to include its co-administration with the immunomodulator methotrexate. In a news release , Horizon said the drug combo can help more people with uncontrolled gout achieve a complete treatment response.
NPR Health - Shots
JULY 14, 2022
Chrysta Bilton's mother was a lesbian who asked a man she'd just met to be her sperm donor. It was only much later that Bilton learned the same man had donated sperm to countless other women.
STAT News
JULY 14, 2022
In the coming weeks, the Supreme Court is expected to decide whether to review a wonky, but exceedingly important, debate over patents that has the pharmaceutical industry on edge. At issue is the extent to which a drug company must describe how to replicate its newly invented medicines when applying for patents, notably biologics. These treatments constitute a highly lucrative market because they are used to help the body fight cancer, infection, and a wide array of other diseases — and
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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.
XTalks
JULY 14, 2022
There is no doubt that business-to-business (B2B) life science webinars allow you to connect with potential and current customers in a very personal way. They can also help increase your brand awareness. In addition, webinars are a great way to generate leads and assist the sales process. There are certainly a lot of benefits that can come with using this medium, so why not perfect your webinar marketing campaign with professional webinar production services?
STAT News
JULY 14, 2022
You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter delivered in your inbox every Tuesday and Thursday.
XTalks
JULY 14, 2022
Every gene in a cell is expressed at exact levels due to complex gene regulatory networks. For example, when T cells (a type of white blood cells that fight off infections and cancer) are activated in our immune systems, thousands of proteins in these cells change. The proteins are interconnected and changes in one protein level can impact that of another.
STAT News
JULY 14, 2022
Can CRISPR edit out a heart attack? What happens on #GutTok? And is health care recession-proof? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Sek Kathiresan, cardiologist and CEO of Verve Therapeutics, joins us to explain the company’s work on preventing heart disease with genome editing.
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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.
BioSpace
JULY 14, 2022
Discover the biggest barriers patients face when seeking healthcare treatment, and find out what physicians can do to help patients overcome these barriers and improve patient engagement.
STAT News
JULY 14, 2022
Value-based drug pricing offers an important way to bring down the high cost of drugs in the United States. In this approach, a drug’s price is tied to demonstrated effectiveness and benefit on patient outcomes. Results-based pricing is built into contracts between pharmaceutical manufacturers, health care payers, and health care providers. The more effective a drug, the higher the target price payers submit, with discounts and rebates given for drugs that are less effective than expected
XTalks
JULY 14, 2022
Responsible leadership coaching includes actively listening and asking questions, as well as providing specific, honest and ongoing feedback. Life sciences and pharma professionals who want to develop as leaders can benefit from their HR business partners who are seeking to coach talent in the company. There are many ways to develop oneself and others professionally, but what does it take to coach and to be coached?
STAT News
JULY 14, 2022
Manifold Bio, a new startup founded by one of Boston’s most prolific biotech entrepreneurs, has raised $40 million to develop a technology that could make testing cancer drugs more efficient. The company is designing a system for “barcoding” protein therapies — giving them a unique label so that dozens or hundreds of them can be tested at the same time to see which are best at targeting tumors.
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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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