Thu.Jun 01, 2023

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ASCO: Merck bills Keytruda, used around surgery, as new standard in 'messy' early lung cancer realm

Fierce Pharma

As doctors weigh various immunotherapy strategies for the treatment of early-stage non-small cell lung cancer, Merck & Co. | As doctors navigate the "messy" early-stage non-small cell lung cancer landscape with various immunotherapy approaches, Merck & Co. has now unveiled new data that it hopes can establish Keytruda, used before and after surgery, as a new standard of care.

Doctors 298
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Pfizer’s RSV Vaccine Wins FDA Approval on Heels of Regulatory Nod for GSK

MedCity News

Pfizer’s Abrysvo is now approved for preventing illness caused by respiratory syncytial virus, or RSV, in adults 60 and older. The regulatory decision comes weeks after GSK won approval for its RSV vaccine, Arexvy.

FDA 107
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AZ, Merck's Lynparza wins FDA nod in prostate cancer subgroup following advisory committee vote

Fierce Pharma

After a panel of independent experts endorsed a narrow approval for AstraZeneca and Merck’s Lynparza in metastatic castration-resistant prostate cancer (mCRPC), the FDA has followed suit. | The drug is now approved to treat BRCA-mutated metastatic castration-resistant prostate cancer in combination with Johnson & Johnson’s Zytiga and a corticosteroid.

FDA 291
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It’s Time for Healthcare To Embrace Patient-Friendly Language

MedCity News

Recent regulations from the Office of the National Coordinator for Health IT (ONC) and Centers for Medicare & Medicaid Services (CMS) have, respectively, focused on prohibiting information blocking and increasing price transparency. Together, these two regulations have put a third issue into the spotlight as well: Reducing the complexity of clinical terminology.

Patients 105
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Look out, GSK. Pfizer has its adult RSV vaccine approval and is raring to launch

Fierce Pharma

About a month after GSK won the world's first approval for a respiratory syncytial virus (RSV) vaccine, rival Pfizer has followed suit. | After winning FDA approvals one month apart, Pfizer and GSK are set to launch competing RSV vaccines this fall.

FDA 281
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Interoperability: Past, Present, and Future

MedCity News

A new decentralized network of the future exists and is in operation today. Large payers and providers are already beginning to use it for administrative transactions, although clinical transactions are also envisioned.

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Pencil-on-Paper Wearable Sensor

Medgadget

Researchers at Penn State have developed a low-cost, wearable sensor using pencil-on-paper technology. This approach involves depositing graphite (pencil ‘lead’) on paper that has been treated with sodium chloride, to create a conductive, low-cost sensor. Previously, these researchers had developed such sensors to detect moisture and even used them to develop a smart diaper ( yes, really ).

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Fierce Pharma Asia—Sun’s Taro buyout, Eli Lilly’s XtalPi collab, Yuhan’s cancer candidate

Fierce Pharma

Sun Pharma picked up Taro Pharmaceutical Industries 16 years after its initial offer. Eli Lilly and XtalPi linked up in a $250 million deal. | Sun Pharma snapped up Taro Pharmaceutical Industries in a $307 million deal after its initial 2007 offer. Eli Lilly and XtalPi linked up in a $250 million collaboration to identify potential drug candidates using the latter's AI technology.

Pharma 148
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UK’s NICE recommends Pfizer’s rimegepant to treat migraine

Pharmaceutical Technology

The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of Pfizer ’s rimegepant (Vydura) to prevent migraine attacks. The therapy has been recommended as an option to prevent episodic migraines in adult patients, who have between four and 15 migraine attacks per month, and where a minimum of three preventive treatments have previously failed.

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Why One Analyst Is Encouraged by Healthcare IT’s Fundraising Rebound

MedCity News

Healthcare IT companies experienced a bounceback in venture capital deal activity during Q1 of 2023. Rebecca Springer, PitchBook ’s lead healthcare analyst, said she is optimistic that healthcare IT startups will be able to keep this momentum going, especially those focused on staffing and value-based care enablement.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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AstraZeneca and MSD’s Lynparza combo bags FDA approval for prostate cancer

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD ’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). On 31 May, the FDA granted approval based on subgroup analysis of the Phase III PROpel trial (NCT03732820) in patients with BRCA mutations.

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Report: 22% of People With a Behavioral Health Condition Account for 41% of Healthcare Spend

MedCity News

About 87% of those with a behavioral health condition also have one or more medical conditions, according to a new analysis from the Evernorth Health Research Institute.

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New UK intracellular drug delivery centre to support RNA development

Pharmaceutical Technology

A new intracellular drug delivery centre will be established in the UK to support potential ribonucleic acid (RNA) vaccines and therapeutics , as well as the development of innovative drug delivery technologies. The centre will be established by UK-based technology innovation centre CPI, in collaboration with Medicines Discovery Catapult, the University of Strathclyde, the University of Liverpool, and Imperial College London.

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CMS Will Cover Approved Alzheimer’s Drugs, But It Still Wants More Evidence

MedCity News

Medicare will cover Alzheimer’s disease drugs granted traditional FDA approval, CMS announced. But the decision keeps the spirit of an earlier coverage determination, which called for the gathering of more evidence about the safety and efficacy of these therapies.

Safety 86
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Rentschler Biopharma, Ikarovec Collaboration Set to Speed Up Ophthalmic Therapy Development

PharmaTech

A partnership between Rentschler Biopharma and Ikarovec will support the accelerated development of novel gene therapies for the treatment of eye diseases.

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Swimming in the AI Data Lake: Why Disclosure and Versions of Record Are More Important Than Ever

Copyright Clearance Center

The post Swimming in the AI Data Lake: Why Disclosure and Versions of Record Are More Important Than Ever appeared first on Copyright Clearance Center.

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Inside One Philadelphia Doctor’s DIY Method to Tackle Health Inequity

MedCity News

Dr. Ala Stanford, founder of the Black Doctors Covid-19 Consortium, provided hundreds of thousands of Covid-19 tests and vaccines to Black and Brown people in Philadelphia’s underserved neighborhoods during the pandemic. In her view, her was impactful because she acted promptly and focused on community-based patient engagement.

Doctors 78
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FDA approves ANDA of 20mg generic Nitisinone capsules

PharmaTimes

Nitisinone capsules are indicated for patients with hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine

FDA 90
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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Investigating Bacterial Motion for New Treatment Strategies

Medgadget

Researchers at Florida State University have developed a 3D model that examines how the bacterium Helicobacter pylori moves through viscous fluids. H. pylori can cause gastrointestinal ulcers and even cancer, moving through the intestinal mucus layer to reach the wall of the gut. Using antibiotics can cause side-effects and can contribute to drug resistance, so these researchers are studying how the bacterium navigates through mucus in an effort to find new therapeutic targets with which to disr

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Innovation in Heart Disease: A Deep Dive

Pharmaceutical Commerce

While generics and adherence challenges are keeping drugmakers up at night, breakthroughs in the pipeline coupled with innovative uses of artificial intelligence and machine learning techniques are bringing optimism to the cardiovascular disease space.

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NICE recommends oral migraine treatment for first time

European Pharmaceutical Review

An oral treatment for preventing migraines has been recommended by the National Institute for Health and Care Excellence (NICE) for the first time. Rimegepant (Vydura) is recommended as an option for episodic migraine in adults after having at least three previous failed preventive treatments. The NICE final draft guidance recommends rimegepant in individuals who have at least four migraine attacks per month but less than 15, stated the UK regulatory body.

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Lonza to acquire Synaffix to strengthen ADC development

PharmaTimes

Synaffix’s technology platform is intended to enhance and extend Lonza’s integrated ADC services - News - PharmaTimes

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Microfluidic device detects bacteria concentration from small sample volumes

European Pharmaceutical Review

A study has shown an ultrasonic nanosieve within a microfluidic device concentrated and detected bacterial cells at low initial concentrations and small sample volumes for the first time. The results demonstrated an efficiency of 99 percent bacterial capturing using the microfluidic device. Additionally, the data showed that the concentrated bacteria can be recovered with an 80 percent efficiency.

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Avacta Acquires Coris BioConcept to Grow Diagnostics Product Portfolio

PharmaTech

Through the acquisition, Avacta gains Coris’ product portfolio consisting of diagnostic tests for respiratory, gastroenteric, and blood-borne pathogens as well as for the detection of antibiotic resistance markers.

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Algernon announces acceptance of Repirinast patent application in Japan

Pharmaceutical Technology

Algernon Pharmaceuticals’ patent application for NP-251 (Repirinast) has been accepted by the Japanese Patent Office (JPO) for the treatment of chronic kidney disease (CKD). The company has announced that the JPO has issued a Notice of Allowance for the patent application. The invention is for use in the prophylaxis or therapeutic treatment of renal fibrosis or kidney disease.

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Qualtrak Real-Time PCR and Digital PCR Ecosystem for Streamlined Biologics Development (June 2023)

PharmaTech

Biologics—including vaccines, cell and gene therapies, monoclonal antibodies (mAbs), and their biosimilars—have great potential for the treatment and prophylaxis of a broad range of diseases. But, rapid and efficient development of new and effective biologics is no easy feat. With such drastic implications for time and resources, it is imperative that biologic manufacturers choose the right commercial collaborators from the start—agile partners who can improve predictivity, speed, and consistenc

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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Focus on Men’s Health: Key Insights from Medicare Claims Analysis

Clarify Health

Men’s Health Awareness Month in June provides a vital opportunity to delve into the unique challenges men face in taking care of their health. The Clarify Health Institute , the research arm of Clarify Health, recently assessed men’s health disparities through analysis of Clarify health insurance claims data. Focusing on the Medicare fee-for-service (FFS) population aged 65-85 years old, and leveraging a 100% sample of Medicare claims available to Clarify Health as a Qualified Entity

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Calcium+Company Expands with Acquisition of CSG Health Group

PM360

Calcium+Company , a leading mid-sized diversified healthcare marketing agency, today announced it has acquired CSG Health Group , a leading global scientific communications agency specializing in promotional and educational strategies and initiatives directed to healthcare professionals. The acquisition is the latest outgrowth of Calcium+Company’s strategy to invest in high-value, diversified services to better serve clients and drive robust company growth.

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Stop Promoting Your Best Sales Reps to Managers—Here’s Why

Quantified

Top sellers are the backbone of your sales team. Leadership teams want to replicate that talent and disperse those skills among other reps. So it makes logical sense to promote your top sellers, right? Not exactly. There’s a name for this—the “Peter Principle.” We promote based on people’s success in their current role without considering the skills and traits they’ll need to succeed in the new position.

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Pneumagen raises £8 million for further study of intranasal antiviral

Pharmaceutical Technology

Pneumagen has raised £8m ($10 million) for the further development of its intranasal antiviral drug neumifil in Phase II studies for chronic obstructive pulmonary disease (COPD) patients suffering from virus-induced exacerbations. A Phase IIb study of neumifil is currently planned to start in 2024, per the 1 June announcement. According to the company’s website, the Phase IIb is planned to begin in early 2024.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.