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.

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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.

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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.

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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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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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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.

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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.

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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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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.

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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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'The Top Line': Democratizing access to women's meds , plus this week's headlines

Fierce Pharma

In this episode of the "The Top Line," Fierce’s Anastassia Gliadkovskaya talks with Autumn Ehnow, vice president of Medicines360, a nonprofit pharma with a mission to produce and sell affordable me | This week on "The Top Line," we discuss the need to democratize access to medications like emergency contraception, plus Elizabeth Holmes, the state of Alzheimer's research, and the rest of the week's headlines.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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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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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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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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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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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.

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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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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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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

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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.

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ABM Success Recipe: Mastering the Crawl, Walk, Run Approach

Shifting to an account-based marketing (ABM) strategy can be both exciting and challenging. Well-implemented ABM motions build engagement with high-value accounts and drive impactful campaigns that resonate with your audience. But where do you begin, and how do you progress from crawling to running? Watch now as Demand Gen experts delve into the essentials of each stage of the ABM process.

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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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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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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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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.

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How Intent Data Helps Marketers Convert A-List Accounts

One of the biggest challenges for any B2B marketer is understanding your prospects’ next move — who is most likely to buy and when. Without these insights, marketing campaigns can feel more like guesswork, with high investment and little return. We’re here to tell you there’s a better way. By tracking buyers’ digital footprints and online activity, such as website visits, product reviews, and spikes in content consumption, you can engage prospects with a message that really resonates.

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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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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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Sanofi’s frexalimab shows early potential in in Phase II multiple sclerosis trial

Pharmaceutical Technology

Sanofi has announced that its anti-CD40L antibody frexalimab demonstrated significantly reduced disease activity in a Phase II trial of patients with relapsing multiple sclerosis (RMS). The Phase II trial (NCT03732820) was a double-blind, placebo-controlled study that enrolled 129 patients with RMS who were randomised to receive two different doses of frexalimab or placebo over the course of 12 weeks.

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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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Solving the Biggest Tech Challenges in RevOps

In this eBook, we’ll run through real-world examples that show how RevOps teams can benefit from modern solutions for the access, management, and activation of their GTM data. Whether you need to improve lead response times, boost adoption of core tools, improve lead qualification, or target and automate your GTM motions, you’ll find examples of how revenue teams are solving some of the toughest problems in modern business.

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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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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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Drive GTM Efficiency with Tech Stack Consolidation

Consolidating your tech stack is an effective cost-saving measure that drives GTM efficiency and adds value to your enterprise. With a cohesive, integrated tech stack, your revenue teams can deliver an excellent customer experience that sets you up to win faster than your competitors.