2023

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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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How AI Will Change the Way Patients Get Medication

MedCity News

There is a huge opportunity for PBMs and health systems to use AI to help address the challenges surrounding the affordability and accessibility of medicines, from navigating formularies to resolving prior authorization. More automation in pharmacies and with ordering workflows is one piece of that puzzle.

Medical 139
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BioNTech’s RNA vaccine sparks potential in pancreatic cancer

Pharmaceutical Technology

Results published in Nature for a personalised pancreatic cancer vaccine that uses neoantigens from patients’ tumours have lent further support to early positive signals. The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later. In the study, 16 patients were treated with a vaccine called autogene cevumeran that contained a maximum of 20 neoantigens, alongside Roche’s anti-PD-L1 immunotherapy Tecentriq (atez

Patients 138
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Supporting integrity of the scholarly record: Our commitment to curation and selectivity in the Web of Science

Clarivate

We have the important responsibility of providing our customers with trustworthy intelligence to help them transform the world for the better. The need for high-quality data from rigorously selected sources is becoming ever more important as the scholarly record becomes increasingly polluted. A trusted record of research is essential for the global R&D community to effectively use published research outcomes to elevate ideas that will benefit everyday life.

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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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First nasal monoclonal antibody COVID-19 treatment shows potential

European Pharmaceutical Review

A pilot study has demonstrated that a nasal version of the drug Foralumab, an anti-CD3 monoclonal antibody suppressed the inflammatory T cell response and decreased lung inflammation in patients with COVID-19. “This is the first nasal monoclonal antibody—other monoclonal antibody treatments were delivered intravenously and are no longer given as treatment because they are not effective against currently circulating viral variants,” explained Dr Howard Weiner, founder and Director of the Brigham

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More Trending

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Scientists Grow Electrodes Inside The Body

Medgadget

Researchers at Linköping University in Sweden have developed a method whereby the body can ‘grow its own’ electrodes. The minimally invasive technique involves injecting a hydrogel that is laden with enzymes into target tissues. The enzymes interact with molecules that are present in the tissue to change the structure of the gel and allow it to become electrically conductive.

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Your Guide to Virtual Reality Reimbursement in the U.S. Healthcare Market

Nixon Gwilt Law

As a law firm focused specifically on healthcare innovation, we get really excited about developing areas of the healthcare industry. One area we are particularly excited about? Virtual Reality. Providers are already integrating Virtual Reality ( VR ) into patient care in a variety of ways. For example, using VR to gamify physical therapy exercises for pediatric patients to keep them engaged in their treatment, or to provide targeted exposure therapy in a controlled environment for patients with

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Google and DeepMind share work on medical chatbot Med-PaLM

pharmaphorum

Google and DeepMind have developed an artificial intelligence-powered chatbot tool called Med-PaLM designed to generate “safe and helpful answers” to questions posed by healthcare professionals and patients. The tool is an example of a large language model or LLM, which are designed to understand queries and generate text responses in plain language, drawing from large and complex datasets – in this case, medical research.

Medical 137
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A CEO’s quest to solve a 400-year-old medical mystery — and he’s also a patient

PharmaVoice

The CEO of Ventoux Biosciences has the disease that his company is aiming to treat, and it's driving him to find better medications.

Medical 126
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Congress Probes PBM Link to Higher Drug Prices

PharmExec

Latest investigation signals more scrutiny of pharmacy benefit managers and their role in treatment cost and coverage.

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Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease

Fierce Pharma

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease zbecker Fri, 05/19/2023 - 16:25

FDA 363
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Telehealth Companies Applaud DEA for Delaying Telemedicine Restrictions of Controlled Substances

MedCity News

The Drug Enforcement Administration received 38,000 comments on its proposed rule that would roll back Covid-19 flexibilities for the prescribing of controlled substances via telemedicine. In response, the DEA chose to temporarily extend the flexibilities, a decision telehealth companies like Bicycle Health and Mindbloom are in support of.

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Dawn of a new indication: how to study drugs for aging 

Pharmaceutical Technology

For a long time, aging biology and research have been enigmatic areas that biotechs hoped to capitalise on due to their market potential. Whether one refers to such research as “longevity”, “anti-aging” or “extending healthspan”, it is clear this area has evolved massively over the last few years with more scientists now eager to get drugs in this area from bench to bedside.

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The Preprint Citation Index: linking preprints to the trusted Web of Science ecosystem

Clarivate

After many months of planning, we are launching the Preprint Citation Index , a multidisciplinary collection of preprints from leading repositories that helps researchers stay current with the newest research while maintaining confidence in the resources they rely on. With the launch of the Preprint Citation Index , we are making it even easier for researchers to include preprints in their existing research workflows.

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Mass spectrometry software can link different data types

European Pharmaceutical Review

The latest version of software tool MZmine, which aids analysis of mass spectrometry data, has been released. Using this third generation software, scientists can analyse large volumes of data from mass spectrometry, processing thousands of samples within minutes to hours. [the newest version can process] thousands of samples within minutes to hours.” It is the first tool with an entire data processing pipeline that integrates liquid chromatography (LC)-ion mobility spectrometry (IMS)-MS a

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Novel Treatment Achieves Up to 14.9% Weight Loss After 46 Weeks

Pharmacy Times

BI 456906 activates the GLP-1 and glucagon receptors that help to control metabolic function, and could potentially offer clinically relevant benefits for those living with obesity or overweight without type 2 diabetes.

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Tiny Patch for Cardiac Ultrasound Imaging

Medgadget

Engineers at the University of California San Diego have developed a wearable ultrasound system for cardiac imaging. The postage stamp-sized patch can be worn on the skin of the chest and uses AI and ultrasound waves to perform advanced imaging of the heart. The technology can even be worn to perform cardiac ultrasound imaging during exercise. Each patch can be worn for up to 24 hours, and provides information on how much blood the heart is pumping, a key metric in detecting and appraising a var

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In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy

Fierce Pharma

In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy aliu Fri, 04/21/2023 - 22:35

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Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations

Fierce Pharma

Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations zbecker Wed, 04/19/2023 - 11:04

FDA 364
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J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries

Fierce Pharma

J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries mbayer Fri, 02/03/2023 - 09:29

Pharma 363
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FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy

Fierce Pharma

FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy kdunleavy Wed, 05/31/2023 - 13:02

FDA 339
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Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis

Fierce Pharma

Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis zbecker Mon, 05/22/2023 - 14:43

FDA 336
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Alnylam sticks with aggressive litigation strategy against Pfizer and Moderna, filing yet another patent lawsuit

Fierce Pharma

Alnylam sticks with aggressive litigation strategy against Pfizer and Moderna, filing yet another patent lawsuit zbecker Tue, 05/30/2023 - 10:24

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Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license

Fierce Pharma

Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license esagonowsky Fri, 02/24/2023 - 09:18

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Intercept's NASH dreams may be dashed after FDA panel votes against Ocaliva's approval bid

Fierce Pharma

Intercept's NASH dreams may be dashed after FDA panel votes against Ocaliva's approval bid fkansteiner Fri, 05/19/2023 - 17:30

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After Johnson & Johnson loses again in bankruptcy case, it's game on for talc lawsuits

Fierce Pharma

After Johnson & Johnson loses again in bankruptcy case, it's game on for talc lawsuits kdunleavy Mon, 04/03/2023 - 06:44

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JPM23, Day 1: BMS touts new launches as patent cliff looms; Regeneron's Eylea sales disappoint

Fierce Pharma

JPM23, Day 1: BMS touts new launches as patent cliff looms; Regeneron's Eylea sales disappoint. esagonowsky. Mon, 01/09/2023 - 09:55.

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Eli Lilly's weight-loss drug passes 2nd trial with flying colors, setting up likely approval

Fierce Pharma

Eli Lilly's weight-loss drug passes 2nd trial with flying colors, setting up likely approval aliu Wed, 04/26/2023 - 22:30

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GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg

Fierce Pharma

GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg esagonowsky Wed, 02/15/2023 - 09:02

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Johnson & Johnson takes another step in CAR-T race with Bristol Myers in multiple myeloma

Fierce Pharma

Johnson & Johnson takes another step in CAR-T race with Bristol Myers in multiple myeloma kdunleavy Thu, 05/25/2023 - 10:52

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Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit

Fierce Pharma

Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit kdunleavy Tue, 02/14/2023 - 10:29

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Merck's Keytruda dealt another blow in prostate cancer but readies new challenge to AZ's Imfinzi

Fierce Pharma

Merck's Keytruda dealt another blow in prostate cancer but readies new challenge to AZ's Imfinzi aliu Wed, 01/25/2023 - 10:17

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CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices

Fierce Pharma

CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices. zbecker. Tue, 01/17/2023 - 11:49.

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