Clarivate

JUNE 28, 2023

In the 2023 release of our Journal Citation Reports, we have taken significant additional steps to foster research integrity in the Web of Science. This is part of our ongoing efforts to proactively contribute to the maintenance of public trust in scientific and scholarly research. Learn about what’s new and some future changes. Today marks the 2023 release of the annual Journal Citation Reports (JCR ).

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Government Management Marketing 128

Fierce Pharma

JUNE 9, 2023

After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing. | After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing.

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FDA 361

Pharmaceutical Technology

JUNE 20, 2023

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

Safety 145

Safety Medicine Healthcare Healthcare 145

PharmaTech

JUNE 2, 2023

An increase in applications for gene therapies is putting stress on FDA’s resources.

FDA 141

FDA 141

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Sales Management

MedCity News

JUNE 4, 2023

New York-based startup Ezra recently received FDA clearance for an AI tool it plans to use to launch “the world’s first 30-minute full body MRI scan.” The tool, named Ezra Flash, enhances the quality of MR images so that radiologists can detect cancer earlier.

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FDA 138

Dominic Tyer

JUNE 24, 2023

The latest Customer Experience Quotient® (CXQ®) report from DT Consulting is also our first US benchmark and reveals a close race for leadership in pharma

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Pharma Consulting 130

Fierce Pharma

JUNE 12, 2023

Two years after the initial COVID-19 vaccine push swept across the globe, Pfizer’s COVID-19 vaccine partner BioNTech is heading to court in its home country of Germany to defend itself against alle | The drugmaker will defend itself against claims from a German healthcare worker who sued the company for at least 150,000 euros ($161,500). The plaintiff alleges she suffered bodily harm resulting from Pfizer and BioNTech's Comirnaty vaccine.

Healthcare 357

Healthcare Healthcare 357

Pharmaceutical Technology

JUNE 12, 2023

On 9 May, National Fentanyl Awareness Day was observed in recognition of the US opioid crisis. Accordingly, the development of non-opioid painkillers is experiencing a surge in activity and despite numerous novel targets receiving high levels of attention, cannabinoids have emerged as strong favourites to replace opioid-related medications. The North American opioid epidemic highlights limitations in opioid use, such as the potential for drug abuse and overdose.

Medical 143

Medical Prescription Management Manufacturing 143

European Pharmaceutical Review

JUNE 21, 2023

The US Food and Drug Administration (FDA) has approved LODOCO ® , the “first drug to target cardiovascular inflammation,” reported Dr Paul Ridker, MPH, Professor of medicine at Harvard Medical School and Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital. It is the first anti-inflammatory cardiovascular treatment demonstrated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adults with establ

Food and Drug Administration 126

Food and Drug Administration Medicine FDA Food 126

MedCity News

JUNE 26, 2023

Public health is heavily dependent on collecting and sharing accurate patient data. Standards for data collection and interoperability can move the needle toward better health data, but it is up to healthcare organizations to take ownership of their data quality by following best practices and adopting technologies that can detect and eliminate bad patient data before it is disseminated.

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Healthcare Healthcare Patients 133

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Patients

Medgadget

JUNE 6, 2023

Researchers at the University of California San Diego have created a wearable ultrasound system that can monitor deep tissues, as far as 16.5 cm (6.5 inches) below the surface of the body. Moreover, the team employed a machine learning algorithm to reduce the noise associated with movement, helping to obtain reliable readings while the wearer goes about their day.

Training 125

Training Patients 125

Fierce Pharma

JUNE 27, 2023

AbbVie recently filed a patent infring | AbbVie recently filed a patent infringement lawsuit against BeiGene over their blockbuster BTK franchises. Although the litigation was launched right after a patent’s issuance, AbbVie may actually have a case here, according to one expert.

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Fierce Pharma

JUNE 12, 2023

Bayer recently laid out its ambition | Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.

Sales goal 354

Sales goal Sales 354

Fierce Pharma

JUNE 22, 2023

Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. | Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. Intercept is now swinging into restructuring mode, and the NASH baton passes on to Madrigal Pharma.

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FDA Pharma 354

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Fierce Pharma

JUNE 22, 2023

The EMA is scrutinizing GLP-1s, raising a safety signal about the risk that drugs from Novo Nordisk, Eli Lilly and other companies could cause cancer.

Safety 353

Safety 353

Fierce Pharma

JUNE 29, 2023

After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder. | After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.

Doctors 348

Doctors FDA 348

Fierce Pharma

JUNE 16, 2023

Merck’s cancer star Keytruda could be on its way to an updated label in HER2-positive stomach cancer after showing it can stave off tumor progression in a combination study. | After scoring accelerated approval to treat HER2-positive stomach cancer in 2021, the drug has now shown it can stave off tumor progression in patients with PD-L1 positive tumors.

Patients 345

Patients 345

Fierce Pharma

JUNE 16, 2023

In the battle for superiority in the field of next-gen diabetes and obesity treatments, Novo Nordisk holds the lead as the developer of the metabolism-regulating treatment semaglutide. | In the battle for diabetes and obesity superiority, Novo Nordisk holds a head start as the original developer of the metabolism-regulating treatment semaglutide. But Eli Lilly is quickly gaining ground and is primed to become the market leader with its GLP-1 treatment Mounjaro, according to GlobalData.

Leads 340

Leads Marketing 340

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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.

Safety

Fierce Pharma

JUNE 30, 2023

A former statistician at Pfizer and his associate have been charged (PDF) with insider trading, using advance inform | A former statistician at Pfizer and his associate have been charged with insider trading, using advance information to make more than $350,000 from stock purchases that they executed one day before the company made trial results public for COVID-19 blockbuster Paxlovid.

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Fierce Pharma

JUNE 20, 2023

Used by Egyptians 35 centuries ago as a remedy for inflammation, colchicine was found over the ages to be effective against a variety of maladies including gout, dropsy and familial Mediterranean f | Agepha Pharma, a family-owned company based in Slovakia, has gained an FDA approval for Lodoco, which becomes the first drug to target cardiovascular inflammation.

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Pharma FDA 334

Fierce Pharma

JUNE 4, 2023

AstraZeneca and Daiichi Sankyo’s Enhertu has already made waves in breast cancer treatment. | AstraZeneca and Daiichi Sankyo’s Enhertu has already made waves in breast cancer treatment. Now, the companies are positioning the HER2 antibody-drug conjugate for expansion into other tumor types with data that researchers view as very compelling.

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Fierce Pharma

JUNE 16, 2023

Less than a month after AbbVie and Genmab won FDA approval for Epkinly, Roche has crossed the finish line with its bispecific answer to large B-cell lymphoma. | Less than a month after AbbVie and Genmab won FDA approval for Epkinly, Roche has crossed the finish line with its bispecific answer to large B-cell lymphoma, though with a narrower label.

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FDA 328

Advertiser: ZoomInfo

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

Competition

Fierce Pharma

JUNE 7, 2023

Merck has taken the lead, filing a lawsuit seeking to overturn drug pricing measures in the Inflation Reduction Act (IRA). | Merck has filed a lawsuit seeking to overturn drug-pricing measures in the Inflation Reduction Act (IRA). Now, emboldened by the New Jersey drugmaker, other biopharma CEOs are making their concerns known. At the BIO International Convention, Biogen CEO Chris Viehbacher registered severe criticism of the IRA and said his company was considering filing its own lawsuit.

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Biopharma Leads 328

Fierce Pharma

JUNE 14, 2023

Sanofi is jumping on the artificial intelligence boat with a new app and a pledge to become “the first pharma company powered by artificial intelligence at scale.” | Sanofi's new app, plai, provides teams with a “360° view" to aid decision-making. The platform is one step in the company's digital transformation and goal to become the "first pharma powered by AI at scale.

Manufacturing 325

Manufacturing Pharma 325

Fierce Pharma

JUNE 20, 2023

After Merck filed a bombshell lawsuit challenging some measures in the Inflation Reduction Act (IRA), Bristol Myers Squibb has followed on with a case of its own. | After Merck took the first legal stab at the Inflation Reduction Act with a lawsuit against the Department of Health and Human Services (HHS), Bristol Myers Squibb is the latest drugmaker to allege Constitutional violations.

Leads 325

Leads 325

Fierce Pharma

JUNE 12, 2023

Another biosimilar product copying Johnson & Johnson’s top-selling drug Stelara may enter the U.S. market without a patent infringement challenge by early 2025 thanks to a new settlement. | Following a deal with Amgen, J&J has granted Alvotech and Teva a license to launch their Stelara biosimilar no later than Feb. 21, 2025.

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Marketing 324

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.

FDA

Fierce Pharma

JUNE 3, 2023

The rising antibody-drug conjugate class has hit a setback as Seagen’s Adcetris, one of the earliest and fast-growing members of the group, was defeated by immune checkpoint inhibitor. | The rising antibody-drug conjugate class has hit a setback as Seagen’s Adcetris, one of the earliest and fast-growing members of the group, was defeated by immune checkpoint inhibitor in classical Hodgkin lymphoma.

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Fierce Pharma

JUNE 7, 2023

As Alzheimer's disease partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. | As Alzheimer's partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. On Wednesday, that vision came into better focus as the FDA released a document showing how the agency views the drug.

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FDA 324

Fierce Pharma

JUNE 1, 2023

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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FDA 320

Fierce Pharma

JUNE 29, 2023

A new treatment for Alzheimer’s disease agitation episodes might be on the horizon, but a principal trial investigator skirting protocol could muddy the waters. | After a December FDA inspection revealed a principal trial investigator skirted several study protocols, BioXCel found forged emails making it out that the site had properly adhered to reporting requirements for adverse events.

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FDA 318

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Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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