Fierce Pharma

MAY 31, 2023

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

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MedCity News

MAY 29, 2023

While retailers already have a customer service focus, there is a steep learning curve to healthcare and the nuances of how things operate. It will be critical that these brands do their due diligence and invest in innovations that work to improve the fundamentals of healthcare such as efficient provider credentialing and flexible and sustainable working practices for providers.

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European Pharmaceutical Review

MAY 31, 2023

The inventory position of 28 major pharmaceutical manufacturers in 2022 has been revealed in an annual report. Analysis explored the impact of macro-trends on inventory management from corporate reports of Big Pharma companies including Merck, AstraZeneca and Pfizer. It investigated how excessive inventories are affecting the industry and what factors could influence inventory growth in 2023.

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Pharmaceutical Technology

MAY 30, 2023

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. SKYCovion is intended for the prevention of Covid-19 resulting from SARS-CoV-2 infection in individuals aged 18 years and above. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.

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Fierce Pharma

MAY 31, 2023

Adding Kisqali to endocrine therapy after surgery reduced the risk of invasive tumor recurrence or death by 25% in certain early-stage breast cancers.

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MedCity News

MAY 29, 2023

While these are key benefits of digital therapeutics and this optimism may have been laudable, this approach to market relies on promise without proof of efficacy and ignores the fact that not all digital therapeutics are created equal.

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Marketing Biopharma 134

Pharmaceutical Technology

MAY 31, 2023

XtalPi has made a partnership deal with US-based Eli Lilly to leverage artificial intelligence (AI) for drug discovery. XtalPi will receive $250m in upfront and milestone payments. The two companies will use XtalPi’s integrated AI capabilities and robotics platform for the de novo [without consideration of previous instances] design and delivery of drug candidates for an undisclosed target.

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Leads Pharmaceutical Patients 111

Fierce Pharma

JUNE 1, 2023

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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Doctors 255

MedCity News

JUNE 1, 2023

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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PharmaTech

JUNE 2, 2023

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

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FDA 141

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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.

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Pharmaceutical Technology

MAY 30, 2023

According to GlobalData’s Looking Ahead to 2023 – the Future of Pharma report, five drugs set for approval in 2023 are projected to attain blockbuster status or near-blockbuster status by 2028 with US company dominance. Lecanemab by Eisai Co Ltd, a monoclonal antibody therapy marketed for Alzheimer’s disease, is predicted to achieve the most significant commercial debut.

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Sales Marketing Prescription Pharma 105

Fierce Pharma

JUNE 2, 2023

Lynparza may be the most popular PARP inhibitor, but a use restriction in ovarian cancer has been a thorn in AstraZeneca’s side. | AstraZeneca is bringing on Imfinzi to potentially help Lynparza reach a broader ovarian cancer population. But the lack of evidence for contribution from Imfinzi and a regulatory concern over the use of PARP inhibitors outside BRCA-mutant tumors could make it hard for AstraZeneca to win over the FDA.

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FDA Marketing 246

MedCity News

JUNE 2, 2023

Digital maturity will require shared data standards, strategies for streamlining data management and a collaborative approach that involves all players in the biopharma supply chain.

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Biopharma Management 111

Referral MD

MAY 30, 2023

Photo by Marek Studzinski on Unsplash The medical billing process can be a tedious, lengthy, and complex one. This can leave healthcare practitioners struggling to stay afloat financially. Can a healthcare practice increase revenue by improving its medical billing process? A reliable medical billing service or software can help reduce backlogs and increase revenue.

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Medical Insurance Healthcare Healthcare 97

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

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Pharmaceutical Technology

JUNE 2, 2023

The European Commission (EC) has approved TG Therapeutics’ Briumvi (ublituximab-xiiy) to treat relapsing forms of multiple sclerosis (RMS) in adult patients. Briumvi is an anti-CD20 monoclonal antibody indicated for RMS adult patients with active disease which is defined by clinical or imaging features. It has been engineered to remove certain sugar molecules generally expressed on the antibody.

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Food and Drug Administration Engineering Food Patients 98

Fierce Pharma

MAY 30, 2023

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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MedCity News

JUNE 1, 2023

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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Patients Healthcare Healthcare Electronics 111

Clarify Health

MAY 30, 2023

Addressing the mental health crisis in the United States is a complex undertaking, due to multiple factors contributing to prevalence and severity of several conditions. Recent findings from the Clarify Health Institute highlight these growing problems and speak to a need for action to combat this crisis. According to its most recent research brief, “The Kids Are Not Alright: Mental Health Utilization Among Children and Young Adults, 2016-2022,” hospital admissions for mental illnes

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Healthcare Healthcare Education Transportation 92

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

Pharmaceutical Technology

JUNE 1, 2023

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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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 243

MedCity News

JUNE 1, 2023

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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Networking 108

European Pharmaceutical Review

JUNE 2, 2023

A novel refractometry-based process analytical technology (PAT) system used to monitor HEK293T cell cultures during lentiviral vector (LVV) production in real time, was able rapidly identify a relationship between bioreactor pH and culture metabolic activity, a paper has found. Using PAT in the biotechnology and biopharmaceutical industries is a radical vision” Williams et al. stated that to their knowledge, the study represents the first time that pH has been incorporated into a metabolic

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Manufacturing Engineering Medicine Pharmaceutical 91

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Pharmaceutical Technology

MAY 29, 2023

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. Inpefa is a once-daily oral tablet indicated as an inhibitor of sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1). It is intended to lower the risk of cardiovascular death, urgent heart failure visit, and hospitalisation for heart failure.

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Fierce Pharma

MAY 31, 2023

After a yearslong investigation involving politicians and medical professionals alike, Novartis is looking to close the books on its Greek bribery imbroglio. | After an investigation that dates back to 2017, four former Novartis executives and a Greek politician were cleared of bribery charges. But 15 doctors were charged for their alleged involvement.

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Doctors Medical 234

MedCity News

MAY 29, 2023

Ray Therapeutics’ gene therapy is independent of the causative genes driving inherited vision disorders, which CEO Paul Bresge says is important for reaching a broad patient population. Rare disease retinitis pigmentosa is the first disease target, but the startup also plans to test its approach in more prevalent eye disorders.

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Leads Patients Biopharma Pharma 107

European Pharmaceutical Review

MAY 29, 2023

A neurosteroid drug was one of two medicines recommended for approval at the Committee for Medicinal Products for Human Use (CHMP) ’s May 2023 meeting. Ztalmy (ganaxolone) received a positive opinion for epileptic seizures associated with cyclin-dependent kinase-like 5 deficiency disorder. This genetic condition is defined by seizures starting during infancy.

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Safety

Pharmaceutical Technology

MAY 31, 2023

Stealth BioTherapeutics has made an exclusive licensing agreement with Pharmanovia for the commercialisation of its elamipretide to treat Barth syndrome. Pharmanovia will hold exclusive rights for the commercialisation of elamipretide in the EU, other European countries including Switzerland, Norway, Iceland and the UK, and the Middle East and northern Africa region.

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FDA Sales Marketing Patients 98

Fierce Pharma

JUNE 1, 2023

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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FDA 224

MedCity News

MAY 30, 2023

Employers have a responsibility to support the food as medicine movement and help employees who are food insecure, said Jay Bhatt, managing director of Deloitte Services and managing director of the Center for Health Solutions and Health Equity Institute. He made these comments last week at the MedCity INVEST conference in Chicago.

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Food Medicine Management 106

PharmaTech

JUNE 1, 2023

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

Biopharma 98

Biopharma 98

Advertiser: ZoomInfo

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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