European Pharmaceutical Review

MARCH 8, 2023

Now working as a woman in pharma, Dr Ekaterina Malievskaia highlighted her female inspirations in the industry, two of which have held leading roles at Bristol Myers Squibb and the US Food and Drug Administration (FDA). Click here to read EPR’s previous ‘ Women Inspiring Pharma’ series.

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Leads Pharma Food and Drug Administration Medicine 52

European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. The market for biologics The growing interest in biologics resonates with their impressive expansion on the global market. percent through 2027.

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Pharma Marketing Network

MARCH 23, 2023

The Food and Drug Administration (FDA) has recently approved a new drug for the treatment of Alzheimer’s disease called Leqembi. This approval marks a major milestone in the fight against Alzheimer’s, which is the sixth leading cause of death in the United States and affects over 5 million people.

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PM360

MAY 2, 2023

Ardelis Health , a healthcare strategic marketing agency and consulting firm partnering with innovators that discover, differentiate, and launch important therapies, today announced the appointment of industry veteran Timmy Garde as Chief Growth Officer. “We We are thrilled to welcome Timmy to the Ardelis leadership team.

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Food and Drug Administration Healthcare Healthcare Biopharma 52

Pharmaceutical Technology

MAY 12, 2023

SFJ Pharmaceuticals will lead the ongoing clinical trial of bentracimab. In partnership with SERB Pharmaceuticals, the company will also file a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year.

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European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 71

Clarivate

JUNE 23, 2022

As part of our Drugs to Watch series, our team of oncology experts pored over thousands of abstracts for presentations at this year’s just-concluded American Society of Clinical Oncology (ASCO) Annual Meeting. Jemperli, developed by GlaxoSmithKline, has been marketed in the U.S. ADCs and bispecifics aren’t new. About the author.

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Food and Drug Administration Marketing Doctors Patients 52

Pharmaceutical Representative Training

JUNE 22, 2024

Technological advancements, shifting market dynamics, and updated regulations are leading to significant changes within the pharmaceutical industry. It is important to regulate clinical trials, post-marketing surveillance, and adverse event reportings. Department of Justice, 2020).

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Sales Pharmaceutical Ethics Pharmaceutical Sales 52

Penrod

JUNE 6, 2024

Health Cloud was a version of Salesforce CRM tailored to healthcare providers, insurance companies, and other organizations’ unique needs with patient-focused business models. Like many healthcare providers, life science companies aren’t reaching their goals for digital transformation.

CRM 52

CRM Food and Drug Administration Healthcare Provider Management 52

Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. Both drugs have generic equivalents available and are PDE5 inhibitors that can take 30 to 60 minutes to kick in.

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Food and Drug Administration FDA Prescription Food 52

Legacy MEDSearch

NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. Director of Global Sales and Marketing of NeuroLogica. Trauma/ER: The BodyTom 64’s unique combination of internal lead shielding and battery operation allows any standard trauma bay to be transformed into an advanced CT imaging suite.

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FDA Food and Drug Administration Electronics Recruitment 92

Legacy MEDSearch

DECEMBER 1, 2022

HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. market today.

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FDA Food and Drug Administration Recruitment Medical 95

Legacy MEDSearch

MARCH 15, 2023

LIVMOR’s technology was commercially deployed within the VA Healthcare System in Dallas, Texas. LIVMOR’s goals are to dramatically improve patient outcomes and to significantly reduce healthcare system costs with better quality data for diagnosis and treatment of chronic diseases. HeartBeam CEO and Founder. About HeartBeam, Inc.

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Food and Drug Administration FDA Recruitment Physicians 97

PM360

AUGUST 9, 2022

Should the review of Juul’s marketing application result in another product ban, the company has another 30-day period to appeal. EPA Administrator Michael Regan said the agency will take more aggressive action against PFAS. Drug Approvals. In a brief filed in support of a longer-term appeal in the U.S. FDA Update.

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 52

Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

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Food and Drug Administration Side effects Recruitment Safety 52

Contrarian Sales Techniques

DECEMBER 14, 2022

The biotechnology and drug sectors performed well in the second half of 2022 after struggling in the first six months. Moreover, the companies' pipeline successes and positive clinical data have helped lift the market's performance. This can lead to significant losses for large companies.

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pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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Food and Drug Administration Medical Patients FDA 90

European Pharmaceutical Review

JULY 13, 2023

1,2 Moreover, except for countries such as Czechia, Denmark and Germany, the cost of these medications is borne by the patient, rather than national insurance or healthcare systems. 3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside.

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Medical Food and Drug Administration Pharmacology Medicine 79

Legacy MEDSearch

AUGUST 17, 2023

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management.

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FDA Food and Drug Administration Recruitment Management 52

Legacy MEDSearch

MARCH 21, 2023

a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA). Lumicell, Inc., The Lumicell DVS is not commercially available.

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Food and Drug Administration FDA Recruitment Medical 52

Pharmaceutical Technology

MAY 16, 2023

UniQure is selling a part of its royalty rights to the haemophilia B gene therapy Hemgenix (etranacogene dezaparvovec) to HealthCare Royalty and Sagard Healthcare for a gross purchase price of up to $400 million dollars. HealthCare Royalty is a royalty acquisition company. HealthCare Royalty is a royalty acquisition company.

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Food and Drug Administration Healthcare Healthcare Sales 52

Legacy MEDSearch

AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension.

Medical 52

Medical Food and Drug Administration FDA Recruitment 52

Medico Reach

JULY 3, 2022

Given the market’s abundance of competitors, medical device businesses frequently struggle to introduce new product lines successfully. In that case, an effective product launch plan will help it overcome most of the market’s obstacles. Create a Marketing Plan. Begin Preparation Before FDA Approval.

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Medical Food and Drug Administration Training Marketing 97

Clarivate

MAY 21, 2024

Major barriers to the broader adoption of alternative oncology-relevant endpoints in clinical trials include a lack of agreement on their value and the uncertainty among payers that they accurately capture treatment benefits for patients and healthcare systems [4] [6]. Am J Cancer Res, 2021. 1121-1131. [2] 2] Cimen, A., 41 (16_suppl): p.

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Legacy MEDSearch

APRIL 25, 2023

Food and Drug Administration (FDA). Potential benefits include: Reduction in Radiation: Removing the need for high-radiation intraoperative scans throughout the procedure can lead to a 10x reduction in radiation exposure. ” For more information, visit: www.propriovision.com.

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FDA Food and Drug Administration Recruitment Medical 52

Pharmaceutical Technology

MARCH 22, 2023

Healthcare providers are under pressure to address the growing issue of substance use disorders. Substance use disorders leave people with long-term negative mental and physical health implications and can lead to death. GlobalData expects the device to receive full regulatory approval in July 2023.

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Food and Drug Administration Healthcare Healthcare Medical 52

Legacy MEDSearch

JANUARY 18, 2023

Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year. Early detection of sepsis is an invaluable capability for healthcare professionals.

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Food and Drug Administration FDA Recruitment Physicians 98

Nixon Gwilt Law

DECEMBER 16, 2021

What can Healthcare and Life Sciences businesses and investors anticipate for the healthcare industry in 2022? We asked our team five direct questions about innovations in healthcare, life sciences, and digital health in the coming year: What healthcare trends or opportunities are you most excited about?

Healthcare 52

Healthcare Healthcare Food and Drug Administration Ethics 52

PM360

FEBRUARY 12, 2024

Given that less than 10% of rare diseases currently have an available treatment approved by the United States Food and Drug Administration (FDA) , advocating for the speedy development of novel drugs and therapies is a crucial step in improving the quality of life for those affected. What is a Rare Disease?

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Food and Drug Administration Patients Medical Networking 105

Nixon Gwilt Law

SEPTEMBER 7, 2023

However, as with any emerging area of healthcare innovation, new legal and regulatory considerations arise that must be thoughtfully addressed. Some restrict or prohibit certain disclosures of drug and alcohol treatment records for minors, for example. The 3 Key Legal Aspects of Developing Digital Health Tools for Children and Teens 1.

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Food and Drug Administration Education Insurance Healthcare 52

Legacy MEDSearch

JULY 10, 2023

Food and Drug Administration for the use of its FREEDOM60 ® Infusion System with Hizentra ® 50 mL prefilled syringes. “Our studies show up to an 80% reduction in drug preparation tasks for patients using prefilled syringes with the FREEDOM Infusion System as compared to vials.

Medical 40

Medical Food and Drug Administration Recruitment Manufacturing 40

European Pharmaceutical Review

JUNE 27, 2023

At MaaT Pharma our donor-derived products are made through pooling (ie, mixing multiple donors), thus achieving a higher overall richness and standardisation of the resulting drug product. Conversely, in the US, it has always been clear and regulated as a drug.

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Food and Drug Administration Manufacturing Medicine Pharma 93

Legacy MEDSearch

APRIL 6, 2023

The FDA clearance opens the door to the world’s largest medical device market. CardioSTAT has now become the leading wearable cardiac monitoring solution in Canada. The pay by duration model enables healthcare professionals to demonstrate cost savings while addressing a wide range of clinical needs. Icentia Inc.,

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Food and Drug Administration Food FDA Recruitment 98

Legacy MEDSearch

AUGUST 25, 2023

Paragonix Technologies , a leading organ transplant company, received US Food and Drug Administration (“FDA”) clearance for its next-generation donor lung preservation system, BAROguard. For more information about Paragonix Advanced Organ Preservation devices, please visit www.paragonix.com.

FDA 52

FDA Food and Drug Administration Transportation Recruitment 52

Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. We developed or explored over 100 COAs and achieved ethical approval in multiple countries including the U.S.,

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Patients Food and Drug Administration FDA Safety 52

Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. FDA continues to approve the most NASs.

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European Pharmaceutical Review

MARCH 2, 2023

However, a good many companies are not yet well set up for this” In terms of drug development and clinical trials, EU Clinical Trial Regulation and more specifically the Clinical Trial Information System (CTIS) presented one of the main practical changes of 2022. Improvements were also seen in the drug development process itself.

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