2015, Food and Drug Administration and Healthcare

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Biosimilar competition saves US healthcare $21 billion

European Pharmaceutical Review

OCTOBER 14, 2022

Amgen’s 2022 market report has detailed how competition has driven savings across healthcare, estimating that a considerable number of biologics will be in competition with biosimilars in five to 10 years. In Q2, savings in drug spend due to biosimilar availability is estimated to be a substantial $3.2

Competition

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Novel haemophilia B gene therapy approved

European Pharmaceutical Review

APRIL 29, 2024

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. This authorisation of BEQVEZ is based on results from the pivotal Phase III BENEGENE-2 study.

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ESG Top Trends: Technology trends

Pharmaceutical Technology

JULY 21, 2022

Listed below are the key technology trends impacting the ESG performance in the healthcare sector, as identified by GlobalData. AI also speeds up the drug development process, which could translate into cheaper drugs for patients. 3D bioprinting offers an alternative to animal testing in drug development. 3D printing.

Food and Drug Administration

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The potential of tryptamines in treatment-resistant depression

European Pharmaceutical Review

DECEMBER 15, 2022

Psilocybin therapy in mental healthcare. Mental healthcare should promote optimal quality of life through preventing, treating and managing mental health illnesses, such as depression, with the aim of facilitating sustained recovery. The introduction of psilocybin therapy could provide a potential step-change in mental healthcare.

Food and Drug Administration

Food and Drug Administration Healthcare Healthcare Food

Pathbreakers: The journey of first generics

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. First generics are the first opportunity manufacturers have to market new generic drug products in the US.

Food and Drug Administration

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Empirical Spine Completes Full Premarket Approval (PMA) Submission to FDA for Limiflex™ Dynamic Sagittal Tether™

Legacy MEDSearch

DECEMBER 20, 2022

Food & Drug Administration (FDA) submission process for the LimiFlex Dynamic Sagittal Tether (DST). The concept was developed to meet healthcare systems’ increasing demands for improved long-term outcomes with a lower cost of care. Empirical Spine, Inc., “But attempts up to now have fallen short.

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Advamedica Inc announces FDA clearance for Ax-Surgi Surgical Hemostat

Legacy MEDSearch

MARCH 29, 2023

a biomaterial focused medtech startup today announced the US Food and Drug Administration (FDA) 510(k) clearance for its latest innovation, Ax-Surgi Surgical Hemostat. As the healthcare costs continue to rise, surgeons are looking for effective measures to reduce the duration of surgeries. Advamedica Inc., Advamedica Inc.

FDA

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Precision Medicine Needs an Overhaul

PM360

AUGUST 26, 2024

Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers. Over a decade ago, AstraZeneca identified and tested specific biomarkers to develop drug molecules.

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FDA warning letters highlight CAPA concerns

European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. In subsequent years, up to 2022, half this number or less were issued.

FDA

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Realising milestones with gene therapy for SMA

European Pharmaceutical Review

MAY 11, 2023

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. percent of Europe’s annual healthcare spend. This is often called an ‘SMN-based’ or ‘SMN-enhancing’ approach. Stakeholder education is critical to achieving this.

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FDA raises alarm about weight-gain supplement apetamin

Pharmaceutical Technology

MAY 5, 2023

The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and Drug Administration (FDA).

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A history of blood cancer treatment

pharmaphorum

SEPTEMBER 13, 2022

Thanks to the dedicated efforts of doctors, patients, carers, and healthcare professionals, people diagnosed with blood cancer are now living longer, with a steady stream of more effective treatments entering the market each year. However, myelodysplastic syndromes and myeloproliferative neoplasms are also prominent types of blood cancer.

Food and Drug Administration

Food and Drug Administration Patients Engineering Physicians

Pharmaceutical microbiology: key developments 2022

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The US federal drug GMP regulations that first became official in 1977 and their European counterparts will need to be re-interpreted for this new generation of products.

Pharmaceutical

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Cancer: Progress but a long way to go

World of DTC Marketing

MARCH 17, 2022

In recent years, early detection and treatment improvements have helped boost the 3-year survival rate for lung cancer from 21% in 2004 to 31% in 2015 through 2017. Medicare spent nearly $600 million over three years to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease.

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Pharma Rep Focus

Biosimilar competition saves US healthcare $21 billion

Novel haemophilia B gene therapy approved

Trending Sources

ESG Top Trends: Technology trends

The potential of tryptamines in treatment-resistant depression

Pathbreakers: The journey of first generics

Empirical Spine Completes Full Premarket Approval (PMA) Submission to FDA for Limiflex™ Dynamic Sagittal Tether™

Advamedica Inc announces FDA clearance for Ax-Surgi Surgical Hemostat

Precision Medicine Needs an Overhaul

FDA warning letters highlight CAPA concerns

Realising milestones with gene therapy for SMA

FDA raises alarm about weight-gain supplement apetamin

A history of blood cancer treatment

Pharmaceutical microbiology: key developments 2022

Cancer: Progress but a long way to go

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