STAT

JANUARY 1, 2023

The Congressional report on the FDA’s approval of Aduhelm makes some good points. As regulatory science advances, so too must the FDA’s administrative procedures. But this report mustn’t be seen as an excuse for the agency to hew to a 20th century view of drug development and review. The FDA and the industries it regulates must work together to facilitate innovation that results in new and important medical technologies like Aduhelm and other medicines currently in the pipel

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FDA 98

Med Ed 101

JANUARY 1, 2023

Opioids are commonly used in clinical practice. Selection on these agents can often be confusion. We’ve outlined some of the most important pharmacokinetic, pharmacogenomic, and dosage form clinical pearls in the table below. For easier reading, we have also created the Opioid Comparison Table as a free downloadable PDF which you can download at the […].

Dosage 98

Dosage 98

BioPharm

JANUARY 1, 2023

Efforts to optimize the ideal blend of technology and best practices that are needed to protect and deliver time- and temperature-sensitive biologic therapies, vaccines, and cell and gene therapies continue to evolve.

Vaccines 97

Vaccines 97

Pharma Mirror

JANUARY 1, 2023

by Dr Torill Bigg, Chief Carbon Reduction Engineer at Tunley Engineering Businesses globally are looking to reduce their carbon footprints. A number of factors is driving this activity. It is a smart and ethical business practice to operate sustainably for the environment and for grand success. Demonstrating environment leadership enhances business reputation, retains and attracts customers, investors, and staff – and enhances market value.

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Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

OctariusRx

JANUARY 1, 2023

Happy New Year! Here’s to a new start with great possibilities! We hope 2022 was a great year for everyone and that 2023 holds success and good fortune in any endeavor you pursue. Despite the ups and downs you may have faced this past year, it’s important to always look forward to the New Year while removing the past inefficiencies from our lives. This past year, we added more team members, along with more satisfied clients and we are thankful for both.

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BioPharm

JANUARY 1, 2023

Biologic drug development requires relevant bioassays to measure and help predict cellular response.

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97

BioPharm

JANUARY 1, 2023

The testing of new convecdiff membranes shows this material to be well suited for lab- and commercial-scale bind-and-elute applications.

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BioPharm

JANUARY 1, 2023

Affinity chromatography resins must perform well under mild elution conditions yet withstand robust cleaning and sanitization protocols.

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BioPharm

JANUARY 1, 2023

A CCS provides significant benefits to the industry and helps with holistically understanding contamination controls, says Siegfried Schmitt, vice president, Technical at Parexel.

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BioPharm

JANUARY 1, 2023

This compilation allows readers to adjust their thinking to appreciate the full impact certain select technologies will make on the industry by 2026.

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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

BioPharm

JANUARY 1, 2023

Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.

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BioPharm

JANUARY 1, 2023

Coverage of COVID-19 vaccines was surprisingly displaced by this year’s astounding oncology and iconoclastic gene therapy “cures.”.

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Vaccines 40

BioPharm

JANUARY 1, 2023

Cell and gene therapies is unequivocally viewed as the biggest opportunity in the bio/pharma space.

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BioPharm

JANUARY 1, 2023

Politics and drug shortages will continue to impact FDA and drug manufacturers in 2023.

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FDA 52

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