DRUG, DEVICE INDUSTRIES, PATIENT GROUPS DIFFER ON OFF-LABEL COMMUNICATIONS

BRONWYN MIXTER | May 3, 2017

article image
The drug and medical device industries want the FDA to allow them to give more information to payers and health-care professionals about off-label, or unapproved, uses of their products to help them make decisions.

Spotlight

Drugs & Diagnostics for Tropical Diseases

Our mission is to develop treatments and diagnostics for neglected tropical diseases that affect the most impoverished social groups. An urgent gap in treatment technology has left millions in sub-Saharan Africa at risk of debilitating and deadly parasitic diseases--but we're developing a novel diagnostic device that will end this. There is an urgent need for a simple, rapid, and quantitative diagnostic test to detect loiasis, an infection of the parasitic roundworm Loa loa (L. loa). Even though treatments exist, there are no commercial diagnostic tests available to identify the disease and monitor treatment efficacy.

OTHER ARTICLES

Clinical Development Risks and Issues in a COVID-19 World

Article | March 20, 2020

Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).

Read More

Artificial intelligence in pharma: utilising a valuable resource

Article | March 11, 2020

The pharmaceutical industry is set to greatly benefit from the use of artificial intelligence (AI), due to its wide range of applications. Sydney Tierney discusses how machine learning can enhance marketing, manufacturing and drug trials. Artificial intelligence (AI) can be applied to nearly every aspect of the pharmaceutical and healthcare industry, to enhance data processing. Adopting the technology will reveal the astonishing potential of the healthcare sector, with success rates flying higher than ever before – especially in the research and development of crucial, life-changing drugs.

Read More

How pharma can continue engaging HCPs in a world gripped by COVID-19

Article | April 10, 2020

Medscape is the leading source of clinical news, health information, and point-of-care tools for healthcare professionals. Medscape offers specialists, primary care physicians, and other health professionals the most robust and integrated medical information and educational tools. Medscape Education (medscape.org) is the leading destination for continuous professional development, consisting of more than 30 specialty-focused destinations offering thousands of free CME and CE courses and other educational programmes for physicians, nurses, and other healthcare professionals. Both Medscape and Medscape Education are part of WebMD Health Corp., an Internet Brands company. Face-to-face interactions between pharma and physicians have essentially ceased overnight during the COVID-19 pandemic, but that doesn’t mean HCPs have stopped looking for new medical information.

Read More

Enabling Active Pharma Ingredients for Batch Balancing and Integration to SAP EWM

Article | April 6, 2020

Batch and its Classification system are two most potent weapons used in Chemical, Pharma or Medical life science industry to record the potency of a batch or technically called as Active Pharma Ingredients(API). These material consist of one or more active ingredients, concentrates, carrier materials, or impurities, and so on. The potency of the active ingredients varies from batch to batch. The active ingredient is the substance of greatest interest in the bill of materials, the proportion of which may vary from batch to batch. Therefore, during creation of a process order, the system must be able to select and adjust the batches needed to obtain the required amount of active ingredient. Take an example of a drug hydroxychloroquine which is used as potent weapon to fight COVID-19. This drug is manufactured by using API, however, the Potency of this API material vary from batch to batch. To map this kind of requirement in SAP ERP, SAP calls it as Material Quantity Calculation.

Read More

Spotlight

Drugs & Diagnostics for Tropical Diseases

Our mission is to develop treatments and diagnostics for neglected tropical diseases that affect the most impoverished social groups. An urgent gap in treatment technology has left millions in sub-Saharan Africa at risk of debilitating and deadly parasitic diseases--but we're developing a novel diagnostic device that will end this. There is an urgent need for a simple, rapid, and quantitative diagnostic test to detect loiasis, an infection of the parasitic roundworm Loa loa (L. loa). Even though treatments exist, there are no commercial diagnostic tests available to identify the disease and monitor treatment efficacy.

Events