May 19, 2020

FDA Advisors Reverse Decision on Weight-Loss Drug Qnexa

Business Review USA
FDA
FDA Approval
FDA Decision
Bizclik Editor
2 min
FDA Advisors Reverse Decision on Weight-Loss Drug Qnexa

With the growing problem of obesity in the U.S. hastened by deep-seated roots stemming from a largely sedentary lifestyle and unhealthy eating habits, it’s no surprise that a quick-fix continues to be the elusive carrot on a stick.

Pharmaceutical giants, including Arena Pharmaceuticals, Lorcaserin and Vivus Inc., are jostling for the chance to be the first company to release an FDA-approved prescription weight-loss drug since the last, and only, approved prescription drug of its kind hit the market in 1999.

The search for a “magic pill” has been hindered in recent months as Vivus’ drug, Qnexa, was struck down by the FDA’s advisory committee last year, citing direct connections to heightened risk of cardiovascular problems and birth defects. In an apparent change of heart, a panel of medical experts released a 20-2 vote in favor of Qnexa Wednesday, likely meaning the FDA’s final decision later in the year will be to approve the drug.

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The drug manufacturer, based out of Mountain View, California, addressed the original health concerns by proposing monthly pregnancy tests for patients administered the drug, as well as strictly controlled distribution by registered pharmacies and specialized training for healthcare providers to better educate them on the risks of the medication. Vivus also recommended implementing a program to closely monitor heart risks in patients using the drug.

"We are confident the Qnexa [risk management program] balances the safeguards while allowing access for appropriate patients,” Dr. Barbara Troupin, Vivus' senior director of global medical affairs, told the committee. Qnexa combines the appetite suppressant phentermine and anticonvulsant drug topiramate. Users lost an average of 10% of their body weight during clinical trials.

Over-the-counter weight loss supplements remain popular, despite recalls and negative side effects, including dozens of deaths linked to the Fen Phen craze of the ‘90s. Marketdata projects diet pill and meal replacement sales alone will total $3.04 billion in yearly sales by 2014.

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Jun 18, 2021

Intelliwave SiteSense boosts APTIM material tracking

APTIM
Intelliwave
3 min
Intelliwave Technologies outlines how it provides data and visibility benefits for APTIM

“We’ve been engaged with the APTIM team since early 2019 providing SiteSense, our mobile construction SaaS solution, for their maintenance and construction projects, allowing them to track materials and equipment, and manage inventory.

We have been working with the APTIM team to standardize material tracking processes and procedures, ultimately with the goal of reducing the amount of time  spent looking for materials. Industry studies show that better management of materials can lead to a 16% increase in craft labour productivity.

Everyone knows construction is one of the oldest industries but it’s one of the least tech driven comparatively. About 95% of Engineering and Construction data captured goes unused, 13% of working hours are spent looking for data and around 30% of companies have applications that don’t integrate. 

With APTIM, we’re looking at early risk detection, through predictive analysis and forecasting of material constraints, integrating with the ecosystem of software platforms and reporting on real-time data with a ‘field-first’ focus – through initiatives like the Digital Foreman. The APTIM team has seen great wins in the field, utilising bar-code technology, to check in thousands of material items quickly compared to manual methods.

There are three key areas when it comes to successful Materials Management in the software sector – culture, technology, and vendor engagement.

Given the state of world affairs, access to data needs to be off site via the cloud to support remote working conditions, providing a ‘single source of truth’ accessed by many parties; the tech sector is always growing, so companies need faster and more reliable access to this cloud data; digital supply chain initiatives engage vendors a lot earlier in the process to drive collaboration and to engage with their clients, which gives more assurance as there is more emphasis on automating data capture. 

It’s been a challenging period with the pandemic, particularly for the supply chain. Look what happened in the Suez Canal – things can suddenly impact material costs and availability, and you really have to be more efficient to survive and succeed. Virtual system access can solve some issues and you need to look at data access in a wider net.

Solving problems comes down to better visibility, and proactively solving issues with vendors and enabling construction teams to execute their work. The biggest cause of delays is not being able to provide teams with what they need.

On average 2% of materials are lost or re-ordered, which only factors in the material cost, what is not captured is the duplicated effort of procurement, vendor and shipping costs, all of which have an environmental impact.

As things start to stabilise, APTIM continues to utilize SiteSense to boost efficiencies and solve productivity issues proactively. Integrating with 3D/4D modelling is just the precipice of what we can do. Access to data can help you firm up bids to win work, to make better cost estimates, and AI and ML are the next phase, providing an eco-system of tools.

A key focus for Intelliwave and APTIM is to increase the availability of data, whether it’s creating a data warehouse for visualisations or increasing integrations to provide additional value. We want to move to a more of an enterprise usage phase – up to now it’s been project based – so more people can access data in real time.

 

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