For those in the health care industry – including biotech, pharmaceuticals and health care providers – knowledge of regulatory activities can be critical.
In the pharmaceutical space, for example, it’s imperative to know as soon as a competitor’s drug is approved in order to manage company strategy accordingly.
Fortunately, information about approvals, warnings and more are readily available through regulatory websites that govern the pharmaceutical and medical device industries. Changes in status of a drug or device is reflected on the regulator’s site.
Unfortunately, regulatory sites are notoriously difficult to navigate – a maze of pages without robust search capabilities that make finding something specific extremely difficult.
With AlphaSense, it is easy to find key information from health regulators, including the Food and Drug Administration (U.S.), European Medicines Agency (European Union), Medicines and Health Care Products Regulatory Agency (U.K.), Health Canada and the Health Sciences Authority (Singapore). Key information from these agencies, including drug approvals and warnings, are captured and easily searchable.
Instead of scouring pages and conducting unfruitful searches within the regulators’ websites, AlphaSense provides users with this content on an easy to use search platform that also allows users to save, annotate and share these documents.
For example, if I was involved with establishing drug coverage policy for a health insurer, I would want to know which generics may be coming out for various pharmaceuticals, so I could prepare accordingly. If I was looking at new generics approved in the U.S. for treating hypertension, I would run a search in AlphaSense for hypertension and generic, limiting the source to FDA.gov – New and Generic Drug Approvals under the Health Care Regulators filter.
Using AlphaSense, I learned that in May 2017, the FDA approved a generic drug called Nebivolol Hydrochloride for Glenmark Pharmaceuticals ($GLENMARK). I wasn’t familiar with that drug, so I highlighted its name, selected the magnifying glass and then chose All Documents. A few minutes later, I had scanned documents with mentions of the generic and found what I needed.
I discovered that in November 2015, the compound Nebivolol Hydrochloride had been approved by the FDA for Watson Laboratories ($TEVA). The corresponding approval letter for the Abbreviated New Drug Application (ANDA) mentioned that Watson’s drug was based on Forest Laboratory’s ($AGN) Bystolic, a hypertension drug currently on the market, and Watson’s version was “bioequivalent and, therefore, therapeutically equivalent,” to Forest’s. The letter also mentioned that Bystolic was protected under patent until 2021, meaning Watson would have to wait until then to sell their generic.
With the help of AlphaSense, within a few minutes I learned about a new generic for hypertension, a competitive generic, the original drug the generics were based on and the patent expiration date of the original.
In addition, I used AlphaSense to set alerts on my new search. Now, I’ll receive an email with text snippets whenever new regulatory content is released or updated on hypertension generics.
For comparison, I looked for the same information on the FDA website and typed in the same keywords for my search on hypertension generic.
The first result shows a generic, approved in 2015. The second shows a study about savings on generics (potentially interesting, but currently irrelevant). I would need to spend more time sifting through pages and running multiple searches for other terms to find what I need.
In contrast, with AlphaSense, my task of finding and classifying new generics was greatly simplified.
Instead of wasting time with irrelevant search results, or clicking through countless links, AlphaSense allows users to focus their time on analysis and communication and advance their firm’s success – and their own productivity – beyond what they’ve experienced before.