Charging for an investigational drug provided through an EAP

For some sick patients, receiving medication through an Expanded Access Program (EAP), also known as managed access, compassionate use, named patient, etc., is the only viable treatment option left. These programs allow the patients to gain access to investigational new drugs which are still in the clinical trial phase and are not, yet, licensed for use ...Read More

By |2019-07-22T17:14:05+01:00November 17th, 2016|Expanded Access Programs|

Specialty Pharmaceuticals

Specialty pharmaceuticals, which once occupied a very small niche in the market, are fast becoming a critical growth segment in drug development. In fact, in 2012, around 65% of spending on new drugs was dedicated to specialty pharmaceutical products, according to a report from IMS Health ...Read More

By |2019-07-22T17:14:32+01:00November 15th, 2016|Big Pharma|

Health Service Medical Supplies (Costs) Bill

Generic drugs have long been advertised as cost-effective alternatives to expensive brand name drugs. But it seems even generic drug manufacturers have joined the bandwagon, in recent years, when it comes to racking up drug prices and charging patients absurd amounts of money. ...Read More

By |2019-07-22T17:15:17+01:00November 11th, 2016|Big Pharma|

Right to Try Laws

Right to Try laws are becoming increasingly common in states across the US. The first was introduced in Colorado in 2014, and, since then, 31 states have followed. But what exactly is a Right to Try law, and why have so many state governments chosen to enact this new legislation? ...Read More

By |2019-07-22T17:15:28+01:00November 8th, 2016|Expanded Access Programs|

Physical attributes should be considered when developing generic drugs

Reference listed drugs (RLDs) play a crucial role in generic drug development. According to the US Food and Drug Administration (FDA) regulations, generic drugs must replicate the RLD by having; the same main active ingredient, the same strength and dosage form, the same route of administration and intended use, and bioequivalence to the RLD. ...Read More

By |2019-07-22T17:15:40+01:00November 3rd, 2016|Reference Listed Drug|