FDA initiates complex innovative trial designs (CID) pilot program

The FDA has recently initiated a pilot program which will help drug manufacturers use complex innovative trial designs (CID). This move comes after the agency committed to helping facilitate and advance the use of complex adaptive, Bayesian, and other novel clinical trial designs, as part of the sixth iteration of the Prescription Drug User Fee [...]

By | 2018-08-31T10:54:23+00:00 August 31st, 2018|Drug Manufacturers, FDA|Comments Off on FDA initiates complex innovative trial designs (CID) pilot program

EMA survey on Brexit preparedness

Late last month, the European Medicines Agency (EMA) released a survey to help assess pharmaceutical companies’ preparedness for Brexit. The purpose of this assessment is to identify and address any issues that could potentially disrupt medicines access, or negatively affect human and animal health, following the UKs departure from the European Union (EU). The survey [...]

By | 2018-03-07T10:54:50+00:00 February 20th, 2018|Drug Manufacturers|Comments Off on EMA survey on Brexit preparedness

The CREATES Act not passed as part of US budget plan

President Donald Trump has recently released his budget plan, and many within the healthcare sector are disappointed to see that The Creating and Restoring Equal Access to Equivalent Samples Act, or CREATES Act for short, has been left out. This bill promises to increase competition and lower prescription drug prices, by eliminating abusive delay tactics [...]

By | 2018-03-07T11:28:03+00:00 February 13th, 2018|Drug Manufacturers, Legislation, Reference Listed Drug|Comments Off on The CREATES Act not passed as part of US budget plan

Three things patients should know about companies providing expanded access use of their investigational drugs

Expanded Access Programs (EAPs), also referred to as Managed Access or Compassionate Use Programs, allow patients with no viable treatment options available to them to access investigational drugs before they are approved for market use. In the US, the FDA is charged with approving these programs before patients can receive drug, and many see this [...]

By | 2018-03-07T11:51:54+00:00 January 23rd, 2018|Drug Manufacturers, Expanded Access Programs|Comments Off on Three things patients should know about companies providing expanded access use of their investigational drugs

New bill aims to tackle drug waste in the US

Over the past year, there has been a lot of talk around how to reduce prescription drug prices in the US. However, there has been little consensus on the issue, which has made passing actual drug pricing reform difficult. As a result, lawmakers have recently introduced legislation which could cut costs in a way that [...]

By | 2018-03-07T12:26:24+00:00 November 21st, 2017|Drug Manufacturers, Legislation|Comments Off on New bill aims to tackle drug waste in the US

New tax reform bill would eliminate tax credits for companies developing orphan drugs

House Republicans recently released a tax reform bill which would eliminate the tax credits currently awarded to drug companies for developing drugs for rare diseases. These tax credits are part of a package of incentives awarded to companies under the Orphan Drug Act of 1983, a piece of legislation introduced to try and encourage the [...]

By | 2018-03-07T12:34:16+00:00 November 8th, 2017|Drug Manufacturers, Legislation|Comments Off on New tax reform bill would eliminate tax credits for companies developing orphan drugs

Should Randomized Controlled Trials remain the gold standard for testing and evaluating new drugs?

For years, Randomized Controlled Trials (RCTs) have been the gold standard for assessing the safety and efficacy of investigational new drugs. These trials are considered the most effective at overcoming bias and yielding high-quality evidence because patients are allocated at random to receive either the study drug or a comparison/control product. Patients are unaware of [...]

By | 2018-03-07T12:41:08+00:00 October 24th, 2017|Drug Manufacturers, Legislation, Unlicensed Medicine Access|Comments Off on Should Randomized Controlled Trials remain the gold standard for testing and evaluating new drugs?

EMA and EU healthcare payers meet to discuss how to foster timely access to medicines

Last month, the European Medicines Agency (EMA) and European Union healthcare payers came together for the first time to discuss synergies for fostering timely and affordable access to medicines. The meeting took place at the EMA headquarters in London and marked an important first step in a bid to streamline drug availability for EU citizens. [...]

By | 2018-03-07T12:50:06+00:00 October 6th, 2017|Drug Manufacturers, Legislation|Comments Off on EMA and EU healthcare payers meet to discuss how to foster timely access to medicines

CAR T cell therapy: an exciting potential treatment option for cancer patients

Immunotherapy has become a hot topic in the oncology space over the past decade. For many cancer patients, the traditional treatment options, like chemotherapy, radiation therapy, or targeted therapies like Gleevec or Herceptin, are ineffective in treating their disease. For these patients, immunotherapy, which uses the body’s own immune system to fight cancer, is offering [...]

By | 2018-03-30T10:56:55+00:00 August 3rd, 2017|Drug Manufacturers, FDA|Comments Off on CAR T cell therapy: an exciting potential treatment option for cancer patients

Insurance companies contributing to price cutting efforts for expensive drugs

Rising drug prices is an issue that can no longer be ignored, and serious efforts are now being made, by multiple different industry stakeholders, to deal with the problem. Bills focused on price cutting initiatives are being considered by lawmakers at the state and federal level; the FDA is working on speeding up generic drug [...]

By | 2018-03-07T16:44:03+00:00 July 19th, 2017|Drug Manufacturers|Comments Off on Insurance companies contributing to price cutting efforts for expensive drugs