FDA’s Pazdur and Blumenthal: the march of checkpoint inhibitors will continue

21 February 2017 - More approvals of new immune-checkpoint inhibitors, targeted and personalised therapies, as well as the use of ...

Read more →

FDA drug trials snapshots and diversity when testing new drugs

13 February 2017 - Did you know that some drugs affect men and women differently?  ...

Read more →

The challenges of generating evidence to support precision medicine

13 February 2017 - Major recent advances in science and technology now enable new kinds of measurements that can characterise an ...

Read more →

U.S. House panel to take up bill to spur generic drug development

2 February 2017 - A U.S. House of Representatives subcommittee will take up bipartisan legislation next week to foster generic ...

Read more →

Drug development challenges for small biopharmaceutical companies

1 February 2017 - Small biopharmaceutical companies are becoming increasingly important as drivers of innovation in drug development. ...

Read more →

Trump pushes drug makers for lower prices, more U.S. production

31 January 2017 - U.S. President Donald Trump on Tuesday met with top executives from some of the biggest drug ...

Read more →

Benefit-risk assessments at the US Food and Drug Administration: finding the balance

20 January 2017 - The US FDA’s independent evaluation of medical products for safety and effectiveness prior to granting approval ...

Read more →

Statement from FDA Commissioner announcing FDA Oncology Center of Excellence launch

19 January 2017 - Today the U.S. FDA is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard ...

Read more →

Composite endpoints and the distortion of risk–benefit analysis

17 January 2017 - Evidence-based medicine is a reassuring phrase, but when we prescribe has the evidence for safety and efficacy ...

Read more →

Drug makers manipulate orphan drug rules to create prized monopolies

17 January 2017 - More than 30 years ago, Congress overwhelmingly passed a landmark health bill aimed at motivating pharmaceutical ...

Read more →

Interpretation of surrogate endpoints in the era of the 21st Century Cures Act

14 January 2017 - Surrogate endpoints are commonly used in clinical trials to get quicker results, but Kevin Knopf and ...

Read more →

What Trump gets wrong about drug companies

12 January 2017 - President-elect Donald Trump was hardly timid in declaring Wednesday that drug companies are “getting away with ...

Read more →

Biopharma needs to stop getting blindsided by Donald Trump

11 January 2017 - The day after Donald Trump won the US presidential election, pharma and biotech investors seemed to ...

Read more →

National Cancer Institute and drug companies aim to speed up clinical trials

11 January 2017 - The National Cancer Institute launched an effort Wednesday to speed up clinical trials by getting researchers ...

Read more →

Don’t thank big government for medical breakthroughs

5 January 2017 - New cures come from private research, not cash dumped into the National Institutes of Health. ...

Read more →