Clinical

All articles by Clinical

Bipartisan VALID Act aims to modernize clinical testing regulations, but lab groups push back
Bipartisan VALID Act aims to modernize clinical testing regulations, but lab groups push back
Lecia Bushak
June 22, 2022
2:49 pm

The VALID Act would create a new category of medical products under the FDA’s oversight and a process for the agency to regulate these tests.

Sanofi’s Rx-to-OTC Cialis switch on hold at FDA
Sanofi’s Rx-to-OTC Cialis switch on hold at FDA
Marc Iskowitz
June 1, 2022
9:31 am

The agency put a clinical hold on the trial, the drugmaker said Monday.

Ahead of ASCO meet, two oncology upstarts run into difficulty
Ahead of ASCO meet, two oncology upstarts run into difficulty
Marc Iskowitz
June 1, 2022
9:18 am

Even amid a disappointing year for the biotech sector, setbacks facing the two biotechs stand out.

The FDA’s upcoming clinical research revamp
The FDA’s upcoming clinical research revamp
Lecia Bushak
November 29, 2021
12:00 pm

Here’s what a restructuring of clinical trials might look like under FDA commissioner pick Dr. Robert Califf.

Sundeep Bhan, Prognos
Sundeep Bhan, Prognos
May 1, 2018
12:00 pm

Sundeep Bhan is cofounder and CEO of Prognos.

Ortho CEO leads massive turnaround
Ortho CEO leads massive turnaround
Larry Dobrow
March 7, 2018
10:00 am

When Ortho Clinical Diagnostics lived under the roof of Johnson & Johnson, it had the luxury of focusing on its product and service mix — and not a whole lot else.

Five things for pharma marketers to know: Friday, December 8, 2017
Five things for pharma marketers to know: Friday, December 8, 2017
Virginia Lau
December 8, 2017
3:20 pm

FDA approves first nebulized LAMA COPD treatment; more than 2,000 cancer immunotherapies in development; FDA issues 3D-printing guidance

Five things for pharma marketers to know: Thursday, November 16, 2017
Five things for pharma marketers to know: Thursday, November 16, 2017
Virginia Lau
November 16, 2017
3:20 pm

Docs biased against research from poor countries, study finds; Astellas probed over patient-assistance charity support; Acorda reports deaths in Parkinson’s trial

Five things for pharma marketers to know: Monday, November 13, 2017
Five things for pharma marketers to know: Monday, November 13, 2017
Virginia Lau
November 13, 2017
3:15 pm

Dynavax receives FDA approval for hepatitis-B vaccine; Novartis strikes R&D deal with gene-editing startup; White House nominates new HHS head

Can marketing techniques save clinical trials?
Can marketing techniques save clinical trials?
Larry Dobrow
September 5, 2017
11:00 am

No crucial area in pharma is more desperately in need of a fix — or more stubbornly resistant to change.

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