01:57 , Mar 22, 2019 |  BC Innovations  |  Product Development

Regulating regeneration in Europe

As Europe rethinks its policies on regenerative medicine, the question is whether it can regain its footing in a competitive field it once led, given the in-built inconsistencies across the EU’s member states. Europe positioned...
18:29 , Mar 21, 2019 |  BC Extra  |  Politics & Policy

New FDA biosimilars office, flatter Office of Commissioner finalized

When Ned Sharpless arrives at FDA headquarters as acting commissioner on April 8, his name will be placed at the top of an organizational chart that looks very different from the structure that was in...
19:40 , Mar 19, 2019 |  BC Extra  |  Politics & Policy

FDA issues guidances for long-acting PrEP, pediatric HIV drug development

FDA released final versions of two guidances Tuesday aimed at developing drugs for pediatric HIV patients and for pre-exposure prophylaxis (PrEP), which HHS Secretary Alex Azar said was in line with the Trump administration's HIV...
00:00 , Mar 19, 2019 |  BioCentury  |  Regulation

Talk less, do more: Germline gene editing needs real plans, not just moratoria

We’ve moved on from sound and fury. We’re now just signifying nothing. The latest public proclamation on germline gene editing, couched in a call for a moratorium, is as much preaching to the choir as...
19:01 , Mar 18, 2019 |  BC Extra  |  Politics & Policy

FDA to hold public meeting on facilitating access to unapproved drugs

FDA will convene a public meeting on May 16 to discuss its plans for becoming more actively involved in helping patients gain access to unapproved drugs. The meeting will discuss an initiative FDA calls “Project...
21:15 , Mar 12, 2019 |  BC Extra  |  Politics & Policy

FDA looks to broaden cancer trial eligibility

In an attempt to accelerate development of cancer therapies for under-represented patient populations, FDA is aiming to expand eligibility criteria to increase enrollment of children, adolescents and other patient groups in trials of cancer drugs....
16:49 , Mar 12, 2019 |  BC Extra  |  Politics & Policy

NCI’s Sharpless to become acting FDA commissioner

Ned Sharpless, director of the National Cancer Institute, will serve as acting FDA commissioner when Scott Gottlieb leaves the agency in mid-April. Speaking at a congressional hearing Tuesday, HHS Secretary Alex Azar announced that Douglas...
23:15 , Mar 11, 2019 |  BC Extra  |  Politics & Policy

Trump's FY20 budget includes $362M boost for FDA

President Donald Trump's FY20 budget request would include the third consecutive increase for FDA under his administration, a $362 million increase over FY19 to $3.3 billion, if enacted. The proposed increase includes a $266 million...
23:06 , Mar 11, 2019 |  BC Extra  |  Politics & Policy

Trump wants to use budget to complete drug pricing blueprint

The Trump administration signaled Monday that it wants to use the budget process as a vehicle for implementing elements in its drug pricing blueprint that require legislation. While Congress usually makes substantial changes to presidential...
02:35 , Mar 9, 2019 |  BioCentury  |  Regulation

Sharpless has the edge on FDA job

Norman (Ned) Sharpless, director of the National Cancer Institute, is the leading candidate to take over FDA leadership, Trump administration officials told BioCentury. HHS Secretary Alex Azar hasn’t made a final decision, the officials said....