23:07 , Jul 20, 2018 |  BioCentury  |  Regulation

FDA’s positive reinforcement

Companies are still sifting through a half dozen gene therapy guidance documents issued by FDA, but so far it appears the recommendations support the paths taken by some of the most advanced clinical candidates for...
19:08 , May 18, 2018 |  BC Week In Review  |  Company News

FDA names, shames ‘anticompetitive’ drug companies

FDA Commissioner Scott Gottlieb Thursday made public a list of 41 branded drug companies that generics manufacturers have accused of blocking access to drug samples to thwart development of competitive generic drugs. The list includes...
13:30 , May 17, 2018 |  BC Extra  |  Politics & Policy

FDA names, shames ‘anticompetitive’ drug companies

FDA Commissioner Scott Gottlieb Thursday made public a list of 41 branded drug companies that generics manufacturers have accused of blocking access to drug samples to thwart development of competitive generic drugs. The list includes...
01:18 , May 12, 2018 |  BioCentury  |  Finance

HKEX opportunity knocking

The rapid growth of biotech in the greater China region is something Jefferies does not intend to miss. With the opening of a new biotech chapter on the Hong Kong Exchanges and Clearing Ltd. on April...
18:15 , May 11, 2018 |  BC Week In Review  |  Clinical News

FDA panel backs volanesorsen approval

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 12-8 to approve Waylivra volanesorsen from Akcea Therapeutics Inc. (NASDAQ:AKCA) to treat familial chylomicronemia syndrome, a rare lipid disorder that results from lipoprotein lipase deficiency. The company is...
20:05 , May 8, 2018 |  BC Extra  |  Company News

FDA reviewers question Akcea candidate's safety

FDA reviewers said volanesorsen from Akcea Therapeutics Inc. (NASDAQ:AKCA) will "almost certainly" require a REMS if approved, although even that step "may not be sufficient" to ensure the candidate's safe use due to risks of...
23:25 , Nov 10, 2017 |  BioCentury  |  Regulation

Regulation relocation

Moving EMA’s headquarters hundreds of miles in a 16-month period is a mammoth task, considering it took the agency three years to move addresses from one end of London’s Canary Wharf to another. The move,...
20:22 , Nov 3, 2017 |  BioCentury  |  Regulation

Frame work

A little over four years into its implementation, FDA’s structured benefit-risk framework appears to be meeting its objectives of creating transparency into its approval decisions. The agency began to incorporate the framework templates into its reviews...
21:52 , Mar 16, 2017 |  BC Extra  |  Politics & Policy

Former FDA commissioners blast importation

On Thursday, four former FDA commissioners warned that proposals to allow importation of pharmaceuticals would create serious risks for consumer and patients, and would produce only minimal savings. President Trump has recently expressed support for...
02:49 , Mar 4, 2017 |  BioCentury  |  Product Development

Race to the finish

Top-line data showing that axicabtagene ciloleucel continues to produce high response rates through six months while rates of adverse events have declined form the last cobblestone in Kite Pharma Inc.’s path to market. The company...