01:35 , Mar 9, 2019 |  BioCentury  |  Regulation

Gottlieb’s exit interview

FDA Commissioner Scott Gottlieb sat down with BioCentury after announcing his resignation to discuss his approach to promoting medical product innovation, the importance of strategic communications, and how a reorganization will bring FDA drug reviews...
18:30 , Jan 11, 2019 |  BC Week In Review  |  Company News

Former Insys CEO pleads guilty to opioid prescription kickbacks

Michael Babich, former president and CEO of Insys Therapeutics Inc. (NASDAQ:INSY), pleaded guilty on Jan. 9 in conspiring to bribe physicians to unnecessarily prescribe Subsys fentanyl sublingual spray and defraud insurance companies. The opioid is...
18:32 , Aug 10, 2018 |  BC Week In Review  |  Company News

FDA reviewers say data are lacking on TIRF drug use

FDA reviewers pointed to significant data gaps for evaluating the REMS program for transmucosal immediate-release fentanyl (TIRF) drugs at a joint advisory committee meeting Aug. 3. Participants gave "important feedback" that insufficient data exists to...
21:33 , May 11, 2018 |  BioCentury  |  Finance

Seroquel stepping stone

The $538 million acquisition by Luye Pharma Group Ltd. (HKSE:2186) of Seroquel quetiapine fumarate from AstraZeneca plc (LSE:AZN; NYSE:AZN) will lay the commercial groundwork in new emerging markets for the Chinese pharma’s internal CNS pipeline....
21:18 , Apr 4, 2018 |  BC Extra  |  Politics & Policy

NIH, FDA announce opioids plans

At the National Rx Drug Abuse and Heroin Summit on Wednesday, NIH released details on its plans for spending $1.1 billion in FY18 to address the opioid abuse epidemic and FDA described plans for extending...
21:55 , Dec 1, 2017 |  BC Week In Review  |  Company News

Melinta acquires Medicines Co.'s infectious disease unit

Melinta Therapeutics Inc. (NASDAQ:MLNT) will acquire the infectious disease business unit of The Medicines Co. (NASDAQ:MDCO), including marketed drugs Vabomere meropenem/vaborbactam, Orbactiv oritavancin and Minocin IV minocycline. Medicines Co. will receive $270 million up front,...
00:16 , Nov 30, 2017 |  BC Extra  |  Company News

Melinta acquires Medicines Co.'s infectious disease unit

Melinta Therapeutics Inc. (NASDAQ:MLNT) will acquire the infectious disease business unit of The Medicines Co. (NASDAQ:MDCO), including marketed drugs Vabomere meropenem/vaborbactam, Orbactiv oritavancin and Minocin IV minocycline. Medicines Co. will receive $270 million up front,...
21:36 , Nov 2, 2017 |  BioCentury  |  Finance

Frazier follows performance

Frazier Healthcare Partners plans to ramp up company creation with its new $419 million life sciences fund. According to Frazier’s Jamie Topper, Frazier Life Sciences IX, which closed on Oct. 31, will invest $5-$30 million...
21:40 , Oct 27, 2017 |  BC Week In Review  |  Company News

Medicines Co. to cut workforce, focus on inclisiran

In its 3Q17 earnings announcement, The Medicines Co. (NASDAQ:MDCO) said it would reduce headcount to fewer than 60 employees to focus on developing inclisiran (PCSK9si). On Oct. 25, the company said it plans to start...
22:24 , Oct 25, 2017 |  BC Extra  |  Company News

Medicines Co. to cut workforce, focus on inclisiran

In its 3Q17 earnings announcement, The Medicines Co. (NASDAQ:MDCO) said it would reduce headcount to fewer than 60 employees to focus on developing inclisiran ( PCSK9si ). Next week, the company plans to start a...