01:34 , Dec 15, 2018 |  BioCentury  |  Regulation

FDA to facilitate access to unapproved drugs

FDA plans to launch a new program in 2019 that will help patients gain access to unapproved therapies. The agency will field telephone requests from physicians and patients, streamline the application process, and act as...
00:12 , Feb 28, 2017 |  BC Extra  |  Clinical News

Merck CMV prophylaxis headed for U.S., EU submissions

Merck & Co. Inc. (NYSE:MRK) said it will submit applications in the U.S. and EU this year for letermovir (MK-8228) to prevent cytomegalovirus (CMV) infection in CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplantation...
07:00 , Oct 3, 2016 |  BioCentury  |  Finance

ASH and others

Cancer and hematology companies are likely to garner the most headlines in 4Q16 thanks to ESMO in October and ASH in December, but some investors also are branching out to events that typically receive less...
07:00 , Jul 11, 2016 |  BioCentury  |  Finance

Shedding red

Steve Edelson, Senior Editor   Brexit nearly wiped out what looked to be a rebound quarter for biotech. Only two market cap segments finished in positive territory, and smaller companies continued to get pounded. Big...
07:00 , May 16, 2016 |  BC Week In Review  |  Clinical News

Brincidofovir: Phase III data

Next half, Chimerix plans to disclose final 36-week mortality data from AdVise. The company will not seek brincidofovir’s approval based on the AdVise data and instead intends to conduct a comparative trial. Chimerix said it...
01:25 , May 10, 2016 |  BC Extra  |  Clinical News

Brincidofovir fails to improve survival in adenovirus study

Chimerix Inc. (NASDAQ:CMRX) slipped $0.21 to $4.91 on Monday after disclosing with its 1Q16 financial results that brincidofovir ( CMX001 ) did not meaningfully improve overall survival at week 24 compared to historical controls in...
08:00 , Feb 29, 2016 |  BC Week In Review  |  Clinical News

Brincidofovir: Additional Phase III data

Additional data from the double-blind, international Phase III SUPPRESS trial in 452 CMV-seropositive hematopoietic stem cell transplant (HSCT) recipients showed that 51% of patients who received twice-weekly 100 mg oral brincidofovir had clinically significant CMV...
02:39 , Feb 23, 2016 |  BC Extra  |  Clinical News

Chimerix falls after brincidofovir update

Chimerix Inc. (NASDAQ:CMRX) fell $3.08 (40%) to $4.55 on Monday after reporting detailed data over the weekend from the Phase III SUPPRESS trial of brincidofovir ( CMX001 ) to prevent cytomegalovirus (CMV) infections and discontinuing...
08:00 , Jan 11, 2016 |  BioCentury  |  Finance

Sowing season

Stephen Hansen, Associate Editor   BUYSIDE VIEW XXIV While the biotech sector's three-year rocket ride isn't likely to continue in 2016, fund managers are still anticipating a slew of high-profile milestones in the New Year....
08:00 , Jan 4, 2016 |  BioCentury  |  Analyst Picks & Changes

Analyst picks & changes

Analyst picks & changes Analyst picks & changes Company Bank Analyst Coverage Opinion Wk chg 12/31 cls ArQule Inc. (NASDAQ:ARQL) RBC Capital Markets Adnan Butt Upgrade Outperform (from sector performer) -3% $2.17 Butt also raised...