BioCentury | Apr 29, 2020
Product Development

April 28 Quick Takes: Syndax gains on leukemia data; plus Supernus, Neurocrine, Avadel, Insilico-Astellas, Innovent-Lilly, Chimerix

...Reimbursement Drug List (see “Innovent’s Tyvyt Edges Out PD-1s” ). Chimerix plans rolling NDA for brincidofovir...
...Inc. (NASDAQ:CMRX) said it received clearance from FDA to begin a rolling NDA submission for brincidofovir...
BioCentury | May 9, 2019
Company News

May 9 Company Quick Takes: Chimerix, Puma, Janssen

...Chimerix abandons brincidofovir trials Chimerix Inc. (NASDAQ:CMRX) will cut its workforce in half after deciding to...
...cut its workforce in half after deciding to discontinue all clinical trials of adenovirus candidate brincidofovir...
...application for brincidofovir to treat smallpox under FDA's Animal Rule in 2020 (see "Turnabout" ; "Brincidofovir...
BioCentury | Dec 15, 2018
Regulation

FDA to facilitate access to unapproved drugs

...In 2014, when the decision by Chimerix Inc. to deny seven-year-old Josh Hardy access to brincidofovir...
...denied the investigational drug. FDA persuaded the company to open a clinical trial to study brincidofovir...
BioCentury | Feb 28, 2017
Clinical News

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

...to prevent CMV infection in at-risk populations. In 2015, Chimerix Inc. (NASDAQ:CMRX) said brincidofovir ( CMX001...
BioCentury | Oct 3, 2016
Finance

ASH and others

...Co. Inc. (NYSE:MRK) Zinplava bezlotoxumab Clostridium difficile infection (CDI) PDUFA date 10/23/16 Chimerix Inc. (NASDAQ:CMRX) Brincidofovir...
BioCentury | Jul 11, 2016
Finance

Shedding red

...Mycapssa octreotide to treat acromegaly. Chiasma said FDA asked for another trial Chimerix Inc. (NASDAQ:CMRX) Brincidofovir...
BioCentury | May 16, 2016
Clinical News

Brincidofovir: Phase III data

...Chimerix plans to disclose final 36-week mortality data from AdVise. The company will not seek brincidofovir’s...
...of brincidofovir vs. standard of care (SOC). Chimerix Inc. (NASDAQ:CMRX), Durham, N.C. Product: Brincidofovir ( CMX001...
...>=13 weighing >50 kg received 100 mg brincidofovir and patients ages <=12 received 2 mg/kg brincidofovir...
BioCentury | May 10, 2016
Clinical News

Brincidofovir fails to improve survival in adenovirus study

...$0.21 to $4.91 on Monday after disclosing with its 1Q16 financial results that brincidofovir ( CMX001...
...the open-label Phase III AdVise study to treat adenovirus infection. The company will not seek brincidofovir's...
...disclose final 36-week mortality data from AdVise and give an update on its plans for brincidofovir...
BioCentury | Feb 29, 2016
Clinical News

Brincidofovir: Additional Phase III data

...cell transplant (HSCT) recipients showed that 51% of patients who received twice-weekly 100 mg oral brincidofovir...
...in the brincidofovir arm between weeks 14 and 24 vs. 11% in the placebo arm. Brincidofovir...
...kidney transplant recipients to protect against BKV. Chimerix Inc. (NASDAQ:CMRX), Durham, N.C. Product: Brincidofovir ( CMX001...
BioCentury | Feb 23, 2016
Clinical News

Chimerix falls after brincidofovir update

...reporting detailed data over the weekend from the Phase III SUPPRESS trial of brincidofovir ( CMX001...
...acute GvHD in the brincidofovir arm (57.1% vs. 32.2% for placebo). Chimerix said diarrhea in brincidofovir-treated...
...its brincidofovir programs. The company will discontinue the Phase III SUSTAIN and SURPASS trials of brincidofovir...
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