BC Week In Review | Jan 25, 2019
Clinical News

Tyme shares tumble after pancreatic cancer data

Tyme Technologies Inc. (NASDAQ:TYME) lost $1.32 (35%) to $2.41 on Jan. 18 after the company reported preliminary data from the open-label Phase II Tyme-88-Panc trial. The company said that once-daily oral SM-88 as monotherapy showed...
BioCentury | Jan 17, 2019
Regulation

Products on shutdown standby

Products on shutdown standby On Jan. 14, FDA said it has reserves to continue drug reviews for five more weeks if the government shutdown continues. There are at least six PDUFA dates for new products...
BC Week In Review | Sep 29, 2017
Clinical News

Tyme reports Phase I data of SM-88 in metastatic cancer

Tyme Technologies Inc. (NASDAQ:TYME) reported data from an open-label Phase I trial in 30 patients with progressive metastatic cancer showing that SM-88 (TYME-88, SM88) led to 8 complete or partial tumor responses according to RECIST...
BC Week In Review | Jun 23, 2017
Clinical News

Tyme reports Phase I data for TYME-88 in pancreatic cancer

Tyme Technologies Inc. (OTCQB:TYMI) reported data from 11 evaluable patients with refractory pancreatic cancer in an open-label, U.S. Phase I trial showing that TYME-88 (SM-88, SM88) led to 1 complete response, 2 partial responses and...
BC Week In Review | Jun 23, 2017
Clinical News

Tyme reports Phase Ib/II data for TYME-88 in prostate cancer

Tyme Technologies Inc. (OTCQB:TYMI) reported interim data from 8 evaluable patients with recurrent, non-metastatic prostate cancer in a 6-month Phase Ib/II trial showing that oral TYME-88 (SM-88, SM88) led to a radiographic progression-free survival (PFS)...
BC Week In Review | Jun 20, 2016
Clinical News

SM88: Phase Ib/II started

Tyme began an open-label, dose-escalation, dose-expansion, U.S. Phase Ib/II trial to evaluate SM-88 in up to 54 patients who failed previous androgen deprivation therapy. Tyme Inc. (OTCQB:TYMI), New York, N.Y.   Product: SM88 , SM-88  ...
BioCentury | Sep 14, 2015
Politics, Policy & Law

Defining excess

In a case against Pfizer Inc. and Flynn Pharma Ltd. , the U.K. government has for the first time shown a willingness to bring charges against drug companies for excessive pricing. The case could set a...
BC Innovations | Jan 26, 2012
Distillery Therapeutics

Indication: Neurology

This week in therapeutics Indication Target/marker/pathway Summary Licensing status Publication and contact information Neurology Rett syndrome Sodium channels Patient and mouse studies suggest inhibiting sodium channels could help prevent lethal cardiac arrhythmias in patients with...
BC Week In Review | May 9, 2011
Company News

Baxter, Hikma Pharmaceuticals deal

Hikma completed its previously announced acquisition of Baxter's U.S. generic injectables business for about $112 million in cash. As part of a settlement with the Federal Trade Commission to allow the acquisition, Hikma will divest...
BC Extra | Sep 17, 2010
Politics & Policy

FDA panel to discuss anti-seizure drugs

FDA's Peripheral and Central Nervous System Drugs and Drug Safety and Risk Management advisory committees will meet on Nov. 3 to discuss safety concerns with IV anti-seizure drugs phenytoin and fosphenytoin, including the condition of...
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