Theorem Clinical Research

United States

Second Turkish man sentenced for smuggling counterfeit cancer drugs

Monday, January 26, 2015 12:41 PM

The U.S. District Court of the Eastern District of Missouri has sentenced Sabahhadin Akman, an owner of the Turkish firm Ozay Pharmaceuticals, to 30 months imprisonment and a $150,000 fine for smuggling counterfeit, misbranded and adulterated cancer treatment drugs into the U.S., including multiple shipments of Altuzan, the Turkish version of Avastin.

More... »

Quest Diagnostics

Sen. Warren to push law establishing “swear jar” concept for drug companies facing fraud penalties to help fund NIH

Friday, January 23, 2015 02:40 PM

Democratic Senator Elizabeth Warren of Massachusetts told the audience at a national healthcare advocacy conference Thursday she will introduce a new law—the Medical Innovation Act—to advance medical research.

More... »


BIO responds to President Obama's State of the Union speech

Friday, January 23, 2015 11:53 AM

The Biotechnology Industry Organization (BIO), a trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the U.S. and in more than 30 other nations, has issued a statement in response to President Obama's State of the Union speech.

More... »

CytRx announces FDA's removal of partial clinical hold for aldoxorubicin trials

Thursday, January 22, 2015 02:41 PM

CytRx, a biopharmaceutical R&D company specializing in oncology, has announced that the FDA has removed the partial clinical hold on the company's aldoxorubicin clinical trials. Enrollment and dosing of new patients now is permitted after study sites' Institutional Review Boards (IRBs) approve the revised trial protocols.

More... »

Celator Pharmaceuticals receives FDA Fast Track for CPX-351 for AML

Thursday, January 22, 2015 01:54 PM

The FDA granted Fast Track designation for Celator Pharmaceuticals’ CPX-351 (cytarabine:daunorubicin) for the treatment of elderly patients with secondary acute myeloid leukemia (AML).

More... »

INC enhances clinical delivery focus with executive leadership promotions

Thursday, January 22, 2015 01:38 PM

INC Research Holdings, a, global phase I to IV CRO based in Raleigh, N.C., has announced the promotions of Alistair Macdonald and Michael Gibertini, Ph.D., to key roles within the C-suite.

More... »

med fusion expands solid tumor profiling services

Thursday, January 22, 2015 12:20 PM

med fusion, an integrated Molecular Center of Excellence and clinical trials service organization headquartered in Lewisville, Texas, has released its solid tumor molecular profiling testing services (SEQ) enhanced by next generation sequencing (NGS) technology. The introduction of NGS will further enable physicians to interrogate their patient’s tumor at the molecular level in order to develop a personalized treatment plan according to the genetic makeup of their specific tumor.

More... »

SV Bio renames itself Lifecode, launches oncology assay

Thursday, January 22, 2015 12:17 PM

Silicon Valley Biosystems (SV Bio) has changed its name to Lifecode. The new name is consistent with the company's mission to improve the lives of patients by providing concise, accurate and actionable molecular information. Lifecode also has released its flagship next generation sequencing (NGS)-based oncology assay, the Pan Cancer Somatic Panel (PCSP), to a select group of physicians nationwide in advance of a broad launch later this spring.

More... »

Report: Midwest healthcare companies raise $1.8B in 2014

Wednesday, January 21, 2015 01:06 PM

Midwest healthcare companies attracted $1.8 billion in new investments across 243 companies in 2014, according to the BioEnterprise Midwest Healthcare Growth Capital Report. The totals are the highest recorded in both dollars and number of companies funded since BioEnterprise began compiling the report in 2005, surpassing the banner 2007 by 46% and 2013 by 135%. BioEnterprise is a business formation, recruitment, and acceleration initiative designed to grow healthcare companies and commercialize bioscience technologies based in Cleveland, Ohio.

More... »

FDA approves record 41 new drugs in 2014, over 40% for rare diseases

Friday, January 16, 2015 02:52 PM

Pharmaceutical innovation had a banner year in 2014, as the FDA approved 41 novel drugs and biologics—the largest number in 18 years and a 52% increase from the 27 approved in 2013.

More... »

`

CWWeekly

March 2

Huntingdon Life Sciences-Harlan prepares for rebranding and U.S. expansion to compete with early phase CROs Covance, CRL

Patients' increased sharing of clinical trial experiences through social media can help sponsors improve outcomes, enrollment

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

Already a subscriber?
Log in to your digital subscription.

Purchase the March issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

Already a subscriber?
Log in to your digital subscription.

Purchase the February issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs