Theorem Clinical Research

Ethics/Regulatory

Report: regulatory innovation should adapt to new health economy

Wednesday, January 28, 2015 01:25 PM

Consumers and drug and device manufacturers are changing practices and shifting attitudes toward the FDA.

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Quest Diagnostics

EMA recommends suspending medicines over flawed studies

Monday, January 26, 2015 12:43 PM

A number of medicines for which authorization in the European Union (E.U.) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended, according to the EMA. The recommendation is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of marketing authorization holders.

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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.

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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.

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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.

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Academy of Medical Royal Colleges not supporting Medical Innovation Bill

Friday, January 23, 2015 11:43 AM

The Academy of Medical Royal Colleges has released a statement on the proposed Medical Innovation Bill.

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EMA opens public consultation on transparency rules of E.U. Clinical Trial Regulation

Thursday, January 22, 2015 12:11 PM

The public consultation on how the transparency rules of the European Clinical Trial Regulation will be applied in the new clinical trial database has been launched by the EMA. Stakeholders are invited to send their comments before Feb. 18.

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New EMA guide for implementing safety monitoring changes

Thursday, January 22, 2015 12:10 PM

The EMA has published a guide to support the implementation of a new international standard for the safety monitoring of medicines in the E.U. The so-called ISO ICSR standard improves the reporting of suspected side effects of medicines in Individual Case Safety Reports (ICSRs). The use of the new international standard will take effect on July 1, 2016.

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Verified Clinical Trials, Quorum Review IRB collaborate to prevent dual enrollment

Monday, January 19, 2015 12:53 PM

Verified Clinical Trials and Quorum Review IRB have developed an expedited research subject authorization review process that reduces cost and time. Research sites, CROs and sponsors will benefit from this alliance in the effort to stop dual enrollment in clinical trials and reduce significant protocol deviations. 

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

Friday, January 16, 2015 02:52 PM

By Ronald Rosenberg
CenterWatch Staff Writer

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.

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AiCure
CWWeekly

March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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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

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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

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