Ethics/Regulatory

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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NHS increases budget for cancer drugs fund to an expected $400M

Wednesday, January 14, 2015 12:40 PM

The NHS Cancer Drugs Fund (CDF) has published a review of drugs included in the fund and increased the budget for cancer drugs. The budget for the CDF will grow from $235 million in 2013-2014, to $329 million in 2014-2015, and an estimated $400 million from April 2015. This represents a total increase of 70% since August 2014.

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January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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