Ethics/Regulatory

U.K. industry paid $456.7M in 2014 to underwrite medicines bill

Friday, March 13, 2015 12:28 PM

The Association of the British Pharmaceutical Industry (ABPI) and the U.K. Department of Health have announced a fourth quarter payment from industry of $119.3 million to underwrite the growth of the medicines bill under the 2014 Pharmaceutical Price Regulation Scheme (PPRS). This takes the total payment made by industry during 2014 to $456.7 million.

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FDA approves first biosimilar Zarxio from Sandoz

Friday, March 6, 2015 12:24 PM

Sandoz, a Novartis company, has became the first company to receive approval of a biosimilar in the U.S. through the new FDA biosimilar pathway established under the Biologics Price Competition and Innovation Act.

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FDA launches drug shortages mobile app

Thursday, March 5, 2015 12:34 PM

The FDA has launched the agency’s first mobile application specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved shortages and discontinuations of drug products.

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Pearl IRB granted AAHRPP accreditation

Thursday, February 26, 2015 03:32 PM

Pearl IRB, an Indianapolis-based provider of central IRB review services, has received accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Pearl IRB earned this distinction in December 2014 by demonstrating extensive safeguards in all levels of the research operations and abiding by high standards of excellence for all research.

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Obama outlines his Precision Medicine Initiative

Friday, January 30, 2015 12:31 PM

Building on President Obama’s announcement in his State of the Union Address, the administration is unveiling details about the Precision Medicine Initiative, a new research effort to revolutionize how to improve health and treat disease.

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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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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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CWWeekly

June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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