Ethics/Regulatory

FDA announces approval of first breakthrough-designated test

Friday, December 8, 2017

The FDA approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing (NGS)-based in vitro diagnostic (IVD) test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. The Centers for Medicare & Medicaid Services (CMS) at the same time proposed coverage of the F1CDx. The test is the second IVD to be approved and covered after overlapping review by the FDA and CMS under the Parallel Review Program, which facilitates earlier access to innovative medical technologies for Medicare beneficiaries.

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BioMarin sells second Priority Review Voucher for $125M

Friday, December 1, 2017

BioMarin Pharmaceutical announced that it has entered into a definitive agreement to sell the Rare Pediatric Disease Priority Review Voucher (PRV) it obtained in April of this year for a lump sum payment of $125,000,000. The Company received the voucher under a FDA program intended to encourage the development of treatments for rare pediatric diseases. BioMarin was awarded the voucher when it received approval of Brineura, a new biological product for patients with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency, a form of Batten disease. The transaction remains subject to customary closing conditions, including anti-trust review.  

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New EudraVigilance system is live for patients across Europe

Monday, November 27, 2017

The EMA has launched a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorized or being studied in clinical trials in the European Economic Area (EEA). The new system makes it easier for marketing authorization holders and sponsors of clinical trials to report suspected adverse reactions and allows for better analysis of this information for the benefit of patient safety in Europe.

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ACRO urges modernization of the R&D Tax Credit

Wednesday, November 22, 2017

As the Senate begins debate on a tax reform bill, the clinical research industry hopes that attention will be given to a small but substantive issue—updating a tax code provision that has had strong bipartisan support for more than 30 years.

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FDA approves pill with sensor to track patients adherence

Tuesday, November 14, 2017

The FDA approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

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ACRO testifies about clinical trials in New Jersey

Tuesday, October 24, 2017

ACRO Executive Director Doug Peddicord, Ph.D., testified at a public hearing of the New Jersey Division of Consumer Affairs about a regulation that, if adopted, would have a devastating impact on the availability of clinical trials for patients in New Jersey and cripple the ability of New Jersey physicians to conduct industry-sponsored clinical trial research on investigational therapies.

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