EMA

PAREXEL adds senior executives from FDA and oncology industry

Wednesday, November 15, 2017

PAREXEL, a global biopharmaceutical services provider, announced the appointment of three former senior regulatory consulting executives from the FDA and Oncology industry positions. The new hires are part of PAREXEL’s Global Integrated Product Development and Compliance team and will be focused on helping PAREXEL clients deliver commercially viable, reimbursable products to market faster and more cost-effectively.

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Jazz Pharma submits Vyxeos MAA to EMA for high-risk AML

Friday, November 3, 2017

Jazz Pharmaceuticals announced the submission of a Marketing Authorization Application (MAA) to the EMA‘s Committee for Medicinal Products for Human Use (CHMP) for Vyxeos (daunorubicin and cytarabine) powder for concentrate for infusion to treat adults with high-risk acute myeloid leukemia (AML) defined as therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

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MTPConnect funds Certara-Monash University program

Thursday, October 26, 2017

MTPConnect (the Medical Technologies and Pharmaceuticals Industry Growth Centre) will provide a proposed AUD750,000 provisional funding to the CertaraMonash University Industry Fellowship Program over two years, with proposed matched funding of AUD750,000 coming from Certara. Together, this funding will allow the Certara-Monash University Industry Fellowship Program to identify and develop the next generation of industry-experienced drug development scientists through training in clinical pharmacology, pharmacometrics and regulatory science to help shape the future and sustainability of the medical research sector in Australia. The program will be located at Monash University Faculty of Pharmacy and Pharmaceutical Sciences and will involve a combination of academic coursework, hands-on industry training, international industry/academic placements and research.

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New evidence extends validation for quality review

Monday, October 2, 2017

The Good ReseArch for Comparative Effectiveness (GRACE) checklist is a simple 11-item tool that considers the study purpose and provides questions to guide high-level evaluation of methods, data quality and analytics for use in health technology assessments of effectiveness and safety studies. It provides a scoring tool to help evaluate studies in the context of the study goal, and can be used by sophisticated and less experienced users.

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Kyowa Hakko Kirin joins Certara’s Simcyp consortium

Wednesday, September 13, 2017

Certara, a provider of model-informed drug development and regulatory science, announced that Kyowa Hakko Kirin has joined the Simcyp Consortium and licensed the Simcyp Population-based Simulator. Kyowa Hakko Kirin is the 36th leading biopharmaceutical company and the 11th Japanese pharmaceutical company to join the Consortium. Member companies meet in a pre-competitive environment and work together to progress the evolution of modeling and simulation (M&S) and the Simcyp Simulator.

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ProQR’s QRX-421 for Usher syndrome receives FDA/EMA Orphan Designation

Tuesday, September 5, 2017

ProQR Therapeutics announced that investigational drug QRX-421 for Usher syndrome has received orphan drug designation (ODD) from the FDA and EMA. This marks the third drug candidate in the company’s ophthalmology pipeline and the fourth drug in the broader pipeline to receive ODD from the FDA and EMA. QR-421 is a first-in-class investigational RNA-based oligonucleotide designed to address the underlying cause of Usher syndrome due to mutations in exon 13 of the USH2A gene. Usher syndrome is the leading cause of combined deafness and blindness. 

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Omeros responds to Statnews.com story

Tuesday, August 29, 2017

Omeros stated that it continues to pursue legal action to hold responsible those behind a series of defamatory reports about the company posted online under the pseudonym “Art Doyle,” an entity or group that self-identifies as having a short position in Omeros’ stock. Because of its ongoing legal action, including a number of steps aimed at unmasking the identity of the individual(s) responsible, Omeros elected not to respond to queries from a writer for statnews.com who evidently had early access to and commented through Twitter on the initial “Art Doyle” false report before it was broadly made public.

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Gilead announces FDA priority review designation for fixed-dose treatment of HIV

Friday, August 11, 2017

Gilead Sciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for an investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI) and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection. Gilead filed the NDA for BIC/FTC/TAF with a Priority Review voucher on June 12, 2017, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of February 12, 2018.

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Partnership unveils EHR-EDC integration

Monday, July 24, 2017

Two industry innovators have joined forces to take the lead in real-world studies. Clinerion and Cisiv have formed a groundbreaking partnership to offer a revolutionary approach to observational research by enabling automated data transfer from electronic hospital records (EHRs) to electronic data capture (EDC).

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