2016

Three Questions: Irina Petrova, M.D., OCT

Monday, December 12, 2016

CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Karyn Korieth spoke with Irina Petrova, M.D., director of Clinical Operations at OCT, a full-service CRO based in Russia that also operates in Europe and the U.S.

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Horizon Pharma announces phase III results from Friedreich’s Ataxia study

Friday, December 9, 2016

Horizon Pharma, a biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, has announced that the phase III trial, STEADFAST (Safety, Tolerability and Efficacy of ACTIMMUNE Dose Escalation in Friedreich’s Ataxia study), evaluating ACTIMMUNE (interferon gamma-1b) for the treatment of Friedreich’s ataxia (FA) did not meet its primary endpoint of a statistically significant change from baseline in the modified Friedreich’s Ataxia Rating Scale (FARS‐mNeuro) at 26 weeks versus treatment with placebo. FARS‐mNeuro is an exam-based rating scale that measures disease progression based on functional parameters such as speech, ability to swallow, upper and lower limb coordination, gait and posture.

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Report: Higher M&A activity and investor cash expected in 2017

Friday, December 9, 2016

Despite the uncertainty that loomed over the pharma and biotech sectors with unexpected outcomes from both the U.S. presidential election and U.K.’s vote to leave the EU, 2017 may bring renewed energy to the industry with potential for more corporate activity and cash flow. According to EP Vantage, the editorial branch of the market intelligence firm Evaluate, the Trump victory may lead to a slew of business-friendly initiatives, based on the predicted lessening of political scrutiny towards drug pricing. The report shows that although the issue of drug pricing is not going away, 2017 will start with a flush of new confidence for investors, and a possible uptick in mergers and acquisitions.

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NovogeneAIT, GIS to establish genome sequencing center in Singapore

Friday, December 9, 2016

Novogene, a commercial provider of genomic services and solutions with cutting edge next-generation sequencing and bioinformatics expertise; AITbiotech, a Singapore biotechnology company; and the Genome Institute of Singapore (GIS) have announced that NovogeneAIT Genomics Singapore (NovogeneAIT) a new joint venture between Novogene and AITbiotech will establish a joint whole genome sequencing (WGS) center at Biopolis, Singapore.

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Report: Global drug market will hit $1.5T in 2021

Friday, December 9, 2016

Total spending on medicines is forecast to reach $1.5 trillion by 2021, up 33% from 2016 levels, even as annual growth moderates from the record pace set in 2014 and 2015, according to new research released by the QuintilesIMS Institute. While historically large numbers of high-quality new medicines will emerge from the R&D pipeline in the next five years, pricing and market access pressures, lower volume growth in pharmerging markets and greater savings from patent expiries will contribute to the lower rate of growth.

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Spotlight Innovation appoints Chitra Edwin SVP of Regulatory Affairs and Compliance

Thursday, December 8, 2016

Spotlight Innovation, a pharmaceutical company advancing technologies designed to address rare, emerging and neglected diseases, has announced the appointment of Chitra Edwin, Ph.D., RAC, as senior vice president of Regulatory Affairs and Compliance. Dr. Edwin will provide leadership for all U.S. and international regulatory matters including strategic planning for regulatory approvals, preparation of regulatory submissions, serving as the primary contact with the FDA and other regulatory authorities, and ensuring compliance with regulatory requirements.

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