After a Decade of Disappointment, a Portent of Promise in Parkinson’s

parkinson's

If Alzheimer’s disease (AD) has been a graveyard for drug development over the past 10 years, Parkinson’s disease (PD) has been on life support, limping along with mostly lackluster reformulations and extended-release versions of levodopa (L-dopa). The dopamine precursor became a clinically relevant treatment in the late 1960s based on research conducted by George Cotzias and colleagues, garnering Cotzias the 1969 Lasker Prize. (more…)

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Cancer Immunotherapy Continues to Rack up More Successes

Immunotherapy

Immunotherapy can deliver remissions that last long enough to make the most hardened oncologist consider the possibility that their patient might be cured. But only a minority of patients responds to immunotherapy at all. (more…)

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Endocrine Society Publishes Report on Hormone Health Statistics

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The Endocrine Society published the first chapter of a new report compiling the latest peer-reviewed statistics on hormone health conditions into a single resource. (more…)

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From Advisory Committee to Approval: FDA Makes Move to Approve a First US Biosimilar Medicine

biosimilar

The Food and Drug Administration (FDA) approved Zarxio (filgrastim-sndz), the first biosimilar product (or biosimilar), on March 6, 2015, making for a quick approval decision following the January 7, 2015 meeting of the Oncologic Drugs Advisory Committee (ODAC). ODAC members unanimously favored the granting of licensure to EP2006, at that time a proposed biosimilar to Amgen’s Neupogen (filgrastim), for all 5 indications included in the Neupogen labeling. Panelists commended the sponsor on the extensive data in support of the application, including robust results from outside the US (AdComm Bulletin, 2015).” This application from Sandoz is the first to have been brought before an FDA advisory committee for review. (more…)

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UK Firms Enjoy Robust Public, Private Financing and a Record IPO in 2014

financing rounds

New data show UK life sciences companies had a resurgent year in 2014, with 114 financing rounds bringing in $2.86 billion. (more…)

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The Economist Pharma Summit 2015

Economist Pharma Summit

The Economist’s 21st Pharma Summit held in London, UK, at the end of February welcomed various stakeholders from the Pharmaceutical and Biopharmaceutical industry, government, health and finance industries and patient groups with one common goal: to improve the economic conditions in which treatments are developed and administered. Presentations and panel discussions focused on various aspects of the pharmaceutical industry including regulatory hurdles, cost effectiveness of treatments, patient affordability and patient access to medicine in emerging markets. Other areas covered included the comparison of biosimilars with biologics, use of big data in clinical trials, patient engagement in the drug development process and patient education in diabetes self-management. Poor innovation and investment in less financially-attractive (poor return on investment (ROI)) diseases, such as microbial infections and dementia, were also discussed, including the keynote presentation on the economic impact of antimicrobial resistance. (more…)

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Building a Viable U.S. Market is the Next Big Quest for Biosimilars

biosimilars

While the FDA may have opened the biosimilar pipeline with its approval of Sandoz Inc.’s Zarxio Friday, a lot of heavy lifting has to be done before biosimilars are a viable market in the U.S. (more…)

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Market Trends, Commercial Strategies & Growth Opportunities: World Generic Medicines Congress Europe 2015

World Generic Medicines Congress

The market drivers that previously propelled the generic industry have shifted. Over the next five years, emerging markets are expected to demonstrate strong pharmaceutical market growth, and specific therapy areas will see escalation around the world. The World Generic Medicines Congress Europe brought together numerous industry stakeholders to discuss future growth drivers in the industry. Many of the high value opportunities require diversification away from the traditional generic business model. (more…)

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MicroRNAS: From Biomarkers to Gene Therapy

MicroRNAS

10 years ago, the first human microRNA (miRNA) was discovered. Today, as per Thomson Reuters Integrity(SM), 210 miRNA-based therapeutics are in various study phases. 28,645 entries representing precursor miRNAs, expressing 35,828 mature miRNAs, in 223 species have been annotated according to the miRBase Sequence Database release June 2014. (more…)

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Latin America: Changes to Brazil’s Health Surveillance Rules Could Help Med-tech Industry

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A change to Brazil’s health surveillance regulations that president Dilma Rousseff signed into law last month could be another sign of a changing regulatory landscape. (more…)

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