PMA Approvals for Medical Devices and Diagnostics

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The Devices and Diagnostics edition of the PharmSource Lead Sheet focuses on high risk devices that require Premarket Approval (PMA) from the US FDA. If we take a look at data extracted from the FDA’s database and the PharmSource Lead Sheet database, we can observe PMA approval trends over time. As shown in Figure 1, […]

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Follow the Money to Bio/Pharmaceutical Opportunities
Spotlight on ContraVir Pharmaceuticals, Inc.

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Follow the Money to Bio/Pharmaceutical Opportunities highlights a newly funded bio/pharmaceutical company. This includes important insights into the featured company’s product pipeline, manufacturing and business relationships, and likely sourcing opportunities. ContraVir Pharmaceuticals is a U.S. public bio/pharmaceutical company that develops and commercializes targeted antiviral therapies for the treatment of Hepatitis B, shingles and shingles pain. […]

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Follow the Money to Medical Devices & Diagnostics
Spotlight on Aspect Imaging, Inc.

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Follow the Money to Medical Device & Diagnostic Opportunities highlights a newly funded medical device or diagnostic company. This includes important insights into the featured company’s product pipeline, manufacturing and business relationships, and likely sourcing opportunities. Aspect Imaging, Inc. is a private company based in Israel that develops and manufactures preclincial MRI systems. It raised […]

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CMOs and CROs Have Different Trajectories

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CMOs may be gaining as strategic partners to large bio/pharma companies, but they have a much harder path to navigate. A growing number of observers, including the Wall Street analysts that follow the publicly-traded contract research organizations (CROs) and contract manufacturing organizations (CMOs), have made statements recently suggesting that the CMO industry is following the […]

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2016 Results Summary: A Rising Tide Lifts All Contract Service Boats

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The Contract Development and Manufacturing Organization (CDMO) sector enjoyed a strong 2016, with all components reporting robust, albeit uneven, growth. Early-stage companies posted especially impressive results, bolstered by generous external funding, and the API sector continued its recent recovery, especially in the small molecule space (see Figure 1, below). The impressive top line results do, […]

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Strong Economic Growth Draws Pharma Companies to Malaysia

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A rapidly growing pharma market and environment friendly to clinical trials are among the features that are attracting a growing number of multinational pharmaceutical companies to Malaysia. However, those pluses are balanced by decided favoritism toward domestic production, seen in government supply contracts and tax codes. According to a September 2016 report by PharmSource’s colleagues […]

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NDA Outsourcing Up, Despite NME Decline

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In 2016, outsourced dose form manufacturing of NDA approvals reached 60%, some 10% higher than the five-year average. This and other insights into CMO performance were revealed in PharmSource’s recently published CMO Scorecard. In what proved to be a mediocre year for drug approvals, the increase in outsourcing levels was restricted to the manufacture of […]

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Follow the Money to Bio/Pharmaceutical Opportunities
Spotlight on BioCryst Pharmaceuticals, Inc.

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Follow the Money to Bio/Pharmaceutical Opportunities highlights a newly funded bio/pharmaceutical company. This includes important insights into the featured company’s product pipeline, manufacturing and business relationships, and likely sourcing opportunities. BioCryst Pharmaceuticals is a U.S. public bio/pharmaceutical company that discovers drugs for the treatment of infectious diseases, inflammatory diseases and cancer. It plans to raise […]

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Follow the Money to Medical Devices & Diagnostics
Spotlight on RenalGuard Solutions, Inc.

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Follow the Money to Medical Device & Diagnostic Opportunities highlights a newly funded medical device or diagnostic company. This includes important insights into the featured company’s product pipeline, manufacturing and business relationships, and likely sourcing opportunities. RenalGuard Solutions, Inc. is a U.S. private company that develops cardiac and vascular technologies. It raised $14.5 million in […]

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PharmSource Coverage of AACR 2017 Yields Valuable BD Info

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You might have noticed it was a busy week on the PharmSource Lead Sheet. The beginning of April found myself and fellow Research Analyst, Mahdia Hashimy, covering the 2017 American Association for Cancer Research (AACR) conference in Washington DC. Here we gathered all the latest news and early research data in the oncology field from […]

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