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BioWorld - Monday, December 16, 2019
Home » Topics » Analysis and data insight

Analysis and data insight
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Week in review

November 18, 2019
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Affimed NV priced its public offering for net proceeds expected to be approximately $28.2 million.
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Word on the street

November 18, 2019
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“We’re surprised by this outright failure as well as the lack of an investor call to discuss the most significant development in the history of the company.”
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Week in Washington

November 18, 2019
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The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously concluded that Amarin Corp. plc provided sufficient evidence of efficacy and safety to support approval of fish oil-based Vascepa (icosapent ethyl).
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Regulatory submissions, approvals and other actions: October 2019

November 18, 2019
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Regulatory decisions affecting biopharma products in development, including approvals, recommendations, rejections and the granting of regulatory pathways in October 2019.
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The week's biggest gainers and losers for Nov. 11-15, 2019

November 18, 2019
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The top 10 biopharma stock gainers and losers for the week of Nov. 11-15, 2019.
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BioWorld stock report for public biotechnology companies

November 18, 2019
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All of the biopharma stocks tracked by BioWorld, including their weekly and year-to-date percent changes and weekly trading volumes.
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AHA Scientific Sessions

Analysts react to ISCHEMIA trial, with at least one seeing reduction in stent sales

November 18, 2019
By Liz Hollis
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The annual American Heart Association's Scientific Sessions saw some significant findings, with the results of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial standing out in particular. Of note, investigators found no evidence that invasive procedures – such as stent implants or bypass surgery – in individuals with severe but stable heart disease had lower rates of major, disease-related events vs. those treated with medications and lifestyle changes alone, also known as optimal medical therapy (OMT).
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Axonics misses consensus on Q3 results, but urinary nod from FDA paves the way for full U.S. launch

November 18, 2019
By Meg Bryant
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Axonics Modulation Technologies Inc., of Irvine, Calif., reported revenue of $1.3 million for the third quarter of 2019, up from $0.2 million in the same period last year, but below Wall Street's forecast of $1.4 million. CEO Raymond Cohen attributed the miss to a seasonal slowdown in implants of Axonics' rechargeable sacral neuromodulation (r-SNM) system in international markets, as well as some U.S. physicians who were waiting for the device to win urinary approval. That milestone came Thursday when the U.S. FDA approved Axonics' r-SNM for the treatment of overactive bladder (OAB) and urinary retention. The indication for urinary retention represents the largest segment of the market for SNM devices and comes just two months after FDA approved the r-SNM to help patients with fecal incontinence. (See BioWorld MedTech, Sept. 10, 2019.)
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Senseonics lowers full-year guidance after dismal Q3

November 14, 2019
By Meg Bryant
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Senseonics Inc., of Germantown, Md., reported gloomy results for its 2019 third quarter, with revenue of $4.3 million, down 17% from the same period last year. The tally also fell far short of the consensus on Wall Street, which estimated third-quarter revenue of $6.07 million.
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Megaminds in Megatrends

XR tech: Sea of opportunities ahead for the med-tech sector

November 12, 2019
By Sergio Held
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SAN JOSE, Costa Rica – Cross reality (XR) technology is gaining traction in the med-tech sector thanks to advancements in the virtual reality (VR), augmented reality (AR) and mixed reality (MR) fields that comprise it, triggered by a surge of investments that have driven cash flow to med-tech startups. The new technology is already impacting the health care sector.
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