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1/18/2018

A previously announced private offering of additional 4.375% senior notes due 2025 and 4.625% senior notes due 2028 was priced by Hologic at $1,000 per $1,000 in hopes of raising $1 billion. The net proceeds, along with available cash, will be used for the redemption of outstanding 5.25% senior notes due 2022.

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Hologic
1/18/2018

NeuroMetrix and GlaxoSmithKline have reached a strategic partnership under which GSK will pay $5 million upfront plus up to $21.5 million in potential milestone payments for the exclusive ownership of NeuroMetrix's Quell wearable pain relief technology for non-US markets. The collaboration, which may be extended by the companies, also calls for further development of the technology over the next three years.

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Proactive Investors
1/18/2018

A transferable right to buy a unit of common stock and Series Z warrants worth $2.25 per share and redeemable at $3 each will be granted by PAVmed to stockholders for each common share under the newly set terms of its previously announced rights offering. PAVmed makes the CarpX minimally invasive carpal tunnel syndrome device for the relief of median nerve compression.

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common stock, Pavmed
1/18/2018

A round of Series B financing brought in approximately $22.6 million for HalioDx, an immuno-oncology diagnostics firm based in France. The company intends to use the proceeds for continued development of its CE-IVD marked Immunoscore colon cancer assay, as well as to expand the Immunoscore assays to target more cancer types.

1/18/2018

BioAdvance, an early-stage life sciences fund, has made almost $3.2 million worth of investments in mid-Atlantic-based companies, including TalexMedical, which markets a nonsurgical ear molding device for the correction of ear deformities in newborns. Other companies that secured investments were Enzium, a developer of assays for protease-based detection of direct-acting oral anticoagulant levels; Curative Orthopedics, a maker of noninvasive orthopedic products for nighttime back pain relief; and Group K Diagnostics, a point-of-care microfluidic diagnostic device developer.

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BioAdvance, diagnostic device
1/18/2018

Three more strategic priorities have been outlined by the FDA's Center for Devices and Radiological Health for 2018 to 2022 after accomplishing its three goals from 2016 to 2017. The new goals include improved engagement of its employees and reduction in turnover rates, creation of new work with a more diverse group of companies and stakeholders, and simplification and modernization of at least 80% of its processes.

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Regulatory Focus
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FDA
1/18/2018

CDC and Brazilian researchers analyzed data on Zika virus infections and microcephaly for births in Brazil's Paraiba state between Aug. 1, 2015, and Feb. 1, 2016, and found that infants with microcephaly were more likely to have had Zika virus infection or been born to a mother who had Zika infection in the first trimester. The findings were published in The Lancet Child & Adolescent Health.

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microcephaly, CDC, Zika
1/18/2018

The CDC reported in the American Journal of Public Health that cases of acute hepatitis C virus infection increased 133% between 2004 and 2014. A 93% jump in substance use disorder treatment admissions related to opioid injection was also noted. Injection drug use is considered the primary risk factor for transmission of HCV.

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MD Magazine online
1/18/2018

Onconova Therapeutics announced it will expand enrollment and move forward with a planned late-stage study to evaluate its lead candidate rigosertib as a therapy for patients with treatment-resistant myelodysplastic syndromes. The decision was based on an independent data monitoring committee's interim analysis of preliminary data.

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Onconova Therapeutics
1/18/2018

US patients with sickle cell disease will now be able to purchase L-glutamine oral powder, or Endari, after Emmaus Life Sciences announced its availability by prescription. The FDA approved Endari in July for pediatric sickle cell disease patients ages 5 and older.

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Rare Disease Report
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Emmaus Life Sciences, FDA