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Emmes-Supported Study Results in the First Pediatric Drug Labeling Change for 2019

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ROCKVILLE, Md.April 2, 2019 /PRNewswire/ — Emmes today announced that it provided the data management support for a study, funded by the National Institutes of Health (NIH) and approved by the Food and Drug Administration (FDA), to safely use Acyclovir to treat infants infected with the Herpes Simplex Virus. Acyclovir, known by the brand name Zovirax, now includes recommended usage and dosage for newborns and infants up to three months of age on its label.

The Best Pharmaceuticals for Children Act (BPCA) mandates that NIH prioritize therapeutic areas in critical need for pediatric labeling, sponsor pediatric clinical trials, and submit the data to the FDA for consideration for labeling changes. The clinical trials are sponsored by the National Institute of Child Health and Human Development (NICHD), with the labeling reviews and approvals administered by the FDA.

In the NIH news release, Dr. Perdita Taylor-Zapata, BPCA program lead at NICHD, stated: “With this label change, healthcare providers have clear guidance on how to use and prescribe this drug for their youngest patients.”

Newborns can become infected with the virus during pregnancy, labor and delivery, or shortly after birth if the mother develops genital herpes near the end of her pregnancy. The Herpes Simplex Virus in newborns can cause death or long-term problems such as blindness and damage to the brain and other organs.

Emmes has served as a data coordinating center for the BPCA contract since August 2009. This entails study design, data management, regulatory support, pharmacovigilance, site monitoring, and statistical analyses.

Dr. Anne Lindblad, president and chief executive officer of Emmes, said, “This is one of our  largest contracts and one that our Emmes team is extremely proud to support. Our role as a data coordinating center is a critical step in the process to study drugs and therapies used for infants and children and determine whether drug labeling updates are needed.”

Click here to read the entire release.

Osiris to be acquired by British medical device company for $660.5M

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A British medical device manufacturing company plans to acquire Osiris Therapeutics Inc. for $660.5 million.

Smith & Nephew plc will pay $19 per share for Osiris in the all-cash deal expected to close in the second quarter. Columbia-based Osiris is coming off a tumultuous three-year period in which four CEOs left the company and several former executives faced criminal charges for fraud. Osiris develops products for wound care, orthopedics and sports medicine using stem cells.

London-based Smith & Nephew is paying a 37 percent premium from the 90-day weighted average stock price. Shares of Osiris were up less than 1 percent in trading Tuesday morning to $19.03.

Peter Friedl, chairman and co-founder of Osiris, said in a statement the deal is a “very good outcome” for shareholders and will help “take the business to the next level.”

“I am immensely proud of the business we have built from our research into advanced regenerative technologies,” Friedl said. “I believe Smith & Nephew is the right home for Osiris and will allow our products to reach more customers, helping to restore quality of life for more patients.”

All 360 of Osiris’ employees are expected to join Smith & Nephew upon completion of the deal.

Click here to read more via the Baltimore Business Journal.

These 3 tech investors are the most active in the DMV: report

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Three investment firms topped the list of local tech investors in the DMV region according to CB Insights‘ report, The United States of Venture Capital.

The report looks at the most active venture capital firms in each U.S. state based on unique tech portfolio investments. Chevy Chase, Md.-based New Enterprise Associates (NEA) was listed as the most active tech investor in the District while CIT GAP Funds topped the list in Virginia and TCP Venture Capital in Maryland. The report looked at their unique tech investments between 2014 and Jan. 24, 2019.

CB Insights said it excluded debt deals and only considered venture capital, corporate venture capital, super angel and growth equity firms. In the case of a tie, CB Insights used recency of deals, overall deal activity and investor quality. NEA was the only firm to lead more than one state with the most investments in D.C. and New Jersey. CB Insights’ last conducted this report in May 2017 and since then, there has been 21 changes in the top investor slots. According to CB Insights, Fortify Ventures led the way in D.C back in May 2017.

Click here to read more via Technic.ly DC

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