News

Emmes today announced that Kathleen Wolf has joined the company as vice president of clinical operations. She has two decades of leadership experience in the biopharmaceutical industry, including most recently as a senior director with AstraZeneca’s MedImmune unit. Dr. Anne Lindblad, president and chief executive officer of Emmes, said, “Kathleen is an outstanding addition to our leadership team. Her background in both biotech and pharmaceutical settings will be a great asset. Her experience in building collaborative, cross-functional teams complements our clinical operations platform.”

Overview of how regulators in selected CEE countries react to COVID 19 pandemic

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Emmes today announced that the Food and Drug Administration (FDA) has extended the labeling of ampicillin, a commonly used antibiotic, to include use in infants younger than 28 days in the treatment of serious conditions meningitis and septicemia. FDA’s approval was based in part on a National Institute of Child Health and Human Development (NICHD)-funded study, conducted under the Best Pharmaceuticals for Children Act (BPCA).

Emmes today announced that the U.S. Food and Drug Administration (FDA) has approved a prescription-only medical device used to estimate the weight of infants who are up to 90 days of age.

Emmes today announced that it is part of a team of medical centers, universities and private industry supporting the development of a “universal influenza vaccine” that could provide longer-lasting protection than current vaccines and combat a wider variety of influenza viruses.

Emmes today announced that Lynn Lewis has joined the company as chief business officer, a newly created position. Her overall focus is to build deeper relationships with existing clients and to develop new business opportunities, particularly among biotech and pharmaceutical companies.

Emmes today announced the award of eight new task order contract awards associated with the Helping to End Addiction Long-term℠ Initiative, known as the NIH HEAL Initiative℠. The total value for the eight contracts is more than $9 million. The contract awards’ duration ranges from one to five years.

Emmes today announced that it was ranked as one of the 100 largest private companies in the Washington metropolitan area. The ranking is compiled annually by the Washington Business Journal. The company was ranked as the 83rd largest private company this year. Its most recently reported revenues were more than $114 million, and about 600 of the company’s 725 employees work in the Washington area.

Emmes today announced that it has received a Workplace Excellence Seal of Approval from Alliance for Workplace Excellence (AWE). This is the fifth consecutive year the company has received the AWE Workplace Excellence award.

New Medical Device Guidance on Article 15 of the MDR and IVDR regarding person responsible for regulatory compliance

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.