ProPhase faces NASDAQ delisting
DOYLESTOWN, Pa. — ProPhase Labs on Tuesday announced that it received a letter from the NASDAQ Stock Market indicating that the company no longer is in compliance with NASDAQ listing rules because the closing bid price per share of its common stock has dropped below $1 per share for 30 consecutive trading days.
ProPhase will have until Dec. 27 to push its stock price above $1 for a minimum of 10 consecutive trading days to regain compliance or risk being delisted.
ProPhase stated that all options were on the table to resolve the matter, including a possible reverse stock split.
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Former Asteres CEO joins H. D. Smith
SPRINGFIELD, Ill. — H. D. Smith, the fourth-largest national pharmaceutical wholesaler, on Tuesday named Mark de Bruin to the post of corporate VP managed care.
In his new position at H. D. Smith, 29-year industry veteran de Bruin will be responsible for the company’s third party network, creating and maintaining an alliance of prescription and healthcare service providers.
"Our third party network is one of the many solutions H. D. Smith developed to address efficiency and reimbursement demands facing community pharmacies," Chris Smith, H. D. Smith COO Chris Smith said. "Mark’s retail pharmacy experience, cultivated at Rite Aid, together with his significant managed care and pharmacy government affairs acumen will spark growth and development of the network to the benefit of our customers."
De Bruin most recently served as CEO at Asteres, providing patented automated technology solutions to retail pharmacies, grocery stores, hospitals and the military. De Bruin served at Rite Aid as EVP pharmacy; Albertsons/American Stores as VP pharmacy and managed care; and RxAmerica/American Stores as president and GM.
De Bruin is a registered pharmacist in Utah, Pennsylvania and California. He earned a bachelor of science degree in pharmacy from the University of Utah. De Bruin also has served on numerous industry boards, including the Federal Medicaid Commission.
FDA issues new dietary ingredient guidance
WASHINGTON — The Food and Drug Administration on Tuesday published long-awaited guidance on new dietary ingredients in the Federal Register.
Once enacted, the guidance will establish an additional pillar of credibility to the dietary supplement industry, adding to the veracity building across the industry with the implementation of a codified, supplement-specific good manufacturing practices; the adoption of the mandatory reporting of serious adverse event reports; industry efforts to educate lawmakers and healthcare professionals around the benefits of supplementation; and an industry-sponsored initiative with the National Advertising Division of the Better Business Bureau to help the industry self-regulate inaccurate advertising claims.
Specifically, the guidance establishes a protocol around when a supplement manufacturer must file a premarket safety notification of a dietary supplement containing a new dietary ingredient. The guidance addresses in question-and-answer format what qualifies as an NDI, when an NDI notification is necessary, the procedures for submitting an NDI notification, the types of data and information that the FDA recommends manufacturers and distributors consider when they evaluate the safety of a dietary supplement containing an NDI, and what should be included in an NDI notification. In addition, the guidance contains questions and answers about parts of the dietary supplement definition that can affect whether a particular substance may be marketed as a dietary ingredient in a dietary supplement.
“The dietary supplement industry has eagerly awaited this guidance in the hope that it will provide clarity and an appropriate framework for introducing new ingredients and products into the supplement marketplace,” Council for Responsible Nutrition president and CEO Steve Mister said. “This draft guidance … represent[s] an important step for the dietary supplement industry — and for the agency — as it demonstrates further implementation of the requirements of the Dietary Supplement Health and Education Act and will give companies clearer understanding of [the] FDA’s expectations under the law.”
To help explain the nuances of the new guidance for the industry, the Natural Products Association will host a webinar conference on July 11. Speakers will include Daniel Fabricant, director of the Division of Dietary Supplement Programs at the FDA’s Center for Food Safety and Applied Nutrition; Scott Bass, head of the Global Life Sciences Team at Sidley Austin; Cara Welch, Natural Products Association VP scientific and regulatory affairs; and John Gay, Natural Products Association executive director and CEO. To join the call register here.
Review the draft guidance here.
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